COSCIENS Biopharma Inc 6-K, filed Jun 10, 2024
COSCIENS Biopharma Inc. (CSCIF)
About this 6-K
COSCIENS Biopharma Inc filed this 6-K on June 10, 2024.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 OF THE SECURITIES EXCHANGE ACT OF 1934
For the month of May 2024
Commission File Number: 001-38064
Aeterna Zentaris Inc.
(Translation of registrant’s name into English)
c/o Norton Rose Fulbright Canada, LLP, 222 Bay Street, Suite 3000, PO Box 53, Toronto ON M5K 1E7
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
Explanatory Note
On June 3, 2024, Aeterna Zentaris Inc. (“Aeterna”, “we”, “our” or the “Company”) and Ceapro Inc. (“Ceapro”) closed the previously announced business combination transaction (the “Arrangement”) pursuant to the Arrangement Agreement, dated as of December 13, 2023 (as amended by the Amendment Agreement, dated January 16, 2024, and as may be further amended, supplemented or otherwise modified from time to time, the “Arrangement Agreement”). Pursuant to the Arrangement Agreement, at the effective time of the Arrangement (the “Effective Time”), Aeterna acquired all of the issued and outstanding common shares in the capital of Ceapro in a company-approved Plan of Arrangement (the “Plan of Arrangement”) under the Canada Business Corporations Act such that at the Effective Time Ceapro became a wholly-owned subsidiary of Aeterna. Aeterna will continue the operations of Aeterna and Ceapro on a combined basis. In connection with the closing of the Arrangement, Aeterna issued a news release on June 3, 2024, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Also on June 3, 2024, Aeterna filed with the Canadian Securities Regulatory Authorities on SEDAR+ a material change report relating to the closing of the Arrangement, a copy of which is attached hereto as Exhibit 99.2 and is incorporated herein by reference.
On the same date, Aeterna also filed on SEDAR+ the executed Warrant Agreement, dated as of May 31, 2024, between Aeterna and Computershare Trust Company of Canada, governing the terms of the common share purchase warrants issued in accordance with the Plan of Arrangement, a copy of which is attached hereto as Exhibit 99.3 and is incorporated herein by reference.
On the same date, Aeterna also filed on SEDAR+ its report on modern slavery pursuant to the Fighting Against Forced Labour and Child Labour in Supply Chains Act for the financial year ended December 31, 2023, a copy of which is attached hereto as Exhibit 99.4 and is incorporated herein by reference.
On May 29, 2024, Aeterna issued a news release announcing that it had applied to extend the date for its annual meeting of shareholders. A copy of the news release is attached hereto as Exhibit 99.5 and is incorporated herein by reference.
On June 3, 2024, Aeterna issued a Notice of Meeting and Record Date to NASDAQ and to Canadian Securities Regulatory Authorities. Copies of the Notices of Meeting and Record Date are attached hereto as Exhibits 99.6 and 99.7 and are incorporated herein by reference.
Exhibit 99.1 included with this Report on Form 6-K is hereby incorporated by reference into Aeterna’s Registration Statements on Forms S-8 (No. 333-224737, No. 333-210561, No. 333-200834 and No. 333-279844) and Form F-3 (No. 333-254680) (collectively, the “Registration Statements”) and shall be deemed to be a part thereof from the date on which this Report on Form 6-K is furnished, to the extent not superseded by documents or reports subsequently filed or furnished. The information contained on any websites referenced in Exhibit 99.1 included with this Report on Form 6-K is not incorporated by reference or deemed to be a part of this Report on Form 6-K or any of the Registration Statements.
Aeterna has filed a Registration Statement on Form F-1 (including a prospectus) (File No. 333-277115) (the “Form F-1 Registration Statement”) with the U.S. Securities and Exchange Commission (the “SEC”) for the issuance of common share purchase warrants and Common Shares issuable upon exercise thereof in connection with the Plan of Arrangement. Before you invest in any Common Shares, you should read the prospectus in the Form F-1 Registration Statement and the other documents incorporated by reference therein for more complete information about Aeterna, Ceapro, the Arrangement and the common share purchase warrant offering.
