COSCIENS Biopharma Inc. (NASDAQ: CSCI) (TSX: CSCI) (“COSCIENS” or
the “Company”), a specialty biopharmaceutical company which
develops and commercializes a diversified portfolio of
cosmeceutical, nutraceutical and pharmaceutical products, today
reported its financial and operating results for the quarter ended
June 30, 2024 and provided a corporate update.
“We are very pleased with the ongoing
post-merger integration process and expect to be providing a
fulsome update shortly. The newly combined management team is
currently completing our detailed work to identify synergies and
cost reduction opportunities as we review and prioritize our now
combined portfolio of programs and products. In that review, our
goal remains to focus our resources and cash on those programs and
products that we believe will allow us to propel the Company into
its next phase of growth as a diversified biopharmaceutical
company. We are also excited that we remain on track to obtain and
announce in Q’3 2024 top-line data from our recently completed
Phase 3 safety and efficacy study AEZS-130-P02 (the "DETECT-trial")
evaluating macimorelin for the diagnosis of Childhood Onset Growth
Hormone Deficiency (“CGHD”),” stated Gilles Gagnon, M.Sc., MBA,
President and CEO of COSCIENS.
Summary of Second Quarter 2024 Financial
Results
All amounts are in U.S. dollars.
Cash and cash equivalents
The Company had $27.8 million in cash and cash equivalents at
June 30, 2024.
Results of operations for the three-month period ended
June 30, 2024
For the three-month period ended June 30, 2024,
we reported a net loss of $1.4 million, or $0.64 loss per common
share, as compared with a net loss of $0.9 million, or $0.47 loss
per common share for the three-month period ended June 30, 2023.
The $0.5 million increase in net loss is primarily due to increases
in both research and development costs of $0.8 million and selling,
general and administrative costs of $1.8 million offset by an
increase in other income of $1.9 million and an increase in income
tax recovery of $0.2 million.
Revenues
-
Our total revenue for the three-month period ended June 30, 2024
was $2.3 million as compared with $1.4 million for the same period
in 2023. This increase of $0.9 million was due to higher sales of
Avenanthramides, Oat Beta Glucan and Oat Oil in the quarter.
Operating Expenses
- Our total operating
expenses for the three-month period ended June 30, 2024, was $4.5
million as compared with $1.9 million for the same period in 2023.
This increase of $2.6 million was due to higher research and
development costs associated with the Avenanthramides and DETECT
clinical trials of $0.8 million and selling, general and
administrative costs of $1.8 million due primarily to the
acquisition transaction recently completed between Aeterna and
Ceapro.
Results of operations for the six-month period ended
June 30, 2024
For the six-month period ended June 30, 2024, we
reported a consolidated net loss of $2.8 million, or $1.39 loss per
common share, as compared with a consolidated net loss of $1.1
million, or $0.62 loss per common share for the same period in
2023. The $1.7 million increase in net loss is primarily due to
increases in research and development costs of $1.5 million and
selling, general and administrative costs of $2.4 million offset by
an increase in other income of $1.9 million and a decrease in gross
margin of $0.3 million.
Revenues
- Our total revenue for the six-month
period ended June 30, 2024 was $4.4 million as compared to $4.0
million for the same period in 2023. This increase of $0.4 million
was due to higher sales of Avenanthramides, Oat Beta Glucan and Oat
Oil in the quarter.
Operating Expenses
- Our total operating expenses for
the six-month period ended June 30, 2024, was $7.4 million as
compared with $3.5 million for the same period in 2023,
representing an increase of $3.9 million. This increase was due to
higher research and development costs associated with the
Avenanthramides and DETECT clinical trials of $1.5 million and
selling, general and administrative costs of $2.4 million due
primarily to the acquisition transaction recently completed between
Aeterna and Ceapro.
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 2024, as well as the Company's consolidated
financial statements as of June 30, 2024, will be available on the
Company's website (www.cosciensbio.com) in the Investors section or
at the Company's SEDAR+ and EDGAR profiles at www.sedarplus.ca and
www.sec.gov, respectively.
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 Commission 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
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 statements and expectations regarding
the ongoing integration efforts and plans to identify synergies and
cost reductions, and the timing of top-line data from the
DETECT-trial.
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, including our reliance on
the success of the DETECT-trial for Macrilen™ (macimorelin);
results from our other products under development may not be
successful or may not support advancing the product; our 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
(including AVA and OBG) and its customers, the continued
availability of funds and resources to successfully commercialize
the product; the ability to secure strategic partners for late
stage development, marketing, and distribution of our products,
including our ability to enter into a new license agreement or
similar arrangement following the termination of the license
agreement with Novo Nordisk AG for rights to Macrilen™ in North
America; 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@cosciensbio.com+1
(780) 421-4555
Investor Contact:Jenene ThomasJTC TeamT (US):
+1 (833) 475-8247E: jenene@jtcir.com
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