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 second quarter ended June 30, 2021. The Company
also provided an update on its pre-clinical and clinical
development programs.
“Our team continues its solid execution to drive
forward the development across our clinical and preclinical
programs. During the second quarter, we achieved key milestones
across multiple fronts including bolstering our management team and
scientific expertise, commencing our pivotal Phase 3 DETECT-trial
of macimorelin, and advancing our earlier-stage preclinical
development pipeline,” commented Dr. Klaus Paulini, Chief Executive
Officer of Aeterna. “I believe we are well-positioned to propel the
Company forward with the goal of creating meaningful shareholder
value.”
Recent Highlights:
- Engaged neuro-immunologist, Michael
Levy, MD, PhD, Research Director of the Division of Neuroimmunology
& Neuroinfectious Disease at Massachusetts General Hospital as
a scientific consultant to support the development of the Company's
targeted, highly specific immunosuppressive therapeutic proteins
(“AIM Biologicals”) for the potential treatment of neuromyelitis
optica spectrum disorder (“NMOSD”).
- Advanced preclinical development
planning for potential orally active COVID-19 (SARS-CoV-2)
live-attenuated bacterial vaccine program.
- Initiated the preclinical program
to qualify macimorelin for clinical development as a potential
treatment option for amyotrophic lateral sclerosis (ALS; Lou
Gehrig's disease).
- Commenced its pivotal Phase 3
safety and efficacy study AEZS-130-P02 (“the DETECT-trial")
evaluating macimorelin for the diagnosis of childhood-onset growth
hormone deficiency (“CGHD”) in collaboration with Novo
Nordisk.
- In consultation with The University
of Sheffield, UK, selected AEZS-150 as the lead candidate in the
Company's delayed clearance parathyroid hormone fusion polypeptides
(“DC-PTH”) program.
- Appointed Michael Teifel, Ph.D. as
Senior Vice President, Non-Clinical Development and Chief
Scientific Officer.
- Fully settled
the previously disclosed class-action lawsuit against it in the
U.S. District Court for the District of New Jersey, as approved by
the U.S. District Court for the District of New Jersey.
All amounts in this press release are in U.S.
dollars unless otherwise noted.
Preclinical and Clinical Programs
Update:
Diagnostics Development Pipeline
Macimorelin
Diagnostic: Ghrelin agonist in
development for diagnostic use in childhood-onset growth hormone
deficiency (“CGHD”)
Aeterna Zentaris is currently conducting its
pivotal Phase 3 safety and efficacy study AEZS-130-P02 ("the
DETECT-trial") evaluating macimorelin for the diagnosis of CGHD.
Children and adolescents from two to less than 18 years of age with
suspected GHD are 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. Macimorelin growth
hormone stimulation test (“GHST”) will be performed twice for
repeatability data and two standard GHSTs will be used as controls:
arginine (i.v.) and clonidine (p.o.). On April 22, 2021, the U.S.
FDA Investigational New Drug Application associated with this
clinical trial became active. The first clinical site in the U.S.
is now open for patient recruitment.
Next Steps
- Conduct and completion of the
DETECT-trial.
Therapeutics and Vaccine Development
Pipeline
AIM Biologicals: Targeted,
highly specific autoimmunity modifying therapeutics for the
potential treatment of neuromyelitis optica spectrum disorder
(“NMOSD”)
In January 2021, Aeterna Zentaris entered into
an exclusive patent license and research agreement with
Julius-Maximilians-University of Wuerzburg, Germany for worldwide
rights to develop, manufacture and commercialize AIM Biologicals
for the potential treatment of NMOSD. The Company is currently
conducting in-vitro and in-vivo assessments to identify and
characterize an AIM Biologicals-based development candidate for the
treatment of NMOSD and to develop a manufacturing process for the
selected candidate. Additionally, the Company recently engaged
neuro-immunologist, Dr. Michael Levy, who will provide scientific
support and advice in the field of inflammatory CNS disorders,
autoimmune diseases of the nervous system, and NMOSD.
Next Steps
- Conduct further preclinical
research to identify and characterize an AIM Biologicals-based
development candidate for the treatment of NMOSD.
- Manufacturing process development
for selected candidate.
Macimorelin
Therapeutic: Ghrelin agonist in development for
the treatment of ALS (Lou Gehrig’s disease)
In January 2021, the Company entered into a
material transfer agreement (“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 ALS (Lou Gehrig’s
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. They also
plan to conduct a subsequent investigator initiated clinical trial
given positive pre-clinical results.
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 like ALS.
Next Steps
- Work with Queensland University to
conduct proof-of-concept studies with macimorelin in
disease-specific animal models.
- Assess alternative
formulations.
- Formalize preclinical development
plan.
