COSCIENS Biopharma Inc 6-K, filed Aug 13, 2024
COSCIENS Biopharma Inc. (CSCIF)
About this 6-K
COSCIENS Biopharma Inc filed this 6-K on August 13, 2024.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 OF THE SECURITIES EXCHANGE ACT OF 1934
For the month of August 2024
Commission
File Number:
(Translation of registrant’s name into English)
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
Exhibits 99.1 and 99.2 included with this report on Form 6-K are hereby incorporated by reference into the Registrant’s Registration Statements on Form S-8 (No. 333-224737, No. 333-210561 and No. 333-200834) and shall be deemed to be a part thereof from the date on which this report is furnished, to the extent not superseded by documents or reports subsequently filed or furnished.
DOCUMENTS INDEX
| (2) |
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.
| AETERNA ZENTARIS INC. | |||
| Date: August 13, 2024 | By: | /s/ Gilles Gagnon | |
| Gilles Gagnon | |||
| President and Chief Executive Officer | |||
| (3) |
Exhibit 99.1
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Condensed Interim Consolidated Financial Statements
As of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In thousands of US dollars)
(Unaudited)
| 1 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Condensed Interim Consolidated Statements of Financial Position
(In thousands of US dollars)
(Unaudited)
As
of | As
of | |||||||
| $ | $ | |||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | ||||||||
| Trade and other receivables | ||||||||
| Inventories (note 5) | ||||||||
| Income taxes receivable | ||||||||
| Prepaid expenses and other assets (note 6) | ||||||||
| Total current assets | ||||||||
| Non-current assets | ||||||||
| Restricted cash and cash equivalents | ||||||||
| Investment tax credit receivable | ||||||||
| Property and equipment (note 7) | ||||||||
| Intangible assets (note 8) | ||||||||
| Deferred tax assets | ||||||||
| Total non-current assets | ||||||||
| Total assets | ||||||||
| LIABILITIES | ||||||||
| Current liabilities | ||||||||
| Payables and accrued liabilities (note 9) | ||||||||
| Provisions | ||||||||
| Income taxes payable | ||||||||
| Current portion of deferred revenues (note 4) | ||||||||
| Current portion of lease liabilities | ||||||||
| Warrant liability (note 11) | ||||||||
| DSU liability (note 12) | ||||||||
| Total current liabilities | ||||||||
| Non-current liabilities | ||||||||
| Deferred revenues (note 4) | ||||||||
| Lease liabilities | ||||||||
| Employee future benefits (note 10) | ||||||||
| Total non-current liabilities | ||||||||
| Total liabilities | ||||||||
| Shareholders’ equity | ||||||||
| Share capital (note 13) | ||||||||
| Contributed surplus | ||||||||
| Retained earnings | ||||||||
| Accumulated other comprehensive loss | ( | ) | ( | ) | ||||
| Total Shareholders’ equity | ||||||||
| Total liabilities and shareholders’ equity | ||||||||
Commitments (note 18)
The accompanying notes are an integral part of these condensed interim consolidated financial statements.
Approved by the Board of Directors
| /s/ Ronnie Miller | /s/ Dennis Turpin | |
| Ronnie Miller, Chair of the Board | Dennis Turpin, Director |
| 2 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Condensed Interim Consolidated Statements of Changes in Shareholders’ Equity
For the six months ended June 30, 2024, and 2023
(In thousands of US dollars)
(Unaudited)
| Share capital | Contributed surplus | Retained earnings | Accumulated other comprehensive loss | Total | ||||||||||||||||
| $ | $ | $ | $ | $ | ||||||||||||||||
| Balance – January 1, 2024 | ( | ) | ||||||||||||||||||
| Net loss | ( | ) | ( | ) | ||||||||||||||||
| Other comprehensive loss: | ||||||||||||||||||||
| Foreign currency translation adjustments | ( | ) | ( | ) | ||||||||||||||||
| Comprehensive loss | ( | ) | ( | ) | ( | ) | ||||||||||||||
| Acquisition of Aeterna Zentaris Inc. (note 3) | ||||||||||||||||||||
| Share-based compensation costs | ||||||||||||||||||||
| Balance – June 30, 2024 | ( | ) | ||||||||||||||||||
| Share capital | Contributed surplus | Retained earnings | Accumulated other comprehensive loss | Total | ||||||||||||||||
| $ | $ | $ | $ | $ | ||||||||||||||||
| Balance – January 1, 2023 | ( | ) | ||||||||||||||||||
| Balance | ( | ) | ||||||||||||||||||
| Net loss | ( | ) | ( | ) | ||||||||||||||||
| Other comprehensive loss: | ||||||||||||||||||||
| Foreign currency translation adjustments | ||||||||||||||||||||
| Comprehensive income | ( | ) | ( | ) | ||||||||||||||||
| Options exercised | ( | ) | ||||||||||||||||||
| Share-based compensation costs | ||||||||||||||||||||
| Balance – June 30, 2023 | ( | ) | ||||||||||||||||||
| Balance | ( | ) | ||||||||||||||||||
The accompanying notes are an integral part of these condensed interim consolidated financial statements.
| 3 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Condensed Interim Consolidated Statements of Loss and Comprehensive Loss
For the three and six months ended June 30, 2024, and 2023
(In thousands of US dollars, except share and per share data)
(Unaudited)
| Three months ended | Six months ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| $ | $ | $ | $ | |||||||||||||
| Revenues (note 4) | ||||||||||||||||
| Cost of sales | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Gross profit | ||||||||||||||||
| Research and development | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Selling, general and administrative | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Loss from operations | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Gain due to changes in foreign currency | ||||||||||||||||
| Finance costs | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other income | ||||||||||||||||
| Change in fair value of warrant and DSU liabilities | ||||||||||||||||
| Other income | ||||||||||||||||
| Loss before income taxes | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Income tax recovery | ||||||||||||||||
| Net loss | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other comprehensive loss: | ||||||||||||||||
| Items that may be reclassified subsequently to profit or loss: | ||||||||||||||||
| Foreign currency translation adjustments | ( | ) | ( | ) | ||||||||||||
| Comprehensive loss | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Basic and diluted loss per share (note 16) | ) | ) | ) | ) | ||||||||||||
| Weighted average number of shares outstanding (basic and diluted) | ||||||||||||||||
The accompanying notes are an integral part of these condensed interim consolidated financial statements.
| 4 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Condensed Interim Consolidated Statements of Cash Flows
For the three and six months ended June 30, 2024, and 2023
(In thousands of US dollars)
(Unaudited)
| Three months ended | Six months ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| $ | $ | $ | $ | |||||||||||||
| Cash flows from operating activities | ||||||||||||||||
| Net loss for the period | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Items not affecting cash and cash equivalents: | ||||||||||||||||
| Depreciation and amortization | ||||||||||||||||
| Share-based compensation costs | ||||||||||||||||
| Employee future benefits | ||||||||||||||||
| Change in fair value of warrant and DSU liabilities | ( | ) | ( | ) | ||||||||||||
| Other non-cash items | ||||||||||||||||
| Income tax recovery | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Changes in operating assets and liabilities (note 15) | ( | ) | ( | ) | ||||||||||||
| Net cash used in operating activities | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Cash flows from financing activities | ||||||||||||||||
| Exercise of stock options | ||||||||||||||||
| Payments on lease liabilities | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Net cash used in financing activities | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Cash flows from investing activities | ||||||||||||||||
| Acquisition of Aeterna Zentaris Inc. (note 3) | ||||||||||||||||
| Purchase of property and equipment | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Net cash used in investing activities | ( | ) | ( | ) | ||||||||||||
| Effect of exchange rate changes on cash and cash equivalents | ( | ) | ( | ) | ||||||||||||
| Net change in cash and cash equivalents | ( | ) | ( | ) | ||||||||||||
| Cash and cash equivalents – Beginning of period | ||||||||||||||||
| Cash and cash equivalents – End of period | ||||||||||||||||
The accompanying notes are an integral part of these condensed interim consolidated financial statements.
| 5 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
1. Business overview
Summary of business
COSCIENS Biopharma Inc. (the “Company”), formerly Aeterna Zentaris Inc., is a specialty biopharmaceutical company developing and commercializing a diversified portfolio of cosmeceutical, nutraceutical and pharmaceutical products. The Company’s patented technologies include Pressurized Gas eXpanded (PGX) 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 active ingredient 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 health benefits.
The Company’s lead 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). The Company is leveraging the clinical success and safety profile of macimorelin to develop it for the diagnosis of childhood-onset growth hormone deficiency (CGHD).
The Company is also dedicated to the development of its therapeutic assets and has established a pre-clinical development pipeline to potentially address unmet medical needs across a number of indications, including treatment of inflammation-based diseases, idiopathic pulmonary fibrosis (IPF), neuromyelitis optica spectrum disorder (NMOSD), Parkinson’s disease (PD), hypoparathyroidism and amyotrophic lateral sclerosis (ALS; Lou Gehrig’s disease).
