UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
6-K
REPORT
OF FOREIGN PRIVATE ISSUER
PURSUANT
TO RULE 13a-16 OR 15d-16 OF THE SECURITIES EXCHANGE ACT OF 1934
For
the month of November 2023
Commission
File Number: 001-38064
Aeterna
Zentaris Inc.
(Translation
of registrant’s name into English)
c/o
Norton Rose Fulbright Canada, LLP, 222 Bay Street, Suite 3000, PO Box 53, Toronto ON M5K 1E7
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form
20-F ☒ Form 40-F ☐
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
Exhibits
99.1 and 99.2 included with this report on Form 6-K are hereby incorporated by reference into the Registrant’s Registration Statements
on Forms S-8 (No. 333-224737, No. 333-210561 and No. 333-200834), Forms F-3 (No. 333-254680) and Forms F-1 (No.333-239264, No. 333-248561
and No. 333-239019) and shall be deemed to be a part thereof from the date on which this report is furnished, to the extent not superseded
by documents or reports subsequently filed or furnished.
DOCUMENTS
INDEX
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
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AETERNA
ZENTARIS INC. |
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| Date:
November 9, 2023 |
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By: |
/s/
Klaus Paulini |
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Klaus
Paulini |
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|
President
and Chief Executive Officer |
Exhibit 99.1
Aeterna
Zentaris Reports Third Quarter 2023 Financial Results
| - | Launch
of Ghryvelin™ in a number of key countries in the European Economic Area |
| - | Approval
of Macrilen® in South Korea in September |
| - | Ended
the quarter with $38.8 million in cash, expected to fund operations and advancement of priority
pipeline programs into 2025 |
TORONTO,
ONTARIO, November 8, 2023 – 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 September 30, 2023.
“We
are pleased with the progress made in the last quarter with respect to the commercialization of Ghryvelin™ (macimorelin and previously
sold in the United States as Macrilen®) in the European Economic Area (EEA). Following regional pricing approvals, Pharmanovia,
our commercialization partner in the EEA, has launched Ghryvelin™ in the UK, Germany, Scandinavia and other countries in the EEA,
and is expecting to launch Ghryvelin™ in additional countries in the EEA during the remainder of 2023 and into the first half of
2024. In South Korea, Macrilen® granules received MFDS approval in September so that, together with our partner NK Meditech,
we are now preparing to launch Macrilen® in the South Korean market,” commented Dr. Klaus Paulini, Chief
Executive Officer of Aeterna. “We are also encouraged with the progress we are making with our ongoing research program involving
the use of the AIM biologics platform to treat neuromyelitis optica spectrum disorder (NMOSD) where we achieved ex-vivo proof
of mode of action by regulatory T-Cell activation in human peripheral blood mononuclear cells of healthy donors and NMOSD patients. Our
efforts to advance our programs are supported by our strong cash position which we believe enables us to meet our currently projected
cash needs into 2025.”
Summary
of Third Quarter 2023 Financial Results
All
amounts are in U.S. Dollars
Cash
and cash equivalents
The
Company had $38.8 million in cash and cash equivalents at September 30, 2023.
Results
of operations for the three-month period ended September 30, 2023
For
the three-month period ended September 30, 2023, we reported a consolidated net loss of $4.1 million, or $0.85 loss per common share
(basic and diluted), as compared with a consolidated net loss of $3.4 million, or $0.70 loss per common share (basic) for the three-month
period ended September 30, 2022.
