Aeterna Zentaris Engages Advisors and Provides Update to Shareholders
09 August 2017 - 6:40AM
Business Wire
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (the
“Company”), announced today that the special committee of
independent directors (the “Strategic Review Committee”) has
engaged a consulting firm and a financial advisor to assist in its
efforts. As previously announced, the Strategic Review Committee
has been tasked to consider and evaluate various strategic and
financing alternatives available to the Company to maximize
shareholder value, including continuing to execute on its existing
business plan and/or considering and recommending changes to the
Company’s management and governance.
Both selected firms have well regarded reputations in the
pharmaceutical, biotechnology and life sciences sectors. The
Strategic Review Committee retained these firms in part to validate
the commercial potential of Macrilien™ in order to determine the
best means of maximizing value, which includes evaluating and
recommending modes of distribution including entering into
partnerships or building an internal sales force, raising capital
including through an investment from a strategic partner, or
selling some or all of the company and its assets.
As shareholders are also aware, the board of directors of the
Company (the “Board”) recently appointed Michael Ward as the
Company’s Chief Executive Officer. Mr. Ward and the Board have
quickly aligned on the Company’s priorities, including ensuring
that the Company’s expenditures are focused on the greatest
risk-adjusted opportunities for shareholders including
Macrilien™.
Mr. Ward has taken steps to reduce and rationalize overhead over
the next several months, including reducing or eliminating
expenses, resources and overhead that were associated with the
Company’s discontinued Zoptrex™ product. Mr. Ward has also assumed
the role of Managing Director of Frankfurt operations and in that
role, he implemented a restructuring plan, reaching an agreement
with the local “Works Council” to support the realignment of
resources focused on Macrilien™. The Company has also eliminated an
executive position in South Carolina. These efforts are expected to
result in significant net savings to the Company.
The Board welcomes Mr. Ward’s fresh perspective on the Company’s
future plans and his readiness to execute on those plans.
The Board and the Strategic Review Committee will also consider
certain enhancements that have been under discussion at the Board
for the last several months. These include ensuring that the Board
has the commensurate mix of skills and experience to guide the
Company in the execution of its business plan and has individuals
who reflect a diversity of backgrounds including gender diversity.
The Board has also discussed formally adopting a director share
ownership requirement to ensure an even greater level of alignment
with shareholders. Currently, Board compensation is split between
cash and equity consideration, a best practice the Board adopted
some time ago.
There can be no assurance that evaluation of strategic
alternatives will result in any transaction being pursued, entered
into or consummated. The Company does not intend to make
further comment in regard to this process except as required by
applicable securities laws or the policies of NASDAQ and the
Toronto Stock Exchange.
About MacrilenTM (macimorelin)
Macimorelin, a ghrelin agonist, is an orally-active small
molecule that stimulates the secretion of growth hormone.
Macimorelin has been granted orphan drug designation by the FDA for
diagnosis of AGHD. The Company owns the worldwide rights to this
patented compound and has significant patent protection left. The
Company’s U.S. composition of matter patent expires in 2022 and its
U.S. utility patent runs through 2027. The Company proposes,
subject to FDA approval, to market macimorelin under the tradename
Macrilen™.
About AGHD
AGHD affects approximately 75,000 adults across the U.S., Canada
and Europe. Growth hormone not only plays an important role in
growth from childhood to adulthood, but also helps promote a
hormonally-balanced health status. AGHD mostly results from damage
to the pituitary gland. It is usually characterized by a reduction
in bone mineral density, lean body mass, exercise capacity, and
overall quality of life as well as an increase of cardiovascular
risks.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a specialty biopharmaceutical company
engaged in developing and commercializing novel pharmaceutical
therapies. We are engaged in drug development activities and in the
promotion of products for others. We recently resubmitted an NDA to
the FDA seeking approval of Macrilen™, an internally developed
compound. 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
non-U.S. 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.
Forward-Looking Statements
This press release contains forward-looking statements made
pursuant to the safe harbor provision of the U.S. Securities
Litigation Reform Act of 1995, which reflect our current
expectations regarding future events. 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 risks and uncertainties, many of which are discussed
under the caption “Key Information – Risk Factors” in our most
recent Annual Report on Form 20-F filed with the relevant Canadian
securities regulatory authorities in lieu of an annual information
form and with the U.S. Securities and Exchange Commission (“SEC”).
Such statements include, but are not limited to, statements about
the progress of our research, development and clinical trials and
the timing of, and prospects for, regulatory approval and
commercialization of our product candidates, the timing of expected
results of our studies, anticipated results of these studies,
statements about the status of our efforts to establish a
commercial operation and to obtain the right to promote or sell
products that we did not develop and estimates regarding our
capital requirements and our needs for, and our ability to obtain,
additional financing. Known and unknown risks and uncertainties
could cause our actual results to differ materially from those in
forward-looking statements. Such risks and uncertainties include,
among others, the availability of funds and resources to pursue our
research and development 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 rejection or non-acceptance of
any new drug application by one or more regulatory authorities and,
more generally, uncertainties related to the regulatory process
(including whether or not the regulatory authorities will
definitively accept the Company’s conclusions regarding Macrilen™
and approve its registration following the Company’s re-submission
of an NDA for the product as described elsewhere in this press
release), the ability of the Company to efficiently commercialize
one or more of its products or product candidates, the degree of
market acceptance once our products are approved for
commercialization, our ability to take advantage of business
opportunities in the pharmaceutical industry, our ability to
protect our intellectual property, and 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 securities commissions and the SEC
for additional information on risks and uncertainties. Given these
uncertainties and risk factors, readers are cautioned not to place
undue reliance on these 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 applicable law.
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Bayfield Strategy, Inc.1-844-226-3222 (North American Toll Free
Number)1-416-855-0238 (Outside North
America)info@bayfieldstrategy.com
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