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
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 June 30, 2024 and December 31, 2023 and for the three and six months ended June 30, 2024 and 2023 reflect the results of operations and financial position of Ceapro for the periods presented and includes 28 days of the results of operations of Aeterna as of June 30, 2024 and for three and six months ended June 30, 2024 subsequent to the Transaction, which was completed on June 3, 2024. Refer to Note 3 for additional information.
The accompanying consolidated financial statements include the accounts of COSCIENS Biopharma 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 JuventeDC 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.
| 6 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
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 Reporting as 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:
Business combinations
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.
Foreign currency
Effective June 30, 2024, Ceapro has changed its reporting currency from Canadian dollars to U.S. dollars. This change in reporting currency has been applied retrospectively such that all amounts in the consolidated financial statements of the Company and the accompanying notes thereto are expressed in U.S. dollars. References to “$” are U.S. dollars and references to “CA $” are to Canadian dollars. For comparative purposes, historical consolidated financial statements of Ceapro were recast in U.S. dollars by translating assets and liabilities at the closing exchange rate in effect at the end of the respective period, revenues, expenses and cash flows at the average exchange rate in effect for the respective period and equity transactions at historical exchange rates. Translation gains and losses are included in the cumulative foreign currency translation adjustment, which is reported as a component of shareholders’ equity under accumulated other comprehensive loss.
| 7 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
Post-employment benefits
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.
Intangible assets
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
Warrant liabilities
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 recognised in profit or loss.
| 8 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
Reclassifications
Certain
prior period amounts have been reclassified to conform to current period presentation. In the consolidated statement of financial position,
trade receivables of $
New standards and amendments
Several amendments apply for the first time for reporting periods beginning after January 1, 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.
Critical accounting 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, 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 obligations: key actuarial assumptions (note 10); and | |
| ● | Business acquisition: identification of the acquirer, determination of the fair value of the consideration transferred and fair value of some of the assets acquired and liabilities assumed (note 3). |
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.
| 9 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of June 30, 2024, and for the three and six months ended June 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:
Preliminary Purchase Price Allocation
| Number | Amount | |||||||
| # | $ | |||||||
| Purchase price | ||||||||
| Shares deemed issued to Aeterna shareholders(1) | ||||||||
| Warrants issued to Aeterna shareholders(2) | ||||||||
| Replacement share-based payment awards: | ||||||||
| Equity-settled options(3) | ||||||||
| Cash-settled DSUs(3) | ||||||||
| Warrants deemed issued(4) | ||||||||
| Recognized 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 assets(5) | ||||||||
| Accounts payable and accrued liabilities | ( | ) | ||||||
| Provisions | ( | ) | ||||||
| Income tax payable | ( | ) | ||||||
| Deferred revenues | ( | ) | ||||||
| Lease liabilities | ( | ) | ||||||
| Employee future benefits | ( | ) | ||||||
| Total provisional identifiable net assets (liabilities) | ||||||||
| (1) |
| 10 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
| (2) |
| (3) |
| (4) |
| (5) |
The
fair value of the replacement awards is $
Schedule of fair value at acquisition date was estimated using a Black-Scholes option
| Options | ||||
| Expected dividend yield | $ | |||
| Weighted average expected volatility | % | |||
| Weighted average risk-free rate | % | |||
| Weighted average expected life (years) | ||||
| Share price | $ | |||
| Weighted average exercise price | $ | |||
| Weighted average fair value | $ | |||
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 $ per DSU was based on the listed share price of Ceapro as at June 3, 2024 (CA$), after
giving effect to the exchange of each outstanding Ceapro common share for
| (4) | The fair value of the |
| Warrants | ||||
| Expected dividend yield | $ | |||
| Weighted average expected volatility | % | |||
| Weighted average risk-free rate | % | |||
| Weighted average expected life (years) | ||||
| Share price | $ | |||
| Weighted average exercise price | $ | |||
| Weighted average fair value | $ | |||
| (5) | The identifiable intangible
assets consist of patents |
For
the period subsequent to the Transaction, Aeterna contributed revenue of $
| 11 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of June 30, 2024, and for the three and six months ended June 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. 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
| Three months ended | Six months ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| $ | $ | $ | $ | |||||||||||||
| Active ingredients | ||||||||||||||||
| Pharmaceutical | ||||||||||||||||
| Total | ||||||||||||||||
Deferred revenue
The deferred revenue balance primarily relates to the advance consideration received in the form of non-refundable non-creditable upfront payment and milestone payments relating to list price approvals of Ghryvelin™ in the United Kingdom, Spain and Germany as per an exclusive licensing agreement for the commercialization of macimorelin (the “Licensed Product”) in the European Economic Area and the United Kingdom and an exclusive supply agreement for a period of ten years, subject to renewal, to supply such Licensed Product.
Revenue for this contract will be recognized based on units of Licensed Product supplied. The total units that the Company expects to supply pursuant to the Pharmanovia Agreement is an estimate, based on current projections and anticipated market demand, and therefore will be a significant judgment that will be relied upon when using the outputs method to recognize revenue. The Company expects to recognize the balance of the deferred revenue over the remaining period of eight years, 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 six months ended June 30, 2024, the Company recognized $ and $ respectively as revenue from the deferred revenue balance originating from the acquisition of Aeterna Zentaris Inc. (note 3).
Liabilities related to contracts with customers
The following table provides a summary of deferred revenue balances:
Summary of deferred revenue
| Current | Non-current | Total | ||||||||||
| June 30, 2024 | ||||||||||||
| Current | Non-current | Total | ||||||||||
| $ | $ | $ | ||||||||||
| Pharmanovia | ||||||||||||
| NK Meditech | ||||||||||||
| Contract liabilities | ||||||||||||
| 12 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of June 30, 2024, and for the three and six months ended June 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
| June 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| $ | $ | |||||||
| Raw materials | ||||||||
| Work in progress | ||||||||
| Finished goods | ||||||||
| Inventories | ||||||||
Inventories
expensed to cost of goods sold during the three-month period ended June 30, 2024, are $
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
| June 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| $ | $ | |||||||
| Prepaid insurance | ||||||||
| Prepaid research and development | ||||||||
| Other | ||||||||
| Total | ||||||||
| 13 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of June 30, 2024, and for the three and six months ended June 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
| Cost | ||||||||||||||||||||||||
| Equipment Not Available for Use | Equipment | Office and Computer Equipment | Buildings | Leasehold Improvements | Total | |||||||||||||||||||
| $ | $ | $ | $ | $ | $ | |||||||||||||||||||
| At January 1, 2023 | ||||||||||||||||||||||||
| Additions | ||||||||||||||||||||||||
| Disposals | ( | ) | ( | ) | ||||||||||||||||||||
| Impact of foreign exchange rate changes | ||||||||||||||||||||||||
| At December 31, 2023 | ||||||||||||||||||||||||
| Property plant and equipment | ||||||||||||||||||||||||
| Acquisition of Aeterna (note 3) | ||||||||||||||||||||||||
| Additions | ||||||||||||||||||||||||
| Impact of foreign exchange rate changes | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||
| At June 30, 2024 | ||||||||||||||||||||||||
| Property plant and equipment | ||||||||||||||||||||||||
| Accumulated Depreciation | ||||||||||||||||||||||||
| Equipment Not Available for Use | Equipment | Office and Computer Equipment | Buildings | Leasehold Improvements | Total | |||||||||||||||||||
| $ | $ | $ | $ | $ | $ | |||||||||||||||||||
| At January 1, 2023 | ||||||||||||||||||||||||
| Amortization | ||||||||||||||||||||||||
| Disposals | ( | ) | ( | ) | ||||||||||||||||||||
| Impact of foreign exchange rate changes | ||||||||||||||||||||||||
| At December 31, 2023 | ||||||||||||||||||||||||
| Property plant and equipment | ||||||||||||||||||||||||
| Amortization | ||||||||||||||||||||||||
| Impact of foreign exchange rate changes | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||||
| At June 30, 2024 | ||||||||||||||||||||||||
| Property plant and equipment | ||||||||||||||||||||||||
| Carrying amount | ||||||||||||||||||||||||
| Equipment Not Available for Use | Equipment | Office and Computer Equipment | Buildings | Leasehold Improvements | Total | |||||||||||||||||||
| $ | $ | $ | $ | $ | $ | |||||||||||||||||||
| At December 31, 2023 | ||||||||||||||||||||||||
| Property plant and equipment, Beginning | ||||||||||||||||||||||||
| At June 30, 2024 | ||||||||||||||||||||||||
| Property plant and equipment, Ending | ||||||||||||||||||||||||
| 14 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of June 30, 2024, and for the three and six months ended June 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 of goods sold | Selling, general and administrative | Research and development | Total | |||||||||||||
| $ | $ | $ | $ | |||||||||||||
| Six Months Ended June 30, 2023 | ||||||||||||||||
| Six Months Ended June 30, 2024 | ||||||||||||||||
Included
right-of-use in the net carrying amount of property and equipment at June 30, 2024, are assets relating to buildings, in the amount of
$
Included
in the carrying amount of leasehold improvements is $
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 $
| 15 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
8. Intangible assets
Changes in the carrying value of the Company’s identifiable intangible assets are summarized below.
