6-K
COSCIENS Biopharma Inc. (CSCIF)
UNITEDSTATES
SECURITIESAND EXCHANGE COMMISSION
Washington,D.C. 20549
FORM6-K
REPORTOF FOREIGN PRIVATE ISSUER
PURSUANTTO RULE 13a-16 OR 15d-16 OF THE SECURITIES EXCHANGE ACT OF 1934
For the month of November, 2024
Commission File Number: 001-38064
COSCIENSBiopharma Inc.
(Translation of registrant’s name into English)
c/oNorton 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and shall be deemed to be a part thereof from the date on which this Report on Form 6-K is furnished, to the extent not superseded by documents or reports subsequently filed or furnished.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-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 and clinical programs as well as in respect<br> of the top line data from the DETECT-trial; |
| ● | the<br> Company’s business strategy; |
| ● | the<br> strategic decision to sunset the Company’s Amyotrophic Lateral Sclerosis (ALS) program; |
| ● | 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 Biopharma Inc. Reports Third Quarter 2024 Financial Results and Provides Update on Advancements with Merger Integration Process and Ongoing Development Programs |
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> November 12, 2024 | By: | /s/ Giuliano La Fratta |
| Giuliano<br> La Fratta | ||
| Chief<br> Financial Officer |
Exhibit99.1
COSCIENSBiopharma Inc. Reports Third Quarter 2024 Financial Results and Provides Update on Advancements with Merger Integration Process and OngoingDevelopment Programs
Continuedexecution on merger integration with Ceapro Inc. and advancements across business
Companyended the quarter with US$20.0 million in cash
TORONTO,ONTARIO, November 12, 2024 – 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 September 30, 2024 and provided a corporate update.
“We have conducted a thorough evaluation and prioritization of our combined pipeline of products and programs. This evaluation focused on prioritizing programs and products in the nutraceutical and cosmeceutical space and critically assessing the required investment and timelines for our pharmaceutical projects to reach key value inflection points. We are pleased with the continued progress in our Phase 1/2a clinical trial of our Avenanthramide product being developed as a potential anti-inflammatory. We remain on track to complete enrollment of the Phase 1 component by the end of 2024 and expect to complete enrollment in the Phase 2a component by Q3 2025. In contrast, the projected timelines and costs to reach the next value inflection point in the pre-clinical auto-immune modifying disease (“AIMS Biologicals”) platform and Delayed Clearance Parathyroid Hormone (“DC-PTH”, AEZS-150) fusion proteins program are increasingly challenging and, as a result, we have made the decision to discontinue further investment in these programs,” stated Gilles Gagnon, M.Sc., MBA, President and CEO of COSCIENS.
Integrationand Pipeline Update
Following our prioritization evaluation and decisions, we will be focusing on the following programs:
MarketedProducts
| Cosmeceutical | |
|---|---|
| ● | Avenanthramides<br> (“AVA”) |
| ● | Oat<br> Beta Glucan (“OBG”) |
| ● | Oat<br> oil |
| ● | Juvente<br> DC product line |
| Pharmaceutical | |
| ● | Macimorelin<br> (Macrilen^®^; GHRYVELIN^™^) for diagnosis of adult growth hormone deficiency |
DevelopmentPipeline
| Stage | ||
|---|---|---|
| Cosmeceutical Projects | ||
| ● | AVA<br> enriched oat flour | Pre-commercial |
| ● | OBG<br> powder - Ingredient | Pre-commercial |
| Nutraceutical Projects | ||
| ● | OBG<br> chewable - Cholesterol reduction | Pre-commercial |
| ● | AVA<br> chewable - Exercise inflammation | Pre-commercial |
| ● | Yeast<br> beta glucan (“YBG”) capsule - Immunity | Pre-commercial |
| Pharmaceutical Projects and Potential Indications | ||
| ● | AVA<br> tablets – Anti-inflammatory | Phase<br> 1-2a |
On August 27, 2024, the Company announced that the Phase 3 safety and efficacy study AEZS-130-P02 (the “DETECT-trial”) evaluating macimorelin for the diagnosis of Childhood Onset Growth Hormone Deficiency (“CGHD”) had failed to meet its primary endpoints according to the definitions in the study protocol. The detailed analysis of those results are in progress following which a decision will be made whether future investment in macimorelin for the diagnosis of CGHD is warranted.