You may get copies of the Form F-1 Registration Statement for free by visiting EDGAR on the SEC website at www.sec.gov or at SEDAR+ at www.sedarplus.ca. Alternatively, you may obtain copies of them by contacting the following:
Media Contact
Joel Shaffer
FGS Longview
joel.shaffer@fgslongview.com
416-670-6468
No Offer or Solicitation
This Report on Form 6-K and the exhibit attached hereto and incorporated by reference herein, and the information contained herein and therein are not, and do not, constitute an offer to sell any securities or a solicitation of an offer to buy any securities in the United States or any other state or jurisdiction, nor shall any securities of Aeterna be offered or sold in any jurisdiction in which such an offer, solicitation or sale would be unlawful. Neither the SEC nor any state securities commission has approved or disapproved of the transactions described herein or determined if this communication is truthful or complete. Any representation to the contrary is a criminal offense.
You should not construe the contents of this Report on Form 6-K or the exhibit attached hereto and incorporated herein by reference as legal, tax, accounting or investment advice or a recommendation. You should consult your own counsel and tax and financial advisors as to legal and related matters concerning the matters described herein.
Forward-Looking Statements
The information in this Report on Form 6-K and the exhibit attached hereto and incorporated herein by reference include forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, specifically Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. These forward-looking statements involve a number of known and unknown risks, uncertainties and other factors that could cause actual results and outcomes to be materially different from historical results or from any future results expressed or implied by such forward-looking statements.
Forward-looking statements include, but are not limited to, those relating to Aeterna’s expectations regarding the anticipated benefits and synergies as well as the assets, cost structure, financial position, cash flows and growth prospects of the combined company.
Risks and factors that could cause actual results or outcomes to differ materially from expectations include, among others, the following:
| ● | Aeterna’s ability to raise capital and obtain financing to continue its currently planned operations; |
| ● | Aeterna’s ability to maintain compliance with the continued listing requirements of the NASDAQ and to maintain the listing of its common shares on the NASDAQ; |
| ● | Aeterna’s ability to continue as a going concern, which is dependent, in part, on its ability to transfer cash from Aeterna Zentaris GmbH to Aeterna and its U.S. subsidiary and to secure additional financing; |
| ● | Aeterna’s 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, including its heavy reliance on the success of the license and assignment agreement with Novo Nordisk A/S; |
| ● | Aeterna’s ability to enter into out-licensing, development, manufacturing, marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect; |
| ● | Aeterna’s reliance on third parties for the manufacturing and commercialization of Macrilen™ (macimorelin); |
| ● | potential disputes with third parties, leading to delays in or termination of the manufacturing, development, out-licensing or commercialization of Aeterna’s product candidates, or resulting in significant litigation or arbitration; |
| ● | uncertainties related to the regulatory process; |
| ● | unforeseen global instability, including the instability due to the global pandemic of the novel coronavirus; |
| ● | Aeterna’s ability to efficiently commercialize or out-license Macrilen™ (macimorelin); |
| ● | Aeterna’s reliance on the success of the pediatric clinical trial in the European Union (“E.U.”) and U.S. for Macrilen™ (macimorelin); |
| ● | the degree of market acceptance of Macrilen™ (macimorelin); |
| ● | Aeterna’s ability to obtain necessary approvals from the relevant regulatory authorities to enable it to use the desired brand names for its product; |
| ● | Aeterna’s ability to successfully negotiate pricing and reimbursement in key markets in the E.U. for Macrilen™ (macimorelin); |
| ● | any evaluation of potential strategic alternatives to maximize potential future growth and shareholder value may not result in any such alternative being pursued, and even if pursued, may not result in the anticipated benefits; |
| ● | Aeterna’s ability to protect its intellectual property; and |
| ● | the potential of liability arising from shareholder lawsuits and general changes in economic conditions. |
Additional risk factors that could cause actual results to differ materially include those risks identified in Item 3. “Key Information – Risk Factors” contained in Aeterna’s most recent Annual Report on Form 20-F filed with the SEC and its other filings and submissions from time to time, including those containing its quarterly and annual results, with the SEC, which are available on Aeterna’s website located at www.aeterna.com.