Schedule of Intangible Assets
| As at June 30, 2024 | ||||||||||||
| Cost | Accumulated amortization | Carrying value | ||||||||||
| $ | $ | |||||||||||
| At January 1, 2024 | ( | ) | ||||||||||
| Acquisition of Aeterna (note 3) | ||||||||||||
| Amortization | ( | ) | ( | ) | ||||||||
| Impact of foreign exchange rate changes | ( | ) | ||||||||||
| At June 30, 2024 | ( | ) | ||||||||||
| As at December 31, 2023 | ||||||||||||
| Cost | Accumulated amortization | Carrying value | ||||||||||
| $ | $ | |||||||||||
| At January 1, 2023 | ( | ) | ||||||||||
| Acquisition of Aeterna (note 3) | ||||||||||||
| Amortization | ( | ) | ( | ) | ||||||||
| Impact of foreign exchange rate changes | ||||||||||||
| At December 31, 2023 | ( | ) | ||||||||||
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
| June 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| $ | $ | |||||||
| Trade accounts payable | ||||||||
| Accrued research and development costs | ||||||||
| Accrued employee benefits | ||||||||
| Payroll tax and other statutory liabilities | ||||||||
| Other accrued liabilities | ||||||||
| 16 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of June 30, 2024, and for the three and six months ended June 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
| $ | $ | $ | ||||||||||
Six months ended June 30, 2024 | ||||||||||||
| Pension | Other | |||||||||||
| benefit plans | benefit plans | Total | ||||||||||
| $ | $ | $ | ||||||||||
| Change in plan liabilities | ||||||||||||
| Balances – Beginning of the period | ||||||||||||
| Acquisition of Aeterna (note 3) | ||||||||||||
| Current service cost | ||||||||||||
| Interest cost | ||||||||||||
| Actuarial gain from changes in financial assumptions | ||||||||||||
| Benefits paid | ( | ) | ( | ) | ||||||||
| Impact of foreign exchange rate changes | ( | ) | ( | ) | ( | ) | ||||||
| Balances – End of the period | ||||||||||||
| Change in plan assets | ||||||||||||
| Balances – Beginning of the period | ||||||||||||
| Acquisition of Aeterna Zentaris Inc. (note 3) | ||||||||||||
| Interest income from plan assets | ||||||||||||
| Employer contributions | ||||||||||||
| Employee contributions | ||||||||||||
| Benefits paid | ( | ) | ( | ) | ||||||||
| Impact of foreign exchange rate changes | ( | ) | ( | ) | ||||||||
| Balances – End of the period | ||||||||||||
| Net liability of the unfunded plans | ||||||||||||
| Net liability of the funded plans | ||||||||||||
| Net amount recognized as Employee future benefits | ||||||||||||
| Amounts recognized: | ||||||||||||
| In net loss | ||||||||||||
| Actuarial gain on defined benefit plans in other comprehensive loss | ||||||||||||
The
calculation of the employee future benefit obligation is sensitive to the discount rate assumption and other assumptions such as the
rate of the pension benefit increase. There was no change in the discount rate of
| 17 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of June 30, 2024, and for the three and six months ended June 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 six months ended June 30, 2024, was as follows:
Summary of warrants activity reclassified equity
| Warrants | Weighted average exercise price | Amount | ||||||||||
| # | $ | $ | ||||||||||
| Balance – December 31, 2023 | ||||||||||||
| Warrants either issued or assumed as part of the acquisition of Aeterna (note 3) | ||||||||||||
| Change in fair value of warrants | ( | ) | ||||||||||
| Balance – June 30, 2024 | ||||||||||||
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 June 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
| June 30, 2024 | ||||
| Expected dividend yield | $ | |||
| Expected volatility | % | |||
| Risk-free annual interest rate | % | |||
| Expected life (years) | ||||
| Weighted average share price | $ | |||
| Weighted average exercise price | $ |
Schedule of warrants outstanding
| Issuance date | Number | Weighted average remaining contractual life | Weighted average exercise price | |||||||||
| # | years | $ | ||||||||||
| September 2019 | ||||||||||||
| February 2020 | ||||||||||||
| July 2020 | ||||||||||||
| August 2020 | ||||||||||||
| February 2021 | ||||||||||||
| June 2024 | ||||||||||||
| Balance – June 30, 2024 | ||||||||||||
| 18 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of June 30, 2024, and for the three and six months ended June 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 six months ended June 30, 2024, was a gain of $ (2023 - ) and is presented in selling, general and administrative expenses. DSU activity for the six months ended June 30, 2024, was as follows:
| Units | Amount | |||||||
| # | $ | |||||||
| Balance – January 1, 2024 | ||||||||
| Granted – Replacement awards (note 3) | ||||||||
| Change in fair value of DSUs | ( | ) | ||||||
| Balance – June 30, 2024 | ||||||||
Share capital
The Company has authorized an unlimited number of common shares (being voting and participating shares) with no par value, as well as an unlimited number of preferred, first and second ranking shares, issuable in series, with rights and privileges specific to each class, with no par value.
| Common shares | Amount | |||||||
| # | $ | |||||||
| Balance – December 31, 2023 | ||||||||
| Deemed issuance of shares to Aeterna shareholders (note 3) | ||||||||
| Balance – June 30, 2024 | ||||||||
As discussed in Note 1, Business Overview, on June 3, 2024, each outstanding Ceapro common share was exchanged for of an Aeterna common share. Accordingly, all common shares, stock options and per share amounts in these interim condensed consolidated financial statements have been retroactively adjusted for all periods presented to give effect to the share exchange.
Share-based compensation
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 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 six months ended June 30, 2024, the Company granted (2023 – ) 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:
| June 30, 2023 | ||||
| Expected dividend yield | $ | |||
| Expected volatility | % | |||
| Risk-free annual interest rate | % | |||
| Expected life (years) | ||||
| Share price | $ | |||
| Exercise price | $ | |||
| Grant date fair value | $ | |||
| 19 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
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.
The
compensation expense for the three months ended June 30, 2024, was $
| Stock options | Weighted average exercise price | |||||||
| # | $ | |||||||
| Balance – January 1, 2024 | ||||||||
| Granted - Replacement options (note 3) | ||||||||
| Cancelled / Forfeited | ( | ) | ||||||
| Balance – June 30, 2024 | ||||||||
| Stock options | Weighted average exercise price | |||||||
| # | $ | |||||||
| Balance – January 1, 2023 | ||||||||
| Granted | ||||||||
| Exercised | ( | ) | ||||||
| Cancelled / Forfeited | ( | ) | ||||||
| Balance – June 30, 2023 |
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) in active markets for identical assets or liabilities at the reporting date; | |
| ● | Level 2: inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly; and | |
| ● | Level 3: inputs that are based on little or no observable market data, therefore requiring entities to develop their own assumptions. |
The Company has determined that, excluding the derivative warrants, 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 June 30, 2024 and December 31, 2023, the warrants is the only financial instrument measured at fair value in the condensed interim consolidated statement of financial position. The warrants having an exercise price of $ 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 all other warrants measured at fair value are classified in level 3.
| 20 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of June 30, 2024, and for the three and six months ended June 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 months ended | Six months ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| $ | $ | $ | $ | |||||||||||||
| Changes in operating assets and liabilities: | ||||||||||||||||
| Trade and other receivables | ( | ) | ||||||||||||||
| Inventory | ( | ) | ( | ) | ||||||||||||
| Prepaid expenses and other current assets | ||||||||||||||||
| Payables and accrued liabilities | ( | ) | ( | ) | ||||||||||||
| Provision for restructuring and other costs | ||||||||||||||||
| Employee future benefits | ( | ) | ( | ) | ||||||||||||
| Increase (decrease) in operating assets and liabilities | ( | ) | ( | ) | ||||||||||||
Summary of pertinent data relating to computation of basic and diluted net loss per share
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Three months ended | Six months ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| $ | $ | $ | $ | |||||||||||||
| Net loss | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Basic and diluted weighted-average shares outstanding | ||||||||||||||||
| Basic and diluted loss per share | ) | ) | ) | ) | ||||||||||||
| Items excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: | ||||||||||||||||
| Stock options and DSUs | ||||||||||||||||
| Warrants | ||||||||||||||||
| 21 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of June 30, 2024, and for the three and six months ended June 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 June 30, 2024 and a result of the transaction, the Company has two reportable and operating segments: Active ingredient and Biopharmaceutical. The Group’s chief operating decision maker assesses the performance of the reportable segments based on revenues and operating loss before selling, general & administrative expenses, other income and tax by segment. Selling, general and administrative expenses are expenses and salaries related to centralized functions, such as corporate finance, legal, human resources and technology teams, which are not allocated to segments. Accounting policies applied for the Active ingredient and the Biopharmaceutical segments are identical to those used for the purposes of the consolidated financial statements as described in Note 2.
