6-K
COSCIENS Biopharma Inc. (CSCIF)
UNITEDSTATES
SECURITIESAND EXCHANGE COMMISSION
Washington,D.C. 20549
FORM6-K
REPORTOF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDERTHE SECURITIES EXCHANGE ACT OF 1934
For the month of December, 2025
Commission File Number: 001-38064
COSCIENSBiopharma Inc.
(Translation of registrant’s name into English)
c/oNorton Rose Fulbright Canada, LLP
222Bay Street, Suite 3000, PO Box 53
TorontoON 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 ☐
On December 1, 2025, COSCIENS Biopharma Inc. (the “Company”) issued a press release announcing an Exclusive Distribution Agreement with Wuzhou Drug International for Macrilen® in Hainan-Guangdong-Hong Kong-Macao Greater Bay Area and Singapore. A copy of the press release is attached to this Form 6-K as Exhibit 99.1 and is incorporated by reference herein. The press release contains forward-looking statements and includes cautionary statements identifying important factors that could cause actual results to differ materially from those in the forward-looking statements.
Forward-LookingStatements
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<br> Company’s patented technologies and value-driving products, and development thereof; |
|---|---|
| ● | the<br> extraction, production and commercialization of active ingredients from natural sources and our ability to successfully market related<br> products; |
| ● | the<br> successful development and marketing of our oat-based pipeline products, including oat-beta glucan, avenanthramides and beta glucan<br> from yeast, as well as such products’ capability to address unmet needs within the nutraceuticals markets; |
| ● | Macrilen®<br> (macimorelin) and the Company’s plans in respect of same, including commercialization. |
| ● | the<br> Company’s business strategy; |
| ● | the<br> strategic decision to sunset the Company’s Amyotrophic Lateral Sclerosis (ALS), AIM Biologicals and Delayed Clearance Parathyroid<br> Hormone (DC-PTH) programs ; |
| ● | the<br> transition to a new presidential administration in the United States, including the potential use and effects of tariffs to address<br> the administration’s policy goals, could materially impact our costs and revenues, as well as the macroeconomic framework in<br> which we operate. |
| ● | the<br> Company’s positioning in its target markets; |
| ● | the<br> Company’s ability to accelerate the scale-up of PGX Technology towards commercial levels; |
| ● | expectations<br> for completion of the Company’s Edmonton facility and Natex Termitz facility; |
| ● | pre-clinical<br> and clinical studies and trials and their expected timing and results, including the potential to bring certain products to market<br> following such studies and trials; |
| ● | the<br> ability of our pharmaceutical therapeutic assets to address unmet medical needs across a number of indications; |
| ● | management’s<br> assumptions, estimates and judgements; |
| ● | liquidity<br> and capital resources; |
| ● | adequacy<br> of our financial resources to finance operations and expenditure requirements; |
| ● | limitations<br> on internal controls over financial reporting; and |
| ● | the<br> 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.
DOCUMENTSINDEX
| Exhibit | Description |
|---|---|
| 99.1 | COSCIENS<br> Announces Exclusive Distribution Agreement with Wuzhou Drug International for Macrilen® in Hainan-Guangdong-Hong Kong-Macao Greater<br> Bay Area and Singapore |
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:<br> December 1, 2025 | By: | /s/ Giuliano La Fratta |
| Name: | Giuliano<br> La Fratta | |
| Title: | Chief<br> Financial Officer |
Exhibit 99.1
COSCIENSAnnounces Exclusive Distribution Agreement with Wuzhou Drug International for Macrilen® in Hainan-Guangdong-Hong Kong-Macao GreaterBay Area and Singapore
TORONTO,ONTARIO, December 1, 2025 – COSCIENS Biopharma Inc. (TSX: CSCI) (FINRA: CSCIF) (“COSCIENS” or the “Company”), a life sciences company focused on pharmaceutical therapies, diagnostic products, and natural ingredients solutions, today announced that its wholly-owned subsidiary, Aeterna Zentaris GmbH, has entered into an exclusive distribution agreement with Wuzhou Drug International Trading Limited (“Wuzhou”) for the commercialization of Macrilen® (macimorelin) in Hong Kong, Macao, Singapore, and the Chinese provinces of Guangdong and Hainan.
