Full Press Release Details
Discussion and Analysis of Financial Condition and Results of Operations
Management's Discussion and Analysis ("MD&A") provides a review of the results of operations, financial condition
and cash flows of COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.) for the three-month and nine-month period ended September
30, 2024. In this MD&A, "COSCIENS", the "Company", "we", "us" and "our"
mean COSCIENS Biopharma Inc. and its subsidiaries. This discussion should be read in conjunction with the information contained in the
Company's unaudited interim condensed consolidated financial statements (the "interim consolidated financial statements")
and the notes thereto as of September 30, 2024, and for the nine-month periods ended September 30, 2024, and 2023. Our unaudited consolidated
financial statements have been prepared in accordance with International Financial Reporting Standards as issued by the International
Accounting Standards Board ("IFRS").
June 3, 2024, Aeterna Zentaris Inc. and Ceapro Inc. closed their all-stock merger of equals transaction and on August 6, 2024, the Company
changed its name to COSCIENS Biopharma Inc. For further details on these transactions and the basis for presentation of this MD&A,
see "Plan of Arrangement" and "Name Change", below, as well as Note 3 to the unaudited consolidated financial
Company's common shares are listed on both The Nasdaq Capital Market ("Nasdaq") and on the Toronto Stock Exchange ("TSX")
under the symbol "CSCI".
amounts in this MD&A are presented in thousands of United States ("U.S.") dollars, except for share and per share data,
or as otherwise noted. This MD&A was approved by the Company's Board of Directors (the "Board") on November 11,
2024. This MD&A is dated November 11, 2024.
Forward-Looking Statements
information in this MD&A has been prepared as of November 6, 2024. Certain statements in this MD&A, 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 MD&A, 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.
statements in this MD&A include, but are not limited to, statements, comments and expectations relating to: the Company's patented
technologies and value-driving products, and development thereof; the extraction, production and commercialization of active ingredients
from natural sources and our ability to successfully market related products; the successful development and marketing of our oat-based
pipeline products, including oat-beta glucan, avenanthramides and beta glucan from yeast, as well as such products' capability
to address unmet needs within the nutraceuticals markets; Macrilen (macimorelin) and the Company's plans in respect
of same, including commercialization and clinical programs as well as in respect of the top line data from the DETECT-trial; the Company's
business strategy; the strategic decision to sunset the Company's Amyotrophic Lateral Sclerosis (ALS) program; the Company's
positioning in its target markets; the Company's ability to accelerate the scale-up of PGX Technology towards commercial levels;expectations
for completion of the Company's Edmonton facility and Natex Termitz facility; pre-clinical and clinical studies and trials and
their expected timing and results, including the potential to bring certain products to market following such studies and trials; the
ability of our pharmaceutical therapeutic assets to address unmet medical needs across a number of indications; management's assumptions,
estimates and judgements; liquidity and capital resources; adequacy of our financial resources to finance operations and expenditure
requirements; limitations on internal controls over financial reporting; and the plans, objectives, future outlook and financial position
of the Company in general.
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 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 Company's present and future business strategies; operations performance within expected ranges; anticipated
future cash flows; local and global economic conditions and the environment in which the Company operates; anticipated capital and operating
costs; uncertainty in technology development as well as product development and related clinical trials and validation studies, including
our reliance on the success of the pediatric clinical trial in the European Union and U.S. for Macrilen (macimorelin);
the result of the DETECT-trial may not support receipt of regulatory approval in child-onset growth hormone deficiency; 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; 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; 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.
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 for the year ended December 31, 2023 and under the heading
"Risks and Uncertainties" in Exhibit 99.2 of our Form 6-K furnished to the SEC on May 14, 2024 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.
forward-looking statements contained herein about prospective results of operations, financial position or cash flows may constitute
a financial outlook. Such statements are based on assumptions about future events that management believe to be reasonable, are given
as of the date hereof and are based on economic conditions, proposed courses of action and management's assessment of currently
available relevant information. The Company's management has approved the financial outlook as of the date hereof. Readers are
cautioned that such financial outlook information contained herein should not be used for purposes other than for which it is disclosed
Material Information
MD&A includes information that we believe to be material to investors after considering all circumstances. We consider information
and disclosures to be material if they result in, or would reasonably be expected to result in, a significant change in the market price
or value of our securities, or where it is likely that a reasonable investor would consider the information and disclosures to be important
in making an investment decision.
are a reporting issuer under the securities legislation of all of the provinces of Canada, and our securities are registered with the
U.S. Securities and Exchange Commission ("SEC"). We are therefore required to file or furnish continuous disclosure information,
such as interim and annual financial statements, management's discussion and analysis, proxy or information circulars, annual reports
on Form 20-F, material change reports and press releases with the appropriate securities regulatory authorities. Additional information
about the Company and copies of these documents may be obtained free of charge upon request from our Corporate Secretary or on the Internet
Biopharma Inc. is a specialty biopharmaceutical company developing and commercializing a diversified portfolio of products for the cosmeceutical,
nutraceutical and pharmaceutical markets. Such products being produced using the Company's proprietary technologies. The Company's
patented technologies include the Pressurized Gas eXpanded (PGX) technology, which is a unique and disruptive technology that generates
high-value yields of active ingredients from natural plant resources for use in novel cosmeceutical, nutraceutical and therapeutics products.
The Company's two value-driving products, oat beta glucan and avenanthramides, are found in many household name cosmetic and personal
care brands. These products are manufactured from the Company's proprietary oat extraction manufacturing technology and are known
for their well-documented health benefits.
addition to our portfolio of nutraceutical and cosmeceutical products and programs, the Company is also conducting a Phase 1/2a
clinical trial with the goal of developing our avenanthramides product as an anti-inflamatory. The Company's lead commercial
pharmaceutical product, macimorelin (Macrilen ;
Ghryvelin ), is the first and only U.S. FDA and European Commission approved oral test indicated for the diagnosis of
adult growth hormone deficiency (AGHD).
June 3, 2024, Aeterna Zentaris Inc. ("Aeterna") and Ceapro Inc. ("Ceapro") closed their all-stock merger of equals
transaction (the "Transaction"). The Transaction was completed by way of court approved plan of arrangement pursuant to the
terms of an arrangement agreement entered into by Aeterna and Ceapro on December 14, 2023. As a result of the Transaction, each outstanding
Ceapro common share was exchanged for 0.02360 of an Aeterna common share. Additionally, as part of the Transaction, Aeterna issued to
its shareholders immediately prior to the closing of the Transaction, 0.47698 of a share purchase warrant (a "New Warrant")
for each Aeterna common share or warrant held.