Active ingredients
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.
| 22 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of June 30, 2024, and for the three and six months ended June 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 ingredient | Biopharmaceutical | Total | ||||||||||
| Three months ended June 30, 2024 | ||||||||||||
| Active ingredient | Biopharmaceutical | Total | ||||||||||
| $ | $ | $ | ||||||||||
| Revenue | ||||||||||||
| Cost of sales | ( | ) | ( | ) | ( | ) | ||||||
| Gross margin | ( | ) | ||||||||||
| Research and development | ( | ) | ( | ) | ( | ) | ||||||
| Loss from operations before SG&A and other income (expenses) | ( | ) | ( | ) | ||||||||
| Selling, general & administrative | ( | ) | ||||||||||
| Loss from operations | ( | ) | ||||||||||
| Net other income | ||||||||||||
| Loss before income taxes | ( | ) | ||||||||||
| Active ingredient | Biopharmaceutical | Total | ||||||||||
| Three months ended June 30, 2023 | ||||||||||||
| Active ingredient | Biopharmaceutical | Total | ||||||||||
| $ | $ | $ | ||||||||||
| Revenue | ||||||||||||
| Cost of sales | ( | ) | ( | ) | ||||||||
| Gross margin | ||||||||||||
| Research and development | ( | ) | ( | ) | ||||||||
| Income from operations before SG&A and other income (expenses) | ||||||||||||
| Selling, general & administrative | ( | ) | ||||||||||
| Loss from operations | ( | ) | ||||||||||
| Net other income | ||||||||||||
| Loss before income taxes | ( | ) | ||||||||||
| 23 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of June 30, 2024, and for the three and six months ended June 30, 2024, and 2023
(In thousands of US dollars, except share and per share data and as otherwise noted)
(Unaudited)
| Active ingredient | Biopharmaceutical | Total | ||||||||||
| Six months ended June 30, 2024 | ||||||||||||
| Active ingredient | Biopharmaceutical | Total | ||||||||||
| $ | $ | $ | ||||||||||
| Revenue | ||||||||||||
| Cost of sales | ( | ) | ( | ) | ( | ) | ||||||
| Gross margin | ( | ) | ||||||||||
| Research and development | ( | ) | ( | ) | ( | ) | ||||||
| Loss from operations before SG&A and other income (expenses) | ( | ) | ( | ) | ( | ) | ||||||
| Selling, general & administrative | ( | ) | ||||||||||
| Loss from operations | ( | ) | ||||||||||
| Net other income | ||||||||||||
| Loss before income taxes | ( | ) | ||||||||||
| Active ingredient | Biopharmaceutical | Total | ||||||||||
| Six months ended June 30, 2023 | ||||||||||||
| Active ingredient | Biopharmaceutical | Total | ||||||||||
| $ | $ | $ | ||||||||||
| Revenue | ||||||||||||
| Cost of sales | ( | ) | ( | ) | ||||||||
| Gross margin | ||||||||||||
| Research and development | ( | ) | ( | ) | ||||||||
| Income from operations before SG&A and other income (expenses) | ||||||||||||
| Selling, general & administrative | ( | ) | ||||||||||
| Loss from operations | ( | ) | ||||||||||
| Net other income | ||||||||||||
| Loss before income taxes | ( | ) | ||||||||||
Major Customer
During
the three and six months ended June 30, 2024, the Company had export sales to one major distributor of the Company’s products representing
| 24 |
COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.)
Notes to the Condensed Interim Consolidated Financial Statements
As of June 30, 2024, and for the three and six months ended June 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 than 1 year | ||||
| 1 - 3 years | ||||
| 4 - 5 years | ||||
| More than 5 years | ||||
| Minimum lease payments, net | ||||
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 $
In
addition, the Company previously entered into license agreements for technologies to increase the concentration of avenanthramides in
oats and the rights to the PGX technology. As part of these agreements the Company shall pay an annual royalty percentage rate of
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 June 30, 2024 the remaining purchase commitment is $
| 25 |
Exhibit 99.2
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Introduction
This Management’s Discussion and Analysis (“MD&A”) provides a review of the results of operations, financial condition and cash flows of COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.) for the three-month and six-month period ended June 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 “unaudited consolidated financial statements”) and the notes thereto as of June 30, 2024, and for the six-month periods ended June 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 June 9, 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 August 12, 2024. This MD&A is dated August 12, 2024.
About Forward-Looking Statements
The information in this MD&A has been prepared as of August 12, 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; Macrilen® (macimorelin) and the Company’s plans in respect of same, including commercialization and clinical programs; the Company’s business strategy; the Company’s positioning in its target markets; the Company’s ability to accelerate the scale-up of PGX Technology towards commercial levels; 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 judgments; 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. 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.
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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 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.
About Material Information
This MD&A includes information that we believe to be material to investors after considering all circumstances. We consider information and disclosures to be material if they result in, or would reasonably be expected to result in, a significant change in the market price or value of our securities, or where it is likely that a reasonable investor would consider the information and disclosures to be important in making an investment decision.
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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Company Overview
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.
The Company’s lead 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). The Company is leveraging the clinical success and compelling safety profile of macimorelin to develop it for the diagnosis of childhood-onset growth hormone deficiency (CGHD), an area of significant unmet need.
The Company is also dedicated to the development of its therapeutic assets and has established a pre-clinical development pipeline to potentially address unmet medical needs across a number of indications, including treatment of inflammation-based diseases, idiopathic pulmonary fibrosis (IPF), neuromyelitis optica spectrum disorder (NMOSD), Parkinson’s disease (PD), hypoparathyroidism and amyotrophic lateral sclerosis (ALS; Lou Gehrig’s disease).
Plan of 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 June 30, 2024, and December 31, 2023 and for the three and six months ended June 30, 2024 and 2023 reflect the results of operations and financial position of Ceapro for the periods presented and includes 28 days of the results of operations of Aeterna for the three and six months ended June 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. 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 JuventeDC 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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Name Change
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.
Key Operational Developments
Active ingredients
The Company’s active ingredient segment focuses on leveraging our unique expertise in the extraction, production and commercialization of active ingredients from natural sources. The Company’s commercialized products are well positioned in the cosmeceutical market and mostly focused on the documented health benefits of two bio actives extracted from oats; beta glucan and avenanthramides. These products include:
| ● | A commercial line of natural active ingredients, including beta glucan, avenanthramides (colloidal oat extract), oat powder, oat oil, and oat peptides, which are marketed to the personal care, cosmetic, medical, and animal health industries through our distribution partners and direct sales; | |
| ● | A commercial line of natural anti-aging skincare products, utilizing active ingredients including oat beta glucan and avenanthramides, which are marketed to the cosmeceuticals market through our wholly owned subsidiary, JuventeDC Inc.; and | |
| ● | Veterinary therapeutic products, including an oat shampoo, an ear cleanser, and a dermal complex/conditioner, which are manufactured and marketed to veterinarians in Japan and Asia. |
The Company’s core technologies used to extract and process bio actives include proprietary Ethanol Fractionation Processes (EFP) and Pressurized Gas eXpanded (PGX) Technology. EFP is mostly used to produce liquid formulations while PGX is used for powder formulations. PGX is a patented, unique and disruptive technology with several key advantages over conventional drying and purification technologies that can be used to process biopolymers into high-value and novel biocomposites. In a single step and using green solvents, It has the ability to 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 towards commercial levels 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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Oat Beta Glucan – Chewable for cholesterol reduction
Leveraging approved claims for the use of oat beta glucan as a proven cholesterol reduction ingredient in Canada, the United States of America and the European Union, 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.
Beta glucan from yeast (YBG)- nutraceutical-capsule as an immune booster
While yeast beta glucan is a commercial product with well-known immune properties, the obtention of a consistently high-purity product represents a major challenge for suppliers. Using the PGX technology, the company has successfully processed several formulations of yeast beta glucan 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, potential treatment of inflammation based diseases, and fibrotic diseases such idiopathic pulmonary fibrosis (IPF), neurodegenerative conditions like neuromyelitis optica spectrum disorder (NMOSD), Parkinson’s disease (PD), hypoparathyroidism), amyotrophic lateral sclerosis (ALS; Lou Gehrig’s disease).) and endocrinology pathologies like hypoparathyroidism.
Macimorelin Commercialization Program
Macrilen® (macimorelin), is the first and only U.S. Food and Drug Administration (“FDA”) and European Medicines Agency (“EMA”) approved oral test indicated for the diagnosis of patients with 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.