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 uses. In consultation
with the University, Aeterna has selected AEZS-150 as the lead
candidate in its delayed clearance parathyroid hormone fusion
polypeptides (“DC-PTH”) program. Aeterna will now start the formal
preclinical development of AEZS-150 in preparation for a potential
IND filing for conducting the first in-human clinical study of
AEZS-150. AEZS-150 is being developed with the goal of providing a
potential new treatment option of primary hypoparathyroidism in
adults.
Next Steps
- Work with The University of
Sheffield to conduct in depth characterization of development
candidate (in-vitro and in-vivo).
- Develop manufacturing process.
Oral Coronavirus Vaccine
Platform: 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, so-far 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 work and preclinical development studies on
the potential vaccine, the results of which will be included within
the scope of the license agreement.
Next Steps
- Conclude in-vivo
immunology experiments with antigen variant vaccine
candidates.
- Perform
challenge experiments in immunized transgenic animals as proof of
concept.
- Select a
development candidate for initiation of the formal preclinical
toxicology and safety studies.
- Start
manufacturing process assessment / development.
Financing and Warrant
Exercises
During the period between January 1, 2021 and
June 30, 2021, holders have exercised certain of the Company’s
outstanding warrants to purchase 35,011,187 of the Company’s common
shares for gross proceeds of approximately $20.0 million. The
Company had $69.9 million cash and cash equivalents at June 30,
2021 (March 31, 2021 – 73.4 million).
Summary of
Second Quarter
2021 Financial
Results
Results of operations for the
three-month period ended June
30,
2021
For the three-month period ended June 30, 2021,
we reported a consolidated net loss of $2.0 million, or $0.02 loss
per common share (basic), as compared with a consolidated net loss
of $3.5 million, or $0.15 loss per common share (basic) for the
three-month period ended June 30, 2020. The $1.5 million
improvement in net loss is primarily from an increase in net
finance income of $2.1 million and an increase of $0.5 million in
total revenues, partially offset by an increase of $1.2 million in
total operating expenses.
Revenues
- Our total revenue for the
three-month period ended June 30, 2021 was $0.60 million as
compared with $0.07 million for the same period in 2020,
representing an increase of $0.53 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 $0.02 million in royalty income (2020 - $0.01
million). The licensing revenue was earned from the recognition of
a portion of the deferred €5 million payment from Novo Nordisk
received with the amendment to the Novo License agreement in the
fourth quarter of 2020.
Operating expenses
- Our total operating expenses for
the three-month period ended June 30, 2021 was $2.7 million as
compared with $1.5 million for the same period in 2020,
representing an increase of $1.2 million. This increase arose
primarily from a $0.5 million increase in research and development
costs and $0.5 million increase in general and administrative
expenses and an increase of $0.1 million in selling expenses. This
increase in total operating expense is due to the initiation of
research and development projects as announced in the first quarter
of 2021, and higher public company costs incurred holding our
annual shareholders meeting in May 2021, subsequent to our issuance
of common shares in the February 2021 financing and the 2021
warrant exercises, in addition to higher auditor fees mostly
related to F-3 warrant registration filings.
Net finance (costs) income
- Our net finance income for the
three-month period ended June 30, 2021 was $0.1 million as compared
with net finance costs of ($2.0 million) for the same period in
2020, representing an increase in net finance income of $2.1
million. This is primarily due to the $2.1 million decrease in
change in fair value of warrants. Unlike as at June 30, 2020, the
Company did not account for its warrants as liabilities as at June
30, 2021. As at June 30, 2020, the fair value of such liabilities
was classified as a finance cost in the consolidated statements of
loss and comprehensive loss.
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
second quarter of 2021, as well as the Company's unaudited
consolidated interim financial statements as of June 30, 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 (Macrilen™), 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 preclinical pipeline to potentially address unmet medical
needs across a number of indications, including neuromyelitis
optica spectrum disorder (NMOSD), hypoparathyroidism and
amyotrophic lateral sclerosis (ALS; Lou Gehrig’s 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 regarding the enrollment of subject in the
DETECT-trial, the application of the Macimorelin growth hormone
stimulation test and the completion of the DETECT-trial); Aeterna’s
expectations regarding conducting preclinical research to identify
and characterize an AIM Biologicals-based development candidate for
the treatment of NMOSD and developing a manufacturing process for a
selected candidate; Queensland University undertaking a subsequent
investigator initiated clinical trial evaluating macimorelin as a
potential therapeutic for the treatment of ALS and Aeterna
formulating a pre-clinical development plan for same; the
commencement of Aeterna’s formal preclinical development of
AEZS-150 in preparation for a potential IND filing for conducting
the first in-human clinical study of AEZS-150; Aeterna’s plans to
perform challenge experiments, select a development candidate and
establish a manufacturing process for the orally active COVID-19
(SARS-CoV-2) live-attenuated bacterial vaccine.
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; 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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