Many of these risks and factors are beyond Aeterna’s control. Aeterna cautions you not to place undue reliance on these forward-looking statements. All written and oral forward-looking statements attributable to Aeterna and/or Ceapro, or persons acting on their behalf, are qualified in their entirety by these cautionary statements. Moreover, unless required by law to update these statements, Aeterna will not necessarily update any of these statements after the date hereof, either to conform them to actual results or to changes in their expectation.
DOCUMENTS INDEX
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| AETERNA ZENTARIS INC. | ||
| Date: June 10, 2024 | By: | /s/ Giuliano La Fratta |
| Giuliano La Fratta | ||
| Chief Financial Officer | ||
Exhibit 99.1
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Aeterna Zentaris and Ceapro Complete Merger Transaction
TORONTO and EDMONTON, June 3, 2024 – Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (“Aeterna” or the “Company”) and Ceapro Inc. (TSX-V: CZO) (OTCQX: CRPOF) (“Ceapro”), two innovative biopharmaceutical development companies, are pleased to announce the successful completion and closing of their all-stock merger of equals transaction (the “Transaction”), which was previously announced by Aeterna and Ceapro in their joint press release of December 14, 2023.
“This is an important day for shareholders of both companies as Aeterna and Ceapro have now officially come together to create a diversified business that is expected to create value for many years to come,” said Ronald W. Miller, Chair of the Company. “With the successful completion of this merger, we are now optimized to bring value-driving, transformational products to the market.”
Gilles Gagnon, Chief Executive Officer of the Company, said: “with the shared benefits, additional competencies and resources resulting from this merger, we are now poised to push forward exciting development programs in selected areas while continuing to grow our revenue generating base business and constantly looking for strategic growth opportunities”.
“We would like to thank Aeterna shareholders for their support for this transaction,” said Carolyn Egbert, former Chair of the Company. “We also look forward to working with the Ceapro team to build a long-term, sustainable business”.
| ● | Greater potential for stable cash flow to support R&D of potentially higher return pharmaceutical products. The Company currently generates revenues from two main active ingredients, oat beta glucan and avenanthramides, extracted and purified using its proprietary technology. Cash from these products is planned to be used along with the Company’s revenue from the commercialization or licensing of its macimorelin product to support the development of exciting, high potential-return products, ideally creating growing and sustainable revenue for the Company and investors. | |
| ● | Greater diversification of commercial and development product pipeline lowers risk. The Company is expected to benefit from an extensive and diversified pipeline of innovative products in development, including quicker-to-market biotechnology products and exciting potentially higher return, but longer-horizon, products. With this pipeline rejuvenation, the Company is anticipated to boast: |
| ● | more products in the pipeline that are closer to potential commercialization; | |
| ● | an enhanced ability to strategically focus financial and company resources in a manner that provides the most value to the company and shareholders; and | |
| ● | a more compelling value proposition and lower risk profile. |
| ● | Expanded pharmaceutical research and development capabilities. The Company’s talented team brings deep expertise and knowledge that are expected to play a key role in advancing the Company and its development pipeline. The Company has the infrastructure to support development activities and potentially offer improved efficiencies, in addition to cost savings. It now also has an expanded development pipeline of products which its leadership is committed to prioritizing as they evaluate what will provide the best overall potential for the Company, shareholders, and consumers. |
| ● | Compelling North American + European combination. The Company now has an operational presence in North America and Europe. While the Company expects to continue to maintain some presence in Europe, its leadership believes that it needs to re-focus operations within the North American biotechnology market, to provide optimal exposure to potential new investors, business development opportunities and talent. | |
| ● | Expertise and efficiencies. The Company can now leverage the combined experience and expertise of its predecessor companies, including navigating the conduct of human clinical trials and the crucial regulatory approval process required to bring pharmaceutical products to market. The Company plans to leverage this expertise with the higher value pharmaceutical opportunities being advanced for its active ingredients and technologies. |
Following the closing of the Transaction, Aeterna’s board of directors now consists of eight directors: Ronald W. Miller (Chair), Carolyn Egbert, Gilles Gagnon, Ulrich Kosciessa, Geneviève Foster, William Li, Dennis Turpin and Peter Edwards. The executive leadership team now consists of Gilles Gagnon, President and Chief Executive Officer, and Giuliano La Fratta, Senior Vice President and Chief Financial Officer.