Macimorelin Clinical 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. The Company remains on track to report top-line data for the DETECT-trial in Q3 2024.
Avenanthramides for Potential Applications in Inflammation Based Diseases
Avenanthramides have garnered significant interest due to their suggested bioactivities, including potent antioxidant and anti-inflammatory effects both in vitro and in vivo. In November 2023, the Company initiated 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.
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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 expects to initiate 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.
Yeast Beta Glucan as treatment for Idiopathic Pulmonary Fibrosis (IPF)
IPF is a progressive disease with a median survival from 2-7 years. While IPF can occur at any age, up to 1 out of every 200 individuals above age 65 will have IPF. With an aging population as well as a significant number of COVID-19 patients developing IPF post infection, prevalence and impact of IPF are expected to grow.
PGX-processed yeast beta glucan (PGX-YBG) can be uniformly “loaded” with a variety of bioactives as a delivery system for inhaled therapeutics. In 2019, the Company, in partnership with McMaster University, initiated a review of preliminary data collected to assess delivery systems to optimize drug formulations used for treatment of Idiopathic Pulmonary Fibrosis (IPF). While yeast beta glucan appeared to be a promising compound, researchers believe the ideal formulation to treat fibrotic lung disorders would be to develop an inhalable complex produced by loading a currently marketed drug onto PGX-YBG. Following preliminary experiments with PGX-YBG alone and in combination with the commercialized a drug, the team concluded that PGX-YBG could be used as a stand-alone the active component to treat fibrotic in a new antifibrotic treatment for the most severe lung diseases including COVID-19 patients.
In 2023, in partnership with McMaster University, we completed a further pre-clinical CHRP study evaluating PGX-YBG as a potential therapeutic option for individuals suffering from interstitial lung diseases (ILD). The positive results from the CHRP study not only, demonstrated that PGX-YBG was respirable, but it could safely and reliably reprogram macrophages in the lungs of mice, providing confidence in its potential to safely penetrate deep into human lungs when self-administered using a hand-held inhaler. These results were presented at the 2023 CSPS/CC-CRS Annual Symposium – The Next Frontiers in Pharmaceutical Sciences to on May 24-26, 2023.
The company is evaluating the next steps for PGX-YBG for ILD. If the company decides to progress it to clinical trial as a potential inhalable immune-therapeutic treatment for severe forms of ILD which may include IPF and COVID-19 related lung fibrosis, we would first be required to undertake and obtain results from IND enabling toxicology studies before.
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AIM Biologicals: Targeted, highly specific autoimmunity modifying therapeutics for the potential treatment of neuromyelitis optica spectrum disorder (NMOSD) and Parkinson’s disease
AIM Biologicals are based on a natural process during pregnancy, which induces immunogenic tolerance of the maternal immune system to the partially foreign fetal antigens. Fetal proteins are processed and presented on certain immunosuppressive major histocompatibility complex class I molecules to induce this tolerance. In an autoimmune disease, the immune system is misdirected and targets the body’s own protein. With AIM Biologicals, we aim to restore the tolerance against such proteins to treat autoimmune diseases. Our AIM Biologics program is focused on the rare and orphan indication NMOSD and on the second most common neurodegenerative disorder, Parkinson’s disease.
In January 2021, we entered into an exclusive patent license and research agreement with the University of Wuerzburg, Germany, for worldwide rights to develop, manufacture, and commercialize AIM Biologicals for the potential treatment of NMOSD. Additionally, we have engaged neuro-immunologist Dr. Michael Levy from the Massachusetts General Hospital (“MGH”) in Boston as consultants for scientific support and advice in the field of inflammatory central nervous system “CNS” disorders, autoimmune diseases of the nervous system, and NMOSD. In September 2021, we entered into an additional exclusive license with the University of Wuerzburg for early pre-clinical development towards the potential treatment of Parkinson’s disease. On May 12, 2022 we announced positive pre-clinical results in an innovative mouse model of Parkinson’s disease, where treatment with α-Synuclein specific AIM Biologicals showed a trend towards improved motoric function, as well as significant induction of regulatory T cells and rescue of substantia nigra neurons. The data were presented at IMMUNOLOGY2022™, the annual event of the American Association of Immunologists, held on May 6-10, 2022 in Portland, Oregon. On June 13, 2022, we announced that we had achieved proof-of-concept for the treatment of NMOSD in both in-vitro and in mouse models. These findings were presented at the 13th International Congress on Autoimmunity on June 10-13, 2022, in Athens, Greece. In October 2022, we entered into a research and development agreement with MGH in Boston and Dr. Michael Levy, to conduct pre-clinical ex-vivo and in-vivo studies in NMOSD.
NMOSD is an autoimmune disease targeting the protein aquaporin 4, primarily found in optic nerves and the spinal cord. The disease leading to blindness and paralysis has a prevalence of 0.7-10 in 100,000. NMOSD progresses in often life-threatening relapses, which are aggressively treated with high-dose steroids and plasmapheresis. Current treatment options include treatment with immunosuppressive monoclonal antibodies, which carries risk of serious infections. We are evaluating the data obtained to date and considering our plans for the treatment of NMOSD using an AIM Biologicals platform.
Parkinson’s disease is a neurological disease commonly associated with motoric problems with a slow and fast progression form. It is the second most common neurodegenerative disease affecting 10 million people worldwide. The hallmark of PD is the neuronal inclusion of mainly α-synuclein protein (αSyn) associated with the death of dopamine-producing cells. Dopaminergic medication is the mainstay treatment of PD symptoms. Up to now there is no pharmacological therapy available to prevent or delay disease progression. For the development of AIM Biologicals as potential PD therapeutics, Aeterna utilizes, among others, an innovative animal model on neurodegeneration by α-synuclein-specific T cells in AAV-A53T-α-synuclein Parkinson’s disease mice, which has recently been published by University of Wuerzburg researchers. We are currently continuing in-vitro and in-vivo testing of antigen-specific AIM Biologics candidate molecules for the potential treatment of Parkinson’s disease.
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AEZS-150 – Delayed Clearance (“DC”) Parathyroid Hormone (“PTH”) (“DC-PTH”) Fusion Polypeptides: Potential treatment for chronic hypoparathyroidism
On March 11, 2021, we entered into an exclusive license agreement with The University of Sheffield, United Kingdom, for the intellectual property relating to PTH fusion polypeptides covering the field of human use, which will initially be studied by Aeterna for the potential therapeutic treatment of chronic hypoparathyroidism (“HypoPT”). Under the terms of the agreement, we obtained worldwide rights to develop, manufacture and commercialize PTH fusion polypeptides covered by the licensed patent applications for all human uses. We will be responsible for the further development, manufacturing, approval, and commercialization of the licensed products.
The researchers at the University of Sheffield have developed a method to increase the serum clearance time of peptides, which the Company is applying to the development of a treatment for HypoPT. HypoPT is an orphan disease where the PTH level is abnormally low or absent, with a prevalence per 100,000 of 37 in the U.S., 22 in Denmark, 9.4 in Norway, and 5.3 to 27 in Italy. Standard treatment is calcium and vitamin D supplementation. The lead candidate AEZS-150 is being developed to provide a weekly treatment option of chronic hypoparathyroidism in adults. Recent progress includes the successful verification and reproduction of previous in-vivo data from the University of Sheffield, in a rat model of hypoparathyroidism. We are also reviewing the potential manufacturing process for AEZS-150 with the Company’s contract development and manufacturing organization.
AEZS-130 - Macimorelin Pre-clinical Program
On January 13, 2021, we entered into a material transfer agreement with Queensland University and subsequently in July 2022, into a research and option to license agreement with UniQuest Pty Ltd., the commercialization company of The University of Queensland (UQ), Brisbane, Australia, to conduct of preclinical studies and advance the development of macimorelin as a potential therapeutic for the treatment of ALS.
ALS is a rare progressive neurological disease primarily affecting the neurons controlling voluntary movement, leading to the disability
to control movements such as walking, talking, and chewing. Most people with ALS die from respiratory failure, usually between 3-5 years
after diagnosis. Currently there is no cure for ALS and no effective treatment to halt or reverse the progression of the disease. Ghrelin
is a hormone with wide-ranging biological actions, most known for stimulating growth hormone release, which is demonstrating emerging
evidence as therapeutic for ALS.
Through research we are funding at The University of Queensland, we have been conducting pre-clinical experiments to seek to identify a potential alternative formulation suitable for use in ALS patients, the results of which we are currently evaluating.
