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 first quarter ended March 31, 2021. The Company
also provided an update on its preclinical and clinical development
programs.
“Over the course of the first quarter, we
continued to execute on our key strategic priorities by
significantly strengthening our balance sheet and expanding our
development pipeline. This solid execution provides us with
optionality to advance and accelerate our pipeline programs,”
commented Dr. Klaus Paulini, Chief Executive Officer of
Aeterna.
Recent Highlights:
-
Regained compliance with minimum bid price requirement for
continued listing on Nasdaq;
-
Closed bought deal offering of common shares for gross proceeds of
$34.2 million;
-
Received $20.0 million in proceeds from exercise of warrants in
2021;
-
Entered into a material transfer agreement (the “MTA”) with The
University of Queensland (“Queensland University”), for the
advancement of macimorelin as a potential therapeutic for the
treatment of an undisclosed neurodegenerative disease; and
-
Executed on building preclinical projects pipeline to expand assets
in development for potential high-value indications through
multiple licensing agreements with universities in Europe.
“I firmly believe we have positioned Aeterna
Zentaris for a transformational year. We have secured intellectual
property and assets in high-value indications that we believe hold
significant promise, the necessary capital to advance our pipeline
as rapidly as possible, and the team and expertise to execute and
deliver results, all of which we believe will build shareholder
value in the near- and long-term,” added Dr. Paulini.
Preclinical and Clinical Programs Update:
Diagnostics Development Pipeline
Macimorelin Diagnostic:
Ghrelin agonist in development for diagnostic use in
childhood-onset growth hormone deficiency (“CGHD”)
With the investigational new drug application,
“Multicenter, open-label trial to investigate the efficacy and
safety of a single oral dose of 1.0 mg/kg macimorelin acetate as
growth hormone stimulation test (“GHST”) in pediatric patients with
suspected growth hormone deficiency (“GHD”),” now active,
preparations remain ongoing to initiate the pivotal Phase 3 study
(the “DETECT-trial”). Children and adolescents from two to less
than 18 years of age with suspected growth hormone deficiency are
expected to be included. The study is expected to include
approximately 100 subjects worldwide, with at least 40 subjects in
pre-pubertal and 40 subjects in pubertal status. A macimorelin GHST
will be performed twice to ensure the repeatability of the data.
Two standard GHSTs will be used as controls: arginine (i.v.) and
clonidine (p.o.).
Next Steps
- Initiate DETECT-trial study sites and patient enrollment, which
is expected in the second quarter of 2021.
Therapeutics and Vaccine Development
Pipeline
AIM Biologicals: Targeted, highly specific
immunosuppressive therapeutics for the potential treatment of
neuromyelitis optica spectrum disorder (“NMOSD”)
In January 2021, the Company entered into an
exclusive patent license agreement and research agreement with
Julius-Maximilians-University of Wuerzburg, Germany for worldwide
rights to develop, manufacture and commercialize targeted, highly
specific immunosuppressive therapeutic proteins (“AIM Biologicals”)
for the potential treatment of NMOSD.
AIM Biologicals utilize a novel mechanism which
is believed to demonstrate that peptide antigens presented on
immunosuppressive major histocompatibility complex class I
molecules can selectively and efficiently induce antigen-specific
tolerance. Based on this mechanism, the targeted immunosuppressive
therapeutics are being designed as optimized soluble molecules with
the goal that they may be adapted to selectively induce tolerance
to various autoantigens.
Next Steps
- Conduct further
preclinical research to identify and characterize an
AIMBiologicals-based development candidate for the treatment of
NMOSD and develop manufacturing process for selected
candidate.
Delayed Clearance Parathyroid Hormone
(“DC-PTH”) Fusion Polypeptides: Potential treatment for
primary hypoparathyroidism
In March 2021, Aeterna entered into an exclusive
patent and know-how license agreement and research agreement with
The University of Sheffield, United Kingdom, for the intellectual
property relating to DC-PTH fusion polypeptides with delayed
clearance covering the field of all human use.
DC-PTH is a modified growth hormone binding
protein (GHBP) linked to PTH1-34 with the goal of providing
parathyroid hormone activity with a delayed clearance of one or two
weeks. PTH is a key regulating hormone and may help patients with
primary hypoparathyroidism maintain normal serum calcium and
phosphate levels during chronic use.
Next Steps
- Work with The
University of Sheffield to conduct in depth characterization of
development candidate (in vitro and in vivo).