A new name for the combined company is expected to be announced in the coming weeks and will be put forward for shareholder approval at the upcoming annual meeting of shareholders, details of which are expected to be announced shortly.
Full details of the Transaction and certain other matters are set out in the respective information circulars filed by Aeterna and Ceapro which are available under each company’s profile on SEDAR+ at www.sedarplus.ca or, as regards Aeterna, its reports on Form 6-K and other filings on EDGAR at www.sec.gov.
Aeterna is an “Eligible Interlisted Issuer” as such term is defined in the TSX Company Manual. As an Eligible Interlisted Issuer, the Company has relied on an exemption pursuant to Section 602.1 of the TSX Company Manual, the effect of which is that the Company was not required to comply with certain requirements relating to the issuance of securities in connection with the Transaction.
Information for Ceapro Shareholders
The shares of Ceapro are expected to be delisted from the TSX Venture Exchange within five business days. Ceapro is also in the process of applying to cease to be a reporting issuer under applicable Canadian securities laws.
Pursuant to the Transaction, former Ceapro shareholders are entitled to receive 0.02360 of an Aeterna Zentaris share for each Ceapro share held. In order to receive Aeterna Zentaris shares in exchange for Ceapro shares, Ceapro registered shareholders must complete, sign, date and return (together with the certificate or DRS statement representing their shares) the letter of transmittal that was mailed to them prior to closing of the Transaction. The letter of transmittal is also available under Ceapro’s profile on SEDAR+ at www.sedarplus.ca and by contacting Computershare Investor Services Inc., the depositary, by telephone at 1-514-982-7555 or toll-free in North America at 1-800-564-6253 or by email at corporateactions@computershare.com.
For those shareholders of Ceapro whose shares are registered in the name of a broker, investment dealer, bank, trust company or other intermediary or nominee, they should contact such intermediary or nominee for assistance in depositing their Ceapro shares and should follow the instructions of such intermediary or nominee.
About Aeterna Zentaris Inc.
Aeterna is a specialty biopharmaceutical company engaged in the development and commercialization of a diverse portfolio of pharmaceutical and diagnostic products, including those focused on areas of significant unmet medical need. One of Aeterna’s lead products is macimorelin (Macrilen; Ghryvelin), the first and only U.S. FDA and European Commission approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). Aeterna is also engaged in the development of therapeutic assets and proprietary extraction technology, which is applied to the production of active ingredients from renewable plant resources currently used in cosmeceutical products (i.e., oat beta glucan and avenanthramides which are found in leading skincare product brands like Aveeno and Burt’s Bees formulations) and being developed as potential nutraceuticals and/or pharmaceuticals.
The company is listed on the NASDAQ Capital Market and the Toronto Stock Exchange, and trades on both exchanges under the ticker symbol “AEZS”. For more information, please visit Aeterna’s website at www.zentaris.com.
Forward-Looking Statements
The information in this news release has been prepared as of June 3, 2024. Certain statements in this news release, referred to herein as “forward-looking statements”, constitute “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended, and “forward-looking information” under the provisions of Canadian securities laws. All statements, other than statements of historical fact, that address circumstances, events, activities, or developments that could or may or will occur are forward-looking statements. When used in this news release, words such as “anticipate”, “assume”, “believe”, “could”, “expect”, “forecast”, “future”, “goal”, “guidance”, “intend”, “likely”, “may”, “would” or the negative or comparable terminology as well as terms usually used in the future and the conditional are generally intended to identify forward-looking statements, although not all forward-looking statements include such words. Forward-looking statements in this news release include, but are not limited to, statements relating to the future business and operations of the combined Company, including cash flow, research and development, and costs.