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Condensed Interim Consolidated Statements of Loss and Comprehensive Loss Data
| (in thousands of US dollars, except loss per share) | Three months ended | Six months ended | ||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| $ | $ | $ | $ | |||||||||||||
| Revenues | 2,337 | 1,392 | 4,394 | 3,977 | ||||||||||||
| Cost of sales | (1,518 | ) | (595 | ) | (2,671 | ) | (1,992 | ) | ||||||||
| Gross profit | 819 | 797 | 1,723 | 1,985 | ||||||||||||
| Research and development | 1,530 | 691 | 2,592 | 1,115 | ||||||||||||
| Selling, general and administrative | 3,044 | 1,220 | 4,710 | 2,352 | ||||||||||||
| Loss from operations | (3,755 | ) | (1,114 | ) | (5,579 | ) | (1,482 | ) | ||||||||
| Gain due to changes in foreign currency | 17 | - | 42 | - | ||||||||||||
| Finance costs | (22 | ) | (24 | ) | (85 | ) | (90 | ) | ||||||||
| Other income | 109 | 43 | 158 | 114 | ||||||||||||
| Change in fair value of warrant and DSU liabilities | 1,755 | - | 1,755 | - | ||||||||||||
| Other income | 1,859 | 19 | 1,870 | 24 | ||||||||||||
| Loss before income taxes | (1,896 | ) | (1,095 | ) | (3,709 | ) | (1,458 | ) | ||||||||
| Income tax recovery | 474 | 235 | 886 | 313 | ||||||||||||
| Net loss | (1,422 | ) | (860 | ) | (2,823 | ) | (1,145 | ) | ||||||||
| Other comprehensive loss: | ||||||||||||||||
| Items that may be reclassified subsequently to profit or loss: | ||||||||||||||||
| Foreign currency translation adjustments | (47 | ) | 479 | (506 | ) | 546 | ||||||||||
| Comprehensive loss | (1,469 | ) | (381 | ) | (3,329 | ) | (599 | ) | ||||||||
| Basic and diluted loss per share | (0.64 | ) | (0.47 | ) | (1.39 | ) | (0.62 | ) | ||||||||
| Weighted average number of shares outstanding (basic and diluted) | 2,220,303 | 1,846,775 | 2,033,539 | 1,846,759 | ||||||||||||
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Summarized Interim Consolidated Statements of Financial Position Data
| (in thousands of US dollars) | June 30, 2024 | December 31, 2023 | ||||||
| $ | $ | |||||||
| Cash and cash equivalents | 27,804 | 6,678 | ||||||
| Trade and other receivables and other current assets | 4,020 | 1,398 | ||||||
| Inventory | 3,055 | 4,009 | ||||||
| Restricted cash equivalents | 332 | 8 | ||||||
| Property, equipment and intangible assets | 14,834 | 11,652 | ||||||
| Total assets | 50,045 | 23,745 | ||||||
| Payables and accrued liabilities and income taxes payable | 5,949 | 1,012 | ||||||
| Current portion of provisions | 430 | - | ||||||
| Current portion of deferred revenues | 97 | - | ||||||
| Lease liabilities | 1,687 | 1,698 | ||||||
| Non-financial non-current liabilities (1) | 15,655 | - | ||||||
| Total liabilities | 23,818 | 2,710 | ||||||
| Shareholders’ equity | 26,227 | 21,035 | ||||||
| Total liabilities and shareholders’ equity | 50,045 | 23,745 | ||||||
| (1) | Comprised mainly of employee future benefits, provisions and non-current portion of deferred revenues. |
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Revenue and cost of sales
The following table summarizes our gross margin earned during the periods indicated:
| (in thousands of US dollars, except percentages) | Three months ended June 30, | |||||||||||||||
| 2024 | 2023 | Change | Change | |||||||||||||
| $ | $ | $ | % | |||||||||||||
| Revenue | ||||||||||||||||
| Active ingredients | 2,334 | 1,392 | 942 | 68 | % | |||||||||||
| Pharmaceutical | 3 | - | 3 | 100 | % | |||||||||||
| Total revenue | 2,337 | 1,392 | 945 | 68 | % | |||||||||||
| Cost of sales | ||||||||||||||||
| Active ingredients | 1,514 | 595 | 919 | 154 | % | |||||||||||
| Pharmaceutical | 4 | - | 4 | 100 | % | |||||||||||
| Total cost of sales | 1,518 | 595 | 923 | 155 | % | |||||||||||
| Gross Margin | 819 | 797 | 22 | |||||||||||||
| Gross Margin % | 35 | % | 57 | % | ||||||||||||
Our total revenue for the three-month period ended June 30, 2024, increased by $0.9 million. The increase was due to higher sales of Avenanthramides, Beta Glucan and Oat Oil in the quarter as compared to the same period in 2023. Cost of sales for the three-month period ended June 30, 2024, increased by $0.9 million. The increase was due primarily to the higher sales volumes during the period as well as an increase in production costs from prior period.
| (in thousands of US dollars, except percentages) | Six months ended June 30, | |||||||||||||||
| 2024 | 2023 | Change | Change | |||||||||||||
| $ | $ | $ | % | |||||||||||||
| Revenue | ||||||||||||||||
| Active ingredients | 4,391 | 3,977 | 414 | 10 | % | |||||||||||
| Pharmaceutical | 3 | - | 3 | 100 | % | |||||||||||
| Total revenue | 4,394 | 3,977 | 417 | 10 | % | |||||||||||
| Cost of sales | ||||||||||||||||
| Active ingredients | 2,667 | 1,992 | 675 | 34 | % | |||||||||||
| Pharmaceutical | 4 | - | 4 | 100 | % | |||||||||||
| Total cost of sales | 2,671 | 1,992 | 679 | 34 | % | |||||||||||
| Gross Margin | 1,723 | 1,985 | (262 | ) | ||||||||||||
| Gross Margin % | 39 | % | 50 | % | ||||||||||||
Our total revenue for the six-month period ended June 30, 2024, increased by $0.4 million. The increase was due to higher sales of Avenanthramides and Beta Glucan in the first half of 2024 as compared to the same period in 2023. Cost of sales for the six-month period ended June 30, 2024, increased by $0.7 million. The increase was due primarily due to the higher sales volumes during the period as well as an increase in production costs from prior period.
| 12 |
Research and development expenses
The following table summarizes our research and development expenses incurred during the periods indicated:
| (in thousands of US dollars, except percentages) | Three months ended June 30, | |||||||||||||||
| 2024 | 2023 | Change | Change | |||||||||||||
| $ | $ | $ | % | |||||||||||||
| Direct research and development expenses: | ||||||||||||||||
| Avenanthramides for inflammation-based diseases | 522 | 262 | 260 | 99 | % | |||||||||||
| Macimorelin pediatric DETECT-trial | 381 | - | 381 | 100 | % | |||||||||||
| PGX | 19 | 44 | (25 | ) | -57 | % | ||||||||||
| Additional programs | 286 | 190 | 96 | 51 | % | |||||||||||
| Sub total | 1,208 | 496 | 712 | 144 | % | |||||||||||
| Employee-related expenses | 301 | 190 | 111 | 58 | % | |||||||||||
| Facilities, depreciation, and other expenses | 21 | 5 | 16 | 320 | % | |||||||||||
| Total | 1,530 | 691 | 839 | 121 | % | |||||||||||
Our total research and development expenses for the three-month period ended June 30, 2024, were $1.5 million as compared to $0.7 million for the same period in 2023, an increase of $0.8 million. This increase was primarily due to:
| ● | Increased spending on the phase 1-2a clinical study on avenanthramides for inflammation-based diseases with the MHI of $0.3 million; and | |
| ● | An increase in trial costs associated with the DETECT trial of $0.4 million and increases in employee-related costs of $0.1 million, attributable to the acquisition of Aeterna. |
| (in thousands of US dollars, except percentages) | Six months ended June 30, | |||||||||||||||
| 2024 | 2023 | Change | Change | |||||||||||||
| $ | $ | $ | % | |||||||||||||
| Direct research and development expenses: | ||||||||||||||||
| Avenanthramides for inflammation-based diseases | 1,273 | 299 | 974 | 326 | % | |||||||||||
| Macimorelin pediatric DETECT-trial | 381 | - | 381 | 100 | % | |||||||||||
| PGX | 49 | 85 | (36 | ) | -42 | % | ||||||||||
| Additional programs | 336 | 302 | 34 | 11 | % | |||||||||||
| Sub total | 2,039 | 686 | 1,353 | 197 | % | |||||||||||
| Employee-related expenses | 526 | 418 | 108 | 26 | % | |||||||||||
| Facilities, depreciation, and other expenses | 27 | 11 | 16 | 145 | % | |||||||||||
| Total | 2,592 | 1,115 | 1,477 | 132 | % | |||||||||||
Our total research and development expenses for the six-month period ended June 30, 2024, were $2.6 million as compared to $1.1 million for the same period in 2023, an increase of $1.5 million. This increase was primarily due to:
| ● | Increased spending on the phase 1-2a clinical study on avenanthramides for inflammation-based diseases with the MHI of $1.0 million; and | |
| ● | An increase in trial costs associated with the DETECT trial of $0.4 million and increases in employee-related costs of $0.1 million, attributable to the acquisition of Aeterna. |
| 13 |
Selling, general and administrative expenses
The following table summarizes our Selling, general and administrative expenses incurred during the period indicated:
| (in thousands of US dollars, except percentages) | Three months ended June 30, | |||||||||||||||
| 2024 | 2023 | Change | Change | |||||||||||||
| $ | $ | $ | % | |||||||||||||
| Selling, general and administrative expenses: | ||||||||||||||||
| Salaries & benefits | 492 | 513 | (21 | ) | -4 | % | ||||||||||
| Insurance | 117 | 58 | 59 | 102 | % | |||||||||||
| Professional fees | 1,339 | 232 | 1,107 | 477 | % | |||||||||||
| Other office & general expenses | 1,096 | 417 | 679 | 163 | % | |||||||||||
| Total selling, general and administrative expenses | 3,044 | 1,220 | 1,824 | 150 | % | |||||||||||
Our total selling, general and administrative expenses for the three-month period ended June 30, 2024, were $3.0 million as compared to $1.2 million for the same period in 2023, an increase of $1.8 million. This increase from the prior period is primarily due to the acquisition of Aeterna.