DevelopmentProjects Update
Pharmaceuticals:
| ● | Avenanthramides tablets (Avs) in development as an anti-inflammatory: Phase 1-2a clinical trial being conducted at the Montreal Heart Institute:<br> 64 subjects have completed to date the Phase 1 part of the study. We anticipate all 72 will be enrolled in the Phase 1 part of the<br> study by year end 2024. To date, no significant side effects have been observed from ascending doses ranging from 30 mg to 960 mg.<br> We believe the Phase 2a efficacy study will be initiated in Q1 2025, with expected completion in Q3 2025. |
|---|
Cosmeceuticals:
| ● | Oat beta glucan powder (OBG): The OBG powder formulation has been successfully prepared and shipped to Symrise AG, Ceapro’s<br> long-term distribution partner, for liquid reformulation and assessment for potential use and commercialization in the Chinese market. |
|---|---|
| ● | Enriched Oat Flour with High Concentration of Avenanthramides: We have successfully produced and delivered the first batches to potential<br> customers for their evaluation of the product. |
Nutraceuticals:
| ● | Yeast beta glucan (YBG) - Immune booster: Our YBG product has been successfully manufactured as part of our PGX scale up project<br> in Edmonton, Alberta. Our YBG product is being finalized for commercialization in capsule form. We plan to submit to Health Canada<br> to obtain a Natural Product Number for YBG with the goal to commercialize YBG as an immune booster in Q2 2025. |
|---|---|
| ● | Chewable Oat Beta Glucan (OBG) - Cholesterol reduction: We have successfully developed a unique, standardized formulation for a healthy<br> confection which includes a high concentration of OBG with daily dosage according to approved claims in 10 developed countries. Health<br> Canada has approved our Novel Nutraceutical Product (NPN 80127493). The substantive claims derived from this approval include reduction<br> of LDL cholesterol, supporting cardiovascular health reduction of Type 2 diabetes risks, source of fiber for the maintenance of general<br> good health and support of a healthy digestive system. COSCIENS’ team anticipates the official commercial launch of its approved<br> chewable OBG natural health product in Q1 2025, marking an important chapter in the Company’s journey toward promoting wellness<br> while expanding its business model. |
Technology:
| ● | Pressurized Gas eXpanded Technology (PGX Technology): |
|---|---|
| ○ | Edmonton<br> Main Facility PGX Scale Up 50 Liters Vessel: The project is completed and the equipment is ready to produce YBG at the small-scale<br> commercial level. |
| --- | --- |
| ○ | Natex<br> Facility, Austria PGX Scale Up 100 Liters Vessel: The PGX equipment has been received and is ready to be installed. We expect the<br> commissioning and validation of that equipment to be completed in Q1 2025. |
Summaryof Third Quarter 2024 Financial Results
Allamounts are in U.S. dollars.
Cashand cash equivalents
The Company had $20.0 million in cash and cash equivalents at September 30, 2024.
Resultsof operations for the three-month period ended September 30, 2024
For the three-month period ended September 30, 2024, we reported a net loss of $5.8 million, or $1.85 loss per common share, as compared with a net loss of $0.8 million, or $0.42 loss per common share for the three-month period ended September 30, 2023. The $5.0 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 $1.5 million, an impairment expense of $1.5 million, and a decrease of $0.1 million in revenues offset by a decrease of $0.2 million in cost of sales and an increase of $0.3 million of other income.
Revenues
| ● | Our<br> total revenue for the three-month period ended September 30, 2024 was $1.9 million as compared with $2.0 million for the same period<br> in 2023. This decrease of $0.1 million was due to a $0.3 million decrease in sales of Avenanthramides, Oat Beta Glucan and Oat Oil<br> in the quarter offset by an addition of $0.2 million in sales of macimorelin. |
|---|
OperatingExpenses
| ● | Our<br> total operating expenses for the three-month period ended September 30, 2024, was $7.3 million as compared with $1.9 million for<br> the same period in 2023. This increase of $5.4 million was due to higher research and development costs associated with the Avenanthramides<br> and DETECT clinical trials, as well as other pharmaceutical projects of $2.4 million, selling, general and administrative costs of<br> $1.5 million due primarily to the acquisition transaction recently completed between Aeterna and Ceapro, and a $1.5 million impairment<br> expense. |
|---|
Resultsof operations for the nine-month period ended September 30, 2024
For the nine-month period ended September 30, 2024, we reported a consolidated net loss of $8.6 million, or $3.58 loss per common share, as compared with a consolidated net loss of $1.9 million, or $1.04 loss per common share for the same period in 2023. The $6.7 million increase in net loss is primarily due to increases in research and development costs of $3.8 million, selling, general and administrative costs of $3.9 million, and an impairment expense of $1.5 million offset by an increase in other income of $2.0 million and an increase in income tax recovery of $0.5 million.
Revenues
| ● | Our<br> total revenue for the nine-month period ended September 30, 2024 was $6.3 million as compared to $5.9 million for the same period<br> in 2023. This increase of $0.4 million was due to a $0.2 million increase in sales of Avenanthramides, Oat Beta Glucan and Oat Oil<br> in the quarter as well as an addition of $0.2 million in sales of macimorelin. |
|---|
OperatingExpenses
| ● | Our<br> total operating expenses for the nine-month period ended September 30, 2024, was $14.6 million as compared with $5.4 million for<br> the same period in 2023, representing an increase of $9.2 million. This increase was due to higher research and development costs<br> associated with the Avenanthramides and DETECT clinical trials, as well as other pharmaceutical projects of $3.8 million, selling,<br> general and administrative costs of $3.9 million due primarily to the acquisition transaction recently completed between Aeterna<br> and Ceapro, and a $1.5 million impairment expense. |
|---|
ConsolidatedFinancial Statements and Management’s Discussion and Analysis
For reference, the Management’s Discussion and Analysis of Financial Condition and Results of Operations for the third quarter 2024, as well as the Company’s consolidated financial statements as of September 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.
AboutCOSCIENS Biopharma Inc.
COSCIENS is a specialty biopharmaceutical 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-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: our goals and expectations regarding our plans related to the development, manufacture or commercialization of our products.
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
InvestorContact:
Jenene Thomas
JTC Team
T (US): +1 (908) 824-0775
E: csci@jtcir.com