COSCIENS Biopharma Inc 6-K, filed Mar 20, 2025
COSCIENS Biopharma Inc. (CSCIF)
About this 6-K
COSCIENS Biopharma Inc filed this 6-K on March 20, 2025.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 OF THE SECURITIES EXCHANGE ACT OF 1934
For the month of March, 2025
Commission File Number: 001-38064
COSCIENS Biopharma Inc.
(Translation of registrant’s name into English)
c/o Norton Rose Fulbright Canada, LLP, 222 Bay Street, Suite 3000, PO Box 53, Toronto ON M5K 1E7
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
Exhibit 99.1 included with this Report on Form 6-K is hereby incorporated by reference into the Company’s Registration Statements on Form S-8 (No. 333-224737, No. 333-210561, No. 333-200834 and No. 333-279844) (collectively, the “Registration Statements”) and shall be deemed to be a part thereof from the date on which this Report on Form 6-K is furnished, to the extent not superseded by documents or reports subsequently filed or furnished. The information contained on any websites referenced in Exhibit 99.1 included with this Report on Form 6-K is not incorporated by reference or deemed to be a part of this Report on Form 6-K or any of the Registration Statements.
Forward-Looking Statements
The information in this Report on Form 6-K and the exhibit attached hereto and incorporated herein by reference include forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, specifically Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and under the provisions of Canadian securities laws. These forward-looking statements involve a number of known and unknown risks, uncertainties and other factors that could cause actual results and outcomes to be materially different from historical results or from any future results expressed or implied by such forward-looking statements.
Forward-looking statements include, but are not limited to, those relating to the Company’s expectations regarding the anticipated benefits and synergies as well as the assets, cost structure, financial position, cash flows and growth prospects of the combined company.
Risks and factors that could cause actual results or outcomes to differ materially from expectations include, among others, the following:
| ● | 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. |
| ● | the Company’s business strategy; |
| ● | the strategic decision to sunset the Company’s Amyotrophic Lateral Sclerosis (ALS), AIM Biologicals and Delayed Clearance Parathyroid Hormone (DC-PTH) programs ; |
| ● | the transition to a new presidential administration in the United States, including the potential use and effects of tariffs to address the administration’s policy goals, could materially impact our costs and revenues, as well as the macroeconomic framework in which we operate. |
| ● | 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. |
Additional risk factors that could cause actual results to differ materially include those risks identified in Item 3. “Key Information – Risk Factors” contained in the Company’s most recent Annual Report on Form 20-F filed with the SEC and its other filings and submissions from time to time, including those containing its quarterly and annual results, with the SEC, which are available on the Company’s website located at www.cosciensbio.com.
Many of these risks and factors are beyond the Company’s control. The Company cautions you not to place undue reliance on these forward-looking statements. All written and oral forward-looking statements attributable to the Company or persons acting on their behalf, are qualified in their entirety by these cautionary statements. Moreover, unless required by law to update these statements, the Company will not necessarily update any of these statements after the date hereof, either to conform them to actual results or to changes in their expectation.
DOCUMENTS INDEX
| Exhibit | Description | |
| 99.1 | COSCIENS Biopharma Inc. Announces Possible Delay in Filing Year-End Reporting Documents |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| COSCIENS Biopharma Inc. | ||
| Date: March 19, 2025 | By: | /s/ Giuliano La Fratta |
| Giuliano La Fratta | ||
| Chief Financial Officer | ||
Exhibit 99.1
COSCIENS Biopharma Inc. Announces Possible Delay in Filing Year-End Reporting Documents
TORONTO, ONTARIO, March 19, 2025 – COSCIENS Biopharma Inc. (NASDAQ: CSCI) (TSX: CSCI) (“COSCIENS” or the “Company”), a life science company which develops and commercializes a diversified portfolio of cosmeceutical, nutraceutical and pharmaceutical products, today announced that there is a potential for delay in the filing of: (a) its annual financial statements as of December 31, 2024 and 2023 and for the years ended December 31, 2024, 2023 and 2022, and its related management’s discussion and analysis (collectively, the “Financial Statements”); (b) the CEO and CFO certificates relating to the Financial Statements; and (c) the Company’s annual information form (in the form of an annual report on Form 20-F) (collectively, the “Required Filings”), beyond the prescribed filing deadline, being March 31, 2025.
The potential delay in filing of the Required Filings is a result of additional time that may be required to address certain matters related to the 2024 all stock merger transaction (the “Transaction”) between the Company and Ceapro Inc. (“Ceapro”). In connection with the Transaction, Ceapro, which was formerly listed on the TSX Venture Exchange, was required to undergo a conversion of its accounting procedures to ensure compliance with the Company’s existing SEC reporting obligations and internal control requirements. This is first audit of the combined entity that has been required since the Transaction, which has not only added additional complexity to the audit process but also required additional time to complete the review of Ceapro’s internal controls. As a result, there has been an unexpected volume of matters necessary to address in order for the Company’s auditors to complete the audit. Relatedly, the Issuer’s management has determined that material weaknesses in the Issuer’s financial controls existed as of the year ended December 31, 2024. Specifically, based on the criteria established by the COSO framework, the Issuer’s management identified deficiencies in the COSO framework principles associated with the control environment, control activities, information and communication and monitoring components of internal control, that constitute material weaknesses, either individually or in the aggregate. Separately, the Company’s auditors have undertaken a review of the impact of the prospective U.S. tariffs on the Issuer, which introduced an additional layer of review.
The Company continues to work diligently with its auditors to complete the Required Filings as soon as practicable, and will issue a news release once the Required Filings have been filed. The Company has made all efforts and allocated all available resources to the preparation, completion and filing of the Required Filings. The Company’s auditors has also made significant efforts to complete its audit of the Required Filings within the prescribed timeframe.
As a precaution, the Company has applied to the Ontario Securities Commission, as principal regulator for the Company, for the imposition of a management cease trade order (“MCTO”) under National Policy 12-23 - Management Cease Trade Orders (“NP 12-203”) throughout the duration of a possible default.
There is no certainty that the MCTO will be granted if the Company is not able to meet the required filing deadline. The MCTO, if, as and when approved, will generally not affect the ability of persons who are not or have not been management of the Company to trade in its securities.
The Company confirms that, in the event an MCTO is granted, it will satisfy the provisions of the alternative information guidelines under NP 12-203 by issuing bi-weekly default status reports in the form of news releases for so long as it remains in default of the above-noted filing requirements.
The potential delay in filing has no immediate effect on the listing of the Company’s common stock on the Nasdaq Capital Market. The Company plans to file its Form 20-F as soon as practicable; however, no assurance can be given as to the definitive date on which such periodic report will be filed.
The Company confirms it is not subject to any insolvency proceeding and that other than its Required Filings, there is no other material information relating to its affairs that has not been generally disclosed.
Other than as disclosed herein, the Company is up to date in its filing obligations.
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About COSCIENS Biopharma Inc.
COSCIENS is a life science company resulting from the merger of Aeterna Zentaris and Ceapro Inc. COSCIENS develops and commercializes a diversified portfolio of cosmeceutical, nutraceutical and pharmaceutical products. We are focused on leveraging our 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: the potential delay in filing the Required Filings; the satisfactory resolution of issues that have led to the potential delay in filing the Required Filings; the issuance of an MCTO by the Ontario Securities Commission and the content of any MCTO, including its anticipated effects on the ability of securityholders to trade in our securities, as well as the possibility that an MCTO will not be issued; the Company’s fulfillment of alternative information guidelines if an MCTO is granted; and the anticipated effects of the potential delay in filing on trading of the Company’s securities on the Nasdaq Capital Market.
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 avenanthramide product and other 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.
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