COSCIENS Biopharma Inc 6-K, filed May 13, 2025
COSCIENS Biopharma Inc. (CSCIF)
About this 6-K
COSCIENS Biopharma Inc filed this 6-K on May 13, 2025.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 OF THE SECURITIES EXCHANGE ACT OF 1934
For
the month of May,
Commission
File Number:
(Translation of registrant’s name into English)
(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 and 99.2 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and shall be deemed to be a part thereof from the date on which this Report on Form 6-K is furnished, to the extent not superseded by documents or reports subsequently filed or furnished.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
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: May 13, 2025 | By: | /s/ Giuliano La Fratta |
| Giuliano La Fratta | ||
| Chief Financial Officer | ||
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Condensed Interim Consolidated Financial Statements
As of March 31, 2025, and for the three months ended March 31, 2025, and 2024
(In thousands of US dollars)
(Unaudited)
| 1 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Condensed Interim Consolidated Statements of Financial Position
(In thousands of US dollars)
(Unaudited)
As of March 31, | As of December 31, 2024 | |||||||
| $ | $ | |||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | ||||||||
| Trade and other receivables | ||||||||
| Inventories (note 4) | ||||||||
| Income taxes receivable | ||||||||
| Prepaid expenses and other assets (note 5) | ||||||||
| Total current assets | ||||||||
| Non-current assets | ||||||||
| Restricted cash and cash equivalents | ||||||||
| Property and equipment (note 6) | ||||||||
| Total non-current assets | ||||||||
| Total assets | ||||||||
| LIABILITIES | ||||||||
| Current liabilities | ||||||||
| Payables and accrued liabilities (note 7) | ||||||||
| Provisions | ||||||||
| Income taxes payable | ||||||||
| Current portion of deferred revenues (note 3) | ||||||||
| Current portion of lease liabilities | ||||||||
| Warrant liability (note 9) | ||||||||
| DSU liability | ||||||||
| Total current liabilities | ||||||||
| Non-current liabilities | ||||||||
| Deferred revenues (note 3) | ||||||||
| Lease liabilities | ||||||||
| Employee future benefits (note 8) | ||||||||
| Total non-current liabilities | ||||||||
| Total liabilities | ||||||||
| Shareholders’ equity | ||||||||
| Share capital (note 10) | ||||||||
| Contributed surplus | ||||||||
| Retained earnings (accumulated deficit) | ( | ) | ( | ) | ||||
| Accumulated other comprehensive loss | ( | ) | ( | ) | ||||
| Total Shareholders’ equity | ||||||||
| Total liabilities and shareholders’ equity | ||||||||
Commitments (note 14)
The accompanying notes are an integral part of these condensed interim consolidated financial statements.
Approved by the Board of Directors
| /s/ Ronnie Miller | /s/ Pierre Labbé | |
| Ronnie Miller, Chair of the Board | Pierre Labbé, Director |
| 2 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Condensed Interim Consolidated Statements of Changes in Shareholders’ Equity
For the three months ended March 31, 2025, and 2024
(In thousands of US dollars)
(Unaudited)
| Share capital | Contributed surplus | Retained earnings | Accumulated other comprehensive loss | Total | ||||||||||||||||
| $ | $ | $ | $ | $ | ||||||||||||||||
| Balance – January 1, 2025 | ( | ) | ( | ) | ||||||||||||||||
| Net loss | ( | ) | ( | ) | ||||||||||||||||
| Other comprehensive loss: | - | |||||||||||||||||||
| Foreign currency translation adjustments | ( | ) | ( | ) | ||||||||||||||||
| Actuarial gain on defined benefit plan (note 8) | ||||||||||||||||||||
| Comprehensive loss | ( | ) | ( | ) | ( | ) | ||||||||||||||
| Share-based compensation costs | ||||||||||||||||||||
| Exercise of warrants (note 9) | ||||||||||||||||||||
| Balance – March 31, 2025 | ( | ) | ( | ) | ||||||||||||||||
| Share capital | Contributed surplus | Retained earnings | Accumulated other comprehensive loss | Total | ||||||||||||||||
| $ | $ | $ | $ | $ | ||||||||||||||||
| Balance – January 1, 2024 | ( | ) | ||||||||||||||||||
| Balance | ( | ) | ||||||||||||||||||
| Net loss | ( | ) | ( | ) | ||||||||||||||||
| Other comprehensive loss: | - | - | ||||||||||||||||||
| Foreign currency translation adjustments | ( | ) | ( | ) | ||||||||||||||||
| Comprehensive income | ( | ) | ( | ) | ( | ) | ||||||||||||||
| Share-based compensation costs | ||||||||||||||||||||
| Balance – March 31, 2024 | ( | ) | ||||||||||||||||||
| Balance | ( | ) | ||||||||||||||||||
The accompanying notes are an integral part of these condensed interim consolidated financial statements.
| 3 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Condensed Interim Consolidated Statements of Loss and Comprehensive Loss
For the three months ended March 31, 2025, and 2024
(In thousands of US dollars, except share and per share data)
(Unaudited)
| 2025 | 2024 | |||||||
| Three months ended | ||||||||
| March 31, | ||||||||
| 2025 | 2024 | |||||||
| $ | $ | |||||||
| Revenues (note 3) | ||||||||
| Cost of sales | ( | ) | ( | ) | ||||
| Gross profit | ||||||||
| Research and development | ( | ) | ( | ) | ||||
| Selling, general and administrative | ( | ) | ( | ) | ||||
| Loss from operations | ( | ) | ( | ) | ||||
| Foreign exchange gain (loss) | ( | ) | ||||||
| Finance costs | ( | ) | ( | ) | ||||
| Interest income | ||||||||
| Other income (expense) | ( | ) | ||||||
| Change in fair value of warrant and DSU liabilities | ( | ) | ||||||
| Other (loss) income | ( | ) | ||||||
| Loss before income taxes | ( | ) | ( | ) | ||||
| Income tax recovery | ||||||||
| Net loss | ( | ) | ( | ) | ||||
| Other comprehensive loss: | ||||||||
| Items that may be reclassified subsequently to profit or loss: | ||||||||
| Foreign currency translation adjustments | ( | ) | ( | ) | ||||
| Items that will not be reclassified subsequently to profit or loss: | ||||||||
| Actuarial gain on defined benefit plans (note 8) | ||||||||
| Comprehensive loss | ( | ) | ( | ) | ||||
| Basic and diluted loss per share (note 12) | ) | ) | ||||||
| Weighted average number of shares outstanding (basic and diluted) | ||||||||
The accompanying notes are an integral part of these condensed interim consolidated financial statements.
| 4 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Condensed Interim Consolidated Statements of Cash Flows
For the three months ended March 31, 2025, and 2024
(In thousands of US dollars)
(Unaudited)
| 2025 | 2024 | |||||||
| Three months ended | ||||||||
| March 31, | ||||||||
| 2025 | 2024 | |||||||
| $ | $ | |||||||
| Cash flows from operating activities | ||||||||
| Net loss for the period | ( | ) | ( | ) | ||||
| Items not affecting cash and cash equivalents: | ||||||||
| Depreciation and amortization | ||||||||
| Share-based compensation costs | ||||||||
| Employee future benefits | ||||||||
| Amortization of deferred revenues | ( | ) | ||||||
| Change in fair value of warrant and DSU liabilities | ||||||||
| Other non-cash items | ||||||||
| Income tax recovery | ( | ) | ||||||
| Changes in operating assets and liabilities (note 11) | ( | ) | ||||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from financing activities | ||||||||
| Payments on lease liabilities | ( | ) | ( | ) | ||||
| Net cash used in financing activities | ( | ) | ( | ) | ||||
| Cash flows from investing activities | ||||||||
| Purchase of property and equipment | ( | ) | ( | ) | ||||
| Proceeds on disposal of property and equipment | ||||||||
| Changes in restricted cash equivalents | ( | ) | ||||||
| Net cash provided by (used) in investing activities | ( | ) | ( | ) | ||||
| Effect of exchange rate changes on cash and cash equivalents | ( | ) | ||||||
| Net change in cash and cash equivalents | ( | ) | ( | ) | ||||
| Cash and cash equivalents – Beginning of period | ||||||||
| Cash and cash equivalents – End of period | ||||||||
The accompanying notes are an integral part of these condensed interim consolidated financial statements.
| 5 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of March 31, 2025, and for the three months ended March 31, 2025, and 2024
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
| 1. | Business overview |
Summary of business
COSCIENS Biopharma Inc. and its subsidiaries (the “Company”), formerly Aeterna Zentaris Inc., is a Life Science company developing and commercializing a diversified portfolio of products for the cosmeceutical, nutraceutical and pharmaceutical markets. These products are produced using the Company’s proprietary technologies. The Company’s patented technologies include the Pressurized Gas eXpanded (PGX) technology, which is a unique technology that generates high-value yields of active ingredients from natural based resources for use in novel cosmeceutical, nutraceutical and pharmaceutical 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.
These unaudited condensed interim consolidated financial statements were approved by the Board of Directors (the “Board”) on May 13, 2025.
These condensed interim consolidated financial statements have been prepared on the basis that the Company will continue as a going concern, which presumes that the Company will be able to realize its assets and discharge its liabilities in the normal course of business for the foreseeable future.