| Revenues |
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|
| ● |
Our
total revenue for the three-month period ended September 30, 2023, was $0.0 million as compared with $1.9 million for the same period
in 2022, representing a decrease of $1.9 million. The decrease was due to required transition time in onboarding our new partner,
Pharmanovia, as it pertained to marketing Ghryvelin™ in the European Economic Area and United Kingdom, as well as the termination
of the Company’s amended agreement with Novo Nordisk Healthcare in May 2023. |
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| Operating
Expenses |
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| ● |
Our
total operating expenses for the three-month period ended September 30, 2023 were $4.6 million as compared with $5.6 million for
the same period in 2022, representing a decrease of $1.0 million. This decrease arose from a $0.5 million decrease in research and
development expenses, related to a decrease of $0.4 million in our AEZS-130 Macimorelin ALS project and a net decrease of $0.1 million
for all other projects, as well as a $0.5 million decrease in the selling, general & administrative expenses. |
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|
| Net
Finance Income |
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|
| ● |
For
the three-month period ended September 30, 2023, our net finance income was $0.4 million as compared to $0.3 million for the three-month
period ended September 30, 2022, representing an increase of $0.1 million. This was primarily due to an increase in interest earned
on bank deposits of $0.4 million offset by a $0.3 million decrease in our gain (loss) due to changes in foreign currency. |
Results
of operations for the nine-month period ended September 30, 2023
For
the nine-month period ended September 30, 2023, we reported a consolidated net loss of $10.9 million, or $2.25 loss per common share
(basic and diluted), as compared with a consolidated net loss of $10.3 million, or $2.12 loss per common share (basic) for the nine-month
period ended September 30, 2022.
| Revenues |
| |
|
| ● |
Our
total revenue for the nine-month period ended September 30, 2023, was $4.4 million as compared to $3.2 million for the same period
in 2022, representing an increase of $1.2 million. The increase was due to an increase in license fee revenue recognized of $0.7
million and development services revenue of $0.7 million relating to the Company’s amended agreement with Novo Nordisk Healthcare,
offset by a combined $0.2 million decrease in all other revenues. |
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| Operating
Expenses |
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|
| ● |
Our
total operating expenses for the nine-month period ended September 30, 2023 were $16.0 million as compared with $14.4 million for
the same period in 2022, representing an increase of $1.6 million. This increase was due to a $1.6 million increase in research and
development expenses, primarily related to a $0.9 million increase in the DETECT trial, a $0.5 million increase in our AEZS-130 Macimorelin
ALS project and a $0.4 million increase in our AIM-Biologicals – NMOSD project offset by a decrease of approximately $0.4 million
for all other projects. |
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|
| Net
Finance Income |
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|
| ● |
For
the nine-month period ended September 30, 2023, our net finance income was $0.7 million as compared to $1.0 million for the nine-month
period ended September 30, 2022, representing a decrease of $0.3 million. This decrease was the result of a $1.0 million decrease
in gains due to changes in foreign currency rates offset by a $0.7 million increase in interest income. |
Consolidated
Financial Statements and Management’s Discussion and Analysis
For
reference, the Company’s Management’s Discussion and Analysis of Financial Condition and Results of Operations for the third
quarter 2023, as well as the Company’s unaudited consolidated interim financial statements as of September 30, 2023, will be available
on the Company’s website (www.zentaris.com) in the Investors section or at the Company’s profile at www.sedarplus.com and
www.sec.gov.
About
Aeterna Zentaris Inc.
Aeterna
Zentaris is a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic
products focused on areas of significant unmet medical need. The Company’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). The Company 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
Zentaris is dedicated to the development of its therapeutic asset 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: expectations
with respect to the launch of Ghryvelin™/ Macrilen® in the European Economic Area and South Korea; Aeterna’s
belief that its cash will be sufficient to meet its needs into 2025; results of its research programs, including with respect to the
AIM biologic platform in NMOSD.
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: risks that the launch of Ghryvelin™/ Macrilen®
in the European Economic Area and South Korea may be delayed or may not be successful; we may not be successful in finding a commercialization
partner for Macrilen® (macimorelin) in the United States or other countries not currently partnered; we may not be able to re-launch
sales of Macrilen® (macimorelin) in the United States; our reliance on the success of the DETECT trial in CGHD, including our ability
to complete enrollment in that trial and to obtain positive results from that trial; results from our ongoing or planned pre-clinical
studies (including AIM biologicals) and our DETECT trial 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 macimorelin (Macrilen®; GHRYVELIN™) and related out-licensing/partnering
arrangements and the continued availability of funds and resources to successfully commercialize the product; our ability to enter into
out-licensing, development, manufacturing, marketing and distribution agreements with other pharmaceutical companies and keep such agreements
in effect; and our ability to continue to list our common shares on the NASDAQ. 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
in our Annual Report on Form 20-F and annual information form under the caption “Risk Factors”. 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.
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
Thomas
JTC Team
T: +1 (833) 475-8247
E: aezs@jtcir.com
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