| (in thousands of US dollars, except percentages) | Six months ended June 30, | |||||||||||||||
| 2024 | 2023 | Change | Change | |||||||||||||
| $ | $ | $ | % | |||||||||||||
| Selling, general and administrative expenses: | ||||||||||||||||
| Salaries & benefits | 855 | 980 | (125 | ) | -13 | % | ||||||||||
| Insurance | 151 | 99 | 52 | 53 | % | |||||||||||
| Professional fees | 2,183 | 512 | 1,671 | 326 | % | |||||||||||
| Other office & general expenses | 1,521 | 761 | 760 | 100 | % | |||||||||||
| Total selling, general and administrative expenses | 4,710 | 2,352 | 2,358 | 100 | % | |||||||||||
Our total selling, general and administrative expenses for the six-month period ended June 30, 2024, were $4.7 million as compared to $2.3 million for the same period in 2023, an increase of $2.4 million. This was primarily attributable to:
| ● | An increase in legal, professional fees of $1.7 million and other office & general expenses of $0.8 million, primarily due to the acquisition of Aeterna as described in the plan of arrangement section above; offset by | |
| ● | A decrease in salaries and benefits of $0.1 million due to a decrease in the number of full-time staff from the prior period. |
Other income (costs)
For the three-month period and six-month period ended June 30, 2024, our net other income was $1.9 million as compared to $19 thousand and $24 thousand respectively for the same periods in the prior year, an increase of $1.9 million in both periods. This was primarily attributable to the change in fair value of warrant and DSU liabilities in the amount of $1.8 million and higher interest income earned of $0.1 million.
| 14 |
Net loss
For the three-month period ended June 30, 2024, we reported a consolidated net loss of $1.4 million, or $0.64 loss per common share, as compared with a consolidated net loss of $0.9 million, or $0.47 loss per common share for the same period in 2023. The $0.5 million increase in net loss is attributable to:
| ● | an increase in research and development costs of $0.8 million due primarily to increase in costs associated with the avenanthramides and DETECT clinical trials; and | |
| ● | an increase in selling, general and administrative costs of $1.8 million due primarily to the acquisition of Aeterna; offset by | |
| ● | an increase in other income of $1.9 million due to changes in the fair value of warrant and DSU liabilities; and | |
| ● | an increase in income tax recovery of $0.3 million. |
For the six-month period ended June 30, 2024, we reported a consolidated net loss of $2.8 million, or $1.39 loss per common share, as compared with a consolidated net loss of $1.1 million, or $0.62 loss per common share for the same period in 2023. The $1.7 million increase in net loss is attributable to:
| ● | a $0.4 million increase in revenues, that was offset by a $0.7 million increase in cost of sales due to an increase in sales volumes and higher production costs; | |
| ● | an increase in research and development costs of $1.5 million due primarily to increase in costs associated with the avenanthramides and DETECT clinical trials; and | |
| ● | an increase in selling, general and administrative of $2.4 million due primarily to the acquisition of Aeterna; offset by | |
| ● | an increase in other income of $1.9 million due to changes in the fair value of warrant and DSU liabilities; and | |
| ● | An increase in income tax recovery of $0.6 million; |
Selected quarterly financial data
| Three months ended | ||||||||||||||||
| (in thousands of US dollars, except for per share data) | June 30, 2024 | March 31, 2024 | December 31, 2023 | September 30, 2023 | ||||||||||||
| $ | $ | $ | $ | |||||||||||||
| Revenues | 2,337 | 2,057 | 1,213 | 1,952 | ||||||||||||
| Net loss | (1,422 | ) | (1,401 | ) | (1,565 | ) | (776 | ) | ||||||||
| Net loss per share (basic and diluted) (1) | (0.64 | ) | (0.47 | ) | (0.52 | ) | (0.26 | ) | ||||||||
| Three months ended | ||||||||||||||||
| (in thousands of US dollars, except for per share data) | June 30, 2023 | March 31, 2023 | December 31, 2022 | September 30, 2022 | ||||||||||||
| $ | $ | $ | $ | |||||||||||||
| Revenues | 1,392 | 2,585 | 2,447 | 2,944 | ||||||||||||
| Net (loss) / profit | (1,339 | ) | (285 | ) | (170 | ) | 774 | |||||||||
| Net (loss) / profit per share (basic and diluted) (1) | (0.47 | ) | (0.09 | ) | (0.06 | ) | 0.26 | |||||||||
| (1) | Net loss per share is based on the weighted average number of shares outstanding during each reporting period, which may differ on a quarter-to-quarter basis. As such, the sum of the quarterly net loss per share amounts may not equal full-year net loss per share. |
Historical quarterly results of operations and net loss cannot be taken as reflective of recurring revenue or expenditure patterns of predictable trends, largely given the non-recurring nature of certain components of our revenues, unpredictable quarterly variations in net finance income and of foreign exchange gains and losses. Historical quarterly sales and results primarily fluctuate due to variations in the timing of customer orders, different product mixes, and changes in the optimal use of our capacity to manufacture products.
| 15 |
Liquidity and 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.
Cash flows
The following table shows a summary of our consolidated cash flows for the periods indicated:
| (in thousands of US dollars) | Three months ended | Six months ended | ||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| $ | $ | $ | $ | |||||||||||||
| Cash and cash equivalents – Beginning of period | 3,506 | 9,295 | 6,678 | 10,190 | ||||||||||||
| Net cash used in operating activities | (1,389 | ) | (813 | ) | (3,790 | ) | (1,642 | ) | ||||||||
| Net cash used in financing activities | (126 | ) | (70 | ) | (198 | ) | (133 | ) | ||||||||
| Net cash used in investing activities | 25,880 | (54 | ) | 25,316 | (85 | ) | ||||||||||
| Effect of exchange rate changes on cash & cash equivalents | (67 | ) | 180 | (202 | ) | 208 | ||||||||||
| Cash and cash equivalents – End of period | 27,804 | 8,538 | 27,804 | 8,538 | ||||||||||||
Operating Activities
Cash used by operating activities was $1.4 million for the three-month period ended June 30, 2024, as compared to $0.8 million in the same period in 2023. This $0.6 million increase in operating cash outflows is attributed primarily to:
| ● | an increase in research and development costs of $0.8 million due primarily to increase in costs associated with the avenanthramides and DETECT clinical trials; and | |
| ● | an increase in selling, general and administrative costs of $1.8 million due primarily to the acquisition of Aeterna; offset by | |
| ● | An increase in operating assets and liabilities of $2.0 million, primarily due to the acquisition of Aeterna. |
Cash used by operating activities was $3.8 million for the six-month period ended June 30, 2024, as compared to $1.6 million in the same period in 2023. This $2.2 million increase in operating cash outflows is attributed primarily to:
| ● | A decrease in gross margin of $0.3 million, primarily due to higher costs of sales during the period; | |
| ● | an increase in research and development costs of $1.5 million due primarily to increase in costs associated with the avenanthramides and DETECT clinical trials; and | |
| ● | an increase in selling, general and administrative of $2.4 million due primarily to the acquisition of Aeterna; offset by | |
| ● | An increase in operating assets and liabilities of $2.0 million, primarily due to the acquisition of Aeterna. |
Investing activities
Cash provided by investing activities totaled $25.9 million for the three-month period ended June 30, 2024, as compared to $0.1 million in the same period in 2023. This $25.8 million increase in investing cash inflows is attributed primarily to cash inflows associated with the acquisition of Aeterna of $26.0 million offset by $0.2 million in purchases of property and equipment.
| 16 |
Capital Stock
As of August 9, 2024, we had 3,115,974 common shares issued and outstanding, as well as, 80,878 stock options, 114,230 deferred share units and 693,534 warrants outstanding. Each stock option, deferred share unit and warrant is exercisable for one common share.
