COSCIENS Biopharma Inc 6-K, filed Apr 9, 2025
COSCIENS Biopharma Inc. (CSCIF)
About this 6-K
COSCIENS Biopharma Inc filed this 6-K on April 9, 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 April, 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and shall be deemed to be a part thereof from the date on which this Report on Form 6-K is furnished, to the extent not superseded by documents or reports subsequently filed or furnished.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. Reports Fourth Quarter and Full Year 2024 Financial Results and Provides a Corporate Update |
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: April 9, 2025 | By: | /s/ Giuliano La Fratta |
| Giuliano La Fratta | ||
| Chief Financial Officer | ||
Exhibit 99.1
COSCIENS Biopharma Inc. Reports Fourth Quarter and Full Year 2024 Financial Results and Provides a Corporate Update
Fully repositioned as a pure-play natural-based product company following strategic review and pipeline prioritization
Ongoing streamlined efficiencies and cost cutting measures taken to refine operations and development pathway forward; Company ended the quarter with US$16.4 million in cash
Revenues of US$9.6M vs US$7.1M in 2023, a 35.2% increase YOY
TORONTO, ONTARIO, April 9, 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 reported its financial and operating results for the fourth quarter and full year ended December 31, 2024 and provided a corporate update.
“2024 was a transformative year for COSCIENS Biopharma. Since the completion of the merger, we have developed a strategic roadmap, established a prioritized pipeline and consolidated financials. All of these efforts align with our strategic imperatives of reducing the expected combined cash burn rate of our two pre-merger businesses while retaining and advancing the most promising programs or products from the legacy organizations.
Following this extensive work and considering the negative topline results of the Phase 3 DETECT-Trial for macimorelin, the Company has stopped investing in pre-clinical programs and into any development program with macimorelin for which we are exploring and validating various strategic options including the potential divestment of this asset. Looking ahead, COSCIENS is emerging as a pure-play natural-based products life science company and we believe the stage is set to propel the company to the next phase of growth,” stated Gilles Gagnon, M.Sc., MBA, President and CEO of COSCIENS.
Development Projects Update
Pharmaceuticals:
| ● | Avenanthramides Tablets (Avs) in Clinical Development as an Anti-Inflammatory Product: |
| ■ | Announced successful Phase 1 results. 72 subjects tested. No significant clinical adverse event observed from ascending doses ranging from 30 mg to 960 mg in Phase 1 clinical study. | |
| ■ | Launched Phase 2a Clinical Efficacy Study on March 15, 2025. The study includes 20 patients divided in two cohorts. The study is progressing very well with a first cohort of 10 patients receiving a daily dose of 480 mg. |
Cosmeceuticals:
| ● | JuventeDC Product Line: New website, juventedc.com, was launched on December 19, 2024. Products available online. |
Nutraceuticals:
| ● | Oat Beta Glucan (OBG) Chewable Bar – Cholesterol Reduction: We have successfully developed a unique, standardized formulation for a healthy confection which includes a high concentration of OBG with daily dosage according to approved OBG product monograph in 10 developed countries. COSCIENS’ team is working with a marketing firm anticipating the official commercial launch of its chewable bar OBG natural health product in H2 2025, marking an important chapter in the Company’s journey toward promoting wellness while expanding its business model. |
| ● | Yeast Beta Glucan (YBG) Powder - Immune Booster: Our YBG product has been successfully manufactured as part of our PGX scale up project in Edmonton, Alberta. Our YBG product is being finalized in capsule form with the goal to commercialize it as an immune booster in H2 2025. Yeast Beta Glucan is also being developed as a potential delivery system when combined with other bio actives for potential applications in wound healing. |
| ● | Avenanthramide (AVA) Chewable Bar (AVA) – Exercise induced inflammation: In line with previously published positive results from our work with researchers from University of Minnesota, we are using our unique standardized AVA extract to develop a high content AVA-protein bar to attenuate exercise induced inflammation. The goal is to launch this new product by year end 2025. |
Technology:
| ● | Pressurized Gas eXpanded Technology (PGX Technology): |
| ■ | Edmonton Main Facility PGX Scale Up 50 Liters Vessel: The project is completed and the equipment is ready to produce YBG at the small-scale commercial level. | |
| ■ | Natex Facility, Austria PGX Scale Up 100 Liters Vessel: The PGX equipment has been installed and system commission completed. | |
| ■ | YBG samples produced in 100L system that meet specifications. | |
| ■ | System now in place to prove scale-up timelines and economics for industrial YBG production and for other advanced biopolymers as part of commercialization plans. |
Summary of Fourth Quarter and Full Year 2024 Financial Results
All amounts are in U.S. dollars.
Cash and cash equivalents
The Company had $16.4 million in cash and cash equivalents at December 31, 2024.
