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 third quarter ended September 30, 2021. The Company
also provided an update on progress in its pre-clinical and
clinical development programs.
“Since January 2021, we have made a concerted
effort to not only advance our clinical-stage program but to expand
our development pipeline. We have delivered on that goal and are
pleased with the progress made to date. The leadership and
expertise we have established at Aeterna Zentaris, now coupled with
a diversified portfolio of assets with the potential to address
areas of significant medical need, has created an exciting time in
the Company’s evolution and multiple potential avenues for value
creation. We are diligently working to execute on the advancement
of all our clinical and pre-clinical programs and are poised to
continue building momentum and value in the near and long term,”
commented Dr. Klaus Paulini, Chief Executive Officer of
Aeterna.
Recent Highlights:
- Entered into an additional
exclusive license with the Julius-Maximilians-University of
Wuerzburg (the “University of Wuerzburg”) for early pre-clinical
development of AIM Biologics for the potential treatment of
Parkinson’s disease.
- Exercised its option under the
agreement with the University of Wuerzburg to expand application of
oral vaccine platform to second indication, chlamydia.
Pre-Clinical and Clinical
Programs Update:
Diagnostics Development Pipeline
Macimorelin
Diagnostic: Ghrelin agonist in
development for diagnostic use in childhood-onset growth hormone
deficiency (“CGHD”)
Aeterna 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
growth hormone deficiency 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 sites in the U.S. are open for patient recruitment. In the
EU and rest of world countries, clinical trial approval procedures
and site initiation activities are ongoing.
Next Steps
- Conduct and complete 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”) and Parkinson’s disease (PD)
In January 2021, Aeterna entered into an
exclusive patent license and research agreement with the University
of Wuerzburg, Germany, for worldwide rights to develop, manufacture
and commercialize AIM Biologicals for the potential treatment of
NMOSD. Additionally, the Company has engaged Prof. Dr. Joerg
Wischhusen of the University of Wuerzburg as well as
neuro-immunologist Dr. Michael Levy (MGH/Boston) as consultants,
who will provide scientific support and advice in the field of
inflammatory CNS disorders, autoimmune diseases of the nervous
system, and NMOSD.
In September 2021, the Company entered into an
additional exclusive license with the University of Wuerzburg for
early pre-clinical development for the potential treatment of
Parkinson’s disease.
Next Steps –
NMOSD
- Conduct in-vitro and in-vivo
assessments to select an AIM Biologicals-based development
candidate.
- Manufacturing process development
for selected candidate.
Next Steps – Parkinson’s
Disease
- Design and produce antigen-specific
AIM Biologics molecules for the potential treatment of Parkinson’s
disease.
- Conduct in-vitro and in-vivo
assessments in relevant Parkinson’s disease models.
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 with the University of Queensland,
Australia, to provide macimorelin for the conduct of pre-clinical
and subsequent clinical studies evaluating macimorelin as a
potential therapeutic for the treatment of ALS (Lou Gehrig’s
disease). The University of Queensland researchers have filed for
supportive grants and aim to conduct pre-clinical studies in
multiple pre-clinical 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 the University of
Queensland to conduct proof-of-concept studies with macimorelin in
disease-specific animal models.
- Assess alternative
formulations.
- Formalize pre-clinical 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 for all human uses. In consultation with The University
of Sheffield, Aeterna has selected AEZS-150 as the lead candidate
in its DC-PTH program. 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.
- Formalized pre-clinical development
of AEZS-150 in preparation for a potential IND filing for
conducting the first in-human clinical study.
Vaccine
Platform: Potential orally active,
live-attenuated bacterial vaccine with application across multiple
coronavirus types, including COVID-19 (SARS-CoV-2) and
chlamydia
In February 2021, Aeterna entered into an
exclusive option agreement with the University of Wuerzburg to
evaluate a pre-clinical, potential COVID-19 vaccine developed at
the University of Wuerzburg. 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 the University of Wuerzburg to
research and develop, manufacture, and sell a potential COVID-19
vaccine. The Company’s vaccine platform is currently undergoing
pre-clinical studies for the prevention of coronavirus diseases,
including COVID-19 (SARS-CoV-2) with the planned start of clinical
development targeted for H1 2023.
In September 2021, the Company exercised its
option under the agreement with the University of Wuerzburg on a
then undisclosed field, now known to be chlamydia. Chlamydia
trachomatis is a sexually transmitted bacterium infecting over 130
million subjects annually. Asymptomatic disease can spread to the
reproductive tract eventually inducing infertility, miscarriage, or
ectopic pregnancy, which is a life-threatening condition. Ocular
infections can lead to inclusion conjunctivitis or trachoma, which
is the primary source of visual impairment or infectious
blindness.
Additionally, the Company has entered into a
Research Agreement under which the Company has engaged the
University of Wuerzburg on a fee-for-service basis to conduct
supplementary research activities and pre-clinical development
studies on the potential vaccines, the results of which will be
included within the scope of the license agreements. Additionally,
Prof. Dr. Thomas Rudel of the University of Wuerzburg was engaged
by the Company in September 2021 as a scientific consultant to
support development of the salmonella-based vaccine platform for
the coronavirus and chlamydia vaccines.
Next Steps –
Coronavirus
Vaccine
- Evaluate
administration route, dose and immunization scheme.
- In-vivo
immunology experiments with antigen variant candidates in relevant
mice models.
- Conduct virus
challenge experiments in immunized transgenic animals.
- Start
manufacturing process assessment / development.
- Conduct
pre-clinical safety and toxicology assessment.
Next Steps – Chlamydia
Vaccine
- Design and
prepare candidate vaccine strains.
- Evaluate
administration route, dose and immunization scheme.
- In-vivo
immunology experiments with candidate strains in relevant mouse
models.
Summary of Third Quarter 2021 Financial
Results
All amounts in this press release are in U.S.
dollars unless otherwise noted.
Financing and Warrant
Exercises
During the period between January 1, 2021, and
September 30, 2021, holders have exercised certain of our
outstanding warrants to purchase 35,011,187 of the Company’s common
shares for gross proceeds of approximately $20.0 million. On
October 1, 2021, the Company received notice of exercise of 100,000
warrants at $0.45 per common share for the issuance of 100,000
common shares of the Company; such exercise was completed on
October 4, 2021.
Cash and cash equivalents
The Company had $68.0 million in cash and cash
equivalents at September 30, 2021 (June 30, 2021 – $69.9
million).
Results of operations for the
three-month period ended September
30,
2021
For the three-month period ended September 30,
2021, the Company reported a consolidated net loss of $1.7 million,
or $0.01 loss per common share (basic), as compared with a
consolidated net loss of $1.1 million, or $0.02 loss per common
share (basic) for the three-month period ended September 30, 2020.
The $0.6 million increase in net loss is primarily from an increase
in total operating expenses of $0.6 million and a decline in net
finance income of $0.5 million, partially offset by an increase of
$0.5 million in total revenue.
Revenues
- Total revenue for the three-month
period ended September 30, 2021, was $0.6 million as compared with
$0.1 million for the same period in 2020, representing an increase
of $0.5 million. 2021 revenue was comprised of $0.52 million in
licensing revenue (2020 - $0.02 million), $0.06 million in supply
chain revenue (2020 - $0.09 million) and $0.02 million in royalty
income (2020 - $0.02 million).
Operating expenses
- The Company’s
total operating expenses for the three-month period ended September
30, 2021, were $2.4 million as compared with $1.9 million for the
same period in 2020, representing an increase of $0.5 million. This
increase arose primarily from a $0.4 million increase in research
and development costs and an increase of $0.1 million in selling
expenses. This increase in total operating expenses was primarily
due to the impact of the initiation of research and development
projects as announced in the first quarter of 2021.
Net finance income
- Net finance income for the
three-month period ended September 30, 2021, was $0.1 million as
compared with net finance income of $0.6 million for the same
period in 2020, representing a decrease in net finance income of
$0.5 million. This was primarily due to the $0.8 million decrease
in the change in fair value of the warrant liability and a $0.1
million decline in the gain from changes in foreign currency
exchange rates partially offset by a $0.4 million reduction in
other finance costs.
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
third quarter of 2021, as well as the Company's unaudited
consolidated interim financial statements as of September 30, 2021,
will be available on the Company’s website (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), an area of significant unmet
need, in collaboration with Novo Nordisk.
Aeterna Zentaris is dedicated to the development
of therapeutic assets and has recently taken steps to establish a
growing pre-clinical 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). Additionally, the Company is developing an oral
prophylactic bacterial vaccine against SARS-CoV-2 (COVID-19) and
chlamydia.
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 expectations with respect to the DETECT-trial
(including regarding the enrollment of subjects in the
DETECT-trial, the application of the Macimorelin growth hormone
stimulation tests and the completion of the DETECT-trial);
Aeterna’s expectations regarding conducting pre-clinical research
to identify and characterize an AIM Biologicals-based development
candidate for the treatment of NMOSD as well as Parkinson’s
disease, and developing a manufacturing process for a selected
candidates; Aeterna’s expectations regarding conducting assessments
in relevant Parkinson’s disease models; The University of
Queensland 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 pre-clinical
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, start clinical development and establish a
manufacturing process for the orally active COVID-19 (SARS-CoV-2)
and chlamydia 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 the University of Wuerzburg 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 the University of Queensland 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 and the amended license agreement
(collectively the Novo Amended License Agreement); 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; 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 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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