Adequacy of financial resources
As of June 30, 2024, the Company had retained earnings of $6.7 million, a net loss of $1.4 million and negative cash flows from operations of $1.4 million for the three-month period ended June 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 2025. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our capital resources sooner than we expect. We may also require additional capital to pursue in-licenses or acquisitions of other product candidates.
Our forecast of the period through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially as a result of a number of factors. Our future capital requirements are difficult to forecast and will depend on many factors, including:
| ● | the terms and timing of any other collaboration, licensing, and other arrangements that we may establish; | |
| ● | the initiation, progress, timing, and completion of preclinical studies and clinical trials for our current and future potential product candidates, as well as other research and development programs; | |
| ● | our alignment with the FDA on regulatory approval requirements; | |
| ● | the number and characteristics of product candidates that we pursue; | |
| ● | the outcome, timing, and cost of regulatory approvals; | |
| ● | delays that may be caused by changing regulatory requirements; | |
| ● | the cost and timing of hiring new employees to support our continued growth and potential expense associated with any loss of key personnel; | |
| ● | the costs involved in filing and prosecuting patent applications and enforcing and defending patent claims; | |
| ● | the costs of filing and prosecuting intellectual property rights and enforcing and defending any intellectual property-related claims; | |
| ● | the costs associated with any potential late receipt or non-receipt of trade and other receivables; | |
| ● | the potential costs associated with foreign currency fluctuations or changing interest rates; | |
| ● | our ability to expand our customer base and related demand fluctuations; | |
| ● | the costs associated with any potential interruption or quality impacts on raw material supplies; | |
| ● | the costs of responding to and defending ourselves against complaints and potential litigation; | |
| ● | the costs and timing of procuring clinical and commercial supplies for our product candidates; and | |
| ● | the extent to which we acquire or in-license other product candidates and technologies. |
Contractual obligations and commitments as of June 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 dollars) | TOTAL | |||
| $ | ||||
| Less than 1 year | 4,352 | |||
| 1 - 5 years | 54 | |||
| 4,406 | ||||
| 17 |
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 $38,573 upon achieving certain sales volumes, regulatory or other milestones related to specific products.
Contingencies
In the normal course of operations, the Company may become involved in various claims and legal proceedings related to, for example, contract terminations and employee-related and other matters.
Critical Accounting Policies, Estimates and Judgments
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, 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 obligations: key actuarial assumptions; and | |
| ● | Business acquisition: identification of the acquirer, determination of the fair value of the consideration transferred and fair value of some of the assets acquired and liabilities assumed. |
Financial Risk Factors and Other Financial Instruments
The nature and extent of our exposure to risks arising from financial instruments, including credit risk, liquidity risk and market risk and how we manage those risks are described in note 15 to the Ceapro’s audited consolidated financial statements for the year ended December 31, 2023.
Related Party Transactions
Other than employment agreements and indemnification agreements with our management, there are no related party transactions.
Off-Balance Sheet Arrangements
As of June 30, 2024, we did not have any interests in special purpose entities or any other off-balance sheet arrangements.
Risk Factors and Uncertainties
An investment in our securities involves a high degree of risk. In addition to the other information included in this MD&A and in the related consolidated financial statements, investors are urged to carefully consider the risks described under the heading “Risk Factors” in 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.
| 18 |
Our most 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 relevant Canadian and U.S. securities’ regulatory authorities at www.sedarplus.ca and with the SEC at www.sec.gov. Investors are urged to consult the risk factors in these documents.
Disclosure Controls and Procedures
The Chief Executive Officer and the Chief Financial Officer of the Corporation 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 June 30, 2024, that have materially affected, or are reasonably likely to materially affect, the disclosure controls and procedures.
Internal Controls 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 Aeterna Zentaris; (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.
Changes in 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 June 30, 2024, that have materially affected, or are reasonably likely to materially affect, internal controls over financial reporting.
| 19 |
Exhibit 99.3
FORM 52-109F2
CERTIFICATION OF INTERIM FILINGS
FULL CERTIFICATE
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 “interim filings”) of COSCIENS Biopharma Inc. (the “issuer”) for the interim period ended June 30, 2024. |
| 2. | No misrepresentations: Based on my knowledge, having exercised reasonable diligence, the interim filings do not contain any untrue statement of a material fact or omit to state a material fact required to be stated or that is necessary to make a statement not misleading in light of the circumstances under which it was made, with respect to the period covered by the interim filings. |
| 3. | Fair presentation: Based on my knowledge, having exercised reasonable diligence, the interim financial report together with the other financial information included in the interim filings fairly present in all material respects the financial condition, financial performance and cash flows of the issuer, as of the date of and for the periods presented in the interim filings. |
| 4. | Responsibility: The issuer’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (DC&P) and internal control over financial reporting (ICFR), as those terms are defined in National Instrument 52-109 Certification of Disclosure in Issuers’ Annual and Interim Filings, for the issuer. |
| 5. | Design: Subject to the limitations, if any, described in paragraphs 5.2 and 5.3, the issuer’s other certifying officer(s) and I have, as at the end of the period covered by the interim filings |
| (a) | designed DC&P, or caused it to be designed under our supervision, to provide reasonable assurance that |
| (i) | material information relating to the issuer is made known to us by others, particularly during the period in which the interim filings are being prepared; and |
| (ii) | information required to be disclosed by the issuer in its annual filings, interim filings or other reports filed or submitted by it under securities legislation is recorded, processed, summarized and reported within the time periods specified in securities legislation; and |
| (b) | designed ICFR, or caused it to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with the issuer’s GAAP. |
| 5.1 | Control framework: The control framework the issuer’s other certifying officer(s) and I used to design the issuer’s ICFR is Internal Control – Integrated Framework: 2013, issued by the Committee of Sponsoring Organizations of the Treadway Commission. |
| 5.2 | N/A |
| 5.3 | N/A |
| 6. | Reporting changes in ICFR: The issuer has disclosed in its interim MD&A any change in the issuer’s ICFR that occurred during the period beginning on April 1, 2024 and ended on June 30, 2024 that has materially affected, or is reasonably likely to materially affect, the issuer’s ICFR. |
Date: August 13th, 2024
| /s/ Gilles Gagnon | |
| Gilles Gagnon | |
| Chief Executive Officer |
Exhibit 99.4
FORM 52-109F2
CERTIFICATION OF INTERIM FILINGS
FULL CERTIFICATE
I, Giuliano La Fratta, Chief Financial Officer, COSCIENS Biopharma Inc., certify the following:
| 1. | Review: I have reviewed the interim financial report and interim MD&A (together, the “interim filings”) of COSCIENS Biopharma Inc. (the “issuer”) for the interim period ended June 30, 2024. |
| 2. | No misrepresentations: Based on my knowledge, having exercised reasonable diligence, the interim filings do not contain any untrue statement of a material fact or omit to state a material fact required to be stated or that is necessary to make a statement not misleading in light of the circumstances under which it was made, with respect to the period covered by the interim filings. |
| 3. | Fair presentation: Based on my knowledge, having exercised reasonable diligence, the interim financial report together with the other financial information included in the interim filings fairly present in all material respects the financial condition, financial performance and cash flows of the issuer, as of the date of and for the periods presented in the interim filings. |
| 4. | Responsibility: The issuer’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (DC&P) and internal control over financial reporting (ICFR), as those terms are defined in National Instrument 52-109 Certification of Disclosure in Issuers’ Annual and Interim Filings, for the issuer. |
| 5. | Design: Subject to the limitations, if any, described in paragraphs 5.2 and 5.3, the issuer’s other certifying officer(s) and I have, as at the end of the period covered by the interim filings |
| (a) | designed DC&P, or caused it to be designed under our supervision, to provide reasonable assurance that |
| (i) | material information relating to the issuer is made known to us by others, particularly during the period in which the interim filings are being prepared; and |
| (ii) | information required to be disclosed by the issuer in its annual filings, interim filings or other reports filed or submitted by it under securities legislation is recorded, processed, summarized and reported within the time periods specified in securities legislation; and |
| (b) | designed ICFR, or caused it to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with the issuer’s GAAP. |
| 5.1 | Control framework: The control framework the issuer’s other certifying officer(s) and I used to design the issuer’s ICFR is Internal Control – Integrated Framework: 2013, issued by the Committee of Sponsoring Organizations of the Treadway Commission. |
| 5.2 | N/A |
| 5.3 | N/A |
| 6. | Reporting changes in ICFR: The issuer has disclosed in its interim MD&A any change in the issuer’s ICFR that occurred during the period beginning on April 1, 2024 and ended on June 30, 2024 that has materially affected, or is reasonably likely to materially affect, the issuer’s ICFR. |
Date: August 13th, 2024
| /s/ Giuliano La Fratta | |
| Giuliano La Fratta | |
| Chief Financial Officer |