Forward-looking statements are necessarily based upon a number of factors and assumptions that, while considered reasonable by the Company as of the date of such statements, are inherently subject to significant business, economic, operational and other risks, uncertainties, contingencies and other factors, including those described below, which could cause actual results, performance or achievements of the combined Company to be materially different from results, performance or achievements expressed or implied by such forward-looking statements and, as such, undue reliance must not be placed on them.
Forward-looking statements involve known and unknown risks and uncertainties which include, among others: the combined Company’s present and future business strategies; operations and performance within expected ranges; anticipated future cash flows; local and global economic conditions and the environment in which the combined Company operates; anticipated capital and operating costs; uncertainty in 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 commencement of the DETECT-trial may be delayed or we may not obtain regulatory approval to initiate that study; we may be unable to enroll the expected number of subjects in the DETECT-trial and 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 Capital Market.
Investors should consult our quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties, including those discussed in our Annual Report on Form 20-F and MD&A filed under the Company’s profile on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. We disclaim any obligation to update any such risks or uncertainties or to publicly announce any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or applicable law.
No securities regulatory authority has either approved or disapproved of the contents of this news release. The Toronto Stock Exchange accepts no responsibility for the adequacy or accuracy of this news release.
For Further Information
Aeterna Investor Contact:
Aeterna, Investor Relations
AZinfo@aezsinc.com
+1 843-900-3223
Aeterna Media Contact:
Joel Shaffer
FGS Longview
joel.shaffer@fgslongview.com
416-670-6468
Exhibit 99.2
Exhibit 99.3
Exhibit 99.4
Aeterna Zentaris Modern Slavery Report
Introduction
This report on modern slavery (“Report”) is made pursuant to the Fighting Against Forced Labour and Child Labour in Supply Chains Act (“Act”). This Report is made by Aeterna Zentaris Inc. (“Aeterna”, the “Company” or “we”) for the financial year ended December 31, 2023 (“Reporting Period”). It describes the risks of forced labour and child labour in our operations and supply chains and the steps we have taken to identify, manage and mitigate those risks.
Steps taken during the Reporting Period to prevent and reduce risks of forced labour and child labour
At Aeterna, we have a long-standing commitment to corporate responsibility. This responsibility includes respecting human rights and ensuring that modern slavery, in all of its forms, is not tolerated within our business or supply chain.
In general terms, the Company took the following steps during the Reporting Period to prevent and reduce the risk that forced labour or child labour is used in our business or supply chains:
| ● | completed a mapping of the first tier of our supply chains; | |
| ● | conducted an internal risk assessment of there being any forced labour or child labour in our operations; | |
| ● | reviewed our Code of Conduct and Business Ethics (“Code”) to assess against international standards, especially with respect to human rights; and | |
| ● | engaged external counsel to provide training and advice in respect of the issues of forced and child labour and the requirements of the Act. |
Structure, activities and supply chains
Overview and Activities
Aeterna is a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests. The Company’s lead product, Macrilen® (“macimorelin”), is the first and only U.S. Food and Drug Administration and European Medicines Agency approved oral test indicated for the diagnosis of patients with adult growth hormone deficiency. Macimorelin is currently marketed under the tradename Ghryvelin™ in the European Economic Area and under the tradename “Macimorelin 60 mg granules for oral suspension in sachet” in the United Kingdom through an exclusive licensing agreement with Pharmanovia. The Company’s several other license and commercialization partners have already received or are 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 also dedicated to the development of therapeutic assets and has established a pre-clinical development pipeline to potentially address unmet medical needs across a number of indications, with a focus on rare and/or orphan indications, including, Neuromyelitis Optica Spectrum Disorder, Parkinson’s Disease, Chronic Hypoparathyroidism and Amyotrophic Lateral Sclerosis (commonly known as Lou Gehrig’s Disease).
