Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (“Aeterna” or the
“Company”), a specialty biopharmaceutical company commercializing
and developing therapeutics and diagnostic tests, today announced
the closing of its previously announced public offering of
20,509,746 common shares of Aeterna, at a price to the public of
$1.45 per share. The gross proceeds from the offering were
approximately $29.7 million, before deducting underwriting
discounts, commissions and offering expenses payable by Aeterna.
H.C. Wainwright & Co. acted as the sole
book-running manager for the offering.
Aeterna also has granted to the underwriter a
30-day option to purchase up to 3,076,461 additional common shares
at the public offering price, less underwriting discounts and
commissions. 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 became effective on August 15, 2019
and the related registration statement on Form F-3 (File No.
333-253178), was filed with the SEC under Rule 462(b) of the
Securities Act of 1933, as amended, relating to the securities
being offered. The offering was made only by means of a prospectus
supplement and accompanying base prospectus. A final prospectus
supplement and the accompanying prospectus relating to the offering
were filed with the SEC and are available for free on the SEC's
website located at www.sec.gov and may also 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 does not constitute an offer
to sell or the solicitation of an offer to buy, nor will there be
any sales of these securities in any jurisdiction in which such
offer, solicitation or sale would be unlawful prior to registration
or qualification under the securities laws of such jurisdiction. No
Canadian prospectus has been or will be filed in a province or
territory of Canada to qualify the common shares in connection with
the offering.
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 anticipated use of proceeds, the
potential of the Julius-Maximilians-University Wuerzburg’s (the
“University”) 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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