Macimorelin Therapeutic: Ghrelin
agonist in development for the treatment of an undisclosed
neurodegenerative disease
In January 2021, the Company entered into the
MTA with Queensland University, Australia, to provide macimorelin
for the conduct of preclinical and subsequent clinical studies
evaluating macimorelin as a potential therapeutic for the treatment
of an undisclosed neurodegenerative disease. Queensland University
researchers have filed for supportive grants and aim to conduct
preclinical studies in multiple models to demonstrate the
therapeutic reach of macimorelin on disease progression and
disease-specific pathology as well as to conduct a subsequent
investigator initiated clinical trial.
Macimorelin, a ghrelin agonist, is an orally
active small molecule that stimulates the secretion of growth
hormone from the pituitary gland. Acting via this mechanism, it is
believed that macimorelin may slow the progression of certain
neurodegenerative diseases.
Next Steps
- Work with
Queensland University to conduct proof-of-concept studies with
macimorelin in disease-specific animal models, assess alternative
formulations and formalize a preclinical development plan.
COVID-19 Vaccine: Potential orally
active COVID-19 (SARS-CoV-2) live-attenuated bacterial vaccine
In February 2021, Aeterna entered into an
exclusive option agreement with Julius-Maximilians-University to
evaluate a preclinical, potential COVID-19 vaccine developed at
Julius-Maximilians-University. In March 2021, the Company exercised
its option and entered into a license agreement where the Company
was granted an exclusive, world-wide, license to certain patent
applications and know-how owned by Julius-Maximilians-University to
research and develop, manufacture, and sell a potential COVID-19
vaccine.
Julius-Maximilians-University also granted
Aeterna an option for the exclusive use of certain patent
applications and know-how in an additional undisclosed field. The
Company has six months from the date of the license agreement to
exercise that option. Additionally, Aeterna entered into a Research
Agreement under which the Company has engaged
Julius-Maximilians-University on a fee-for-service basis to conduct
supplementary research activities and preclinical development
studies on the potential vaccine, the results of which will be
included within the scope of the license agreement.
Next Steps
- Conduct
in vivo immunology experiments with antigen variant candidates,
initiate challenge experiments in immunized transgenic animals as
proof of concept, select a development candidate for initiation of
the formal preclinical toxicology and safety studies and start
manufacturing process assessment and development.
Financing and Warrant Exercises
Between January 1, 2021 and March 24, 2021, the
Company has raised net proceeds of approximately $31.0 million from
a registered public offering and $20.0 million from warrant
exercises. On February 19, 2021, the Company closed a public
offering of 20,509,746 common shares at a price to the public of
$1.45 per common share, for gross proceeds of $29.7 million, before
deducting underwriting discounts, commissions and offering expenses
payable by the Company, in the amount of $2.8 million. Aeterna also
granted the underwriter, which was also the Placement agent, a
30-day overallotment option (the “Underwriter Option”) to purchase
up to 3,076,461 additional common shares at the public offering
price, less underwriting discounts and commissions, and 1,435,682
Placement agent warrants with an exercise price of $1.8125 and
expiring on February 17, 2026. The net cash proceeds to the Company
from the offering totaled $26.9 million. On February 22, 2021, the
underwriter exercised the Underwriter Option in full and received
3,076,461 common shares for gross proceeds to the Company of $4.5
million. In connection with the public offering and the exercise of
the Underwriter Option, the Company paid commissions and other
expenses of $0.4 million and issued 215,352 Placement agent
warrants priced at $1.8125 and expiring on February 17, 2026.
Collectively, this financing is referred to as the “February 2021
Financing.”
Summary of
First Quarter
2021 Financial
Results
All amounts in this press release are in U.S.
dollars unless otherwise noted.
Results of operations for the
three-month period ended March
31, 2021
For the three-month period ended March 31, 2021,
we reported a consolidated net loss of ($1.4 million), or ($0.02)
net loss per common share (basic), as compared with a consolidated
net income of $0.8 million, or $0.04 net income per common share
(basic) for the three-month period ended March 31, 2020. The $2.2
million increase in net loss is primarily from a decrease in net
finance income of $2.3 million and a decrease of $0.5 million in
total revenues, partially offset by a decrease of $0.5 million in
total operating expenses and $0.1 million increase in tax
recovery.
