COSCIENS Biopharma Inc. (NASDAQ: CSCI) (TSX: CSCI) (“COSCIENS” or
the “Company”), a specialty biopharmaceutical company developing
and commercializing a diversified portfolio of cosmeceutical,
nutraceutical and pharmaceutical products, today provided an update
on the progress of its merger integration with Ceapro Inc.
(“Ceapro”), including planned changes to its management team and
advancements across its current business.
“With the initial integration efforts now well
underway, I believe now is the ideal time for the next generation
of leaders to make their mark on the future of COSCIENS. To that
end, with my full support, our Board has engaged an executive
recruiting firm to identify the next President and CEO of COSCIENS.
I remain fully committed to lead and support COSCIENS while that
search is underway and will provide whatever support my successor
needs through the transition,” stated Gilles Gagnon, M.Sc., MBA,
President and CEO of COSCIENS.”
Mr. Gagnon added, “The reason for creating
COSCIENS and the stated goals of the Aeterna Zentaris (now
COSCIENS) and Ceapro combination was, and remains:
- broadening the
revenue base, product offering and pipeline;
- evaluating our
combined product portfolio in an effort to create a mix of
near-term revenue generating products with longer term, potentially
higher reward products, while also diversifying our respective
risks;
- right-sizing
our administrative costs and prioritize capital with a clear focus
on products and programs that have the best chance to succeed and
create value inflection points; and
- taking steps to
recruit future leadership talent and expertise to execute on our
strategy and take COSCIENS to the next level.
The first two goals will take time to achieve –
we want to ensure that we are looking at comprehensive data and
market information when making key product related decisions. We
also want to ensure that the next President and CEO will have a
voice in key decisions as they chart the future direction of
COSCIENS.”
Management has already initiated and is
continuing towards further cost reduction measures, including
efforts to right size the combined business through the elimination
of a number of managerial and technical positions. As part of those
efforts, COSCIENS is also reducing the spend on certain programs
pending completion of data review.
The Company continues to review the results from
the Phase 3 DETECT-Trial of macimorelin for the treatment of
childhood growth hormone deficiency (“CGHD”) and, while that is
occurring, is looking for opportunities to reduce its associated
spend while still supporting macimorelin in its approved
indication, adult human growth hormone deficiency. The Company has
also made the decision to discontinue further spend on the
preclinical research program to evaluate the potential use of
macimorelin for the treatment of amyotrophic lateral sclerosis
(“ALS”). The ALS program has taken far longer and will cost more
than was first anticipated and the Company does not have sufficient
confidence from the data obtained to date that it will ultimately
provide the much needed treatment for ALS patients that it once
hoped."
Development Projects Update
Pharmaceuticals:
Avenanthramides tablets – Anti-inflammatory
product
- The Single Ascending Dose (“SAD”)
arm of the Company’s Phase 1 safety and tolerability study has been
completed with 48 healthy subjects with no significant clinical
adverse events. The Montreal Heart Institute will now enroll 24
additional subjects, each of them receiving specific ascending
doses. The Phase 1 study is expected to be completed by
year-end.
Yeast beta glucan (“YBG”) – Anti-fibrotic
product
- Pre-clinical studies successfully
conducted over the last four years with researchers at McMaster
University were published on September 9, 2024 in the prestigious
publication, Biomaterials Scientific Journal. The data published
demonstrated that PGX-processed yeast beta glucan (PGX-YBG) is
respirable and able to safely and reliably reprogram cells
(macrophages) responsible for the development of fibrotic disease
like lung fibrosis in pre-clinical models.
AIM Biologicals – Parkinson’s Disease (“PD”)
- An abstract related to the
Company’s AIM Biologicals PD development program was presented at
the European Congress of Immunology held September 1-4, 2024, in
Dublin by Dr. Jorg Wischhusen from Wurzburg University as part of
the “INNOVATIVE TECHNOLOGIES AND IMMUNOTHERAPIES” track. The goal
of this pre-clinical program is to demonstrate that the product
confers neuroprotection in an animal model for Parkinson
Disease.
Nutraceuticals:
Yeast beta glucan (YBG) – Immune booster
- Development of a YBG powder
formulation for use as an immune booster has been completed.
Cosmeceuticals:
Avenanthramides (“AVA”) and Oat beta glucan –
Wound healing
- Positive data from a pre-clinical
study using AVA and OBG products were presented by Dr. Vince Li,
Scientific Director of the Angiogenesis Foundation at the 2024
American Society for Nutrition Annual Meeting held in Chicago at
the beginning of July 2024. The pre-clinical data demonstrated that
both AVA and OBG accelerate the speed and quality of healing.
Technology Development:
Pressurized Gas eXpanded Technology (“PGX”):
- Edmonton Main Facility - PGX
Scale-Up 50 Liters Vessel: Construction, installation and
commissioning is completed. Validation trials using YBG were
successfully performed to produce powder formulation. We plan to
sell YBG produced from this facility as a nutraceutical in
capsulation form.
- Austria Natex Facility - PGX
Scale-Up 100 Liters Vessel: The project is on schedule.
