Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (“Aeterna” or the
“Company”), a specialty biopharmaceutical company commercializing
and developing therapeutics and diagnostic tests, today announced
that it has entered into an underwriting agreement with H.C.
Wainwright & Co., LLC under which the underwriter has agreed to
purchase on a firm commitment basis 6,896,552 common shares of
Aeterna, at a price to the public of $1.45 per share, less
underwriting discounts and commissions. The closing of the offering
is expected to occur on or about February 19, 2021, subject to
satisfaction of customary closing conditions.
H.C. Wainwright & Co. is acting as the sole
book-running manager for the offering.
Aeterna also has granted to the underwriter a
30-day option to purchase up to 1,034,482 additional common shares
at the public offering price, less underwriting discounts and
commissions.
The gross proceeds are expected to be
approximately $10.0 million, before deducting underwriting
discounts and commissions and other offering expenses payable by
Aeterna. Aeterna intends to use the net proceeds from the offering
for general corporate purposes, which includes, among other
purposes, the investigation of further therapeutic uses of
Macrilen™ (macimorelin), the expansion of pipeline development
activities, the further expansion of commercialization of
macimorelin in available territories and the potential funding of a
pediatric clinical trial in the E.U. and U.S. for macimorelin.
A shelf registration statement on Form F-3
(Registration No. 333-232935) was filed with the Securities and
Exchange Commission (“SEC”) and was declared effective on August
15, 2019. The offering is being made only by means of a prospectus
supplement and accompanying base prospectus. A preliminary
prospectus supplement and accompanying base prospectus relating to
the offering was filed with the SEC and are available for free on
the SEC's website located at http://www.sec.gov. When available,
electronic copies of the final prospectus supplement and
accompanying base prospectus relating to the public offering may be
obtained by contacting H.C. Wainwright & Co., LLC, 430 Park
Avenue, 3rd Floor, New York, NY 10022, by telephone at (646)
975-6996, or by email to placements@hcwco.com.
In obtaining the approval of the Toronto Stock
Exchange (“TSX”) of the offering, the Company relied on the
exemption set forth in Section 602.1 of the TSX Company Manual
available to "Eligible lnterlisted Issuers," since the Company’s
common shares are also listed on the NASDAQ Capital Market and had
less than 25% of the overall trading volume of its listed
securities occurring on all Canadian marketplaces in the twelve
months immediately preceding the date on which application was made
to TSX to approve the offering.
This press release shall not constitute an offer
to sell or the solicitation of an offer to buy, nor shall there be
any sale of these securities in any jurisdiction in which such
offer, solicitation or sale would be unlawful prior to the
registration or qualification under the securities laws of any such
jurisdiction. Any offer, if at all, will be made only by means of
the prospectus supplement and accompanying base prospectus forming
a part of the effective registration statement.
About Aeterna Zentaris Inc.
Aeterna Zentaris Inc. is a specialty
biopharmaceutical company commercializing and developing
therapeutics and diagnostic tests. The Company’s lead product,
macimorelin, is the first and only U.S. FDA and European Commission
approved oral test indicated for the diagnosis of adult growth
hormone deficiency (AGHD). Macimorelin is currently marketed in the
United States under the tradename Macrilen™ through a license
agreement with Novo Nordisk where Aeterna receives royalties on net
sales. According to a commercialization and supply agreement,
MegaPharm Ltd. will seek regulatory approval and then commercialize
macimorelin in Israel and the Palestinian Authority. Additionally,
upon receipt of pricing and reimbursement approvals, Aeterna
expects that macimorelin will be marketed in Europe and the United
Kingdom through a recently established license agreement with
Consilient Health Ltd. and Aeterna will receive royalties on net
sales and other potential payments.
Aeterna is also leveraging the clinical success
and compelling safety profile of macimorelin to develop it for the
diagnosis of childhood-onset growth hormone deficiency (CGHD), an
area of significant unmet need.
Aeterna is actively pursuing business
development opportunities for the commercialization of macimorelin
in Asia and the rest of the world, in addition to other
non-strategic assets to monetize their value. For more information,
please visit www.zentaris.com and connect with the
Company on Twitter, LinkedIn and Facebook.