During the three-month period ended March 31,
2025, the Company incurred a net loss and had negative cash flow from operating activities of $
Assessing the Company’s ability to continue as a going concern necessitates significant judgment, relying on detailed financial forecasts with inherent estimates related to future sales, operating costs, research and development expenses, and capital expenditures. While the Company currently anticipates that its cash on hand and projected future cash flows from operations will be sufficient to cover its financial liabilities as they become due for at least the next twelve months from the issuance date of these condensed interim consolidated financial statements, these future cash flows are subject to several factors beyond the Company’s control.
A significant portion of the Company’s revenue is derived from a single customer primarily located in the United States (Note 13), exposing the Company to potential volatility in cash flows. Furthermore, on February 1, 2025, the President of the United States issued executive orders imposing new tariffs on imports from Canada, which were subsequently paused for a 90-day period on April 2, 2025, for The Canada-United States-Mexico Agreement (“CUSMA”)-compliant goods. Although the Company’s product sales to the US are CUSMA compliant, the Company is monitoring the potential direct and indirect impacts of tariffs, retaliatory tariffs, or other trade protectionist measures. As a result, the Company is exposed to uncertainty in cash flows from operations and consequently, there is no assurance that projected revenue and positive cash flows will be realized. Failure to achieve these projections could require the Company to reduce or curtail operations and development activities, harming the business, financial condition, and results of operations. The Company has the ability to scale its research and development activities, capital expenditures, and restructure operations, and will do so as necessary, based on cash availability. The Company will also need to consider seeking capital through various means including equity or debt financing, sale of assets, or a combination thereof to meet its liquidity needs. There is no assurance on the availability of future funding which could impact the Company’s ability to continue as a going concern.
As such, there is material uncertainty that raises substantial doubt about the Company’s ability to continue as a going concern for a period of at least 12 months from the date of issuance of these condensed interim consolidated financial statements.
| 6 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of March 31, 2025, and for the three months ended March 31, 2025, and 2024
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
The condensed interim consolidated financial statements have been prepared on a going concern basis and do not include any adjustments that might be necessary if the going concern assumption was not appropriate. If the going concern assumption was not appropriate for these financial statements, then adjustments would be necessary to the carrying value of assets and liabilities, and the classification of items in the condensed interim consolidated statements of financial position. Such adjustments could be material.
| 2. | Basis of presentation |
These unaudited condensed interim consolidated financial statements have been prepared in accordance with IAS 34, Interim Financial Reporting as issued by the International Accounting Standards Board (“IASB”).
The unaudited condensed interim consolidated financial statements do not include all the notes normally included in annual consolidated financial statements. The unaudited condensed interim consolidated financial statements reflect all normal and reoccurring adjustments that are, in the opinion of management, necessary for a fair presentation of the results for the interim periods presented. Accordingly, these unaudited condensed interim consolidated financial statements should be read in conjunction with the Company’s annual consolidated financial statements as of and for the year ended December 31, 2024.
The accounting policies used in these condensed interim consolidated financial statements are consistent with those presented in the Company’s annual consolidated financial statements.
Transaction
On December 14, 2023, Aeterna Zentaris Inc. (“Aeterna”) and Ceapro Inc. (“Ceapro”) entered into a binding arrangement agreement pursuant to which Aeterna would acquire all of the issued and outstanding common shares of Ceapro (the “Transaction”) by way of a plan of arrangement. The Transaction was consummated on June 3, 2024.
For financial reporting and accounting purposes, Ceapro is the acquirer of Aeterna in the Transaction. The condensed interim consolidated financial statements of COSCIENS Biopharma Inc. as of March 31, 2025 and December 31, 2024 and for the three months ended March 31, 2025 and 2024 reflect the results of operations and financial position of Ceapro for the periods presented and includes the results of operations of Aeterna subsequent to the Transaction, which was completed on June 3, 2024.
Change in presentation currency
Effective June 30, 2024, Ceapro has changed its reporting currency from Canadian dollars to U.S. dollars. This change in reporting currency has been applied retrospectively such that all amounts in the consolidated financial statements of the Company and the accompanying notes thereto are expressed in U.S. dollars. References to “$” are U.S. dollars and references to “CA $” are to Canadian dollars. For comparative purposes, historical consolidated financial statements of Ceapro were recast in U.S. dollars by translating assets and liabilities at the closing exchange rate in effect at the end of the respective period, revenues, expenses and cash flows at the average exchange rate in effect for the respective period and equity transactions at historical exchange rates. Translation gains and losses are included in the cumulative foreign currency translation adjustment, which is reported as a component of shareholders’ equity under accumulated other comprehensive loss.
| 7 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of March 31, 2025, and for the three months ended March 31, 2025, and 2024
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
Reclassifications
Certain prior period amounts have
been reclassified to conform to current period presentation. In the consolidated statement of financial position, trade receivables of
$
New standards and amendments
Several amendments apply for the first time for reporting periods beginning after January 1, 2025, but do not have an impact on the interim condensed consolidated financial statements of the Company. The IASB has published several new, but not yet effective, standards, amendments to existing standards, and interpretations. None of these standards, amendments to existing standards, or interpretations have been early adopted by the Company, and management anticipates that all relevant pronouncements will be adopted for the first period beginning on or after the effective date of the pronouncement.
Critical accounting estimates and judgements
The preparation of condensed interim consolidated financial statements in accordance with IFRS Accounting Standards requires management to make judgements, estimates and assumptions about the future that affect the reported amounts of the Company’s assets, liabilities, revenues, expenses and related disclosures. Judgements, estimates and assumptions are based on historical experience, expectations, current trends and other factors that management believes to be relevant at the time at which the Company’s condensed interim consolidated financial statements are prepared.
Management reviews, on a regular basis, the Company’s accounting policies, assumptions, estimates and judgements in order to ensure that the condensed interim consolidated financial statements are presented fairly and in accordance with IFRS Accounting Standards applicable to interim financial statements. Revisions to estimates are recognized prospectively. Critical accounting estimates and assumptions are those that have a significant risk of causing material adjustment and are often applied to matters or outcomes that are inherently uncertain and subject to change. As such, management cautions that future events often vary from forecasts and expectations and that estimates routinely require adjustment.
Critical accounting estimates and assumptions, as well as critical judgements used in applying accounting policies in the preparation of the Company’s condensed interim consolidated financial statements, were the same as those applied to Company’s annual consolidated financial statements as of and for the year ended December 31, 2024, other than the following:
Impairment of property and equipment
The Company is required to make judgments in assessing at the end of each reporting period whether there is any indication that an asset may be impaired. In making this assessment, the Company uses various indicators including, but not limited to, the impact of the US tariffs on the Company’s product sales, sustained decreases in revenue and profitability. When such an indication exists, the Company makes a number of estimates when determining the recoverable amount of an asset or a cash-generating unit, see note 6.
| 8 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of March 31, 2025, and for the three months ended March 31, 2025, and 2024
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
| 3. | Revenue |
The Company derives revenue from the transfer of goods at a point in time in the following categories:
Summary of revenue from transfer of goods and services
| 2025 | 2024 | |||||||
| Three months ended | ||||||||
| March 31, | ||||||||
| 2025 | 2024 | |||||||
| $ | $ | |||||||
| Active ingredients | ||||||||
| Pharmaceutical | ||||||||
| Revenue | ||||||||
Deferred revenue
The deferred revenue balance primarily relates to the advance consideration received in the form of non-refundable non-creditable upfront payment and milestone payments relating to list price approvals of Ghryvelin™ in the United Kingdom, Spain and Germany as per an exclusive licensing agreement for the commercialization of macimorelin (the “Licensed Product”) in the European Economic Area and the United Kingdom and an exclusive supply agreement for a period of ten years, subject to renewal, to supply such Licensed Product.
Revenue for this contract will be
recognized based on units of Licensed Product supplied. The total units that the Company expects to supply pursuant to the Pharmanovia
Agreement is an estimate, based on current projections and anticipated market demand, and therefore will be a significant judgment that
will be relied upon when using the outputs method to recognize revenue. The Company expects to recognize the balance of the deferred
revenue over the remaining period of eight years based on related patent application initiatives. For the three months ended March 31,
2025, the Company recognized $
Liabilities related to contracts with customers
The following table provides a summary of deferred revenue balances:
Summary of deferred revenue
| Current | Non-current | Total | ||||||||||
| March 31, 2025 | ||||||||||||
| Current | Non-current | Total | ||||||||||
| $ | $ | $ | ||||||||||
| Pharmanovia | ||||||||||||
| NK Meditech | ||||||||||||
| Contract liabilities | ||||||||||||
| December 31, 2024 | ||||||||||||
| Current | Non-current | Total | ||||||||||
| $ | $ | $ | ||||||||||
| Pharmanovia | ||||||||||||
| NK Meditech | ||||||||||||
| Contract liabilities | ||||||||||||
| 9 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of March 31, 2025, and for the three months ended March 31, 2025, and 2024
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
| 4. | Inventories |
The Company had the following inventories at the end of each reporting period:
Schedule of inventories
| March 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| $ | $ | |||||||
| Raw materials | ||||||||
| Work in progress | ||||||||
| Finished goods | ||||||||
| Inventories | ||||||||
Inventories expensed to cost of goods
sold during the three-month period ended March 31, 2025, are $
| 5. | Prepaid expenses and other assets |
The Company had the following prepaid expenses at the end of each reporting period:
Summary of prepaid expenses and other current assets
| March 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| $ | $ | |||||||
| Prepaid insurance | ||||||||
| Prepaid research and development | ||||||||
| Other | ||||||||
| Total | ||||||||
| 10 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of March 31, 2025, and for the three months ended March 31, 2025, and 2024
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
| 6. | Property and equipment |
Components of the Company’s property and equipment are summarized below.
Schedule of property and equipment
| Equipment Not Available for Use | Equipment | Office and Computer Equipment | Buildings | Leasehold Improvements | Total | |||||||||||||||||||
| Cost | ||||||||||||||||||||||||
| Equipment Not Available for Use | Equipment | Office and Computer Equipment | Buildings | Leasehold Improvements | Total | |||||||||||||||||||
| $ | $ | $ | $ | $ | $ | |||||||||||||||||||
| At January 1, 2024 | ||||||||||||||||||||||||
| Acquisition of Aeterna | ||||||||||||||||||||||||
| Additions | ||||||||||||||||||||||||
| Impairment | ( | ) | ( | ) | ( | ) | ||||||||||||||||||
| Disposals | ( | ) | ( | ) | ( | ) | ||||||||||||||||||
| Impact of foreign exchange rate changes | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||
| At December 31, 2024 | ||||||||||||||||||||||||
| Additions | ||||||||||||||||||||||||
| Disposals | ( | ) | ( | ) | ( | ) | ||||||||||||||||||
| Impact of foreign exchange rate changes | ||||||||||||||||||||||||
| At March 31, 2025 | ||||||||||||||||||||||||
| Accumulated Depreciation | ||||||||||||||||||||||||
| Equipment Not Available for Use | Equipment | Office and Computer Equipment | Buildings | Leasehold Improvements | Total | |||||||||||||||||||
| $ | $ | $ | $ | $ | $ | |||||||||||||||||||
| At January 1, 2024 | ||||||||||||||||||||||||
| Amortization | ||||||||||||||||||||||||
| Disposals | ( | ) | ( | ) | ( | ) | ||||||||||||||||||
| Impact of foreign exchange rate changes | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||||
| At December 31, 2024 | ||||||||||||||||||||||||
| Property and equipment | ||||||||||||||||||||||||
| Amortization | ||||||||||||||||||||||||
| Disposals | ( | ) | ( | ) | ( | ) | ||||||||||||||||||
| Impact of foreign exchange rate changes | ||||||||||||||||||||||||
| At March 31, 2025 | ||||||||||||||||||||||||
| Property and equipment | ||||||||||||||||||||||||
| Carrying amount | ||||||||||||||||||||||||
| Equipment Not Available for Use | Equipment | Office and Computer Equipment | Buildings | Leasehold Improvements | Total | |||||||||||||||||||
| $ | $ | $ | $ | $ | $ | |||||||||||||||||||
| At December 31, 2024 | ||||||||||||||||||||||||
| Property and equipment, Beginning | ||||||||||||||||||||||||
| At March 31, 2025 | ||||||||||||||||||||||||
During the three-month period ended
March 31, 2025, the Company retired fully depreciated assets no longer in use of $
| 11 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of March 31, 2025, and for the three months ended March 31, 2025, and 2024
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
Included right-of-use in the net carrying
amount of property and equipment at March 31, 2025, are assets relating to buildings, in the amount of $
The Company considers the implementation of US tariffs during the period ended March 31, 2025 as a potential impairment indicator, which is amplified by the prevailing economic climate, pressures on gross margins, persistent revenue volatility, and ongoing operating losses. As a result, the Company performed an impairment assessment on the Active Ingredient CGU based on various probability-weighted scenarios concerning the impact of the US tariffs. The cash flows are derived from the budget for the next five years and do not include restructuring activities that the Company is not yet committed to or significant future investments that will enhance the performance of the assets of the CGU being tested. The significant estimates used in the determination of value in use included forecasted revenues, costs, growth rate, discount rate and the continuation of the CUSMA exemption on the Company’s sales to the US as being the most likely scenario. The recoverable amount of the CGU tested was estimated to be higher than its carrying amount and no impairment was required. No reasonable change in the discount rate or the terminal value growth could cause the carrying amount to exceed the recoverable amount. However, the removal of the CUSMA exemption and the subsequent prolonged application of US tariffs on the Company’s sales could potentially necessitate the recognition of an impairment loss in future periods.
| 7. | Accounts payable |
The Company had the following accounts payable and accrued expenses at the end of each reporting period:
Summary of detailed information about payables and accrued liabilities
| 2025 | 2024 | |||||||
| March 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| $ | $ | |||||||
| Trade accounts payable | ||||||||
| Accrued research and development costs | ||||||||
| Accrued employee benefits | ||||||||
| Payroll tax and other statutory liabilities | ||||||||
| Other accrued liabilities | ||||||||
| Payables and accrued liabilities | ||||||||
| 12 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of March 31, 2025, and for the three months ended March 31, 2025, and 2024
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
| 8. | Employee future benefits |
The change in the Company’s employee future benefit obligations is summarized as follows:
Summary of net defined benefit liability asset
Three months ended March 31, 2025 | Year ended December 31, 2024 | |||||||||||||||
| Pension | Other | |||||||||||||||
| benefit plans | benefit plans | Total | Total | |||||||||||||
| $ | $ | $ | $ | |||||||||||||
| Change in plan liabilities | ||||||||||||||||
| Balances – Beginning of the period | ||||||||||||||||
| Current service cost | ( | ) | ( | ) | ||||||||||||
| Interest cost | ||||||||||||||||
| Actuarial loss (gain) from changes in financial assumptions | ( | ) | ( | ) | ( | ) | ||||||||||
| Benefits paid | ( | ) | ( | ) | ( | ) | ||||||||||
| Impact of foreign exchange rate changes | ( | ) | ||||||||||||||
| Balances – End of the period | ||||||||||||||||
| Change in plan assets | ||||||||||||||||
| Balances – Beginning of the period | ||||||||||||||||
| Interest income from plan assets | ||||||||||||||||
| Employer contributions | ||||||||||||||||
| Employee contributions | ||||||||||||||||
| Benefits paid | ( | ) | ( | ) | ( | ) | ||||||||||
| Remeasurement of plan assets | ||||||||||||||||
| Unrecognized Asset due to Asset Ceiling | ( | ) | ( | ) | ||||||||||||
| Impact of foreign exchange rate changes | ( | ) | ||||||||||||||
| Balances – End of the period | ||||||||||||||||
| Net liability of the unfunded plans | ||||||||||||||||
| Net liability of the funded plans | ||||||||||||||||
| Net amount recognized as Employee future benefits | ||||||||||||||||
| Amounts recognized: | ||||||||||||||||
| In net loss | ( | ) | ||||||||||||||
| Actuarial gain (loss) on defined benefit plans in other comprehensive loss | ( | ) | ||||||||||||||
The calculation of the employee future
benefit obligation is sensitive to the discount rate assumption and other assumptions such as the rate of the pension benefit increase.
Discount rates were
| 13 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of March 31, 2025, and for the three months ended March 31, 2025, and 2024
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
| 9. | Warrants |
Warrant activity for the three months ended March 31, 2025, was as follows:
Summary of warrants activity reclassified equity
| Warrants | Weighted average exercise price | Amount | ||||||||||
| # | $ | $ | ||||||||||
| Balance – December 31, 2024 | ||||||||||||
| Exercised | ( | ) | ( | ) | ||||||||
| Change in fair value of warrants | ||||||||||||
| Balance – March 31, 2025 | ||||||||||||
The fair value of the liability, classified as warrant liability, is subsequently remeasured at each reporting date and at settlement date using the Black-Scholes option pricing model, with changes in fair value recognized in profit or loss. At March 31, 2025, the following warrants were outstanding:
| Issuance date | Number | Weighted average remaining contractual life | Weighted average exercise price | |||||||||
| # | years | $ | ||||||||||
| February 2020 | ||||||||||||
| July 2020 | ||||||||||||
| August 2020 | ||||||||||||
| February 2021 | ||||||||||||
| June 2024 | ||||||||||||
| Balance – March 31, 2025 | ||||||||||||
| 10. | Shareholders’ equity |
Share capital
The Company has authorized an unlimited number of common shares (being voting and participating shares) with no par value, as well as an unlimited number of preferred, first and second ranking shares, issuable in series, with rights and privileges specific to each class, with no par value.
As discussed in Note 1, Business Overview, on June 3, 2024, each outstanding Ceapro common share was exchanged for of an Aeterna common share. Accordingly, all common shares, stock options and per share amounts in these interim condensed consolidated financial statements have been retroactively adjusted for all periods presented to give effect to the share exchange.
| Common shares | Amount | |||||||
| # | $ | |||||||
| Balance – December 31, 2024 | ||||||||
| Granted | ||||||||
| Balance – March 31, 2025 | ||||||||
| Common shares | Amount | |||||||
| # | $ | |||||||
| Balance – December 31, 2023 | ||||||||
| Balance – March 31, 2024 | ||||||||
| 14 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of March 31, 2025, and for the three months ended March 31, 2025, and 2024
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
Share-based compensation
The compensation expense for the three
months ended March 31, 2025, was $
| Stock options | Weighted average exercise price | |||||||
| # | $ | |||||||
| Balance – January 1, 2025 | ||||||||
| Cancelled / Forfeited | ( | ) | ||||||
| Balance – March 31, 2025 | ||||||||
| Stock options | Weighted average exercise price | |||||||
| # | $ | |||||||
| Balance – January 1, 2024 | ||||||||
| Cancelled / Forfeited | ( | ) | ||||||
| Balance – March 31, 2024 | ||||||||
| 11. | Supplemental disclosure of cash flow information |
Summary of changes in operating assets and liabilities
| 2025 | 2024 | |||||||
| Three months ended | ||||||||
| March 31, | ||||||||
| 2025 | 2024 | |||||||
| $ | $ | |||||||
| Changes in operating assets and liabilities: | ||||||||
| Trade and other receivables | ( | ) | ||||||
| Inventory | ||||||||
| Prepaid expenses and other current assets | ( | ) | ||||||
| Payables and accrued liabilities | ( | ) | ||||||
| Deferred revenues | ||||||||
| Provision for restructuring and other costs | ( | ) | ||||||
| Employee future benefits | ( | ) | ||||||
| Increase (decrease) in operating assets and liabilities | ( | ) | ||||||
Additions of property and equipment of $
| 15 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of March 31, 2025, and for the three months ended March 31, 2025, and 2024
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
| 12. | Net loss per share |
Summary of pertinent data relating to computation of basic and diluted net loss per share
| 2025 | 2024 | |||||||
| Three months ended | ||||||||
| March 31, | ||||||||
| 2025 | 2024 | |||||||
| $ | $ | |||||||
| Net loss | ( | ) | ( | ) | ||||
| Basic and diluted weighted-average shares outstanding | ||||||||
| Basic and diluted loss per share | ) | ) | ||||||
| Items excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: | ||||||||
| Stock options and DSUs | ||||||||
| Warrants | ||||||||
| 13. | Segment information |
As of March 31, 2025 and a result of the transaction, the Company has two reportable and operating segments: Active ingredient and Biopharmaceutical. The Company’s chief operating decision maker assesses the performance of the reportable segments based on revenues and operating loss before selling, general & administrative expenses, other income and tax by segment. Selling, general and administrative expenses are expenses and salaries related to centralized functions, such as corporate finance, legal, human resources and technology teams, which are not allocated to segments. Accounting policies applied for the Active ingredient and the Biopharmaceutical segments are identical to those used for the purposes of the consolidated financial statements as described in Note 2.
Active ingredient
The Active ingredient segment involves the development of proprietary extraction technologies and the application of these technologies to the production and development and commercialization of active ingredients derived from oats and other renewable plant resources for healthcare and cosmetic industries. Active ingredients produced include oat beta glucan, oat oil and avenanthramides. These and similar manufactured products are sold primarily through distribution networks.
Biopharmaceutical
The Biopharmaceutical segment includes the results of Aeterna Zentaris from its acquisition on June 3, 2024 (Note 3). The segment involves the commercializing and developing pharmaceutical therapeutics and diagnostic tests, including the Company’s product, Macrilen® (macimorelin). The segment also includes remaining costs associated with the development of our pre-clinical pipeline to potentially address unmet medical needs across several indications with a focus on rare or orphan indications.
| 16 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of March 31, 2025, and for the three months ended March 31, 2025, and 2024
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
The table below summarizes the relevant financial information by operating segment:
Summary relevant financial information by operating segment
| Three months ended March 31, 2025 | ||||||||||||
| Active ingredient | Biopharmaceutical | Total | ||||||||||
| $ | $ | $ | ||||||||||
| Revenue | ||||||||||||
| Cost of sales | ( | ) | ( | ) | ( | ) | ||||||
| Gross margin | ||||||||||||
| Research and development | ( | ) | ( | ) | ( | ) | ||||||
| Loss from operations before SG&A and other income (expenses) | ( | ) | ( | ) | ( | ) | ||||||
| Selling, general & administrative | ( | ) | ||||||||||
| Loss from operations | ( | ) | ||||||||||
| Net other income | ( | ) | ||||||||||
| Loss before income taxes | ( | ) | ||||||||||
| Three months ended March 31, 2024 | ||||||||||||
| Active ingredient | Biopharmaceutical | Total | ||||||||||
| $ | $ | $ | ||||||||||
| Revenue | ||||||||||||
| Cost of sales | ( | ) | ( | ) | ||||||||
| Gross margin | ||||||||||||
| Research and development | ( | ) | ( | ) | ||||||||
| Income from operations before SG&A and other income (expenses) | ( | ) | ( | ) | ||||||||
| Selling, general & administrative | ( | ) | ||||||||||
| Loss from operations | ( | ) | ||||||||||
| Net other income | ||||||||||||
| Loss before income taxes | ( | ) | ||||||||||
Major Customer
During the three months ended March
31, 2025, the Company had export sales to one major distributor of the Company’s products representing
| 17 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of March 31, 2025, and for the three months ended March 31, 2025, and 2024
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
| 14. | Commitments and Contingencies |
Significant expenditure under contracted supply agreements for at the end of the reporting period but not recognized as liabilities is as follows:
Schedule of expected future minimum lease payments
| TOTAL | ||||
| $ | ||||
| Less than 1 year | ||||
| 1 - 5 years | ||||
| More than 5 years | ||||
| Minimum lease payments, net | ||||
The Company previously entered into
license agreements with Agriculture Canada (AG) for a technology to increase the concentration of avenanthramides in selected oat and
with University of Alberta for a Pressurized Gaz expanded Technology (PGX) for the processing of various polymers. The royalty percentage
rate would be
| 18 |
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Introduction
This 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 months ended March 31, 2025. 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 March 31, 2025 and December 31, 2024, and for the three months ended March 31, 2025 and 2024. Our unaudited interim consolidated financial statements have been prepared in accordance with IFRS Accounting Standards as issued by the International Accounting Standards Board.
The Company’s common shares are listed on both The Nasdaq Capital Market (“Nasdaq”) and on the Toronto Stock Exchange (“TSX”) under the symbol “CSCI”.
All 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 May 13, 2025. This MD&A is dated May 13, 2025.
About Forward-Looking Statements
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.
Forward-looking statements are based on the opinions and estimates of the Company as of the date of this MD&A, and they are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking statements, including but not limited to the factors described in “Risk Factors and Uncertainties” and those 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), AIM Biologicals and Delayed Clearance Parathyroid Hormone (DC-PTH) programs; the Company’s positioning in its target markets; potential impacts of changes to the Company’s executive leadership; 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 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 our ability to address identified material weaknesses; and the plans, objectives, future outlook and financial position of the Company in general.
| 1 |
Forward-looking statements involve known and unknown risks and uncertainties, and other factors which may cause the actual results, performance or achievements stated herein to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Such risks and uncertainties include, among others: the 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 Company operates; 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; 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 Childhood Onset Growth Hormone Deficiency (“CGHD”) may impact the market for macimorelin (Macrilen®; Ghryvelin®) in adult hormone growth deficiency (“AGHD”) and the existing relationships we have for that product; ability to raise capital and obtain financing to continue our currently planned operations; the impacts of the sunsetting of our ALS, DC-PTH and AIM Biologicals programs; our ability to accelerate the scale up of our PGX Technology to commercial levels; 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 (“NASDAQ”) or the Toronto Stock Exchange (“TSX”).
These risk factors are not intended to represent a complete list of the risk factors that could affect the Company. These factors and assumptions, however, should be considered carefully. More detailed information about these and other factors is included under “Risk Factors” in the Annual Report on Form 20-F and in other documents incorporated herein by reference.
However, we advise you to review any further disclosures we make on related subjects in our reports on Form 6-K filed or furnished to the SEC and in our other public disclosure filed under our profile on SEDAR+ at www.sedarplus.ca.
Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements, there may be other factors that cause results not to be as anticipated, estimated or intended. Many of these factors are beyond our control. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements, particularly in light of any resulting impacts on the global economy and on the Company’s business. Accordingly, readers should not place undue reliance on forward-looking statements. The Company does not undertake to update any forward-looking statements contained herein, except as required by applicable securities laws. New factors emerge from time to time, and it is not possible for the Company to predict all of these factors, or to assess in advance the impact of each such factor on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement.
About Material Information
This 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.
| 2 |
We 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 at the following addresses: www.cosciensbio.com, www.sedarplus.ca and www.sec.gov.
Company Overview
COSCIENS Biopharma Inc. (together with its subsidiaries, the “Company”), formerly Aeterna Zentaris Inc., is a Life Science company developing and commercializing a diversified portfolio of products for the cosmeceutical, nutraceutical and pharmaceutical markets. These products are produced using the Company’s proprietary technologies. The Company’s patented technologies include the Pressurized Gas eXpanded (PGX) technology, which is a unique technology that generates high-value yields of active ingredients from natural based resources for use in novel cosmeceutical, nutraceutical and pharmaceutical 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.
Plan of Arrangement
On December 14, 2023, Aeterna Zentaris Inc. (“Aeterna”) and Ceapro Inc. (“Ceapro”) entered into a binding arrangement agreement pursuant to which Aeterna would acquire all of the issued and outstanding common shares of Ceapro (the “Transaction”) by way of a plan of arrangement. The Transaction was consummated on June 3, 2024.
Following the closing of the Transaction, former shareholders of Ceapro owned approximately 50% of the Aeterna common shares on a fully diluted basis and former shareholders of Aeterna owned approximately 50% of the Aeterna common shares on a fully diluted basis. For financial reporting and accounting purposes, Ceapro is the acquirer of Aeterna in the Transaction. The condensed interim consolidated financial statements of COSCIENS Biopharma Inc. as of March 31, 2025 and December 31, 2024 and for the three months ended March 31, 2025 and 2024 reflect the results of operations and financial position of Ceapro for the periods presented and includes the results of operations of Aeterna subsequent to the Transaction, which was completed on June 3, 2024.
Effective June 30, 2024, Ceapro has changed its reporting currency from Canadian dollars to U.S. dollars. This change in reporting currency has been applied retrospectively such that all amounts in the consolidated financial statements of the Company and the accompanying notes thereto are expressed in U.S. dollars. References to “$” are U.S. dollars and references to “CA $” are to Canadian dollars. For comparative purposes, historical consolidated financial statements of Ceapro were recast in U.S. dollars by translating assets and liabilities at the closing exchange rate in effect at the end of the respective period, revenues, expenses and cash flows at the average exchange rate in effect for the respective period and equity transactions at historical exchange rates. Translation gains and losses are included in the cumulative foreign currency translation adjustment, which is reported as a component of shareholders’ equity under accumulated other comprehensive loss.
Management Succession Plan
On April 14, 2025, the Company announced the appointment of Anna Biehn as its new Chief Executive Officer, with her role commencing effective May 5, 2025. Ms. Biehn brings over 25 years of global general management and marketing experience across the consumer products and biosciences industries. The outgoing CEO, Gilles Gagnon has transitioned to a role as a special consultant to the CEO to support a smooth leadership transition.
| 3 |
Key Operational Developments
Active ingredients
The Company’s active ingredient segment focuses on leveraging our unique expertise in the extraction, production and commercialization of active ingredients from natural sources. The Company’s commercialized products are well positioned in the cosmeceutical market and mostly focused on the documented health benefits of two bio actives extracted from oats; beta glucan and avenanthramides. These products include:
| ● | A commercial line of natural active ingredients, including beta glucan, avenanthramides (colloidal oat extract), oat powder, oat oil, and oat peptides, which are marketed to the personal care, cosmetic, medical, and animal health industries through our distribution partners and direct sales; |
| ● | A commercial line of natural anti-aging skincare products, utilizing active ingredients including oat beta glucan and avenanthramides, which are marketed to the cosmeceuticals market through our wholly owned subsidiary, JuventeDC Inc.; and |
| ● | Veterinary therapeutic products, including an oat shampoo, an ear cleanser, and a dermal complex/conditioner, which are manufactured and marketed to veterinarians in Japan and Asia. |
The Company’s core technologies used to extract and process bio actives include proprietary Ethanol Fractionation Processes (EFP) and Pressurized Gas eXpanded (PGX) Technology. EFP is mostly used to produce liquid formulations while PGX is used for powder formulations. PGX is a patented, unique and disruptive technology with several key advantages over conventional drying and purification technologies that can be used to process biopolymers into high-value and novel biocomposites. In a single step and using green solvents, it has the ability to generate purified highly porous polymer composites such as aerogels which cannot be made using conventional drying technologies. In 2023, the Company commenced a collaboration with Austria-based NATEX Prozesstechnologie GesmbH to accelerate the scale-up of PGX Technology at both its Edmonton facility and at the Natex Termitz facility. Construction of the PGX unit in Edmonton was completed in Q4, 2024, and both units are expected to be fully operational by the end of 2025.
Given the well-known properties of oat beta glucan and avenanthramides as cholesterol reducer and anti-inflammation respectively, we are actively developing our oat-based pipeline products to address unmet needs within the nutraceuticals markets, with a strategic focus on:
| 4 |
Oat Beta Glucan – Chewable for cholesterol reduction
Leveraging approved claims for the use of oat beta glucan as a proven cholesterol reduction ingredient in Canada, the United States of America and the European Union, the Company has formulated a healthy edible product capable of delivering the appropriate dose of oat beta glucan to meet all regulatory and health requirements. Commercial manufacturing samples have been produced, proving manufacturability of a healthy and delicious edible product containing the high levels of oat beta glucan required to provide a scientifically proven cholesterol reduction in humans. The Company intends to bring this product to the wellness and functional food market B2C via various e-commerce platforms by the end of 2025.
Avenanthramides – nutraceutical-chewable formulation to reduce inflammation
In addition to cosmetic applications, avenanthramides, when taken orally, could treat inflammation-based conditions such as exercise induced inflammation, joint inflammation as well as inflammation at the gastro-intestinal and cardiovascular levels.
Through the use of a unique chromatography purification technology, the Company has successfully developed a highly purified and well characterized pharmaceutical grade powder formulation with the goal that such active pharmaceutical ingredient (API) could be offered as both nutraceutical and pharmaceutical formulations.
The Company’s initial activities for use of avenanthramides in nutraceuticals were focused on assessing the bio-availability and bio-efficacy of the compound under the leadership of Dr. Li Li Ji at the University of Minnesota. Following the completion of the bio-availablity study in 2018, the Company successfully completed two bio-efficacy studies in 2019 using low and high doses of avenanthramides with young men and women demonstrating in a statistically significant manner the efficacy of avenanthramides in alleviating exercise-induced inflammation as evidenced by a significant decrease of inflammation biomarkers in the blood. These studies paved the way for the development of products like superfine oat flour enriched with Avenanthramides used for the production of nutraceuticals as well as for the development of a pharmaceutical grade tablet for clinical trials. The Company is initiating the production of enriched oat flour at small commercial scale at the Edmonton facility.
Beta glucan from yeast (YBG)- nutraceutical-capsule as an immune booster
While yeast beta glucan is a commercial product with well-known immune properties, the obtention of a consistently high-purity product represents a major challenge for suppliers. Using the PGX technology, the Company has successfully processed several formulations of yeast beta glucan that should enable the offer of a very high purity YBG product with very well-defined specifications. The Company further demonstrated the mechanism of action following in vitro and in vivo studies.
Powder formulation produced in Edmonton, using the 50-litre PGX technology, will be offered in capsules as an immune booster product.
Pharmaceutical
The Company is also dedicated to the development of its pharmaceutical therapeutic assets and has established a clinical and pre-clinical development pipeline to potentially address unmet medical needs across a number of indications.
During the third quarter of 2024, the Company made a strategic decision to discontinue its AIM Biological, Amyotrophic Lateral Sclerosis (ALS), and Delayed Clearance Parathyroid Hormone programs. This decision was influenced by several factors, including increasingly challenging timelines and costs associated with reaching the next value inflection point in pre-clinical development.
| 5 |
On August 27, 2024, the Company announced that the Phase 3 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. Based on the results of the study, we are prioritizing our pipeline moving forward and repositioning the Company as a pure play Life Science’s business offering natural-based products. Therefore, while macimorelin for the diagnosis of Adult Growth Hormone Deficiency is still on the market, the Company has decided to not make any future investments in macimorelin for the diagnosis of CGHD and is exploring and validating several options for its commercialization with adults, including the potential to divest this asset.
Macimorelin Commercialization Program
Macrilen® (macimorelin), 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 patients with AGHD. Macimorelin is currently marketed under the tradename Ghryvelin® in the European Economic Area and the United Kingdom through an exclusive licensing agreement with Pharmanovia. To date the product has launched in the United Kingdom, Sweden, Denmark, Finland, Germany, Netherlands and Austria.
Avenanthramides for Potential Applications in Inflammation Based Diseases
Avenanthramides have garnered significant interest due to their suggested bioactivities, including potent antioxidant and anti-inflammatory effects both in vitro and in vivo. In November 2023, the Company initiated a Phase 1 safety study evaluating its flagship product, avenanthramides, for potential applications in managing conditions related to inflammation. The Phase 1-2a study (“AvenActive”) is a double-blind, placebo-controlled, randomized, adaptive, first-in-human study designed to assess safety, tolerability, and pharmacokinetics of single and multiple ascending oral doses of avenanthramide. 72 healthy subjects have completed the Phase 1 portion of the trial which included 48 healthy subjects in a single ascending dose (SAD) arm and 24 healthy subjects in a multiple ascending dose (MAD) arm .
Subjects received doses ranging from 30mg to 960mg per group per day. Given that no significant adverse reactions have been observed during SAD and MAD phases, The Data Safety and Monitoring Board recommended to start the Phase 2a with patients suffering from mild inflammation. A total of 20 patients will be enrolled in the Phase 2a portion which is designed to gather initial insights into its potential efficacy. As the trial progresses, the Company remains focused on collaborating with regulatory authorities, healthcare professionals, and patient communities to bring this innovation to market.
| 6 |
Consolidated Statements of Loss and Comprehensive Loss Data
| (in thousands of US dollars, except loss per share) | Three months ended | |||||||
| March 31, | ||||||||
| 2025 | 2024 | |||||||
| $ | $ | |||||||
| Revenues | 1,500 | 2,057 | ||||||
| Cost of sales | (1,057 | ) | (1,153 | ) | ||||
| Gross profit | 443 | 904 | ||||||
| Research and development | (1,134 | ) | (1,062 | ) | ||||
| Selling, general and administrative | (2,926 | ) | (1,656 | ) | ||||
| Loss from operations | (3,617 | ) | (1,814 | ) | ||||
| Other income (loss) | (38 | ) | 1 | |||||
| (Loss) income before income taxes | (3,655 | ) | (1,813 | ) | ||||
| Income tax recovery | - | 412 | ||||||
| Net loss | (3,655 | ) | (1,401 | ) | ||||
| Other comprehensive loss: | ||||||||
| Items that may be reclassified subsequently to profit or loss: | ||||||||
| Foreign currency translation adjustments | (496 | ) | (456 | ) | ||||
| Items that will not be reclassified subsequently to profit or loss: | ||||||||
| Actuarial gain on defined benefit plans | 1,110 | - | ||||||
| Comprehensive loss | (3,041 | ) | (1,857 | ) | ||||
| Basic loss per share | 1.16 | 0.76 | ||||||
| Weighted average number of shares outstanding (basic) | 3,144,682 | 1,847,718 | ||||||
| 7 |
Revenue and cost of sales
The following table summarizes our gross margin earned during the periods indicated:
| (in thousands of US dollars, except percentages) | Three months ended March 31, | |||||||||||||||
| 2025 | 2024 | Change | Change | |||||||||||||
| $ | $ | $ | % | |||||||||||||
| Revenue | ||||||||||||||||
| Active ingredients | 1,387 | 2,057 | (670 | ) | (33 | %) | ||||||||||
| Pharmaceutical | 113 | - | 113 | 100 | % | |||||||||||
| Total revenue | 1,500 | 2,057 | (557 | ) | (27 | %) | ||||||||||
| Cost of sales | ||||||||||||||||
| Active ingredients | (1,018 | ) | (1,153 | ) | 135 | 12 | % | |||||||||
| Pharmaceutical | (39 | ) | - | (39 | ) | (100 | %) | |||||||||
| Total cost of sales | (1,057 | ) | (1,153 | ) | 96 | 8 | % | |||||||||
| Gross Margin | 443 | 904 | (461 | ) | (51 | %) | ||||||||||
| Gross Margin % | 30 | % | 44 | % | ||||||||||||
Our total revenue for the three-month period ended March 31, 2025, was $1.5 million as compared to $2.1 million for the same period in 2024, a decrease of $0.6 million. This decrease was primarily due to a decrease of $0.7 million in sales of Avenanthramides, Beta Glucan and Oat Oil from prior period, offset by $0.1 million in Macrilen revenue due to the acquisition of Aeterna as described in the plan of arrangement section above. Cost of sales for the three-month period ended March 31, 2025, decreased by $0.1 million, primarily due to the lower sales volumes during the period. The gross margin for the three-month period ended March 31, 2025, was $0.4 million as compared to $0.9 million for the same period in 2024, a decrease of $0.5 million, in line with the movements in revenue.
Research and development expenses
The following table summarizes our research and development expenses incurred during the periods indicated:
| (in thousands of US dollars, except percentages) | Three months ended March 31, | |||||||||||||||
| 2025 | 2024 | Change | Change | |||||||||||||
| $ | $ | $ | % | |||||||||||||
| Direct research and development expenses: | ||||||||||||||||
| Avenanthramides for inflammation-based diseases | 311 | 750 | (439 | ) | (59 | %) | ||||||||||
| Macimorelin pediatric DETECT-trial | 300 | - | 300 | 100 | % | |||||||||||
| Other programs | 95 | 87 | 15 | 19 | % | |||||||||||
| Sub total | 706 | 837 | (124 | ) | (15 | %) | ||||||||||
| Employee-related expenses | 391 | 225 | 166 | 74 | % | |||||||||||
| Facilities, depreciation, and other expenses | 37 | - | 30 | 429 | % | |||||||||||
| Total | 1,134 | 1,062 | 72 | 7 | % | |||||||||||
Our total research and development expenses were consistent quarter over quarter with an increase of $0.1 million related to timing.
| 8 |
Selling, general and administrative expenses
The following table summarizes our Selling, general and administrative expenses incurred during the period indicated:
| (in thousands of US dollars, except percentages) | Three months ended March 31, | |||||||||||||||
| 2025 | 2024 | Change | Change | |||||||||||||
| $ | $ | $ | % | |||||||||||||
| Selling, general and administrative expenses: | ||||||||||||||||
| Salaries & benefits | 1,259 | 363 | 896 | 246 | % | |||||||||||
| Insurance | 289 | 34 | 255 | 750 | % | |||||||||||
| Professional fees | 561 | 844 | (283 | ) | (34 | %) | ||||||||||
| Other office & general expenses | 817 | 415 | 402 | 97 | % | |||||||||||
| Total selling, general and administrative expenses | 2,926 | 1,656 | 1,270 | 77 | % | |||||||||||
Our total selling, general and administrative expenses for the three-month period ended March 31, 2025, were $2.9 million as compared to $1.7 million for the same period in 2024, an increase of $1.2 million. This was primarily attributable to the acquisition of Aeterna as described in the plan of arrangement section above and resulted with:
| ● | An increase in Salaries & benefits of $0.9 million; | |
| ● | An increase in Insurance costs $0.2 million; and | |
| ● | An increase in office & general expenses of $0.4 million; offset by | |
| ● | A decrease in professional fees of $0.3 million primarily due to the additional legal costs in 2024 related to the transaction |
Net loss
For the three-month period ended March 31, 2025, we reported a consolidated net loss of $3.7 million, or $1.16 loss per common share, as compared with a consolidated net loss of $1.3 million, or $0.76 loss per common share for the same period in 2024. The $2.3 million increase in net loss is attributable to:
| ● | a $0.5 million decrease in gross margin due to a $0.6 million decrease in revenues offset by lower cost of sales of $0.1 million; | |
| ● | an increase in operating expenses of $1.4 million due primarily to the acquisition of Aeterna; and | |
| ● | a decrease in income tax recovery of $0.4 million |
| 9 |
Selected quarterly financial data
| Three months ended | ||||||||||||||||
| (in thousands of US dollars, except for per share data) | March 31, 2025 | December 31, 2024 | September 30, 2024 | June 30, 2024 | ||||||||||||
| $ | $ | $ | ||||||||||||||
| Revenues | 1,500 | 3,322 | 1,871 | 2,337 | ||||||||||||
| Net loss | (3,655 | ) | (6,731 | ) | (5,755 | ) | (1,422 | ) | ||||||||
| Net loss per share (basic and diluted) (1) | (1.16 | ) | (2.15 | ) | (1.85 | ) | (0.64 | ) | ||||||||
| Three months ended | ||||||||||||||||
| (in thousands of US dollars, except for per share data) | March 31, 2024 | December 31, 2023 | September 30, 2023 | June 30, 2023 | ||||||||||||
| $ | $ | $ | $ | |||||||||||||
| Revenues | 2,057 | 1,213 | 1,952 | 1,392 | ||||||||||||
| Net loss | (1,401 | ) | (1,565 | ) | (776 | ) | (860 | ) | ||||||||
| Net loss per share (basic and diluted) (1) | (0.76 | ) | (0.85 | ) | (0.42 | ) | (0.47 | ) | ||||||||
| (1) | Net loss per share is based on the weighted average number of shares outstanding during each reporting period, which may differ on a quarter-to-quarter basis. As such, the sum of the quarterly net loss per share amounts may not equal full-year net loss per share. |
Historical quarterly results of operations and net loss cannot be taken as reflective of recurring revenue or expenditure patterns of predictable trends, largely given the non-recurring nature of certain components of our revenues, unpredictable quarterly variations in net finance income and of foreign exchange gains and losses. Historical quarterly sales and results primarily fluctuate due to variations in the timing of customer orders of different product mixes, and changes in the optimal use of our capacity to manufacture products.
Consolidated Statements of Financial Position Data
| (in thousands of US dollars) | March 31, 2025 | December 31, 2024 | ||||||
| $ | $ | |||||||
| Cash and cash equivalents | 13,758 | 16,393 | ||||||
| Trade and other receivables and other assets | 4,141 | 4,897 | ||||||
| Inventory | 2,455 | 2,691 | ||||||
| Restricted cash equivalents | 128 | 123 | ||||||
| Property, equipment and intangible assets | 10,659 | 10,966 | ||||||
| Total assets | 31,141 | 35,070 | ||||||
| Payables, accrued liabilities and income taxes payable | 4,820 | 4,835 | ||||||
| Current portion of provisions | 240 | 385 | ||||||
| Current portion of deferred revenues | 122 | 120 | ||||||
| Lease liabilities | 2,226 | 2,310 | ||||||
| Warrant and DSU liabilities | 1,624 | 1,611 | ||||||
| Non-financial non-current liabilities (1) | 11,965 | 12,648 | ||||||
| Total liabilities | 20,997 | 21,909 | ||||||
| Shareholders’ equity | 10,144 | 13,161 | ||||||
| Total liabilities and shareholders’ equity | 31,141 | 35,070 | ||||||
| (1) | Comprised mainly of employee future benefits and non-current portion of deferred revenues. |
| 10 |
Liquidity and capital resources
The Company’s objective in managing capital, consisting of shareholders’ equity, with cash and cash equivalents and restricted cash equivalents being its primary components, is to ensure sufficient liquidity to finance its manufacturing operations, R&D costs, selling, general and administrative expenses and working capital requirements. Historically, the Company has raised capital via public and private equity offerings and issuances as its primary source of liquidity. The capital management objective of the Company remains the same as that in previous periods. The policy on dividends is to retain cash to keep funds available to finance the activities required to advance the Company’s product development portfolio and to pursue appropriate commercial opportunities as they may arise. The Company is not subject to any capital requirements imposed by any regulators or by any other external source.
Cash flows
The following table shows a summary of our consolidated cash flows for the periods indicated:
| (in thousands of US dollars) | Three months ended | |||||||
| March 31, | ||||||||
| 2025 | 2024 | |||||||
| $ | $ | |||||||
| Cash and cash equivalents – Beginning of period | 16,393 | 6,678 | ||||||
| Net cash used in operating activities | (1,880 | ) | (2,380 | ) | ||||
| Net cash used in financing activities | (200 | ) | (94 | ) | ||||
| Net cash used in investing activities | (615 | ) | (564 | ) | ||||
| Effect of exchange rate changes on cash & cash equivalents | 60 | (134 | ) | |||||
| Cash and cash equivalents – End of period | 13,758 | 3,506 | ||||||
Operating Activities
Cash used by operating activities was $1.9 million for the three-month period ended March 31, 2025, as compared to $2.4 million in the same period in 2024. This $0.5 million decrease in operating cash outflows is attributed primarily to:
| ● | a $0.5 million decrease in gross margin; and | |
| ● | an increase in operating costs of $1.4 million; offset by | |
| ● | a $1.4 million increase in changes in operating assets and liabilities from the previous period due primarily to the acquisition of Aeterna. |
Investing activities
Cash used in investing activities totaled $0.6 million for the three-month period ended March 31, 2025, as compared to $0.6 million in the same period in 2024, remaining consistent quarter over quarter.
Financing activities
Cash used in financing activities totaled $0.2 million for the three-month period ended March 31, 2025, as compared to $0.1 million for the three-month period ended March 31, 2024. This $0.1 million increase in cash flows used in financing activities is primarily related to additional payments of lease liabilities.
Capital Stock
As of May 12, 2025, we had 3,146,772 common shares issued and outstanding, as well as, 114,556 stock options, 64,750 deferred share units and 661,987 warrants outstanding. Each stock option, deferred share unit and warrant is exercisable for one common share.
| 11 |
Adequacy of financial resources
As of March 31, 2025, the Company had an accumulated deficit of $14.7 million and a net loss of $3.7 million resulting in negative cash flows from operations of $1.9 million for the three-month period ended March 31, 2025. We believe that our existing cash on hand will be sufficient to fund our anticipated operating and capital expenditure requirements for at least the next 12 months. We plan to finance our future operations and capital expenditures primarily through products sales and cash on hand. We also believe that our existing cash on hand will be sufficient to fund our anticipated operating and capital expenditure requirements beyond the next 12 months and through to June 2026. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our capital resources sooner than we expect. We may also require additional capital to pursue in-licenses or acquisitions of other product candidates.
Our forecast of the period through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially as a result of a number of factors. Our future capital requirements are difficult to forecast and will depend on many factors, including:
| ● | the terms and timing of any other collaboration, licensing, and other arrangements that we may establish; | |
| ● | the initiation, progress, timing, and completion of preclinical studies and clinical trials for our current and future potential product candidates, as well as other research and development programs; | |
| ● | our alignment with health authorities on regulatory approval requirements; | |
| ● | the number and characteristics of product candidates that we pursue; | |
| ● | the outcome, timing, and cost of regulatory approvals; | |
| ● | delays that may be caused by changing regulatory requirements; | |
| ● | the cost and timing of hiring new employees to support our continued growth and potential expense associated with any loss of key personnel; | |
| ● | the costs involved in filing and prosecuting patent applications and enforcing and defending patent claims; | |
| ● | the costs of filing and prosecuting intellectual property rights and enforcing and defending any intellectual property-related claims; | |
| ● | the costs associated with any potential late receipt or non-receipt of trade and other receivables; | |
| ● | the potential costs associated with foreign currency fluctuations or changing interest rates; | |
| ● | our ability to expand our customer base and related demand fluctuations; | |
| ● | the costs associated with any potential interruption or quality impacts on raw material supplies; | |
| ● | 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 the macroeconomic framework in which we operate. | |
| ● | the costs of responding to and defending ourselves against complaints and potential litigation; | |
| ● | the costs and timing of procuring clinical and commercial supplies for our product candidates; and | |
| ● | the extent to which we acquire or in-license other product candidates and technologies. |
Contractual obligations and commitments as of March 31, 2025
Significant expenditure contracted for at the end of the reporting period but not recognized as liabilities is as follows:
| (in thousands of US dollars) | TOTAL | |||
| $ | ||||
| Less than 1 year | 525 | |||
| 1 - 5 years | - | |||
| 525 | ||||
The Company previously entered into license agreements with Agriculture Canada (AG) for a technology to increase the concentration of avenanthramides in selected oat and with University of Alberta for a Pressurized Gas eXpanded Technology (PGX) for the processing of various polymers. The royalty percentage rate would be 2% strictly for sales made from avenanthramides produced from the AG technology while royalty percentage rates would range between 1.0% to 3.5% for sales made from products manufactured using the PGX Technology, the rate being according to the classification of the resulting product (cosmeceutical, nutraceutical, pharmaceutical).
| 12 |
Contingencies
From time to time, the Company may be a party to litigation and subject to claims incidental to its business. Although the results of litigation and claims cannot be predicted with certainty, the Company currently believes that the final outcome of these matters will not have a material adverse effect on its business. At each reporting period, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable, requiring recognition of a loss accrual, or whether the potential loss is reasonably possible, requiring potential disclosure.
Critical Accounting Estimates and Judgments
Critical accounting estimates and assumptions, as well as critical judgements used in applying accounting policies in the preparation of the Company’s condensed interim consolidated financial statements, were the same as those applied to Company’s annual consolidated financial statements as of and for the year ended December 31, 2024, except for those noted in note 2 of the interim condensed consolidated financial statements for the period ended March 31, 2025.
Financial Risk Factors and Other Financial Instruments
The nature and extent of our exposure to risks arising from financial instruments, including credit risk, liquidity risk and market risk and how we manage those risks are described in note 23 to our audited consolidated financial statements as of December 31, 2024.
Related Party Transactions
During the three-month period ended March 31, 2025, other than employment agreements and indemnification agreements with our management, there are no further related party transactions.
Off-Balance Sheet Arrangements
As of March 31, 2025, we did not have any interests in special purpose entities or any other off-balance sheet arrangements.
Risk Factors and Uncertainties
An investment in our securities involves a high degree of risk. In addition to the other information included in this MD&A and in the related consolidated financial statements, investors are urged to carefully consider the risks described under the heading “Risk Factors” in the Annual Report on Form 20-F for the year ended December 31, 2024 and under the heading “Risks and Uncertainties”, for a discussion of the various risks that may materially affect our business. The risks and uncertainties not presently known to us or that we currently deem immaterial may also materially harm our business, operating results and financial condition and could result in a complete loss of your investment.
Our most recent Annual Report on Form 20-F was filed with the relevant Canadian securities’ regulatory authorities at www.sedarplus.ca and with the SEC at www.sec.gov, and investors are urged to consult such risk factors.
Disclosure Controls and Procedures
The Chief Executive Officer and the Chief Financial Officer of the Company are responsible for establishing and maintaining our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934 and Canadian securities legislation). Our disclosure controls and procedures are designed to ensure that information required to be disclosed in the reports we file or submit under U.S. and Canadian securities legislation is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including the Chief Executive Officer and the Chief Financial Officer, to allow timely decisions regarding required disclosures.
| 13 |
The Chief Executive Officer and the Chief Financial Officer have evaluated the effectiveness of our disclosure controls and procedures as at March 31, 2025. Based on that evaluation, the Chief Executive Officer and Chief Financial Officer have concluded that these disclosure controls and procedures were not effective as of that date due to the material weaknesses in internal control over financial reporting disclosed in our Annual Report on Form 20-F for the year ended December 31, 2024 available on SEDAR+ at www.sedarplus.ca and on EDGAR at sec.gov and as described below.
Management’s Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting as such term is defined in Rules 13a-15(f) and 15d-15(f) promulgated under the Exchange Act. The Company’s internal control over financial reporting is a process designed under the supervision and with the participation of management, including our Chief Executive Officer and our Chief Financial Officer, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with IFRS.
All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentations. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Our management conducted an evaluation of the effectiveness of our internal control over financial reporting as of March 31, 2025, based on the criteria established in Internal Control – Integrated Framework: 2013 issued by the Committee of Sponsoring Organizations of the Treadway Commission (the “COSO framework”). Based on the results of that evaluation, our management concluded that, as of March 31, 2025, the Company’s internal control over financial reporting was not effective due to the identification of the material weaknesses disclosed in our Annual Report on Form 20-F for the year ended December 31, 2024, and described below.
Material Weaknesses
A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the Company’s annual or interim consolidated financial statements may not be prevented or detected on a timely basis.
Our management concluded that material weaknesses existed as of the year ended December 31, 2024. Specifically, based on the criteria established by the COSO framework, our 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.
The Company underwent a business combination on June 3, 2024 pursuant to which Aeterna combined with Ceapro in a plan of arrangement. As part of the integration of Aeterna and Ceapro, our management has put in place a process to standardize policies and procedures and harmonize controls across the Company in order to develop and operate effective internal control over financial reporting. As the harmonization of these controls remains in progress, the following material weaknesses were identified by management as of December 31, 2024:
Ineffective Control Environment: The Company did not maintain an effective control environment based on the criteria established in the COSO framework. The Company did not have sufficient competent personnel with the appropriate levels of knowledge, experience, and training in accounting and internal control over financial reporting. The material weakness in the control environment led to the additional material weaknesses detailed below.
Ineffective Control Activities: The Company did not maintain effective control activities based on the criteria established in the COSO framework. Specifically, these control deficiencies constitute material weaknesses, either individually or in the aggregate:
| (a) | Control activities were not designed, implemented or performed in a timely manner to support the operating effectiveness of the controls to prevent and detect potential material errors. |
| 14 |
| (b) | The Company lacked sufficient personnel with appropriate technical training in, and experience with, IFRS to allow for a detailed review of complex accounting transactions that would identify errors in a timely manner, including in areas such as revenue recognition, inventory, fixed assets and impairment of assets. |
| (c) | The Company did not have an adequate segregation of duties or appropriate level of review that is needed to comply with financial reporting requirements, including segregation of duties over the preparation, independent review, and recording of journal entries. |
Ineffective Information and Communication: Management was unable to generate or provide adequate quality supporting information and communication based on the criteria established in the COSO framework. Management concluded that the Information Technology General Controls were not operating effectively, undermining the Information Technology environment’s capability to support the integrity of financial reporting, with deficiencies identified across all key Information Technology General Controls areas in scope.
Ineffective Monitoring Activities: The Company did not maintain effective monitoring activities based on the criteria established in the COSO framework. Management identified that the Company did not have in place adequate processes for oversight, accountability for performance of internal control over financial reporting responsibilities, and timely implementation of corrective activities, and therefore could not perform sufficient ongoing evaluations to ascertain whether the components of internal control were present and functioning.
Management’s Plan to Remediate the Material Weaknesses
We have developed and are in the process of implementing a remediation plan to address the material weaknesses discussed above and to improve our internal control over financial reporting. The remediation plan includes:
| ● | We are evaluating our long-term resource needs and requirements to ensure we have adequate resources with the necessary technical knowledge, oversight and accountability to ensure there is adequate segregation of duties and to satisfy the Company’s internal control over financial reporting needs and requirements. We have also committed to providing the Company’s personnel with the necessary guidance and on-the-job training to effectively perform their responsibilities related to internal control over financial reporting. |
| ● | We will formalize the documentation of internal control over financial reporting at the Company to assist in assessing, implementing and maintaining an effective control environment, including: scoping and risk assessment; business process flows; risk control matrices; and the evaluation of the design and operating effectiveness of controls. |
| ● | We are implementing a formal monitoring program over our internal control framework that will more effectively identify, evaluate and remediate deficiencies than the current year and regularly report on progress of internal control remediation efforts to the audit committee during 2025. |
| ● | We will implement additional system capabilities and enhance existing controls that support management’s assertions with respect to the completeness, accuracy and validity of complex accounting transactions on a timely basis. |
Although the documentation of internal control over financial reporting has been formalized, the material weaknesses will not be remediated until the necessary controls have been fully implemented and are operationally effective. As we finalize and implement the remediation plan outlined above, we may also identify additional measures to address the material weaknesses or modify certain of the remediation procedures described above. We also may implement additional changes to our internal control over financial reporting as may be appropriate in the course of remediating the material weakness. There can be no assurance that the measures we take in response to the material weaknesses described above will be sufficient to remediate such material weaknesses or to avoid potential future material weaknesses or significant deficiencies.
The material weaknesses will continue to be addressed through 2025.
Changes in Internal Control Over Financial Reporting
There have been no significant changes to our internal controls over financial reporting for the three-month period ended March 31, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls over financial reporting.
| 15 |
Exhibit 99.3
FORM 52-109F2
CERTIFICATION OF INTERIM FILINGS
FULL CERTIFICATE
I, Anna Biehn, Chief Executive Officer, COSCIENS Biopharma Inc., certify the following:
| 1. | Review: I have reviewed the interim financial report and interim MD&A (together, the “interim filings”) of COSCIENS Biopharma Inc. (the “issuer”) for the interim period ended March 31, 2025. |
| 2. | No misrepresentations: Based on my knowledge, having exercised reasonable diligence, the interim filings do not contain any untrue statement of a material fact or omit to state a material fact required to be stated or that is necessary to make a statement not misleading in light of the circumstances under which it was made, with respect to the period covered by the interim filings. |
| 3. | Fair presentation: Based on my knowledge, having exercised reasonable diligence, the interim financial report together with the other financial information included in the interim filings fairly present in all material respects the financial condition, financial performance and cash flows of the issuer, as of the date of and for the periods presented in the interim filings. |
| 4. | Responsibility: The issuer’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (DC&P) and internal control over financial reporting (ICFR), as those terms are defined in National Instrument 52-109 Certification of Disclosure in Issuers’ Annual and Interim Filings, for the issuer. |
| 5. | Design: Subject to the limitations, if any, described in paragraphs 5.2 and 5.3, the issuer’s other certifying officer(s) and I have, as at the end of the period covered by the interim filings |
| (a) | designed DC&P, or caused it to be designed under our supervision, to provide reasonable assurance that |
| (i) | material information relating to the issuer is made known to us by others, particularly during the period in which the interim filings are being prepared; and | |
| (ii) | information required to be disclosed by the issuer in its annual filings, interim filings or other reports filed or submitted by it under securities legislation is recorded, processed, summarized and reported within the time periods specified in securities legislation; and |
| (b) | designed ICFR, or caused it to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with the issuer’s GAAP. |
| 5.1 | Control framework: The control framework the issuer’s other certifying officer(s) and I used to design the issuer’s ICFR is Internal Control – Integrated Framework: 2013, issued by the Committee of Sponsoring Organizations of the Treadway Commission. |
| 5.2 | ICFR – material weakness relating to design: The issuer has disclosed in its interim MD&A for each material weakness relating to design existing at the end of the interim period |
| 1 | a description of the material weakness; | |
| 2 | the impact of the material weakness on the issuer’s financial reporting and its ICFR; and | |
| 3 | the issuer’s current plans, if any, or any actions already undertaken, for remediating the material weakness |
| 5.3 | N/A |
| 6. | Reporting changes in ICFR: The issuer has disclosed in its interim MD&A any change in the issuer’s ICFR that occurred during the period beginning on January 1, 2025 and ended on March 31, 2025 that has materially affected, or is reasonably likely to materially affect, the issuer’s ICFR. |
| Date: May 13th, 2025 | |
| /s/ Anna Biehn | |
| Anna Biehn | |
| Chief Executive Officer |
Exhibit 99.4
FORM 52-109F2
CERTIFICATION OF INTERIM FILINGS
FULL CERTIFICATE
I, Giuliano La Fratta, Chief Financial Officer, COSCIENS Biopharma Inc., certify the following:
| 1. | Review: I have reviewed the interim financial report and interim MD&A (together, the “interim filings”) of COSCIENS Biopharma Inc. (the “issuer”) for the interim period ended March 31, 2025. |
| 2. | No misrepresentations: Based on my knowledge, having exercised reasonable diligence, the interim filings do not contain any untrue statement of a material fact or omit to state a material fact required to be stated or that is necessary to make a statement not misleading in light of the circumstances under which it was made, with respect to the period covered by the interim filings. |
| 3. | Fair presentation: Based on my knowledge, having exercised reasonable diligence, the interim financial report together with the other financial information included in the interim filings fairly present in all material respects the financial condition, financial performance and cash flows of the issuer, as of the date of and for the periods presented in the interim filings. |
| 4. | Responsibility: The issuer’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (DC&P) and internal control over financial reporting (ICFR), as those terms are defined in National Instrument 52-109 Certification of Disclosure in Issuers’ Annual and Interim Filings, for the issuer. |
| 5. | Design: Subject to the limitations, if any, described in paragraphs 5.2 and 5.3, the issuer’s other certifying officer(s) and I have, as at the end of the period covered by the interim filings |
| (a) | designed DC&P, or caused it to be designed under our supervision, to provide reasonable assurance that |
| (i) | material information relating to the issuer is made known to us by others, particularly during the period in which the interim filings are being prepared; and | |
| (ii) | information required to be disclosed by the issuer in its annual filings, interim filings or other reports filed or submitted by it under securities legislation is recorded, processed, summarized and reported within the time periods specified in securities legislation; and |
| (b) | designed ICFR, or caused it to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with the issuer’s GAAP. |
| 5.1 | Control framework: The control framework the issuer’s other certifying officer(s) and I used to design the issuer’s ICFR is Internal Control – Integrated Framework: 2013, issued by the Committee of Sponsoring Organizations of the Treadway Commission. |
| 5.2 | ICFR – material weakness relating to design: The issuer has disclosed in its interim MD&A for each material weakness relating to design existing at the end of the interim period |
| 1 | a description of the material weakness; | |
| 2 | the impact of the material weakness on the issuer’s financial reporting and its ICFR; and | |
| 3 | the issuer’s current plans, if any, or any actions already undertaken, for remediating the material weakness. |
| 5.3 | N/A |
| 6. | Reporting changes in ICFR: The issuer has disclosed in its interim MD&A any change in the issuer’s ICFR that occurred during the period beginning on January 1, 2025 and ended on March 31, 2025 that has materially affected, or is reasonably likely to materially affect, the issuer’s ICFR. |
| Date: May 13th, 2025 | |
| /s/ Giuliano La Fratta | |
| Giuliano La Fratta | |
| Chief Financial Officer |