Corporate Structure
Aeterna is incorporated under the Canada Business Corporations Act. Our common shares are listed for trading on both the Nasdaq Capital Market and the Toronto Stock Exchange under the trading symbol “AEZS”. We have three wholly-owned subsidiaries (direct and indirect): Aeterna Zentaris GmbH (“Aeterna Germany”), which is based in Frankfurt am Main, Germany and incorporated under the laws of Germany; Zentaris IVF GmbH, a direct wholly-owned subsidiary of Aeterna Germany, which is based in Frankfurt am Main, Germany and incorporated under the laws of Germany; and Aeterna Zentaris, Inc., which is based in Charleston, South Carolina, U.S. and incorporated under the laws of the State of Delaware.
As of December 31, 2023, the Company had a total of 21 active employees, three of which were based in Canada, 17 in Germany and one in the U.S.
Supply Chain
The Company’s supply chain operates primarily in the European Economic Area, with a smaller footprint in North America and Asia, and is broadly divided into two categories:
| ● | Commercial operations – relating to the manufacture and supply of active pharmaceutical ingredients for the Company’s lead product, Macrilen®; and | |
| ● | Clinical research and development – relating to the supply of pharmaceutical and other products used in the Company’s clinical DETECT-trial and the Company’s preclinical research on our four pipeline projects. | |
| ● | Our top tier suppliers and their manufacturing operations are based in the European Economic Area, namely Italy, France and Germany. |
Policies and due diligence processes related to forced labour and child labour
Aeterna is committed to conducting our operations in accordance with the highest degree of integrity and in compliance with all applicable laws in the regions in which we operate.
Code of Conduct and Business Ethics
Our Code, which applies to all employees, contractors, officers and directors of Aeterna and its subsidiaries, sets forth our code of ethics and expectations regarding responsible business conduct. The Code includes a statement on supply chains, which reinforces the Company’s expectation that our vendors, suppliers and customers will obey all laws and regulations in providing and purchasing products from the Company. They are also contractually encouraged to adhere to the spirit of the Code in their operations.
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In addition, our suppliers are required to comply with the terms and conditions of the contracts that they enter into with Aeterna. Such contracts require suppliers to comply with all applicable laws and regulations in their performance of the contracts. The Company’s vendor selection process also includes an assessment of the supplier’s reputation in their industry, the geographic location of their operations and where the supplier sources services and materials from.
Code of Business Conduct and Ethics for Members of the Board of Directors
In addition to our Code, this ancillary code ensures that directors comply, and oversee compliance by employees, officers and other directors, with laws, rules and regulations applicable to the Company and its subsidiaries. Directors are required to promote ethical behaviour by, among other things, encouraging employees to report ethical misconduct. To that end, the Company maintains a Whistleblower Protection Policy which encourages employees to report any misconduct, including ethical concerns, through our free and confidential on-line reporting hotline.
Ongoing monitoring
We are committed to continually enhancing various measures, including the terms outlined in our suppliers’ contracts and our Code to address and mitigate any risks of forced labour or child labour.
Areas of risk for forced labour and child labour
Operations
During the Reporting Period, Aeterna completed an internal risk assessment of forced labour and child labour in our operations and assessed the risk to be low. All of our employees are highly skilled and require specific skill sets for their respective roles. They are based in Canada, the U.S. and Germany and are hired in accordance with group-wide standard policies. As mentioned above, Aeterna has a comprehensive Code that outlines the expected behavior of individuals doing work for the Company.
Supply Chain
While we have a global footprint, the majority of our supply chains are centered in the European Economic Area, Canada and the U.S. The materials purchased by the Company, and its suppliers, include chemical compounds and active pharmaceutical ingredients used in the manufacturing of finished drug products. The Company completed a mapping of the first tier of our supply chain, which enabled us to evaluate critical suppliers, group and prioritize them, identify potential vulnerabilities and assess the controls in place. In assessing risks we considered the geographic location of suppliers, the complexity of the supply chains, especially those relating to areas known for forced or child labour, industry-specific risks linked to human rights and labour practices, the duration of our supply relationships and overall spend.