Results of operations for the three-month period ended December 31, 2024
For the three-month period ended December 31, 2024, we reported a consolidated net loss of $6.7 million, or $2.15 loss per common share, as compared with a consolidated net loss of $1.6 million, or $0.85 loss per common share for the same period in 2023. The $5.1 million increase in net loss is primarily due to increases in both research and development costs of $2.4 million and selling, general and administrative costs of $1.0 million, impairment expense of $2.8 million, and a decrease of $1.4 million in income tax recoveries offset by an increase in gross margin of $1.9 million and an increase of $0.6 million of other income.
Revenues
| ● | Our total revenue for the three-month period ended December 31, 2024, was $3.3 million as compared to $1.2 million for the same period in 2023, an increase of $2.1 million. This increase was primarily due to a $1.2 million increase in sales of Avenanthramides and Beta Glucan from prior period, as well as a $0.9 million in Macrilen revenue. |
Operating Expenses
| ● | Our total operating expenses for the three-month period ended December 31, 2024, were $8.4 million as compared with $2.2 million for the same period in 2023. This increase of $6.2 million was due to higher research and development costs associated with the Avenanthramides and DETECT clinical trials, as well as other pharmaceutical projects of $2.4 million, selling, general and administrative costs of $1.0 million due primarily to the acquisition transaction recently completed between Aeterna and Ceapro, and $2.8 million of impairment expense. |
Results of operations for the year ended December 31, 2024
For the twelve-month period ended December 31, 2024, we reported a consolidated net loss of $15.3 million, or $5.93 loss per common share, as compared with a consolidated net loss of $3.5 million, or $1.89 loss per common share for the same period in 2023. The $11.8 million increase in net loss is primarily due to increases in research and development costs of $6.3 million, selling, general and administrative costs of $4.9 million, impairment expense of $4.3 million, and a decrease of $0.9 million in income tax recoveries offset by an increase in gross margin of $1.8 million and an increase of $2.8 million of other income.
Revenues
| ● | Our total revenue for the year ended December 31, 2024, was $9.6 million as compared to $7.1 million for the same period in 2023, an increase of $2.4 million. This increase was primarily due to a $1.3 million increase in sales of Avenanthramides and Beta Glucan from the prior period as well as a $1.1 million in Macrilen revenue. |
Operating Expenses
| ● | Our total operating expenses for the year ended December 31, 2024, were $23.0 million as compared with $7.5 million for the same period in 2023, representing an increase of $15.5 million. This increase was due to higher research and development costs associated with the Avenanthramides and DETECT clinical trials, as well as other pharmaceutical projects of $6.3 million, selling, general and administrative costs of $4.9 million due primarily to the acquisition transaction recently completed between Aeterna and Ceapro, and $4.3 million of impairment expense. |
Required Filings
For reference, the Company’s consolidated financial statements as of December 31, 2024 and for the years ended December 31, 2024, 2023 and 2022 and the related management’s discussion and analysis (collectively, the “Financial Statements”) will be available on the Company’s website (www.cosciensbio.com) in the Investors section and on the Company’s SEDAR+ and EDGAR profiles at www.sedarplus.ca and www.sec.gov, respectively. In addition, the Company has also filed the CEO and CFO certificates relating to the Financial Statements, as well as its annual information form (in the form of an annual report on Form 20-F) (collectively with the Financial Statements, the “Required Filings”) on the Company’s SEDAR+ and EDGAR profiles.
Management Cease Trade Order
Further to its news releases of March 19, 2025 and April 1, 2025, the Company announces that it has now made the Required Filings.
In connection with the Company’s delay in filing the Required Filings, on April 1, 2025, the Ontario Securities Commission (the “OSC”) issued a management cease trade order (the “MCTO”), effective April 1, 2025, restricting all trading in and all acquisitions of securities of the Company, whether direct or indirect, by the Company’s Chief Executive Officer and Chief Financial Officer until such time as the Required Filings have been filed by the Company and the MCTO has been revoked. The MCTO does not affect the ability of shareholders who are not insiders of the Company to trade their securities.
The terms of the MCTO provide that it shall be revoked two full business days following the receipt by the OSC of all filings that COSCIENS is required to make under Ontario securities law (namely, the Required Filings), or further order of the OSC Director. The Company anticipates that the MCTO will be revoked in accordance with its terms, namely that it will be revoked two full business days following the Required Filings being filed on SEDAR+.
About COSCIENS Biopharma Inc.
COSCIENS is a Life Science company which develops and commercializes a diversified portfolio of cosmeceutical, nutraceutical and pharmaceutical products. Our technology includes 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. Our consolidated portfolio also includes 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”).
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 goals and expectations regarding our plans related to the development, manufacture or commercialization of our products, and the revocation of the MCTO.
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. Gagnon
President & CEO
+1 (780) 421-4555
E: ggagnon@ceapro.com
Investor Contact:
Jenene Thomas
JTC Team
T (US): +1 (908) 824-0775
E: csci@jtcir.com