Under the terms of the agreement, Wuzhou will be responsible for the registration, importation, and commercialization of Macrilen® (macimorelin), the Company’s oral diagnostic test for Adult Growth Hormone Deficiency (“AGHD”), within the designated territories. This partnership leverages the “Hong Kong and Macao Medicine and Equipment Connect” policy, allowing for expedited market access in the Guangdong-Hong Kong-Macao Greater Bay Area. The agreement is for an initial ten-year term and includes a commitment by Wuzhou for a minimum initial order of approximately €800,000.
COSCIENSManagement Commentary
Dr. Matthias Gerlach, Senior Vice-President and Managing Director of Aeterna Zentaris GmbH commented: “We are very pleased to partner with Wuzhou, with their proven track record in the Greater China region and Southeast Asia, deep regulatory expertise and strong commercial presence in the Greater Bay Area and Singapore specifically. This agreement represents a key step in our strategy to unlock the global potential of Macrilen® and to build sustainable, long -term revenue streams.” Dr. Gerlach continued, “Entering these dynamic Asian markets allows us to address a significant unmet need for a convenient, oral diagnostic option for patients suspected of suffering from growth hormone deficiency. We look forward to working closely with the Wuzhou team to bring this innovative diagnostic test to patients and healthcare providers across the region and ultimately helping improve patient outcomes through earlier and more accurate diagnosis.”
Statementfrom Wuzhou Drug International
Mr. Zheng Guo Shang, General Manager of Wuzhou commented, “Wuzhou is dedicated to introducing high-quality, innovative healthcare solutions to the Greater China and Southeast Asian markets. We identify a strong strategic fit for Macrilen® within our specialty portfolio, particularly given the clear demand for a reliable and patient-friendly diagnostic tool for AGHD. We are eager to leverage our regulatory capabilities and hospital network to navigate the approval pathways in Hong Kong, Macao, and the pilot zones of Guangdong and Hainan, ensuring that patients have access to this gold-standard diagnostic as swiftly as possible.”
AboutCOSCIENS Biopharma Inc. and Macrilen®
COSCIENS is a life science company with a diverse portfolio focused on the development of natural, plant-based active ingredients and engaged in the commercialization of pharmaceutical and diagnostic products. COSCIENS’ natural active ingredient business leverages the Company’s proprietary manufacturing and extraction technologies to develop Avenanthramides and Beta Glucan active ingredients currently used in leading skincare brands worldwide.
Macrilen® (macimorelin), COSCIENS’ lead pharmaceutical product, is a ghrelin agonist that stimulates the secretion of growth hormone from the pituitary gland and is the first and only U.S. Food and Drug Administration (“FDA”) and European Medicines Agency (“EMA”) approved oral test indicated for the diagnosis of AGHD.
AboutWuzhou Drug International Trading Limited
Wuzhou Drug International Trading Limited is a pharmaceutical trading and services company headquartered in Macao. The company specializes in the introduction, registration, and distribution of innovative medicines, with a focus on ophthalmology, rare diseases, and specialty diagnostics across the Greater Bay Area (including Guangdong, Hong Kong, and Macao) and Singapore.
Forward-LookingStatements
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 expectations regarding the anticipated benefits of the distribution agreement with Wuzhou.
These statements are based on current expectations and assumptions, including factors or assumptions factors or assumptions that were applied in drawing a conclusion or making a forecast or projection, including assumptions based on historical trends, current conditions and expected future developments. Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. The Company cautions that although it is believed that the assumptions are reasonable in the circumstances, these risks and uncertainties give rise to the possibility that actual results may differ materially from those expressed or implied by such forward-looking statements, including but not limited to the factors described in “Risks Relating to Us and Our Business” in the Company’s Annual Report on Form 20-F for the year ended December 31, 2024. Given these risks, undue reliance should not be placed on these forward-looking statements, which apply only as of their dates. 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.
IssuerContact:
Peter H. Puccetti
Interim CEO and Chairman of the Board
Giuliano La Fratta
Chief Financial Officer
InvestorContact: