6-K
COSCIENS Biopharma Inc. (CSCIF)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
6-K
REPORT
OF FOREIGN PRIVATE ISSUER
PURSUANT
TO RULE 13a-16 OR 15d-16 OF THE SECURITIES EXCHANGE ACT OF 1934
For
the month of November, 2024
Commission
File Number: 001-38064
COSCIENS Biopharma Inc.
(Translation of registrant’s name into English)
c/oNorton Rose Fulbright Canada, LLP, 222 Bay Street, Suite 3000, PO Box 53, Toronto ON M5K 1E7
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
Exhibit 99.1 included with this Report on Form 6-K is hereby incorporated by reference into the Company’s Registration Statements on Form S-8 (No. 333-224737, No. 333-210561, No. 333-200834 and No. 333-279844) (collectively, the “Registration Statements”) and shall be deemed to be a part thereof from the date on which this Report on Form 6-K is furnished, to the extent not superseded by documents or reports subsequently filed or furnished. The information contained on any websites referenced in Exhibit 99.1 included with this Report on Form 6-K is not incorporated by reference or deemed to be a part of this Report on Form 6-K or any of the Registration Statements.
Forward-LookingStatements
The information in this Report on Form 6-K and the exhibit attached hereto and incorporated herein by reference include forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, specifically Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and under the provisions of Canadian securities laws. These forward-looking statements involve a number of known and unknown risks, uncertainties and other factors that could cause actual results and outcomes to be materially different from historical results or from any future results expressed or implied by such forward-looking statements.
Forward-looking statements include, but are not limited to, those relating to the Company’s expectations regarding the anticipated benefits and synergies as well as the assets, cost structure, financial position, cash flows and growth prospects of the combined company.
Risks and factors that could cause actual results or outcomes to differ materially from expectations include, among others, the following:
| ● | the<br> Company’s patented technologies and value-driving products, and development thereof; |
|---|---|
| ● | the<br> extraction, production and commercialization of active ingredients from natural sources and our ability to successfully market related<br> products; |
| ● | the<br> successful development and marketing of our oat-based pipeline products, including oat-beta glucan, avenanthramides and beta glucan<br> from yeast, as well as such products’ capability to address unmet needs within the nutraceuticals markets; |
| ● | Macrilen®<br> (macimorelin) and the Company’s plans in respect of same, including commercialization and clinical programs as well as in respect<br> of the top line data from the DETECT-trial; |
| ● | the<br> Company’s business strategy; |
| ● | the<br> strategic decision to sunset the Company’s Amyotrophic Lateral Sclerosis (ALS) program; |
| ● | the<br> Company’s positioning in its target markets; |
| ● | the<br> Company’s ability to accelerate the scale-up of PGX Technology towards commercial levels; |
| ● | expectations<br> for completion of the Company’s Edmonton facility and Natex Termitz facility; |
| ● | pre-clinical<br> and clinical studies and trials and their expected timing and results, including the potential to bring certain products to market<br> following such studies and trials; |
| ● | the<br> ability of our pharmaceutical therapeutic assets to address unmet medical needs across a number of indications; |
| ● | management’s<br> assumptions, estimates and judgements; |
| ● | liquidity<br> and capital resources; |
| ● | adequacy<br> of our financial resources to finance operations and expenditure requirements; |
| ● | limitations<br> on internal controls over financial reporting; and |
| ● | the<br> plans, objectives, future outlook and financial position of the Company in general. |
Additional risk factors that could cause actual results to differ materially include those risks identified in Item 3. “Key Information – Risk Factors” contained in the Company’s most recent Annual Report on Form 20-F filed with the SEC and its other filings and submissions from time to time, including those containing its quarterly and annual results, with the SEC, which are available on the Company’s website located at www.cosciensbio.com.
Many of these risks and factors are beyond the Company’s control. The Company cautions you not to place undue reliance on these forward-looking statements. All written and oral forward-looking statements attributable to the Company or persons acting on their behalf, are qualified in their entirety by these cautionary statements. Moreover, unless required by law to update these statements, the Company will not necessarily update any of these statements after the date hereof, either to conform them to actual results or to changes in their expectation.
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:<br> November 12, 2024 | By: | /s/ Giuliano La Fratta |
| Giuliano<br> La Fratta | ||
| Chief<br> Financial Officer |
Exhibit 99.1

Management’sDiscussion 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-month and nine-month period ended September 30, 2024. 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 September 30, 2024, and for the nine-month periods ended September 30, 2024, and 2023. Our unaudited consolidated financial statements have been prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board (“IFRS”).
On June 3, 2024, Aeterna Zentaris Inc. and Ceapro Inc. closed their all-stock merger of equals transaction and on August 6, 2024, the Company changed its name to COSCIENS Biopharma Inc. For further details on these transactions and the basis for presentation of this MD&A, see “Plan of Arrangement” and “Name Change”, below, as well as Note 3 to the unaudited consolidated financial statements.
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 November 11, 2024. This MD&A is dated November 11, 2024.
AboutForward-Looking Statements
The information in this MD&A has been prepared as of November 6, 2024. 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 in this MD&A include, but are not limited to, statements, comments and expectations 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) program; 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.
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Forward-looking statements are necessarily based upon a number of factors and assumptions that, while considered reasonable by the Company as of the date of such statements, are inherently subject to significant business, economic, operational and other risks, uncertainties, contingencies and other factors, including those described below, which could cause actual results, performance or achievements of the Company to be materially different from results, performance or achievements expressed or implied by such forward-looking statements and, as such, undue reliance must not be placed on them.Forward-looking statements involve known and unknown risks and uncertainties which include, among others: the Company’s present and future business strategies; operations performance within expected ranges; anticipated future cash flows; local and global economic conditions and the environment in which the Company operates; anticipated capital and operating costs; uncertainty in technology development as well as product development and related clinical trials and validation studies, including our reliance on the success of the pediatric clinical trial in the European Union and U.S. for Macrilen^®^ (macimorelin); the result of the DETECT-trial may not support receipt of regulatory approval in child-onset growth hormone deficiency; results from ongoing or planned pre-clinical studies of macimorelin by the University of Queensland or for our other products under development may not be successful or may not support advancing the product to human clinical trials; our ability to raise capital and obtain financing to continue our currently planned operations; our now heavy dependence on the success of Macrilen^®^ (macimorelin) and related out-licensing arrangements and the continued availability of funds and resources to successfully commercialize the product; the ability to secure strategic partners for late stage development, marketing, and distribution of our products, including our ability to enter into a new license agreement or similar arrangement following the termination of the license agreement with Novo Nordisk AG; 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.
Investors should consult our quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties, including those discussed in our Annual Report on Form 20-F for the year ended December 31, 2023 and under the heading “Risks and Uncertainties” in Exhibit 99.2 of our Form 6-K furnished to the SEC on May 14, 2024 filed under the Company’s profile on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. We disclaim any obligation to update any such risks or uncertainties or to publicly announce any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or applicable law.
Certain forward-looking statements contained herein about prospective results of operations, financial position or cash flows may constitute a financial outlook. Such statements are based on assumptions about future events that management believe to be reasonable, are given as of the date hereof and are based on economic conditions, proposed courses of action and management’s assessment of currently available relevant information. The Company’s management has approved the financial outlook as of the date hereof. Readers are cautioned that such financial outlook information contained herein should not be used for purposes other than for which it is disclosed herein.
AboutMaterial 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.
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.
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CompanyOverview
COSCIENS Biopharma Inc. is a specialty biopharmaceutical company developing and commercializing a diversified portfolio of products for the cosmeceutical, nutraceutical and pharmaceutical markets. Such products being produced using the Company’s proprietary technologies. The Company’s patented technologies include the Pressurized Gas eXpanded (PGX) technology, which is a unique and disruptive technology that generates high-value yields of active ingredients from natural plant resources for use in novel cosmeceutical, nutraceutical and therapeutics 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.
In addition to our portfolio of nutraceutical and cosmeceutical products and programs, the Company is also conducting a Phase 1/2a clinical trial with the goal of developing our avenanthramides product as an anti-inflamatory. The Company’s lead commercial pharmaceutical product, macimorelin (Macrilen^®^; Ghryvelin^®^), is the first and only U.S. FDA and European Commission approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD).
Planof arrangement
On June 3, 2024, Aeterna Zentaris Inc. (“Aeterna”) and Ceapro Inc. (“Ceapro”) closed their all-stock merger of equals transaction (the “Transaction”). The Transaction was completed by way of court approved plan of arrangement pursuant to the terms of an arrangement agreement entered into by Aeterna and Ceapro on December 14, 2023. As a result of the Transaction, each outstanding Ceapro common share was exchanged for 0.02360 of an Aeterna common share. Additionally, as part of the Transaction, Aeterna issued to its shareholders immediately prior to the closing of the Transaction, 0.47698 of a share purchase warrant (a “New Warrant”) for each Aeterna common share or warrant held.
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 was the acquirer of Aeterna in the Transaction. The consolidated financial statements of COSCIENS Biopharma Inc. as of September 30, 2024, and December 31, 2023 and for the three and nine months ended September 30, 2024 and 2023 reflect the results of operations and financial position of Ceapro for the periods presented and includes 120 days of the results of operations of Aeterna for the three and nine months ended September 30, 2024 subsequent to the Transaction, which was completed on June 3, 2024.
The accompanying consolidated financial statements include the accounts of COSCIENS Biopharma Inc. Inc., an entity incorporated under the Canada Business Corporations Act, and its wholly owned subsidiaries (the “Group”). COSCIENS Biopharma Inc. is the ultimate parent company of the Group. The Company currently has six wholly-owned direct and indirect subsidiaries, Ceapro Inc. and its wholly-owned subsidiaries Ceapro (P.E.I.) and Juvente^DC^ Inc., based in Canada, Aeterna Zentaris GmbH (“AEZS Germany”) and its wholly-owned subsidiary Zentaris IVF GmbH, based in Frankfurt, Germany, and Aeterna Zentaris, Inc., an entity incorporated in the state of Delaware and with offices in Summerville, South Carolina, in the US.
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Management Succession Plan
With the initial integration efforts now well underway, the Board of Directors, with the full support of current President and CEO Gilles Gagnon, M.Sc., MBA, has engaged an executive recruiting firm to identify and evaluate candidates for the next President and CEO role. This search aims to find a visionary leader who will drive COSCIENS forward and build on the company’s successes.
NameChange
At the Company’s annual general and special meeting of shareholders held on July 16, 2024 (while the Company was known as Aeterna Zentaris Inc.), the shareholders of the Company approved a special resolution authorizing the Board to effect a change of name of the Company from “Aeterna Zentaris Inc.” to “COSCIENS Biopharma Inc.” (the “Name Change”). On August 6, 2024, the Company filed articles of amendment pursuant to the Canada Business Corporations Act in order to effect the Name Change.
On August 9, 2024, the Company’s common shares began trading on the TSX and Nasdaq under the trading symbol “CSCI”, and concurrently ceased trading thereon under the former trading symbol “AEZS”. The Name Change did not result in any changes in the capitalization of the Company.
KeyOperational Developments
Activeingredients
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<br> commercial line of natural active ingredients, including beta glucan, avenanthramides (colloidal oat extract), oat powder, oat oil,<br> and oat peptides, which are marketed to the personal care, cosmetic, medical, and animal health industries through our distribution<br> partners and direct sales; |
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| ● | A<br> commercial line of natural anti-aging skincare products, utilizing active ingredients including oat beta glucan and avenanthramides,<br> which are marketed to the cosmeceuticals market through our wholly owned subsidiary, Juvente^DC^ Inc.; and |
| ● | Veterinary<br> therapeutic products, including an oat shampoo, an ear cleanser, and a dermal complex/conditioner, which are manufactured and marketed<br> 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 make generates 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, which are both expected to be completed in 2024.
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:
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OatBeta 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, and having received approval from Health Canada in December 2023, 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 despite 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.
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 chewable oat bar as a nutraceutical 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.
Betaglucan 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 and is now in a position to offer 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.
This product has been used for the completion of the 5 times scale-up of the PGX technology at the Edmonton facility and will also be used for the 10 times scale-up work being conducted in Austria. Powder formulation produced in Edmonton will be offered in capsules as an immune booster product.
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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, including diagnostic tests for growth hormone deficiency and potential treatment of inflammation based diseases.
During the three-month period ended September 30, 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.

MacimorelinCommercialization 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 adult growth hormone deficiency (“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. More EU countries will follow pending re-imbursement negotiations. The Company’s several other license and commercialization partners are also seeking approval for commercialization of macimorelin in Israel and the Palestinian Authority, the Republic of Korea, Turkey and several non-European Union Balkan countries. The Company is actively pursuing business development opportunities for the commercialization of macimorelin in North America, Asia and the rest of the world.
MacimorelinClinical Program
In late 2020, the Company entered into the start-up phase for the clinical safety and efficacy study, AEZS-130-P02 (“DETECT-trial”), evaluating macimorelin for the diagnosis of child growth hormone deficiency (CGHD). The DETECT-trial is an open-label, single dose, multicenter and multinational study was expected to enroll approximately 100 subjects worldwide (incl. sites in U.S: and EU), with at least 40 pre-pubertal and 40 pubertal subjects. The study design was expected to be suitable to support a claim for potential stand-alone testing, if successful. On April 22, 2021, the U.S. FDA Investigational New Drug Application associated with this clinical trial became active, (see: https://clinicaltrials.gov/ct2/show/NCT04786873), and in Q2, 2024, the last patient visit was conducted successfully in Europe and the study had enrolled a combined 100 subjects in Europe and North America.
In Q3, 2024, the Company reported top line data from the DETECT trial. The findings indicated that macimorelin consistently demonstrated its ability to stimulate growth hormone release as required for a growth hormone stimulation test, however, it did not meet the primary efficacy endpoint as defined in the study protocol. The study compared the macimorelin test to current standard growth hormone stimulation tests (arginine and clonidine). Although further analysis are necessary, an initial review suggests that the comparator tests may have resulted in a high false positive rate, affecting macimorelin’s success in achieving the primary efficacy endpoint. These results necessitate further clarification and re-analysis to consider the trial outcome and the strategy moving forward.
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Avenanthramidesfor 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 its 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 will be enrolled in the Phase 1 portion of the trial. The single ascending dose (SAD) arm includes 6 cohorts of 8 healthy subjects, while the multiple ascending dose (MAD) arm will include 3 cohorts of 8 healthy subjects.
The first arm of the SAD phase of the study has been completed with 6 groups of 8 healthy subjects per group received doses ranging from 30mg to 960mg per group per day. No significant adverse reactions have been observed during this SAD phase. The Company initiated the MAD arm during Q3, the summer 2024. Following the Phase 1 portion, pending successful results, the AvenActive protocol also includes a Phase 2a portion for patients presenting evidence of mild to moderate inflammation. A total of 24 patients will be enrolled in the Phase 2a portion.
The Phase 1-2a trial is designed to evaluate the safety profile of avenanthramides and 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 innovative therapy to market.
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CondensedInterim Consolidated Statements of Loss and Comprehensive Loss Data
| (in thousands of US dollars, except loss<br> per share) | Three months<br> ended | Nine months<br> ended | ||||||
|---|---|---|---|---|---|---|---|---|
| September<br> 30, | September<br> 30, | |||||||
| 2024 | 2023 | 2024 | 2023 | |||||
| Revenues | ||||||||
| Cost of sales | ) | ) | ) | ) | ||||
| Gross profit | ||||||||
| Research and development | ||||||||
| Selling, general and administrative | ||||||||
| Impairment of intangible<br> assets | ||||||||
| Loss<br> from operations | ) | ) | ) | ) | ||||
| Gain due to changes in foreign currency | ) | ) | ||||||
| Finance costs | ) | ) | ) | ) | ||||
| Other income | ||||||||
| Change in fair value of<br> warrant and DSU liabilities | ||||||||
| Other income | ||||||||
| Loss before income taxes | ) | ) | ) | ) | ||||
| Income tax recovery | ||||||||
| Net loss | ) | ) | ) | ) | ||||
| Other comprehensive loss: | ||||||||
| Items that may be reclassified subsequently<br> to profit or loss: | ||||||||
| Foreign currency translation adjustments | ) | ) | ) | ) | ||||
| Items that will not be reclassified subsequently<br> to profit or loss: | ||||||||
| Actuarial loss on defined<br> benefit plans | ) | ) | ||||||
| Comprehensive<br> loss | ) | ) | ) | ) | ||||
| Basic<br> and diluted loss per share | ) | ) | ) | ) | ||||
| Weighted average number of shares outstanding<br> (basic and diluted) |
All values are in US Dollars.
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SummarizedInterim Consolidated Statements of Financial Position Data
| (in thousands of US dollars) | September<br>30,<br>2024 | December 31,<br> <br>2023 |
|---|---|---|
| Cash and cash equivalents | ||
| Trade and other receivables and other assets | ||
| Inventory | ||
| Restricted cash equivalents | ||
| Property, equipment and<br> intangible assets | ||
| Total<br> assets | ||
| Payables and accrued liabilities and income<br> taxes payable | ||
| Current portion of provisions | ||
| Current portion of deferred revenues | ||
| Lease liabilities | ||
| Warrants and DSU liabilities | ||
| Non-financial<br> non-current liabilities ^(1)^ | ||
| Total<br> liabilities | ||
| Shareholders’<br> equity | ||
| Total<br> liabilities and shareholders’ equity |
All values are in US Dollars.
| (1) | Comprised<br> mainly of employee future benefits and non-current portion of deferred revenues. |
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Revenueand cost of sales
The following table summarizes our gross margin earned during the periods indicated:
| (in thousands<br> of US dollars, except percentages) | Three<br> months ended September 30, | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 2024 | 2023 | Change | Change | ||||||
| % | |||||||||
| Revenue | |||||||||
| Active ingredients | ) | -13 | % | ||||||
| Pharmaceutical | 100 | % | |||||||
| Total<br> revenue | ) | -4 | % | ||||||
| Cost of sales | |||||||||
| Active ingredients | 27 | % | |||||||
| Pharmaceutical | ) | -100 | % | ||||||
| Total<br> cost of sales | 20 | % | |||||||
| Gross<br> Margin | 19 | % | |||||||
| Gross<br> Margin % | % | % |
All values are in US Dollars.
Our total revenue for the three-month period ended September 30, 2024, was $1.9 million as compared to $2.0 million for the same period in 2023, a decrease of $0.1 million. This decrease was primarily due to a $0.3 million decrease in sales of Avenanthramides, Beta Glucan and Oat Oil from prior period, offset by a $0.2 million in sales of Macrilen due to the acquisition of Aeterna as described in the plan of arrangement section above. Cost of sales for the three-month period ended September 30, 2024, decreased by $0.2 million, primarily due to the lower sales volumes during the period.
| (in thousands<br> of US dollars, except percentages) | Nine<br> months ended September 30, | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 2024 | 2023 | Change | Change | ||||||
| % | |||||||||
| Revenue | |||||||||
| Active ingredients | 3 | % | |||||||
| Pharmaceutical | 100 | % | |||||||
| Total<br> revenue | 6 | % | |||||||
| Cost of sales | |||||||||
| Active ingredients | ) | -12 | % | ||||||
| Pharmaceutical | ) | -100 | % | ||||||
| Total<br> cost of sales | ) | -14 | % | ||||||
| Gross<br> Margin | ) | -4 | % | ||||||
| Gross<br> Margin % | % | % |
All values are in US Dollars.
Our total revenue for the nine-month period ended September 30, 2024, was $6.3 million as compared to $5.9 million for the same period in 2023, an increase of $0.4 million. This increase was primarily due to a $0.2 million increase in sales of Avenanthramides, Beta Glucan and Oat Oil from the prior period as well as a $0.2 million in sales of Macrilen due to the acquisition of Aeterna as described in the plan of arrangement section above. Cost of sales for the nine-month period ended September 30, 2024, increased by $0.4 million, primarily due to the lower sales volumes during the period.
| 10 |
| --- |
Researchand development expenses
The following table summarizes our research and development expenses incurred during the periods indicated:
| (in thousands<br> of US dollars, except percentages) | Three<br> months ended September 30, | |||||
|---|---|---|---|---|---|---|
| 2024 | 2023 | Change | Change | |||
| % | ||||||
| Direct research and development<br> expenses: | ||||||
| Avenanthramides<br> for inflammation-based diseases | 356 | % | ||||
| Macimorelin pediatric DETECT-trial | 100 | % | ||||
| PGX | 50 | % | ||||
| Additional<br> programs | 415 | % | ||||
| Sub<br> total | 1,008 | % | ||||
| Employee-related expenses | 115 | % | ||||
| Facilities,<br> depreciation, and other expenses | 327 | % | ||||
| Total | 542 | % |
All values are in US Dollars.
Our total research and development expenses for the three-month period ended September 30, 2024, were $2.8 million as compared to $0.4 million for the same period in 2023, an increase of $2.4 million. This increase was primarily due to:
| ● | Increased<br> spending on phase 1-2a clinical study on avenanthramides for inflammation-based diseases of $0.3 million; and | ||||||
|---|---|---|---|---|---|---|---|
| ● | Trial<br> costs associated with the DETECT trial of $1.3 million and $0.5 million costs related to other pharmaceutical projects, attributable<br> to the acquisition of Aeterna; and | ||||||
| ● | An<br> increase in employee and facility related costs of $0.3 million, also attributable to the acquisition of Aeterna. | ||||||
| (in thousands<br> of US dollars, except percentages) | Nine<br> months ended September 30, | ||||||
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2024 | 2023 | Change | Change | ||||
| % | |||||||
| Direct research and development<br> expenses: | |||||||
| Avenanthramides<br> for inflammation-based diseases | 332 | % | |||||
| Macimorelin pediatric<br> DETECT-trial | 100 | % | |||||
| PGX | ) | -33 | % | ||||
| Additional<br> programs | 129 | % | |||||
| Sub<br> total | 384 | % | |||||
| Employee-related expenses | 56 | % | |||||
| Facilities,<br> depreciation, and other expenses | 236 | % | |||||
| Total | 248 | % |
All values are in US Dollars.
Our total research and development expenses for the nine-month period ended September 30, 2024, were $5.4 million as compared to $1.6 million for the same period in 2023, an increase of $3.8 million. This increase was primarily due to:
| ● | Increased<br> spending on phase 1-2a clinical study on avenanthramides for inflammation-based diseases of $1.2 million; |
|---|---|
| ● | An<br> increase in trial costs associated with the DETECT trial of $1.7 million and $0.5 million costs related to other pharmaceutical projects,<br> attributable to the acquisition of Aeterna; and |
| ● | An<br> increase in employee and facility-related costs of $0.4 million, also attributable to the acquisition of Aeterna. |
| 11 |
| --- |
Selling,general and administrative expenses
The following table summarizes our Selling, general and administrative expenses incurred during the period indicated:
| (in thousands<br> of US dollars, except percentages) | Three<br> months ended September 30, | ||||||
|---|---|---|---|---|---|---|---|
| 2024 | 2023 | Change | Change | ||||
| % | |||||||
| Selling, general and administrative<br> expenses: | |||||||
| Salaries &<br> benefits | 194 | % | |||||
| Insurance | 684 | % | |||||
| Professional fees | ) | -33 | % | ||||
| Other<br> office & general expenses | 227 | % | |||||
| Total<br> selling, general and administrative expenses | 102 | % |
All values are in US Dollars.
Our total selling, general and administrative expenses for the three-month period ended September 30, 2024, were $3.0 million as compared to $1.5 million for the same period in 2023, an increase of $1.5 million. This increase from the prior period is primarily due to the acquisition of Aeterna, resulting in $0.8 million additional Salary & benefit costs as a result of the additional headcount, a $0.3 million increase in Insurance and $0.7 million additional other office & general expenses offset by lower $0.2 million Professional fees related to the acquisition in the same period in 2023 that was not repeated in 2024.
| (in thousands<br> of US dollars, except percentages) | Nine<br> months ended September 30, | |||||
|---|---|---|---|---|---|---|
| 2024 | 2023 | Change | Change | |||
| % | ||||||
| Selling, general and administrative<br> expenses: | ||||||
| Salaries &<br> benefits | 48 | % | ||||
| Insurance | 224 | % | ||||
| Professional fees | 116 | % | ||||
| Other<br> office & general expenses | 136 | % | ||||
| Total<br> selling, general and administrative expenses | 101 | % |
All values are in US Dollars.
Our total selling, general and administrative expenses for the nine-month period ended September 30, 2024, were $7.7 million as compared to $3.8 million for the same period in 2023, an increase of $3.9 million. This was primarily attributable due to the acquisition of Aeterna as described in the plan of arrangement section above and resulted with:
| ● | An<br> increase in Salaries & benefits of $0.7 million. |
|---|---|
| ● | An<br> increase in Insurance costs $0.3 million |
| ● | An<br> increase in Professional fees of $1.4 million, incurred primarily in the first six months of 2024 |
| ● | An<br> increase in office & general expenses of $1.5 million. |
Impairmentof intangible assets
During the three-month period ended September 30, 2024, the Company concluded an indicator of impairment existed related to its macimorelin patent intangible assets due to the primary efficacy endpoint for the pediatric clinical trial not being met according to the definitions in the study protocol and thus requiring further analysis of the study results. These results require further clarification and some reanalysis with the aim to consider the trial outcome and the strategy moving forward.
| 12 |
| --- |
As a result, the Company performed an impairment test. The recoverable value of the macimorelin patent intangible assets was based on a fair value less costs of disposal determined using the royalty relief method using discounted cash flow models. Management developed assumptions related to revenue, royalty rates, discount rates and probability of possible scenarios. The royalty rate and the range of discount rates used of 21.7% to 25.8% are key assumptions classified as Level 3 in the fair value hierarchy, as they are not based on observable market data. The Company compared the carrying amount of the intangible asset to the fair value, and the recoverable amount of $1,807 was determined to be lower than the carrying value and a $1,459 impairment loss was recorded in the three months ended September 30, 2024.
A change in the assumption of the probability of possible scenarios by an increase or decrease of 10% would result in a change in the impairment by $375.
As at September 30, 2024, there remains significant uncertainty with regards to the trial outcome and the strategy moving forward.
Netother income (costs)
For the three-month period ended September 30, 2024, our net other income was $0.4 million as compared to $0.1 million for the three-month period ended September 30, 2023, an increase of $0.3 million. This was primarily attributable to the change in fair value of warrant and DSU liabilities in the amount of $0.3 million.
Net other income for the nine-month period ended September 30, 2024, was $2.3 million as compared to $0.1 million for the same period in 2023, an increase of $2.2 million. This was primarily attributable to the change in fair value of warrant and DSU liabilities in the amount of $2.0 million and an increase in net interest income of $0.2 million.
Netloss
For the three-month period ended September 30, 2024, we reported a consolidated net loss of $5.8 million, or $1.85 loss per common share, as compared with a consolidated net loss of $0.8 million, or $0.42 loss per common share for the same period in 2023. The $5.0 million increase in net loss is attributable to:
| ● | a<br> $0.1 million decrease in revenues offset by lower cost of sales of $0.2 million; and |
|---|---|
| ● | an<br> increase in research and development costs of $2.4 million due primarily to increase in costs associated with the avenanthramides<br> and DETECT clinical trials; and |
| ● | an<br> increase in selling, general and administrative costs of $1.5 million due primarily to the acquisition of Aeterna; and |
| ● | a<br> $1.5 million impairment expense related to the Macrilen patents; offset by |
| ● | an<br> increase in other income of $0.3 million due to changes in the fair value of warrant and DSU liabilities. |
For the nine-month period ended September 30, 2024, we reported a consolidated net loss of $8.6 million, or $3.58 loss per common share, as compared with a consolidated net loss of $1.9 million, or $1.04 loss per common share for the same period in 2023. The $6.7 million increase in net loss is attributable to:
| ● | an<br> increase in research and development costs of $3.8 million due primarily to increase in costs associated with the avenanthramides<br> and DETECT clinical trials; and |
|---|---|
| ● | an<br> increase in selling, general and administrative of $3.9 million due primarily to the acquisition of Aeterna; and |
| ● | a<br> $1.5 million impairment expense related to the Macrilen patents; offset by |
| ● | an<br> increase in other income of $2.0 million due to changes in the fair value of warrant and DSU liabilities; and |
| ● | An<br> increase in income tax recovery of $0.5 million. |
| 13 |
| --- |
Selectedquarterly financial data
| Three<br> months ended | ||||||||
|---|---|---|---|---|---|---|---|---|
| (in thousands<br> of US dollars, except for per share data) | September<br> 30, 2024 | June<br> 30, 2024 | March<br> 31, 2024 | December<br> 31, 2023 | ||||
| Revenues | ||||||||
| Net loss | ) | ) | ) | ) | ||||
| Net loss per share (basic<br> and diluted) ^(1)^ | ) | ) | ) | ) |
All values are in US Dollars.
| Three<br> months ended | ||||||||
|---|---|---|---|---|---|---|---|---|
| (in thousands<br> of US dollars, except for per share data) | September<br> 30, 2023 | June<br> 30, 2023 | March<br> 31, 2023 | December<br> 31, 2022 | ||||
| Revenues | ||||||||
| Net (loss) / profit | ) | ) | ) | ) | ||||
| Net (loss) / profit per share<br> (basic and diluted) ^(1)^ | ) | ) | ) | ) |
All values are in US Dollars.
| (1) | Net<br> loss per share is based on the weighted average number of shares outstanding during each reporting period, which may differ on a<br> 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.
Liquidityand capital resources
The Company’s objective in managing capital, consisting of shareholders’ equity, with cash and cash equivalents being its primary components, is to ensure sufficient liquidity to fund research and development costs, production costs, selling expenses, general and administrative expenses and working capital requirements. Over the past several years, we have raised capital via public and private equity offerings and issuances and have entered licensing and collaborative arrangements, consideration from which, together with proceeds from equity issuances, has been our 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.
Cashflows
The following table shows a summary of our consolidated cash flows for the periods indicated:
| (in thousands of US dollars) | Three months<br> ended | Nine months<br> ended | ||||||
|---|---|---|---|---|---|---|---|---|
| September<br> 30, | September<br> 30, | |||||||
| 2024 | 2023 | 2024 | 2023 | |||||
| Cash and cash<br> equivalents – Beginning of period | ||||||||
| Net cash used in operating activities | ) | ) | ) | |||||
| Net cash used in financing activities | ) | ) | ) | ) | ||||
| Net cash used in investing activities | ) | ) | ||||||
| Effect of exchange rate<br> changes on cash & cash equivalents | ) | ) | ) | |||||
| Cash<br> and cash equivalents – End of period |
All values are in US Dollars.
| 14 |
| --- |
OperatingActivities
Cash used by operating activities was $7.8 million for the three-month period ended September 30, 2024, as compared to $0.1 million provided by operating activities in the same period in 2023. This $7.9 million increase in operating cash outflows is attributed primarily to:
| ● | an<br> increase in research and development costs of $2.4 million due primarily to increase in costs associated with the avenanthramides<br> and DETECT clinical trials as well as the additional programs; |
|---|---|
| ● | an<br> increase in selling, general and administrative costs of $1.5 million due primarily to the salaries and benefits expense as well<br> as other office and general expenses; and |
| ● | a<br> decrease in operating assets and liabilities of $4.1 million, primarily due to the acquisition of Aeterna; offset by |
| ● | an<br> increase in gross margin of $0.1 million from prior period. |
Cash used by operating activities was $11.6 million for the nine-month period ended September 30, 2024, as compared to $1.5 million in the same period in 2023. This $10.1 million increase in operating cash outflows is attributed primarily to:
| ● | An<br> increase in research and development costs of $3.8 million due primarily to increase in costs associated with the avenanthramides<br> and DETECT clinical trials as well as the additional programs; and |
|---|---|
| ● | an<br> increase in selling, general and administrative of $3.9 million due primarily to the acquisition of Aeterna as well as salaries and<br> benefits and office and general expenses; and |
| ● | a<br> decrease in operating assets and liabilities of $2.4 million, primarily due to the acquisition of Aeterna. |
Investingactivities
Cash provided by investing activities totaled $0.1 million for the three-month period ended September 30, 2024, as compared to cash used of $0.1 million in the same period in 2023. This $0.2 million increase in investing cash inflows is attributed primarily to a $0.2 million reduction in restricted cash equivalents.
CapitalStock
As of November 6, 2024, we had 3,123,513 common shares issued and outstanding, as well as, 80,062 stock options, 77,250 deferred share units and 672,746 warrants outstanding. Each stock option, deferred share unit and warrant is exercisable for one common share.
Adequacyof financial resources
As of September 30, 2024, the Company had retained earnings of $5.2 million, a net loss of $8.6 million and negative cash flows from operations of $11.6 million for the nine-month period ended September 30, 2024. 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 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<br> terms and timing of any other collaboration, licensing, and other arrangements that we may establish; |
|---|---|
| ● | the<br> initiation, progress, timing, and completion of preclinical studies and clinical trials for our current and future potential product<br> candidates, as well as other research and development programs; |
| 15 |
| --- | | ● | our<br> alignment with the FDA on regulatory approval requirements; | | --- | --- | | ● | the<br> number and characteristics of product candidates that we pursue; | | ● | the<br> outcome, timing, and cost of regulatory approvals; | | ● | delays<br> that may be caused by changing regulatory requirements; | | ● | the<br> cost and timing of hiring new employees to support our continued growth and potential expense associated with any loss of key personnel; | | ● | the<br> costs involved in filing and prosecuting patent applications and enforcing and defending patent claims; | | ● | the<br> costs of filing and prosecuting intellectual property rights and enforcing and defending any intellectual property-related claims; | | ● | the<br> costs associated with any potential late receipt or non-receipt of trade and other receivables; | | ● | the<br> potential costs associated with foreign currency fluctuations or changing interest rates; | | ● | our<br> ability to expand our customer base and related demand fluctuations; | | ● | the<br> costs associated with any potential interruption or quality impacts on raw material supplies; | | ● | the<br> costs of responding to and defending ourselves against complaints and potential litigation; | | ● | the<br> costs and timing of procuring clinical and commercial supplies for our product candidates; and | | ● | the<br> extent to which we acquire or in-license other product candidates and technologies. |
Contractualobligations and commitments as of September 30, 2024
Significant expenditure contracted for at the end of the reporting period but not recognized as liabilities is as follows:
| (in thousands of US<br> dollars) | TOTAL |
|---|---|
| Less than 1 year | |
| 1 - 5 years | |
All values are in US Dollars.
The Company executed various agreements including in-licensing and similar arrangements with development partners. Such agreements may require the Company to make payments on achievement of stages of development, launch or revenue milestones, although the Company generally has the right to terminate these agreements at no penalty. The Company may have to pay up to $30,016 upon achieving certain sales volumes, regulatory or other milestones related to specific products.
In addition, 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. Royalties percentage rate would be 2% strictly for sales made from avenanthramides produced from the AG technology while royalty percentage rates would range between1.0% 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).
The Company has entered into a purchase commitment with a European specialized engineering firm for the supply of engineering, services and equipment related to the construction of a PGX-100 pilot plant. As of September 30, 2024 the remaining purchase commitment is $491 (€438) and is expected to be completed in 2024.
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.
CriticalAccounting Policies, Estimates and Judgements
The preparation of condensed interim consolidated financial statements in accordance with IFRS 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 to ensure that the condensed interim consolidated financial statements are presented fairly and in accordance with IFRS 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.
| 16 |
| --- |
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 Ceapro’s annual consolidated financial statements as of and for the year ended December 31, 2023, except for as described below:
| ● | Measurement<br> of defined benefit obligations: key actuarial assumptions; and |
|---|---|
| ● | Business<br> acquisition: identification of the acquirer, determination of the fair value of the consideration transferred and fair value of some<br> of the assets acquired and liabilities assumed; and |
| ● | Impairment<br> of intangible assets: recoverable value of the intangible assets was based on a fair value less costs of disposal. |
FinancialRisk 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 15 to the Ceapro’s audited consolidated financial statements for the year ended December 31, 2023, as well as in notes 11 and 12 to the COSCIENS Biopharma interim consolidated financial statements for the nine-month period ended September 30, 2024.
RelatedParty Transactions
Other than employment agreements and indemnification agreements with our management, there are no related party transactions.
Off-BalanceSheet Arrangements
As of September 30, 2024, we did not have any interests in special purpose entities or any other off-balance sheet arrangements.
RiskFactors 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 “RiskFactors” in our most recent Annual Report on Form 20-F for the year ended December 31, 2023 and under the heading “Risks and Uncertainties” in Exhibit 99.2 of our Form 6-K furnished to the SEC on May 14, 2024, 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.
| 17 |
| --- |
Ourmost recent Annual Report on Form 20-F and Exhibit 99.2 of our Form 6-K furnished to the SEC on May 14, 2024, were filed with the relevantCanadian and U.S. securities’ regulatory authorities at www.sedarplus.ca and with the SEC at www.sec.gov. Investors are urged toconsult the risk factors in these documents.
DisclosureControls 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 Exchange Act 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 Securities and Exchange Commission’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.
Any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objective and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. There have been no significant changes to our disclosure controls and procedures for the three-month period ended September 30, 2024, that have materially affected, or are reasonably likely to materially affect, the disclosure controls and procedures.
InternalControls 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) of the Exchange Act and Canadian securities legislation). Our internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with IFRS as issued by the IASB.
Our internal control over financial reporting includes those policies and procedures that: (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of COSCIENS Biopharma Inc.; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with IFRS as issued by the IASB, and that receipts and expenditures of the Company are being made only in accordance with authorizations of management and directors of the issuer; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of Company assets that could have a material effect on the financial statements.
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.
Changesin Internal Controls over Financial Reporting
On June 3, 2024, we completed the business combination transaction with Ceapro, which was accounted for a reverse acquisition. We are currently in the process of integrating Ceapro’s internal controls over financial reporting.
Other than with respect to the Ceapro business combination, there have been no significant changes to our internal controls over financial reporting for the three-month period ended September 30, 2024, that have materially affected, or are reasonably likely to materially affect, internal controls over financial reporting.
| 18 |
| --- |
Exhibit99.2

COSCIENSBiopharma Inc. (formerly Aeterna Zentaris Inc.)
Condensed Interim Consolidated Financial Statements
As of September 30, 2024, and for the three and nine months ended September 30, 2024, and 2023
(In thousands of US dollars)
(Unaudited)
| Condensed Interim Consolidated Statements of Financial Position | 2 |
|---|---|
| Condensed Interim Consolidated Statements of Changes in Shareholders’ Equity | 3 |
| Condensed Interim Consolidated Statements of Loss and Comprehensive Loss | 4 |
| Condensed Interim Consolidated Statements of Cash Flows | 5 |
| Notes to the Condensed Interim Consolidated Financial Statements | 6 |
| 1 |
| --- |
COSCIENSBiopharma Inc. (formerly Aeterna Zentaris Inc.)
Condensed Interim Consolidated Statements of Financial Position
(In thousands of US dollars)
(Unaudited)
| As<br> of <br>September 30, 2024 | As<br> of <br>December 31, 2023 | |||
|---|---|---|---|---|
| ASSETS | ||||
| Current<br> assets | ||||
| Cash and cash<br> equivalents | ||||
| Trade and other receivables | ||||
| Inventories (note 5) | ||||
| Income taxes receivable | ||||
| Prepaid<br> expenses and other assets (note 6) | ||||
| Total<br> current assets | ||||
| Non-current<br> assets | ||||
| Restricted cash and cash equivalents | ||||
| Investment tax credit receivable | ||||
| Property and equipment (note<br> 7) | ||||
| Intangible assets (note 8) | ||||
| Deferred<br> tax assets | ||||
| Total<br> non-current assets | ||||
| Total<br> assets | ||||
| LIABILITIES | ||||
| Current<br> liabilities | ||||
| Payables and accrued liabilities<br> (note 9) | ||||
| Provisions | ||||
| Income taxes payable | ||||
| Current portion of deferred<br> revenues (note 4) | ||||
| Current portion of lease liabilities | ||||
| Warrant liability (note 11) | ||||
| DSU liability<br> (note 12) | ||||
| Total<br> current liabilities | ||||
| Non-current<br> liabilities | ||||
| Deferred revenues (note 4) | ||||
| Lease liabilities | ||||
| Employee<br> future benefits (note 10) | ||||
| Total<br> non-current liabilities | ||||
| Total<br> liabilities | ||||
| Shareholders’<br> equity | ||||
| Share capital (note 13) | ||||
| Contributed surplus | ||||
| Retained earnings | ) | |||
| Accumulated<br> other comprehensive loss | ) | ) | ||
| Total<br> Shareholders’ equity | ||||
| Total<br> liabilities and shareholders’ equity |
All values are in US Dollars.
Commitments (note 18)
The accompanying notes are an integral part of these condensed interim consolidated financial statements.
Approvedby the Board of Directors
| /s/Ronnie Miller | /s/ Pierre Labbé |
|---|---|
| Ronnie<br> Miller, Chair of the Board | Pierre<br> Labbé, Director |
| 2 |
| --- |
COSCIENSBiopharma Inc. (formerly Aeterna Zentaris Inc.)
Condensed Interim Consolidated Statements of Changes in Shareholders’ Equity
For the nine months ended September 30, 2024, and 2023
(In thousands of US dollars)
(Unaudited)
| Share<br><br> capital | Contributed<br><br> surplus | Retained<br><br> earnings | Accumulated<br><br> other<br> comprehensive<br> loss | Total | ||||
| Balance<br> – January 1, 2024 | ) | |||||||
| Net loss | ) | ) | ||||||
| Other comprehensive loss: | ||||||||
| Foreign<br> currency translation adjustments | ) | ) | ||||||
| Actuarial<br> loss on defined benefit plan (note 10) | ) | ) | ||||||
| Comprehensive<br> loss | ) | ) | ) | |||||
| Acquisition of Aeterna Zentaris<br> Inc. (note 3) | ||||||||
| Share-based compensation costs | ||||||||
| Exercise of warrants (note<br> 11) | ||||||||
| Balance<br> – September 30, 2024 | ) | ) |
All values are in US Dollars.
| Share capital | Contributed<br><br> surplus | Retained<br><br> earnings | Accumulated<br><br> other<br> comprehensive<br> loss | Total | |
|---|---|---|---|---|---|
| $ | |||||
| Balance<br> – January 1, 2023 | 13,496 | 3,690 | 7,841 | (1,204 | 23,823 |
| Balance | 13,496 | 3,690 | 7,841 | (1,204 | 23,823 |
| Net loss | - | - | (1,921 | - | (1,921 |
| Other comprehensive loss: | |||||
| Foreign<br> currency translation adjustments | - | - | - | (22 | (22 |
| Comprehensive<br> income | (1,921 | (22 | (1,943 | ||
| Exercise of options | 21 | (8 | - | - | 13 |
| Share-based<br> compensation costs | - | 176 | - | - | 176 |
| Balance<br> – September 30, 2023 | 13,517 | 3,858 | 5,920 | (1,226 | 22,069 |
| Balance | 13,517 | 3,858 | 5,920 | (1,226 | 22,069 |
All values are in US Dollars.
The accompanying notes are an integral part of these condensed interim consolidated financial statements.
| 3 |
| --- |
COSCIENSBiopharma Inc. (formerly Aeterna Zentaris Inc.)
Condensed Interim Consolidated Statements of Loss and Comprehensive Loss
For the three and nine months ended September 30, 2024, and 2023
(In thousands of US dollars, except share and per share data)
(Unaudited)
| 2024 | 2023 | 2024 | 2023 | |||||
|---|---|---|---|---|---|---|---|---|
| Three<br> months ended | Nine<br> months ended | |||||||
| September<br> 30, | September<br> 30, | |||||||
| 2024 | 2023 | 2024 | 2023 | |||||
| Revenues<br> (note 4) | ||||||||
| Cost of sales | ) | ) | ) | ) | ||||
| Gross profit | ||||||||
| Research and development | ||||||||
| Selling, general and administrative | ||||||||
| Impairment<br> of intangible assets (note 8) | ||||||||
| Loss<br> from operations | ) | ) | ) | ) | ||||
| Gain due to changes in foreign<br> currency | ) | ) | ||||||
| Finance costs | ) | ) | ) | ) | ||||
| Other income | ||||||||
| Change<br> in fair value of warrant and DSU liabilities | ||||||||
| Other income | ||||||||
| Loss before<br> income taxes | ) | ) | ) | ) | ||||
| Income<br> tax recovery | ||||||||
| Net loss | ) | ) | ) | ) | ||||
| Other comprehensive<br> loss: | ||||||||
| Items that may be reclassified<br> subsequently to profit or loss: | ||||||||
| Foreign currency translation<br> adjustments | ) | ) | ) | ) | ||||
| Items that will not be reclassified<br> subsequently to profit or loss: | ||||||||
| Actuarial<br> loss on defined benefit plans | ) | ) | ||||||
| Comprehensive<br> loss | ) | ) | ) | ) | ||||
| Basic<br> and diluted loss per share (note 16) | ) | ) | ) | ) | ||||
| Weighted average number of<br> shares outstanding (basic and diluted) |
All values are in US Dollars.
The accompanying notes are an integral part of these condensed interim consolidated financial statements.
| 4 |
| --- |
COSCIENSBiopharma Inc. (formerly Aeterna Zentaris Inc.)
Condensed Interim Consolidated Statements of Cash Flows
For the three and nine months ended September 30, 2024, and 2023
(In thousands of US dollars)
(Unaudited)
| 2024 | 2023 | 2024 | 2023 | |||||
|---|---|---|---|---|---|---|---|---|
| Three<br> months ended | Nine<br> months ended | |||||||
| September<br> 30, | September<br> 30, | |||||||
| 2024 | 2023 | 2024 | 2023 | |||||
| Cash flows<br> from operating activities | ||||||||
| Net loss for the<br> period | ) | ) | ) | ) | ||||
| Items not affecting cash and<br> cash equivalents: | ||||||||
| Depreciation<br> and amortization | ||||||||
| Share-based<br> compensation costs | ||||||||
| Impairment<br> of intangible assets (note 8) | ||||||||
| Employee<br> future benefits | ||||||||
| Amortization<br> of deferred revenues | ) | ) | ||||||
| Change<br> in fair value of warrant and DSU liabilities | ) | ) | ||||||
| Other<br> non-cash items | ||||||||
| Income<br> tax recovery | ) | ) | ) | ) | ||||
| Changes<br> in operating assets and liabilities (note 15) | ) | ) | ) | |||||
| Net<br> cash used in operating activities | ) | ) | ) | |||||
| Cash flows<br> from financing activities | ||||||||
| Exercise of stock options | ||||||||
| Payments on exercise of<br> DSUs | ) | ) | ||||||
| Payments<br> on lease liabilities | ) | ) | ) | ) | ||||
| Net<br> cash used in financing activities | ) | ) | ) | ) | ||||
| Cash flows<br> from investing activities | ||||||||
| Acquisition<br> of Aeterna Zentaris Inc. (note 3) | ||||||||
| Purchase<br> of property and equipment | ) | ) | ) | ) | ||||
| Changes<br> in restricted cash equivalents | ||||||||
| Net<br> cash provided by (used) in investing activities | ) | ) | ||||||
| Effect<br> of exchange rate changes on cash and cash equivalents | ) | ) | ) | |||||
| Net<br> change in cash and cash equivalents | ) | ) | ) | |||||
| Cash<br> and cash equivalents – Beginning of period | ||||||||
| Cash<br> and cash equivalents – End of period |
All values are in US Dollars.
The accompanying notes are an integral part of these condensed interim consolidated financial statements.
| 5 |
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COSCIENSBiopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of September 30, 2024, and for the three and nine months ended September 30, 2024, and 2023
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
1. Business overview
Summaryof business
COSCIENS Biopharma Inc. (“the Company”) is a specialty biopharmaceutical company developing and commercializing a diversified portfolio of products for the cosmeceutical, nutraceutical and pharmaceutical markets. Such products being produced using the Company’s proprietary technologies. The Company’s patented technologies include the Pressurized Gas eXpanded (PGX) technology, which is a technology that generates high-value yields of active ingredients from natural plant resources for use in novel cosmeceutical, nutraceutical and therapeutics 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.
In addition to our portfolio of nutraceutical and cosmeceutical products and programs, the Company is also conducting a Phase 1/2a clinical trial with the goal of developing our avenanthramides product as an anti-inflammatory. The Company’s lead commercial pharmaceutical product, macimorelin (Macrilen®; Ghryvelin®), is the first and only U.S. FDA and European Commission approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD).
During the three-month period ended September 30, 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.
These unaudited condensed interim consolidated financial statements were approved by the Board of Directors (the “Board”) on November 11, 2024.
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 pursuant to which, at closing, each outstanding Ceapro common share would be exchanged for 0.02360 of a Aeterna common share (the “Plan of Arrangement”). Additionally, as part of the Transaction, Aeterna would issue to its shareholders immediately prior to the closing of the Transaction, 0.47698 of a share purchase warrant (“New Warrant”) for each Aeterna common share or warrant held. On March 12, 2024, the shareholders of both Ceapro and Aeterna approved the Plan of Arrangement at their respective special meetings. On March 28, 2024, the Court of Kings Bench of Alberta approved the Plan of Arrangement. The Transaction was consummated on June 3, 2024.
In conjunction with the transaction, at the annual general meeting on July 16, 2024, the shareholders approved a special resolution authorizing the Board to change the company name from “Aeterna Zentaris Inc.” to “COSCIENS Biopharma Inc.” On August 6, 2024, the company filed articles of amendment pursuant to the Canada Business Corporations Act to effect this name change.
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 consolidated financial statements of COSCIENS Biopharma Inc. as of September 30, 2024 and December 31, 2023 and for the three and nine months ended September 30, 2024 and 2023 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. Refer to Note 3 for additional information.
| 6 |
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COSCIENSBiopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of September 30, 2024, and for the three and nine months ended September 30, 2024, and 2023
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
The accompanying consolidated financial statements include the accounts of COSCIENS Biopharma Inc., an entity incorporated under the CanadaBusiness Corporations Act, and its wholly owned subsidiaries (the “Group”). COSCIENS Biopharma Inc. is the ultimate parent company of the Group. The Company currently has six wholly-owned direct and indirect subsidiaries, Ceapro Inc. and its wholly-owned subsidiaries Ceapro (P.E.I.) and Juvente^DC^ Inc., based in Canada, Aeterna Zentaris GmbH (“AEZS Germany”) and its wholly-owned subsidiary Zentaris IVF GmbH, based in Frankfurt, Germany, and Aeterna Zentaris, Inc., an entity incorporated in the state of Delaware and with offices in Summerville, South Carolina, in the US.
The registered office of the Company is located at 222 Bay Street, Suite 3000, P.O. Box 53, Toronto, Ontario M5K 1E7, Canada.
The Company’s common shares are listed on both the Toronto Stock Exchange under the symbol CSCI (previously AEZS) and on the NASDAQ Capital Market under the symbol CSCI (previously AEZS).
2. Basis of presentation
These unaudited condensed interim consolidated financial statements have been prepared in accordance with IAS 34, Interim Financial Reportingas issued by the International Accounting Standards Board.
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 Ceapro’s annual consolidated financial statements as of and for the year ended December 31, 2023.
The accounting policies used in these condensed interim consolidated financial statements are consistent with those presented in Ceapro’s annual consolidated financial statements, except for the accounting policies as described below:
Businesscombinations
Business combinations are accounted for using the acquisition method as at the acquisition date when control is transferred. The consideration transferred for the acquisition of a business is the fair value of the assets transferred, and any liability and equity interests issued by the Company to the former owners of the acquired business on the acquisition date. Identifiable assets acquired and liabilities assumed in a business combination are generally measured initially at their fair values at the acquisition date. Acquisition-related costs other than those associated with the issue of debt or equity securities, and other direct costs of a business combination are not considered part of the business acquisition transaction and are expensed as incurred.
Foreigncurrency
Effective June 3, 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 to 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 |
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COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of September 30, 2024, and for the three and nine months ended September 30, 2024, and 2023
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
Post-employmentbenefits
The Company has partially funded and unfunded defined benefit multi-employer pension plans, namely the DUPK pension plan and the RUK 1990 and 2006 pension plans, (the “Pension Benefit Plans”) and unfunded post-employment benefit plans in Germany. Provisions for pension obligations are established for benefits payable in the form of retirement, disability and surviving dependent pensions. The Company also provides defined contribution plans to some of its employees.
For defined benefit pension plans and other post-employment benefits, net periodic pension expense is actuarially determined on a quarterly basis using the projected unit credit method. The cost of pension and other benefits earned by employees is determined by applying certain assumptions, including discount rates, rate of pension benefit increases, the projected age of employees upon retirement and the expected rate of future compensation.
The employee future benefits liability is recognized at its present value, which is determined by discounting the estimated future cash outflows using interest rates of high-quality corporate bonds that are denominated in the currency in which the benefits will be paid and that have terms to maturity approximating the terms of the related future benefit liability. Actuarial gains and losses that arise in calculating the present value of the defined benefit obligation are recognized in other comprehensive loss, net of tax, and simultaneously reclassified in the deficit in the consolidated statement of financial position in the year in which the actuarial gains and losses arise and without recycling to the consolidated statement of loss and comprehensive loss in subsequent periods.
Revenue
The Company generates revenue from supply agreements and licensing agreements with customers for the sale of certain finished goods, semi-finished goods and active pharmaceutical ingredients. The license is generally combined with other promises to supply goods to the customer, and revenue from the combined performance obligation is satisfied at a point in time, which occurs upon shipment. The transaction price for the combined performance obligation includes the license non-refundable non-creditable upfront payment, regulatory milestones, royalties and the selling price of each good supplied. Milestone payments, which are oftentimes payable upon the successful achievement of development or regulatory events, and royalties are included in the transaction price using the most likely amount method only if the milestones are considered probable of being reached and the Company concludes it is highly probable that a significant revenue reversal will not occur. Milestone payments and royalties that are not within the control of the Company or the licensee, such as regulatory approvals, are generally not considered probable of being achieved until those approvals or subsequent sales are received. The Company allocates the transaction price to the projected units that the Company expects to supply pursuant to the contract, estimated based on current projections and anticipated market demand.
Intangibleassets
Intangible assets, consisting of patents, that are acquired by the Company and have finite useful lives are measured at cost less accumulated amortization and any accumulated impairment losses. Patents are amortized on their respective remaining patent life and are expiring between 2027 and 2041.
| 8 |
| --- |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of September 30, 2024, and for the three and nine months ended September 30, 2024, and 2023
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
Warrantliabilities
Warrant liabilities are derivative financial instruments. They are initially measured at fair value. Subsequent to initial recognition, they are measured at fair value, and changes therein are recognized in profit or loss.
Reclassifications
Certain
prior period amounts have been reclassified to conform to current period presentation. In the consolidated statement of financial position, trade receivables of $126 and other receivable of $164 were classified to trade and other receivables. In the consolidated statements of loss for the nine months ended September 30, 2023, the general and administration expenses of $3,807 (for the three months ended September 30, 2023 - $1,471) and the sales and marketing expenses of $25 (for the three months ended September 30, 2023 - $9) were reclassified within Selling, general and administrative expenses.
Newstandards and amendments
Several amendments apply for the first time for reporting periods beginning after January 1, 2024, 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. No pronouncements have been disclosed as they are not expected to have a material impact on the Company’s condensed interim consolidated financial statements.
Criticalaccounting estimates and judgements
The preparation of condensed interim consolidated financial statements in accordance with IFRS 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 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.
| 9 |
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COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of September 30, 2024, and for the three and nine months ended September 30, 2024, and 2023
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
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 Ceapro’s annual consolidated financial statements as of and for the year ended December 31, 2023, except for as described below:
| ● | Measurement of defined benefit<br> obligations: key actuarial assumptions (note 10); and |
|---|---|
| ● | Business acquisition: identification<br> of the acquirer, determination of the fair value of the consideration transferred and fair value of some of the assets acquired and<br> liabilities assumed (note 3); and |
| ● | Impairment of intangible<br> assets: recoverable value of the intangible assets was based on a fair value less costs of disposal (note 8). |
3. Acquisition of Aeterna Zentaris Inc.
As discussed in Note 1, Business Overview, as a result of the Transaction, Ceapro acquired control of Aeterna Zentaris Inc. on June 3, 2024. Aeterna is a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests. Aeterna’s lead product, Macrilen® (macimorelin), is the first and only U.S. FDA and EMA approved oral test indicated for the diagnosis of patients with adult growth hormone deficiency (“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. Aeterna is actively pursuing business development opportunities for the commercialization of macimorelin in North America, Asia and the rest of the world. Aeterna is also dedicated to the development of therapeutic assets and has taken steps to establish a pre-clinical pipeline to potentially address unmet medical needs across several indications with a focus on rare or orphan indications.
| 10 |
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COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of September 30, 2024, and for the three and nine months ended September 30, 2024, and 2023
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
The Transaction was accounted for as a reverse acquisition under the acquisition method of accounting for business combinations. Ceapro was considered to be the accounting acquirer, and Aeterna was considered the legal acquirer. The amounts recorded for certain assets and liabilities are preliminary in nature and are subject to adjustment as additional information is obtained about the facts and circumstances that existed as of the acquisition date. The final determination of the fair values of certain assets and liabilities will be completed within the measurement period of up to one year from the acquisition date. Under the acquisition method of accounting, total consideration exchanged and allocation of the purchase price to the fair values of assets acquired and liabilities assumed in the Transaction were as follows:
Schedule of purchase price to the fair values of assets acquired and liabilities assumed
PreliminaryPurchase Price Allocation
| Number | Amount | |||
|---|---|---|---|---|
| # | ||||
| Purchase<br> price | ||||
| Shares deemed<br> issued to Aeterna shareholders^(1)^ | 1,213,967 | |||
| Warrants issued to Aeterna<br> shareholders^(2)^ | 633,543 | |||
| Replacement share-based<br> payment awards: | ||||
| Equity-settled options^(3)^ | 12,949 | |||
| Cash-settled DSUs^(3)^ | 49,230 | |||
| Warrants<br> deemed issued^(4)^ | 114,405 | |||
| 2,024,094 | ||||
| Recognized<br> amounts of identifiable assets acquired and liabilities assumed | ||||
| Cash and cash equivalents | ||||
| Trade and other receivables | ||||
| Inventories | ||||
| Income tax receivables | ||||
| Prepaid expenses and deposits | ||||
| Restricted cash equivalents | ||||
| Property and equipment | ||||
| Intangible<br> assets^(5)^ | ||||
| Accounts payable and accrued<br> liabilities | ) | |||
| Provisions | ) | |||
| Income tax payable | ) | |||
| Deferred revenues | ) | |||
| Lease liabilities | ) | |||
| Employee future benefits | ) | |||
| Total<br> provisional identifiable net assets (liabilities) |
All values are in US Dollars.
| (1) | The fair value of the 1,213,967<br> common shares deemed issued to Aeterna shareholders of $6.99 per share was based on the listed share price of Ceapro as at June 3,<br> 2024 (CA$0.225), after giving effect to the exchange of each outstanding Ceapro common share for 0.02360 of a Aeterna common share<br> and the foreign currency exchange rate. |
|---|---|
| (2) | The fair value of the 633,543<br> New Warrants (“New Warrants”) issued to Aeterna shareholders was based on the listed share price of Ceapro as at June 3,<br> 2024 of $6.99 (CA$0.225) less the exercise price of $0.01, after giving effect to the exchange of each outstanding Ceapro Common Share<br> for 0.02360 of a Aeterna Zentaris Common Share and the foreign currency exchange rate. |
| (3) | In accordance with the terms<br> of the Plan of Arrangement, Aeterna’s share-based payment awards held by employees of Aeterna continued with no modifications<br> and are deemed to be replacement awards issued. |
| (4) | The fair value of the 114,405<br> warrants deemed issued to Aeterna warrant holders was estimated using a Black-Scholes option pricing model, considering the terms and<br> conditions upon which the warrants were issued, using the following assumptions: |
| --- | --- |
| (5) | The identifiable intangible<br> assets consist of patents expiring between 2027 and 2041 which will be amortized on their respective remaining patent life. To estimate<br> the fair value of the intangible assets, management uses the royalty relief method to value patents using discounted cash flow models.<br> Management developed assumptions related to revenue and EBITDA margin forecasts, attrition rates, royalty rates and discount rates. |
| --- | --- |
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COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of September 30, 2024, and for the three and nine months ended September 30, 2024, and 2023
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
The
fair value of the replacement awards is $356, after taking into account an estimated forfeiture rate of nil. The consideration for the business combination includes $9 for equity-settled options and $344 for cash-settled DSUs transferred to employees of Aeterna when the acquiree’s awards were substituted by the replacement awards, which relates to past service. The balance of $3 will be recognized as post-acquisition compensation cost.
The fair value at acquisition date was estimated using a Black-Scholes option pricing model, considering the terms and conditions upon which the options were granted, using the following assumptions:
Schedule of fair value at acquisition date was estimated using a Black-Scholes option
| Options | |||
|---|---|---|---|
| Expected dividend<br> yield | $ | 0.0 | |
| Weighted average expected volatility | 65 | % | |
| Weighted average risk-free rate | 4.01 | % | |
| Weighted average expected life (years) | 2.87 | ||
| Share price | $ | 6.99 | |
| Weighted average exercise price | $ | 50.15 | |
| Weighted average fair value | $ | 0.90 |
The expected volatility of these options was determined using historical volatility rates and the expected life was determined using the weighted average life of past options issued.
The
fair value of the replacement DSUs of $6.99 per DSU was based on the listed share price of Ceapro as at June 3, 2024 (CA$0.225), after giving effect to the exchange of each outstanding Ceapro common share for 0.02360 of a Aeterna common share and the foreign currency exchange rate.
| (4) | The fair value of the 114,405<br> warrants deemed issued to Aeterna warrant holders was estimated using a Black-Scholes option pricing model, considering the terms and<br> conditions upon which the warrants were issued, using the following assumptions: |
|---|
Schedule of fair value at acquisition date was estimated using a Black-Scholes option
| Warrants | |||
|---|---|---|---|
| Expected dividend<br> yield | $ | 0.00 | |
| Weighted average expected volatility | 65 | % | |
| Weighted average risk-free rate | 4.47 | % | |
| Weighted average expected life (years) | 1.19 | ||
| Share price | $ | 6.99 | |
| Weighted average exercise price | $ | 87.04 | |
| Weighted average fair value | $ | 0.02 | |
| (5) | The identifiable intangible<br> assets consist of patents expiring between 2027 and 2041 which will be amortized on their respective remaining patent life. To estimate<br> the fair value of the intangible assets, management uses the royalty relief method to value patents using discounted cash flow models.<br> Management developed assumptions related to revenue and EBITDA margin forecasts, attrition rates, royalty rates and discount rates. | ||
| --- | --- |
For the period subsequent to the Transaction, Aeterna contributed revenue of $167 and net loss of $3,632 to the Company’s results. If the acquisition had occurred on January 1, 2024, management estimates that revenue would have been $6,271 and consolidated net loss for the year would have been $16,689. In determining these amounts, management has assumed that the fair value adjustments that arose on the date of acquisition would have been the same if the acquisition had occurred on January 1, 2024.
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COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of September 30, 2024, and for the three and nine months ended September 30, 2024, and 2023
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
The
Company incurred acquisition-related costs of $4,081 on legal fees and due diligence costs. These costs have been included in Selling, general and administrative expenses as incurred.
4. 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
| 2024 | |||||
|---|---|---|---|---|---|
| Three<br> months ended | |||||
| September<br> 30, | |||||
| 2024 | |||||
| $ | |||||
| Active<br> ingredients | 1,707 | 1,952 | 6,098 | 5,929 | |
| Pharmaceutical | 164 | - | 167 | - | |
| Total | 1,871 | 1,952 | 6,265 | 5,929 |
All values are in US Dollars.
Deferredrevenue
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, subject to extension based on the outcome of the ongoing clinical development related to the Pediatric Indication and related patent application initiatives. For the three months and nine months ended September 30, 2024, the Company recognized $39 and $39 respectively as revenue from the deferred revenue balance originating from the acquisition of Aeterna Zentaris Inc. (note 3).
Liabilitiesrelated to contracts with customers
The following table provides a summary of deferred revenue balances:
Summary of deferred revenue
| Current | Non-current | Total | |
|---|---|---|---|
| September<br> 30, 2024 | |||
| Current | Non-current | Total | |
| Pharmanovia | |||
| NK Meditech | |||
| Contract<br> liabilities |
All values are in US Dollars.
| 13 |
| --- |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of September 30, 2024, and for the three and nine months ended September 30, 2024, and 2023
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
5. Inventories
The Company had the following inventories at the end of each reporting period:
Schedule of inventories
| September<br> 30, | December<br> 31, | |
|---|---|---|
| 2024 | 2023 | |
| Raw materials | ||
| Work in progress | ||
| Finished<br> goods | ||
| Inventories |
All values are in US Dollars.
Inventories
expensed to cost of goods sold during the three-month period ended September 30, 2024, are $887 (September 30, 2023 - $1,147) and the nine-month period ended September 30, 2024, are $3,354 (September 30, 2023 - $3,139).
6. 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
| September<br> 30, | December<br> 31, | |
|---|---|---|
| 2024 | 2023 | |
| Prepaid insurance | ||
| Prepaid research and development | ||
| Other | ||
| Total |
All values are in US Dollars.
| 14 |
| --- |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of September 30, 2024, and for the three and nine months ended September 30, 2024, and 2023
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
| 7. | Property and equipment |
|---|
Components of the Company’s property and equipment are summarized below.
Schedule of property and equipment
| Equipment<br><br> Not<br> Available<br> for Use | Equipment | Office<br> and<br> Computer<br> Equipment | Buildings | Leasehold<br><br> Improvements | Total | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cost | ||||||||||||
| Equipment<br><br> Not<br> Available<br> for Use | Equipment | Office<br> and<br> Computer<br> Equipment | Buildings | Leasehold<br><br> Improvements | Total | |||||||
| At<br> January 1, 2023 | ||||||||||||
| Additions | ||||||||||||
| Acquisition<br> of Aeterna (note 3) | ||||||||||||
| Amortization | ||||||||||||
| Disposals | ) | ) | ||||||||||
| Impact<br> of foreign exchange rate changes | ||||||||||||
| At<br> December 31, 2023 | ||||||||||||
| Property plant and equipment | ||||||||||||
| Acquisition<br> of Aeterna (note 3) | ||||||||||||
| Additions | ||||||||||||
| Disposals | ) | ) | ||||||||||
| Impact<br> of foreign exchange rate changes | ) | ) | ) | ) | ) | ) | ||||||
| At<br> September 30, 2024 | ||||||||||||
| Property plant and equipment |
All values are in US Dollars.
| Accumulated<br> Depreciation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Equipment<br><br> Not<br> Available<br> for Use | Equipment | Office<br> and<br> Computer<br> Equipment | Buildings | Leasehold<br><br> Improvements | Total | |||||
| At January 1,<br> 2023 | ||||||||||
| Amortization | ||||||||||
| Disposals | ) | ) | ||||||||
| Impact<br> of foreign exchange rate changes | ||||||||||
| At December 31, 2023 | ||||||||||
| Property plant and equipment | ||||||||||
| Amortization | ||||||||||
| Disposals | ) | ) | ||||||||
| Impact<br> of foreign exchange rate changes | ) | ) | ) | ) | ||||||
| At September<br> 30, 2024 | ||||||||||
| Property plant and equipment |
All values are in US Dollars.
| Carrying<br> amount | ||||||
|---|---|---|---|---|---|---|
| Equipment<br><br> Not<br> Available<br> for Use | Equipment | Office<br> and<br> Computer<br> Equipment | Buildings | Leasehold<br><br> Improvements | Total | |
| At<br> December 31, 2023 | ||||||
| Property plant and equipment, Beginning | ||||||
| At<br> September 30, 2024 | ||||||
| Property plant and equipment, Ending |
All values are in US Dollars.
| 15 |
| --- |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of September 30, 2024, and for the three and nine months ended September 30, 2024, and 2023
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
Depreciation expense is allocated to the following expense categories:
Schedule of depreciation expenses
| Cost<br> of <br>goods sold | Selling,<br><br> general and<br> administrative | Research<br> and development | Total | |
|---|---|---|---|---|
| Nine Months<br> Ended September 30, 2023 | ||||
| Nine<br> Months Ended September 30, 2024 |
All values are in US Dollars.
Included
right-of-use in the net carrying amount of property and equipment at September 30, 2024, are assets relating to buildings, in the amount of $1,294 (December 31, 2023 - $1,481).
Included
in the carrying amount of leasehold improvements is $785 (December 31, 2023 - $800) and included in the carrying amount of equipment not available for use is $3,333 (December 31, 2023 - $2,199) which represent the accumulated expenditures incurred on the purchase of an ethanol recovery system, equipment purchased for technology scale-up, other equipment, and the engineering design for the related construction and installation of the ethanol recovery system. Construction and installation activities related to technology scale-up have progressed since year-end. However, as the activities had not yet been finalized, depreciation on these balances has not commenced.
The
Company has entered into a purchase commitment with a European specialized engineering firm for the supply of engineering, services and equipment related to the construction of a PGX-100 pilot plant for $1,134 (€1,015). Payments made toward the purchase are included in the carrying amount of equipment not available for use. As of September 30, 2024, the remaining purchase commitment is $491 (€438) and is expected to be completed in 2024.
| 8. | Intangible assets |
|---|
Changes in the carrying value of the Company’s identifiable intangible assets are summarized below.
Scheduleof Intangible Assets
| Cost | Accumulated<br> amortization | Carrying<br> value | |||||
|---|---|---|---|---|---|---|---|
| As<br> at September 30, 2024 | |||||||
| Cost | Accumulated<br> amortization | Carrying<br> value | |||||
| At January 1,<br> 2024 | (27 | ) | |||||
| Acquisition of Aeterna (note<br> 3) | - | ||||||
| Amortization | (94 | ) | ) | ||||
| Impairment of intangible assets | ) | - | ) | ||||
| Impact<br> of foreign exchange rate changes | - | ||||||
| At September<br> 30, 2024 | (121 | ) |
All values are in US Dollars.
| As at December 31, 2023 | ||||
|---|---|---|---|---|
| Cost | Carrying<br> value | |||
| At January 1, 2023 | 33 | ) | 9 | |
| Acquisition of Aeterna (note<br> 3) | - | - | ||
| Amortization | - | ) | (2 | |
| Impact<br> of foreign exchange rate changes | 1 | ) | - | |
| At December 31, 2023 | 34 | ) | 7 |
All values are in US Dollars.
| 16 |
| --- |
COSCIENSBiopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of September 30, 2024, and for the three and nine months ended September 30, 2024, and 2023
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
During the three-month period ended September 30, 2024, the Company concluded an indicator of impairment existed related to its macimorelin patent intangible assets due to the primary efficacy endpoint for the pediatric clinical trial not being met according to the definitions in the study protocol and thus requiring further analysis of the study results. These results require further clarification and some reanalysis with the aim to consider the trial outcome and the strategy moving forward.
As a result, the Company performed an impairment test. The recoverable value of the macimorelin patent intangible assets was based on a fair value less costs of disposal determined using the royalty relief method using discounted cash flow models. Management developed assumptions related to revenue, royalty rates, discount rates and probability of possible scenarios. The royalty rate and the range of discount rates used of 21.7% to 25.8% are key assumptions classified as Level 3 in the fair value hierarchy, as they are not based on observable market data. The Company compared the carrying amount of the intangible asset to the fair value, and the recoverable amount of $1,807 was determined to be lower than the carrying value and a $1,459 impairment loss was recorded in the three months ended September 30, 2024.
The recoverable value is sensitive to a change in the probability of possible scenarios and an increase or decrease in those
assumptions by 10% would result in a change in the impairment recorded by $375. As at September 30, 2024, there remains significant uncertainty with regards to the trial outcome and the strategy moving forward.
| 9. | Accounts payable |
|---|
The Company had the following accounts payable and accrued expenses at the end of each reporting period:
Summary of detailed information about accounts payable and accrued expenses
| September<br> 30, | December<br> 31, | |
|---|---|---|
| 2024 | 2023 | |
| Trade accounts<br> payable | ||
| Accrued research and development<br> costs | ||
| Accrued employee benefits | ||
| Payroll tax and other statutory<br> liabilities | ||
| Other<br> accrued liabilities | ||
| Accounts<br> Payables and accrued liabilities |
All values are in US Dollars.
| 17 |
| --- |
COSCIENSBiopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of September 30, 2024, and for the three and nine months ended September 30, 2024, and 2023
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
| 10. | Employee future benefits |
|---|
The change in the Company’s employee future benefit obligations is summarized as follows:
Summary of net employee future benefit liability asset
| Nine<br> months ended September<br> 30, 2024 | |||||
| Pension | Other | ||||
| benefit<br> plans | benefit<br> plans | Total | |||
| Change<br> in plan liabilities | |||||
| Balances – Beginning of the period | |||||
| Acquisition of<br> Aeterna (note 3) | |||||
| Current service cost | |||||
| Interest cost | |||||
| Actuarial loss from changes<br> in financial assumptions | |||||
| Benefits paid | ) | ) | |||
| Impact<br> of foreign exchange rate changes | |||||
| Balances<br> – End of the period | |||||
| Change<br> in plan assets | |||||
| Balances – Beginning of the period | |||||
| Acquisition of Aeterna Zentaris<br> Inc. (note 3) | |||||
| Interest income from plan<br> assets | |||||
| Employer contributions | |||||
| Employee contributions | |||||
| Benefits paid | ) | ) | |||
| Impact<br> of foreign exchange rate changes | |||||
| Balances<br> – End of the period | |||||
| Net liability of the unfunded<br> plans | |||||
| Net liability<br> of the funded plans | |||||
| Net<br> amount recognized as Employee future benefits | |||||
| Amounts recognized: | |||||
| In net loss | |||||
| Actuarial loss on defined<br> benefit plans in other comprehensive loss | ) | ) |
All values are in US Dollars.
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 3.40% as of September 30, 2024, and 3.70% as of June 3, 2024, causing the variances in the actuarial loss on defined benefit plan during the nine months ended September 30, 2024.
| 18 |
| --- |
COSCIENSBiopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of September 30, 2024, and for the three and nine months ended September 30, 2024, and 2023
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
| 11. | Warrants |
|---|
Warrant activity for the nine months ended September 30, 2024, was as follows:
Summaryof warrants activity reclassified equity
| Warrants | Weighted<br><br> average exercise price | Amount | ||||
|---|---|---|---|---|---|---|
| # | ||||||
| Balance – December<br> 31, 2023 | - | |||||
| Warrants either<br> issued or assumed as part of the acquisition of Aeterna (note 3) | 747,948 | |||||
| Exercised | (60,167 | ) | ) | |||
| Expired | (13,249 | ) | ||||
| Change<br> in fair value of warrants | - | ) | ||||
| Balance<br> – September 30, 2024 | 674,532 |
All values are in US Dollars.
The method and inputs used in estimating the fair value of warrants on the acquisition date are described in Note 3. The fair values of warrants as at September 30, 2024 are estimated using the Black-Scholes option pricing model. The weighted average assumptions used in the Black-Scholes valuation model for the period presented were as follows:
Summary of fair values of warrants assumptions
| September<br> 30, 2024 | |||
|---|---|---|---|
| Expected dividend<br> yield | $ | 0.00 | |
| Expected volatility | 65.00 | % | |
| Risk-free annual interest<br> rate | 4.47 | % | |
| Expected life (years) | 2.67 | ||
| Weighted average share price | $ | 3.75 | |
| Weighted average exercise price | $ | 11.53 |
At September 30, 2024, the following warrants were outstanding:
Schedule of warrants outstanding
| Issuance<br> date | Number | Weighted<br><br><br> average<br><br> remaining<br><br> contractual life | Weighted<br><br> average <br>exercise price | ||
|---|---|---|---|---|---|
| # | years | ||||
| February 2020 | 11,129 | 1.35 | |||
| July 2020 | 56,210 | 0.89 | |||
| August 2020 | 17,310 | 0.89 | |||
| February 2021 | 16,507 | 1.39 | |||
| June 2024 | 573,376 | 0.76 | |||
| Balance<br> – September 30, 2024 | 674,532 | 2.67 |
All values are in US Dollars.
| 19 |
| --- |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of September 30, 2024, and for the three and nine months ended September 30, 2024, and 2023
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
| 12. | Deferred share units |
|---|
The Company grants deferred share units (“DSUs”) to members of its Board of Directors and DSUs cannot be redeemed until the holder is no longer a director of the Company. Under the terms of the Long-Term Incentive Plan (“LTIP”), DSUs vest immediately and can either be settled via equity issuance or a cash payment, which is determined by the Board of Directors on the date of issuance for each grant. Each DSU settled by the issuance of one common share of the Company, net of applicable withholding taxes, is classified as equity-settled, while the DSUs settled by cash payment are classified as cash-settled.
Cash-settleddeferred share units
The compensation expense for the nine months ended September 30, 2024, was a gain of $131 (2023 - nil) and is presented in selling, general and administrative expenses. Cash-settled DSU activity for the nine months ended September 30, 2024, was as follows:
Summaryof number and weighted average exercise prices of cash settled deferred shares units
| Units | Amount | ||||
|---|---|---|---|---|---|
| # | |||||
| Balance – January 1,<br> 2024 | - | ||||
| Granted –<br> Replacement awards (note 3) | 49,230 | ||||
| Exercised | (12,250 | ) | ) | ||
| Change<br> in fair value of cash-settled DSUs | - | ) | |||
| Balance<br> – September 30, 2024 | 36,980 |
All values are in US Dollars.
The method and inputs used in estimating the fair value of DSUs on the acquisition date are described in Note 3. The fair value of the liability, classified as DSU liability, is subsequently remeasured at each reporting date and at settlement date, with changes in fair value recognized in profit or loss.
Equity-settleddeferred share units
The compensation expense for the nine months ended September 30, 2024, was $411 (2023 - $nil) and is presented in selling, general and administrative expenses. Equity-settled DSU activity for the nine months ended September 30, 2024, was as follows:
Summaryof number and weighted average exercise prices of equity settled deferred shares units
| 2024 | Amount | ||
|---|---|---|---|
| # | |||
| Balance – January 1,<br> 2024 | - | ||
| Granted | 65,000 | ||
| Balance<br> – September 30, 2024 | 65,000 |
All values are in US Dollars.
| 20 |
| --- |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of September 30, 2024, and for the three and nine months ended September 30, 2024, and 2023
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
| 13. | Shareholders’ equity |
|---|
Sharecapital
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.
Summary of share capital
| Common<br> shares | Amount | ||
|---|---|---|---|
| # | |||
| Balance –<br> December 31, 2023 | 1,847,593 | ||
| Deemed issuance of shares<br> to Aeterna shareholders (note 3) | 1,213,967 | ||
| Granted | 60,167 | ||
| Balance<br> – September 30, 2024 | 3,121,727 |
All values are in US Dollars.
As discussed in Note 1, Business Overview, on June 3, 2024, each outstanding Ceapro common share was exchanged for 0.02360 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.
Share-basedcompensation
The Company grants stock options to eligible employees, directors, officers, and consultants under stock option plans. In accordance with the terms of the Plan of Arrangement, the 12,949 share-based payment awards held by employees of Aeterna prior to the transaction date of June 3, 2024 are deemed to be replacement awards issued with no modifications. Furthermore, in the nine months ended September 30, 2024, the Company granted nil (2023 – 21,004) new stock options. The stock options have a term of seven years and will vest over a period of three years. The fair value at grant date is estimated using a Black-Scholes option pricing model, considering the terms and conditions upon which the options were granted, using the following assumptions:
Summary of assumptions to determine share-based compensation options granted
| September<br> 30, 2023 | |||
|---|---|---|---|
| Expected dividend<br> yield | $ | 0.00 | |
| Expected volatility | 65.00 | % | |
| Risk-free annual interest<br> rate | 3.23 | % | |
| Expected life (years) | 5.0 | ||
| Share price | $ | 19.06 | |
| Exercise price | $ | 19.06 | |
| Grant date fair value | $ | 11.00 |
The expected volatility of these stock options was determined using historical volatility rates and the expected life was determined using the weighted average life of past options issued.
| 21 |
| --- |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of September 30, 2024, and for the three and nine months ended September 30, 2024, and 2023
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
The
compensation expense for the three months ended September 30, 2024, was $29 (2023 – $43) and for the nine months ended September 30, 2024, was $43 (2023 – $142) recognized over the vesting period. Option activity for the nine months ended September 30, 2024, and 2023, was as follows:
Summary of number and weighted average exercise prices of deferred shares units
| Stock<br> options | Weighted<br> <br>average <br>exercise price | |||
|---|---|---|---|---|
| # | ||||
| Balance –<br> January 1, 2024 | 74,371 | |||
| Granted - Replacement options<br> (note 3) | 12,949 | |||
| Exercised | (1,416 | ) | ||
| Cancelled<br> / Forfeited | (7,258 | ) | ||
| Balance<br> – September 30, 2024 | 80,062 |
All values are in US Dollars.
| Stock options | Weighted average exercise price | ||
|---|---|---|---|
| # | $ | ||
| Balance – January 1,<br> 2023 | 64,735 | 20.53 | |
| Granted | 21,712 | 19.06 | |
| Exercised | (1,416 | ) | 2.93 |
| Cancelled<br> / Forfeited | (5,939 | ) | 19.06 |
| Balance<br> – September 30, 2023 | 79,091 | 20.53 |
Concurrent with the Transaction described in Note 1, Business Overview, on June 3, 2024, each outstanding stock option was reissued to reflect the exchange rate of the Company’s common shares and to convert the exercise price into U.S. dollar. Accordingly, all quantities and prices in these interim condensed consolidated financial statements have been retroactively adjusted for all periods presented to give effect to the share exchange and related adjustments.
| 14. | Fair value of financial instruments |
|---|
The following presents financial assets and liabilities measured at fair value in the statement of financial position in accordance with the fair value hierarchy.
In establishing fair value, the Company uses a fair value hierarchy based on levels as defined below:
| ● | Level 1: quoted prices (unadjusted)<br> in active markets for identical assets or liabilities at the reporting date; |
|---|---|
| ● | Level 2: inputs other than<br> quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly; and |
| ● | Level 3: inputs that are<br> based on little or no observable market data, therefore requiring entities to develop their own assumptions. |
The Company has determined that, excluding the derivative, the carrying amounts of its current financial assets and financial liabilities approximate their fair value given the short-term nature of these instruments.
As
at September 30, 2024 and December 31, 2023, the New Warrants and DSUs are the only financial instruments measured at fair value in the condensed interim consolidated statement of financial position. The New Warrants having an exercise price of $0.01 and DSUs of $nil are classified in level 2 and their fair value has been estimated by reference to the quoted price of the underlying shares at the reporting date. The fair value of warrants deemed issued to Aeterna warrant holders is measured at fair value are classified in level 3.
| 22 |
| --- |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of September 30, 2024, and for the three and nine months ended September 30, 2024, and 2023
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
| 15. | Supplemental disclosure of cash flow information |
|---|
Summary of changes in operating assets and liabilities
| 2024 | 2023 | 2024 | 2023 | |||||
|---|---|---|---|---|---|---|---|---|
| Three<br> months ended | Nine<br> months ended | |||||||
| September<br> 30, | September<br> 30, | |||||||
| 2024 | 2023 | 2024 | 2023 | |||||
| Changes in operating assets<br> and liabilities: | ||||||||
| Trade and other<br> receivables | (978 | 429 | (1,662 | 1,356 | ||||
| Inventory | (206 | (169 | 688 | (1,203 | ||||
| Prepaid expenses and other<br> current assets | 266 | (82 | (1,627 | (56 | ||||
| Payables and accrued liabilities | (3,566 | 558 | (983 | (408 | ||||
| Deferred revenues | 217 | - | 217 | - | ||||
| Provision for restructuring<br> and other costs | 273 | - | 274 | - | ||||
| Employee<br> future benefits | (131 | - | (175 | - | ||||
| Increase<br>(decrease) in operating assets and liabilities | (4,125 | 736 | (3,268 | (311 |
All values are in US Dollars.
Additions
of property and equipment of $0.5 million for the nine-months ended September 30, 2024 (2023 - nil) were acquired on deferred payment terms, the settlement of which are still outstanding at period end.
| 16. | Net loss per share |
|---|
The following table sets forth pertinent data relating to the computation of basic and diluted net loss per share attributable to common shareholders.
Summary of pertinent data relating to computation of basic and diluted net loss per share
| 2024 | 2023 | 2024 | 2023 | |||||
|---|---|---|---|---|---|---|---|---|
| Three<br> months ended | Nine<br> months ended | |||||||
| September<br> 30, | September<br> 30, | |||||||
| 2024 | 2023 | 2024 | 2023 | |||||
| Net<br> loss | ) | ) | ) | ) | ||||
| Basic and diluted weighted-average<br> shares outstanding | ||||||||
| Basic and<br> diluted loss per share | ) | ) | ) | ) | ||||
| Items excluded from the calculation<br> of diluted net loss per share due to their anti-dilutive effect: | ||||||||
| Stock options and DSUs | ||||||||
| Warrants |
All values are in US Dollars.
| 23 |
| --- |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of September 30, 2024, and for the three and nine months ended September 30, 2024, and 2023
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
| 17. | Segment information |
|---|
As of September 30, 2024 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.
Activeingredient
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 lead product, Macrilen^®^(macimorelin). The segment also includes 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.
| 24 |
| --- |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of September 30, 2024, and for the three and nine months ended September 30, 2024, and 2023
(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
| Active<br> ingredient | Biopharmaceutical | Total | ||||
|---|---|---|---|---|---|---|
| Three<br> months ended September 30, 2024 | ||||||
| Active<br> ingredient | Biopharmaceutical | Total | ||||
| Revenue | ||||||
| Cost of sales | ) | ) | ) | |||
| Gross margin | ||||||
| Research and development | ) | ) | ) | |||
| Impairment<br> of intangible assets | ) | ) | ||||
| Loss<br> from operations before SG&A and other income (expenses) | ) | ) | ||||
| Selling,<br> general & administrative | ) | |||||
| Loss<br> from operations | ) | |||||
| Net other<br> income | ||||||
| Loss<br> before income taxes | ) |
All values are in US Dollars.
| Active<br> ingredient | Biopharmaceutical | Total | |||
|---|---|---|---|---|---|
| Three<br> months ended September 30, 2023 | |||||
| Active<br> ingredient | Biopharmaceutical | Total | |||
| Revenue | |||||
| Cost of sales | ) | ) | |||
| Gross margin | |||||
| Research<br> and development | ) | ) | |||
| Income<br> from operations before SG&A and other income (expenses) | |||||
| Selling,<br> general & administrative | |||||
| Loss<br> from operations | ) | ||||
| Net other<br> income | ) | ||||
| Loss<br> before income taxes | ) |
All values are in US Dollars.
| 25 |
| --- |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of September 30, 2024, and for the three and nine months ended September 30, 2024, and 2023
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
| Active<br> ingredient | Biopharmaceutical | Total | ||||
|---|---|---|---|---|---|---|
| Nine<br> months ended September 30, 2024 | ||||||
| Active<br> ingredient | Biopharmaceutical | Total | ||||
| Revenue | ||||||
| Cost of sales | ) | ) | ) | |||
| Gross margin | ||||||
| Research and development | ) | ) | ) | |||
| Impairment<br> of intangible assets | ) | ) | ||||
| Loss<br> from operations before SG&A and other income (expenses) | ) | ) | ||||
| Selling,<br> general & administrative | ) | |||||
| Loss<br> from operations | ) | |||||
| Net other<br> income | ||||||
| Loss<br> before income taxes | ) |
All values are in US Dollars.
| Active<br> ingredient | Biopharmaceutical | Total | |||
|---|---|---|---|---|---|
| Nine<br> months ended September 30, 2023 | |||||
| Active<br> ingredient | Biopharmaceutical | Total | |||
| Revenue | |||||
| Cost of sales | ) | ) | |||
| Gross margin | |||||
| Research<br> and development | ) | ||||
| Income<br> from operations before SG&A and other income (expenses) | |||||
| Income<br> (Loss) from operations before SG&A and other income (expenses) | |||||
| Selling,<br> general & administrative | ) | ||||
| Loss<br> from operations | ) | ||||
| Net other<br> income | |||||
| Loss<br> before income taxes | ) |
All values are in US Dollars.
MajorCustomer
During
the three months ended September 30, 2024, the Company had export sales to one major distributor of the Company’s products representing 72% of total revenue (2023 - 93% of total revenue). During the nine months ended September 30, 2024, the Company had export sales to one major distributor of the Company’s products representing 85% of total revenue (2023 - 90% of total revenue). As at September 30, 2024, one customer represented 69% of total trade and other receivables (September 30, 2023 – one major customer amounted to 80%).
| 26 |
| --- |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of September 30, 2024, and for the three and nine months ended September 30, 2024, and 2023
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
18.Commitments
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<br> than 1 year | |
| 1<br> - 3 years | |
| 4<br> - 5 years | |
| More<br> than 5 years | |
| Minimum<br> lease payments, net |
All values are in US Dollars.
The
Company executed various agreements including in-licensing and similar arrangements with development partners. Such agreements may require the Company to make payments on achievement of stages of development, launch or revenue milestones, although the Company generally has the right to terminate these agreements at no penalty. The Company may have to pay up to $30,016 upon achieving certain sales volumes, regulatory or other milestones related to specific products.
In addition, 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. Royalties percentage rate would be 2% strictly for sales made from avenanthramides produced from the AG technology while royalty percentage rates would range between1.0% 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).
The
Company has entered into a purchase commitment with a European specialized engineering firm for the supply of engineering, services and equipment related to the construction of a PGX-100 pilot plant (note 7). As of September 30, 2024 the remaining purchase commitment is $491 (€438) and is expected to be completed in 2024.
| 27 |
| --- |
Exhibit 99.3
FORM52-109F2
CERTIFICATIONOF INTERIM FILINGS
FULLCERTIFICATE
I, Gilles Gagnon**, Chief Executive Officer, COSCIENS Biopharma Inc.**, certify the following:
| 1. | Review: I have reviewed the interim financial report and interim MD&A (together, the<br> “interim<br> filings”)<br> of COSCIENS Biopharma Inc. (the “issuer”)<br> for the interim period ended September 30, 2024. |
|---|---|
| 2. | No misrepresentations: Based on my knowledge, having exercised reasonable diligence,<br> the interim filings do not contain any untrue statement of a material fact or omit to state<br> a material fact required to be stated or that is necessary to make a statement not misleading<br> in light of the circumstances under which it was made, with respect to the period covered<br> by the interim filings. |
| --- | --- |
| 3. | Fair presentation: Based on my knowledge, having exercised reasonable diligence, the interim<br> financial report together with the other financial information included in the interim filings<br> fairly present in all material respects the financial condition, financial performance and<br> cash flows of the issuer, as of the date of and for the periods presented in the interim<br> filings. |
| --- | --- |
| 4. | Responsibility: The issuer’s<br> other certifying officer(s) and I are responsible for establishing and maintaining disclosure<br> controls and procedures (DC&P) and internal control over financial reporting (ICFR),<br> as those terms are defined in National Instrument 52-109 Certification of Disclosure in Issuers*’* Annual and Interim Filings, for<br> the issuer. |
| --- | --- |
| 5. | Design: Subject to the limitations, if any, described in paragraphs 5.2 and 5.3, the issuer’s<br> other certifying officer(s) and I have, as at the end of the period covered by the interim<br> filings |
| --- | --- |
| (a) | designed<br> DC&P, or caused it to be designed under our supervision, to provide reasonable assurance<br> that |
| --- | --- |
| (i) | material<br> information relating to the issuer is made known to us by others, particularly during the<br> period in which the interim filings are being prepared; and |
| --- | --- |
| (ii) | information<br> required to be disclosed by the issuer in its annual filings, interim filings or other reports<br> filed or submitted by it under securities legislation is recorded, processed, summarized<br> and reported within the time periods specified in securities legislation; and |
| --- | --- |
| (b) | designed<br> ICFR, or caused it to be designed under our supervision, to provide reasonable assurance<br> regarding the reliability of financial reporting and the preparation of financial statements<br> for external purposes in accordance with the issuer’s<br> GAAP. |
| --- | --- |
| 5.1 | Control framework: The control framework the issuer’s<br> other certifying officer(s) and I used to design the issuer’s<br> ICFR is Internal Control – Integrated Framework: 2013, issued by the Committee of Sponsoring<br> Organizations of the Treadway Commission. |
| --- | --- |
| 5.2 | N/A |
| --- | --- |
| 5.3 | N/A |
| --- | --- |
| 6. | Reporting changes in ICFR: The issuer has disclosed in its interim MD&A any change in the<br> issuer’s<br> ICFR that occurred during the period beginning on July 1, 2024 and<br> ended on September 30, 2024 that has materially affected, or is reasonably likely to materially<br> affect, the issuer’s<br> ICFR. |
| --- | --- |
Date: November 11th, 2024
| /s/ Gilles Gagnon |
|---|
| Gilles Gagnon |
| Chief Executive Officer |
Exhibit 99.4
FORM52-109F2
CERTIFICATIONOF INTERIM FILINGS
FULLCERTIFICATE
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<br> “interim<br> filings”)<br> of COSCIENS Biopharma Inc. (the “issuer”)<br> for the interim period ended September 30, 2024. |
|---|---|
| 2. | No misrepresentations: Based on my knowledge, having exercised reasonable diligence,<br> the interim filings do not contain any untrue statement of a material fact or omit to state<br> a material fact required to be stated or that is necessary to make a statement not misleading<br> in light of the circumstances under which it was made, with respect to the period covered<br> by the interim filings. |
| --- | --- |
| 3. | Fair presentation: Based on my knowledge, having exercised reasonable diligence, the interim<br> financial report together with the other financial information included in the interim filings<br> fairly present in all material respects the financial condition, financial performance and<br> cash flows of the issuer, as of the date of and for the periods presented in the interim<br> filings. |
| --- | --- |
| 4. | Responsibility: The issuer’s<br> other certifying officer(s) and I are responsible for establishing and maintaining disclosure<br> controls and procedures (DC&P) and internal control over financial reporting (ICFR),<br> as those terms are defined in National Instrument 52-109 Certification of Disclosure in Issuers*’* Annual and Interim Filings, for<br> the issuer. |
| --- | --- |
| 5. | Design: Subject to the limitations, if any, described in paragraphs 5.2 and 5.3, the issuer’s<br> other certifying officer(s) and I have, as at the end of the period covered by the interim<br> filings |
| --- | --- |
| (a) | designed<br> DC&P, or caused it to be designed under our supervision, to provide reasonable assurance<br> that |
| --- | --- |
| (i) | material<br> information relating to the issuer is made known to us by others, particularly during the<br> period in which the interim filings are being prepared; and |
| --- | --- |
| (ii) | information<br> required to be disclosed by the issuer in its annual filings, interim filings or other reports<br> filed or submitted by it under securities legislation is recorded, processed, summarized<br> and reported within the time periods specified in securities legislation; and |
| --- | --- |
| (b) | designed<br> ICFR, or caused it to be designed under our supervision, to provide reasonable assurance<br> regarding the reliability of financial reporting and the preparation of financial statements<br> for external purposes in accordance with the issuer’s<br> GAAP. |
| --- | --- |
| 5.1 | Control framework: The control framework the issuer’s<br> other certifying officer(s) and I used to design the issuer’s<br> ICFR is Internal Control – Integrated Framework: 2013, issued by the Committee of Sponsoring<br> Organizations of the Treadway Commission. |
| --- | --- |
| 5.2 | N/A |
| --- | --- |
| 5.3 | N/A |
| --- | --- |
| 6. | Reporting changes in ICFR: The issuer has disclosed in its interim MD&A any change in the<br> issuer’s<br> ICFR that occurred during the period beginning on July 1, 2024 and<br> ended on September 30, 2024 that has materially affected, or is reasonably likely to materially<br> affect, the issuer’s<br> ICFR. |
| --- | --- |
Date: November 11th, 2024
| /s/ Giuliano La Fratta |
|---|
| Giuliano La Fratta |
| Chief Financial Officer |