About Pressurized Gas eXpanded Liquid Technology
(PGX)
COSCIENS Biopharma’s patented Pressurized Gas
eXpanded (PGX) Technology is a unique and disruptive technology
with several key advantages over conventional drying and
purification technologies that can be used to process biopolymers
into high-value, fine-structured, open-porous polymer structures
and novel biocomposites. PGX can make ultra-light, highly porous
polymer structures on a continuous basis, which is not possible
using today's conventional technologies. PGX Technology was
invented by Dr. Feral Temelli from the Department of Agricultural,
Food & Nutritional Science of the University of Alberta (U of
A) along with Dr. Bernhard Seifried who worked on the PGX scale-up.
The license from U of A provides COSCIENS Biopharma with exclusive
worldwide rights in all industrial applications.
About COSCIENS Biopharma Inc.
COSCIENS is a specialty biopharmaceutical
company engaged in the development and commercialization of a
diverse portfolio of pharmaceutical and diagnostic products,
including those focused on areas of significant unmet medical need.
One of COSCIENS' lead products is macimorelin
(Macrilen®; Ghryvelin®), the
first and only U.S. FDA and European Medicines Agency approved oral
test indicated for the diagnosis of adult growth hormone deficiency
(AGHD). COSCIENS is also engaged in the development of therapeutic
assets and proprietary extraction technology, which is applied to
the production of active ingredients from renewable plant resources
currently used in cosmeceutical products (i.e., oat beta glucan and
avenanthramides which are found in leading skincare product brands
like Aveeno and Burt's Bees formulations) and being developed as
potential nutraceuticals and/or pharmaceuticals.
The Company is listed on the NASDAQ Capital
Market and the Toronto Stock Exchange, and trades on both exchanges
under the ticker symbol "CSCI". For more information, please visit
COSCIENS' website at www.cosciensbio.com.
Forward-Looking Statements
The information in this news release has been
prepared as of September 23, 2024. Certain statements in this news
release, referred to herein as "forward-looking statements",
constitute "forward-looking statements" within the meaning of the
United States Private Securities Litigation Reform Act of 1995, as
amended, and "forward-looking information" under the provisions of
Canadian securities laws. All statements, other than statements of
historical fact, that address circumstances, events, activities, or
developments that could or may or will occur are forward-looking
statements. When used in this news release, words such as
"anticipate", "assume", "believe", "could", "expect", "forecast",
"future", "goal", "guidance", "intend", "likely", "may", "would" or
the negative or comparable terminology as well as terms usually
used in the future and the conditional are generally intended to
identify forward-looking statements, although not all
forward-looking statements include such words. Forward-looking
statements in this news release include, but are not limited to,
statements relating to: our goals and expectations regarding the
benefits of the merger of Aeterna Zentaris and Ceapro, our ongoing
integration efforts and plans to identify synergies and cost
reductions, our ability to recruit a successor President and CEO,
and the timing of completion of the Company’s Phase 1 safety and
tolerability study of Avenanthramides tables, our plans to sell YBG
produced from our Edmonton Main Facility.
Forward-looking statements are necessarily based
upon a number of factors and assumptions that, while considered
reasonable by the Company as of the date of such statements, are
inherently subject to significant business, economic, operational
and other risks, uncertainties, contingencies and other factors,
including those described below, which could cause actual results,
performance or achievements of the combined Company to be
materially different from results, performance or achievements
expressed or implied by such forward-looking statements and, as
such, undue reliance must not be placed on them.
Forward-looking statements involve known and
unknown risks and uncertainties which include, among others: the
combined Company's present and future business strategies;
operations and performance within expected ranges; anticipated
future cash flows; local and global economic conditions and the
environment in which the combined Company operates; anticipated
capital and operating costs; uncertainty in our revenue generation
from our marketed products, product development and related
clinical trials and validation studies; results from our products
under development may not be successful or may not support
advancing the product; the failure of the DETECT-trial to achieve
its primary endpoint in CGHD may impact the market for macimorelin
(Macrilen®; Ghryvelin®) in AGHD
and the existing relationships we have for that product; ability to
raise capital and obtain financing to continue our currently
planned operations; our now heavy dependence on sales by and
revenue from our main distributor of our legacy Ceapro products and
its customers, the continued availability of funds and resources to
successfully commercialize our products; the ability to secure
strategic partners for late stage development, marketing, and
distribution of our products; 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 protect and enforce
our patent portfolio and intellectual property; and our ability to
continue to list our common shares on the NASDAQ Capital
Market.
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 discussed in our Annual Report on Form 20-F and MD&A
filed under the Company's profile on SEDAR+ at www.sedarplus.ca and
on EDGAR at www.sec.gov. We disclaim any obligation to update any
such risks or uncertainties 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 news release.
Issuer:Gilles R. GagnonPresident &
CEOggagnon@ceapro.com+1 (780) 421-4555
Investor Contact:Jenene ThomasJTC TeamT (US):
+1 (908) 824-0775E: csci@jtcir.com
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