Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (“Aeterna” or the
“Company”), a specialty biopharmaceutical company developing and
commercializing a diversified portfolio of pharmaceutical and
diagnostic products, today reported its financial and operating
results for the quarter ended March 31, 2024.
Mr. Giuliano La Fratta, Chief Financial Officer
of Aeterna commented, “This year remains exciting for Aeterna. Our
cash position remains strong and we continue to be on track to
complete both the DETECT-trial and the previously announced merger
with Ceapro Inc. (“Ceapro”) in the second quarter.”
Summary of First Quarter 2024 Financial
Results
All amounts are in U.S. dollars.
Cash and cash equivalents
The Company had $29.5 million in cash and cash equivalents at
March 31, 2024.
Results of operations for the three-month period ended
March 31, 2024
For the three-month period ended March 31, 2024,
we reported a net loss of $5.8 million, or $4.74 loss per common
share, as compared with a net loss of $4.3 million, or $3.51 loss
per common share (basic) for the three-month period ended March 31,
2023. The $1.5 million increase in net loss is primarily due to a
$2.1 million decrease in revenue combined with a $1.2 million
increase in selling, general and administrative expenses, mostly
due to non-recurring expenses incurred for the anticipated merger.
This was offset by a $1.4 million decrease in research and
development expenses and a $0.4 million increase in net finance
income.
Revenues
-
Our total revenue for the three-month period ended March 31, 2024,
decreased by $2.1 million. The decrease was due to the termination
of the Company’s amended agreement with Novo Nordisk Healthcare in
May 2023 and as a result, no license fee or development services
revenue was recognized in Q1, 2024.
Operating Expenses
-
Our total operating expenses for the three-month period ended March
31, 2024, was $6.1 million as compared with $6.3 million for the
same period in 2023, representing a decrease of $0.2 million. This
decrease was primarily from a $1.4 million decrease in research and
development expenses offset by a $1.2 million increase in the
selling, general and administrative expenses.
Consolidated Financial Statements and Management's
Discussion and Analysis
For reference, the Management's Discussion and
Analysis of Financial Condition and Results of Operations for the
first quarter 2024, as well as the Company's consolidated financial
statements as of March 31, 2024, will be available on the Company's
website (www.zentaris.com) in the Investors section or at the
Company's SEDAR+ and EDGAR profiles at www.sedarplus.ca and
www.sec.gov, respectively.
About Macimorelin
(Macrilen®;
GHRYVELIN™)
Macimorelin, an oral drug used for the diagnosis
of adult growth hormone deficiency (AGHD) is approved for marketing
under the brand name GHRYVELIN™ in the European Economic Area and
Macrilen® in the United States. In addition, Aeterna Zentaris is
currently conducting the Phase 3 safety and efficacy study
AEZS-130-P02 (the "DETECT-trial") evaluating macimorelin for the
diagnosis of childhood-onset growth hormone deficiency (CGHD).
Macimorelin (Macrilen®; GHRYVELIN™), a ghrelin
receptor agonist, is an orally active peptidomimetic molecule that
stimulates the secretion of growth hormone from the pituitary
gland. Stimulated growth hormone levels are measured in blood
samples taken after oral administration of macimorelin for the
assessment of AGHD. Approval of macimorelin for use in adult was
granted by the FDA in 2017 and by the EMEA in 2019, based on Phase
III data showing that oral macimorelin provides accuracy comparable
to that of standard insulin tolerance testing (ITT), but has a more
favorable safety profile compared to ITT. Oral macimorelin also
reduces false positive test results, helping to avoid unnecessary
treatment of patients.
About Aeterna Zentaris Inc.
Aeterna is a specialty biopharmaceutical company
developing and commercializing a diversified portfolio of
pharmaceutical and diagnostic products focused on areas of
significant unmet medical need. Aeterna's lead product, macimorelin
(Macrilen; Ghryvelin), is the first and only U.S. FDA and European
Commission approved oral test indicated for the diagnosis of adult
growth hormone deficiency (AGHD). Aeterna is 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 also dedicated to the development of
its therapeutic assets and has established a pre-clinical
development pipeline to potentially address unmet medical needs
across a number of indications, including neuromyelitis optica
spectrum disorder (NMOSD), Parkinson's disease (PD),
hypoparathyroidism and amyotrophic lateral sclerosis (ALS; Lou
Gehrig's disease).