Forward-Looking Statements
This press release contains forward-looking
statements (as defined by applicable securities legislation) 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
include those relating to the completion of the offering and the
anticipated use of proceeds, the potential of the University’s
coronavirus vaccine platform technology (and any vaccine candidates
using that technology) to be effective as a vaccine against
COVID-19 (SARS-CoV-2) or any other coronavirus disease (or to offer
an alternative to other approved vaccines against COVID-19, the
ability to obtain approval to commence any clinical trial or the
timeline to develop any potential vaccine, the characteristics of
any potential vaccine (including cost, storage temperatures and
oral availability) and the ability of the Company to negotiate a
mutually agreeable license agreement with the University, those
relating to the Company obtaining approval of macimorelin for CGHD,
the Company’s ability to secure marketing partners for macimorelin
in other key markets, the timing of the commencement of the CGHD
Study P02, and may include, but are not limited to statements
preceded by, followed by, or that include the words "will,"
"expects," "believes," "intends," "would," "could," "may,"
"anticipates," "potential" and similar terms that relate to future
events, performance, or our results. Forward-looking statements
involve known and unknown risks and uncertainties, including those
discussed in this press release and in our Annual Report on Form
20-F, under the caption "Key Information - Risk Factors" filed with
the relevant Canadian securities regulatory authorities in lieu of
an annual information form and with the U.S. Securities and
Exchange Commission. 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, that the University’s coronavirus vaccine platform
technology (and any vaccine candidates using that technology) has
never been tested in humans and so further pre-clinical or clinical
studies of that technology and any vaccine developed using that
technology may not be effective as a vaccine against COVID-19
(SARS-CoV-2) or any other coronavirus disease, that such technology
or vaccines may not receive the necessary approvals to be studied
in human clinical trials, that the timeline to develop a vaccine
may be longer than expected, that such technology or vaccines may
not be capable of being used orally, may not have the same
characteristics (including storage temperatures) as vaccines
previously approved using the Salmonella Typhi Ty21a carrier
strain, any such vaccine developed using the University’s
technology may not lower the evolution of resistant viral mutants
or may not be competitive with vaccines developed by third parties
against COVID-19, and that the Company may not be successful in
negotiating a license to such technology from the University if the
Company elects to exercise its option to negotiate, our ability to
raise capital and obtain financing to continue our currently
planned operations, our ability to continue to list our Common
Shares on the NASDAQ, our now heavy dependence on the success of
Macrilen™ (macimorelin) and related out-licensing arrangements and
the continued availability of funds and resources to successfully
commercialize the product, including our heavy reliance on the
success of the License Agreement with Novo Nordisk, the global
instability due to the global pandemic of COVID-19, and its unknown
potential effect on our planned operations, including studies, our
ability to enter into out-licensing, development, manufacturing,
marketing and distribution agreements with other pharmaceutical
companies and keep such agreements in effect, our reliance on third
parties for the manufacturing and commercialization of Macrilen™
(macimorelin), potential disputes with third parties, leading to
delays in or termination of the manufacturing, development,
out-licensing or commercialization of our product candidates, or
resulting in significant litigation or arbitration, uncertainties
related to the regulatory process, unforeseen global instability,
including the instability due to the global pandemic of the novel
coronavirus, our ability to efficiently commercialize or
out-license Macrilen™ (macimorelin), our reliance on the success of
the pediatric clinical trial in the European Union (“EU”) and U.S.
for Macrilen™ (macimorelin), the degree of market acceptance of
Macrilen™ (macimorelin), our ability to obtain necessary approvals
from the relevant regulatory authorities to enable us to use the
desired brand names for our product, our ability to successfully
negotiate pricing and reimbursement in key markets in the EU for
macimorelin, any evaluation of potential strategic alternatives to
maximize potential future growth and shareholder value may not
result in any such alternative being pursued, and even if pursued,
may not result in the anticipated benefits, 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 our quarterly and
annual filings with the Canadian and U.S. securities commissions
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.
Investor Contact: Jenene Thomas
JTC Team T (US): +1 (833) 475-8247 E: aezs@jtcir.com
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