Revenues
- Our
total revenue for the three-month period ended March 31, 2021 was
$0.6 million as compared with $1.1 million for the same period in
2020, representing a decrease of $0.5 million. The 2021 revenue was
comprised of $0.5 million in licensing revenue (2020 - $0.02
million), $0.04 million in supply chain revenue (2020 - $0.04
million) and $0.01 million in royalty income (2020 - $0.01
million). In the first quarter of 2020, the Company sold $1.0
million in Macrilen™ (macimorelin) to Novo Nordisk Biopharm Limited
(“Novo Nordisk”) while no such sale of product occurred in the
first quarter of 2021.
Operating expenses
- Our
total operating expense for the three-month period ended March 31,
2021 was $1.9 million as compared with $2.4 million for the same
period in 2020, representing a decrease of $0.5 million. This
decrease arose primarily from a $0.8 million decrease in cost of
sales, offset by an increase of $0.1 million in general and
administrative expenses and a $0.2 million one-time gain on
modification of a lease that was incurred in 2020 only. There was a
significant decrease in cost of sales as the Company did not sell
any product in the first quarter of 2021.
Net finance (costs) income
- Our
net finance (costs) for the three-month period ended March 31, 2021
was ($0.3 million) as compared with net finance income $2.1 million
for the same period in 2020, representing a decrease in net finance
income of $2.4 million.
The Company had $73.4 million cash and cash
equivalents at March 31, 2021 (December 31, 2020 – 24.3
million).
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 of 2021, as well as the Company's unaudited
consolidated interim financial statements as of March 31, 2021,
will be available at www.zentaris.com in the Investors section or
at the Company’s profile at www.sedar.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, 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) in collaboration with Novo
Nordisk.
Aeterna Zentaris is dedicated to the development
of therapeutic assets and has recently taken steps to establish a
growing pipeline to address unmet medical needs across a number of
indications, including neuromyelitis optica spectrum disorder
(NMOSD), primary hypoparathyroidism and an undisclosed
neurodegenerative disease. Additionally, the Company is developing
an oral prophylactic bacterial vaccine against SARS-CoV-2, the
virus that causes COVID-19.
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,” “anticipates,” “believes,” “intends,” “potential,”
“possible,” and similar expressions. Such statements, based as they
are on current expectations of management, inherently involve
numerous risks, uncertainties 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 expectation with respect to the DETECT-trial
(including the ability to commence in the second quarter of 2021,
to enroll subjects in the DETECT-trial, and expectations that the
results of the DETECT-trial will be suitable to support a claim
(regulatory approval) for potential stand-alone testing with
macimorelin); Aeterna’s expectation that, upon receipt of pricing
and reimbursement approvals, macimorelin will be marketed in Europe
and the United Kingdom; the aims and details of the pre-clinical
and potential clinical studies involving the potential use of
macimorelin to treat an undisclosed neurodegenerative disease being
conducted by Queensland University; the potential of the
coronavirus vaccine platform technology licensed from
Julius-Maximilians-University (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 and the characteristics
of any potential vaccine; plans for research and trials regarding
the DC-PTH fusion polypeptides licensed from The University of
Sheffield; plans regarding AIM Biologicals in-licensed from
Julius-Maximilians-University and the potential to treat NMOSD; and
Aeterna’s intentions with respect to growth opportunities and its
business focus, including with respect to its cash position and
development pipeline (including the ability to accelerate its
development pipeline).
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 pediatric clinical trial in the
European Union and U.S. for Macrilen™ (macimorelin); the
commencement of the DETECT-trial may be delayed or we may not
obtain regulatory approval to initiate that study, we may be unable
to enroll the expected number of subjects in the DETECT-trial and
the result of the DETECT-trial may not support receipt of
regulatory approval in CGHD, we may be delayed or unsuccessful in
obtaining pricing and reimbursement approvals in Europe and the UK
to market macimorelin; the coronavirus vaccine platform technology
(and any vaccine candidates using that technology) licensed from
Julius-Maximilians-University 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; the timeline to develop a vaccine may be longer than
expected; such technology or vaccines may not be capable of being
used orally, may not have the same characteristics as vaccines
previously approved using the Salmonella Typhi Ty21a carrier
strain; results from ongoing or planned pre-clinical studies of
macimorelin by Queensland University or for our other products
under development may not be successful or may not support
advancing the product to human clinical trials; 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, 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; our ability to enter
into out-licensing, development, manufacturing, marketing and
distribution agreements with other pharmaceutical companies and
keep such agreements in effect. 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 40-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 ThomasJTC TeamT (US): +1 (833) 475-8247E:
aezs@jtcir.com
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