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 statements that may
constitute forward-looking statements within the meaning of U.S.
and Canadian securities legislation and regulations, and such
statements are made pursuant to the safe-harbor provision of the
U.S. Securities Litigation Reform Act of 1995. Forward-looking
statements are frequently, but not always, identified by words such
as "expects," "aiming", "anticipates," "believes," "intends,"
"potential," "possible," and similar expressions. Such statements,
based as they are on current expectations of management, inherently
involve numerous risks, uncertainty and assumptions, known and
unknown, many of which are beyond our control.
Forward-looking statements in this press release
include, but are not limited to, those relating to Aeterna's
expectations regarding: the strength of its cash position, the
completion of the DETECT-trial, the ability of Aeterna and Ceapro
to complete the merger transaction with Ceapro (the “Transaction”)
on the terms described herein, or at all, and and the timing of the
closing of the Transaction.
Forward-looking statements involve known and
unknown risks and uncertainties, and other factors which may cause
the actual results, performance or achievements stated herein to be
materially different from any future results, performance or
achievements expressed or implied by the forward-looking
information. Such risks and uncertainties include, among others,
our reliance on the success of the DETECT clinical trial in the
European Union and U.S. for Macrilen™ (macimorelin) in CGHD;
results from our ongoing or planned pre-clinical studies and our
DETECT clinical trial under development may not be successful or
may not support advancing the product further in pre-clinical
studies, to human clinical trials or regulatory approval; our
ability to raise capital and obtain financing to continue our
currently planned operations; 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; the global instability
due to the global pandemic of COVID-19 and the war in the Ukraine,
and their unknown potential effect on our planned operations; our
ability to enter into out-licensing, development, manufacturing,
marketing and distribution agreements with other pharmaceutical
companies and keep such agreements in effect; our ability to
continue to list our common shares on the NASDAQ; and the
availability and timing of required stock exchange, regulatory and
other approvals for the completion of the transaction with Ceapro.
Investors should consult our quarterly and annual filings with the
Canadian and U.S. securities commissions for additional information
on risks and uncertainties, including those risks discussed under
the caption “Risk Factors” in our Annual Report on Form 20-F, which
is available on the Company’s EDGAR profile at www.sec.gov. Given
the 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.
Information Concerning the Registration
Statement
Aeterna filed a Registration Statement on Form
F-1 (including a prospectus) (File No. 333-277115) (the
“Registration Statement”) with the U.S. Securities and Exchange
Commission (the “SEC”) for the issuance of common share purchase
warrants and common shares issuable upon exercise thereof in
connection with the Transaction, but it has not yet become
effective. The common share purchase warrants and common shares
issuable upon exercise thereof may not be sold nor may offers to
buy them be accepted prior to the time the Registration Statement
becomes effective. Before you invest in any Aeterna common shares,
you should read the prospectus in the Registration Statement and
the other documents incorporated by reference therein for more
complete information about Aeterna, Ceapro, the Transaction and the
common share purchase warrant offering.
You may get copies of the Registration Statement
for free by visiting EDGAR on the SEC website at www.sec.gov or at
SEDAR+ at www.sedarplus.ca. Alternatively, you may obtain
copies of them by contacting Aeterna’s investor contact at the
details provided below. Other than as noted above, none of the
securities to be issued pursuant to or in connection with the
Transaction have been or will be registered under the United States
Securities Act of 1933, as amended (the "U.S. Securities Act"), or
any U.S. state securities laws, and such securities are anticipated
to be issued in reliance on the exemption from the registration
requirements of the U.S. Securities Act provided by Section
3(a)(10) thereof and similar exemptions under applicable state
securities laws.
No Offer or Solicitation
This news release and the information contained
herein are not, and do not, constitute an offer to sell any
securities or a solicitation of an offer to buy any securities in
the United States or any other state or jurisdiction, nor shall any
securities of Aeterna be offered or sold in any jurisdiction in
which such an offer, solicitation or sale would be unlawful.
Neither the SEC nor any state securities commission has approved or
disapproved of the transactions described herein or determined if
this communication is truthful or complete. Any representation to
the contrary is a criminal offense.
You should not construe the contents of this
communication as legal, tax, accounting or investment advice or a
recommendation. You should consult your own counsel and tax and
financial advisors as to legal and related matters concerning the
matters described herein.
No securities regulatory authority has either
approved or disapproved of the contents of this news release. The
Toronto Stock Exchange accepts no responsibility for the adequacy
or accuracy of this release.
Investor Contact:
Jenene ThomasJTC TeamT : +1 (833) 475-8247E: aezs@jtcir.com
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