The Company did not identify any instances of forced labour or child labour and concluded that there is a low risk for human rights violations, including forced and child labour, in our supply chain based on:
| ● | the geographic location of our first-tier suppliers, which are considered low risk; | |
| ● | the pharmaceutical industry in which we operate and the types of products being supplied, which are considered low risk; and | |
| ● | the type of labour employed by the Company and our manufacturers, suppliers and research partners, who are highly skilled and reputable in their respective industries. |
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Remediation measures
As mentioned above, our Whistleblower Protection Policy offers a reporting mechanism for employees to report ethical or legal violations, among other concerns. The management of Aeterna is committed to remedying any non-compliance identified by employees, suppliers and other stakeholders. As a result of the Company not identifying any forced labour or child labour in our operations or supply chains, we have not had to take any measures to remediate any forced labour or child labour or to remediate any loss of income.
Training for the prevention of forced labour and child labour
Certain members of Aeterna’s management received informal training during the Reporting Period, provided by external counsel, regarding the risks of forced labour and child labour and the requirements of the Act. The Company also engaged external counsel to provide formal training for all employees of Aeterna and its subsidiaries. The training, which took place shortly after the end of the Reporting Period, covered a range of topics including the purpose and scope of the Act, international human rights frameworks, statistics related to modern slavery, the meaning and indicators of forced labour and child labour and measures to prevent and reduce modern slavery risks in the supply chain, including an overview of Aeterna’s governance framework and policies.
In addition, all employees of Aeterna and its subsidiaries are required to annually review the Code and certify their compliance with it.
Assessing effectiveness
We understand that we have a responsibility to assess and mitigate the risks of modern slavery in our operations and supply chains over the long term. The Board of Directors of Aeterna has overall responsibility for the strategy around modern slavery. During the Reporting Period, Aeterna put in place a number of measures meant to prevent and reduce the risk that forced labour or child labour is used in our activities and supply chains. We have not yet taken any actions to assess the effectiveness of those actions.
Approval and attestation
This Report was approved pursuant to subparagraph 11(4)(a) of the Act by the Board of Directors of Aeterna. In accordance with the requirements of the Act, and in particular section 11 thereof, I attest that I have reviewed the information contained in this Report for the entity listed above. Based on my knowledge, and having exercised reasonable diligence, I attest that the information in this Report is true, accurate and complete in all material respects, for the purposes of the Act, for the Reporting Period.
I make the above attestation in my capacity as a director of the Board of Directors of Aeterna for and on behalf of the Board.
I have the authority to bind Aeterna Zentaris Inc.
| /s/ Carolyn Egbert | /s/ Dennis Turpin | |
| Carolyn Egbert, Chair of the Board | Dennis Turpin, Director |
May 15th, 2024
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Exhibit 99.5
Aeterna Zentaris Provides Update on Timing for Annual Meeting of Shareholders and Due Bill Redemption Date
TORONTO, ONTARIO, May 29, 2024 – Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (“Aeterna” or the “Company”), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, today announced that it is making an application for an order pursuant to section 133(3) of the Canada Business Corporations Act extending the time for the Company to call and hold its annual meeting of its shareholders to a date that is not later than July 31, 2024 (the “Application”). The Application is scheduled to be heard before a judge of the Ontario Superior Court of Justice, Commercial List (the “Court”) on June 3, 2024, at 11:00 a.m. via videoconference. There can be no assurance that the order sought by Aeterna will be granted.
In support of the Application, the Company will file an application record, a factum and a draft order with the Court. These materials will also be available on the Company’s website at www.zentaris.com. Any shareholder that wishes to attend the hearing may request a link by emailing the Company at AZinfo@aezsinc.com.
Aeterna is seeking the extension from the Court to provide sufficient time to complete the previously announced transaction (the “Transaction”) with Ceapro Inc. (“Ceapro”) in advance of the annual meeting so as to permit former Ceapro shareholders to attend and vote at the annual meeting. At the annual meeting, shareholders will be asked to vote on the new name and director nominees for the combined company. As previously disclosed, subject to obtaining all required approvals and satisfying all required conditions, the Transaction is expected to close on or about June 3, 2024.
The Toronto Stock Exchange has also granted the Company an extension permitting the Company to hold its annual meeting on or before July 31, 2024.
The Company would also like to clarify that the redemption date for the due bills attaching to the Company’s common shares as a result of the previously announced warrant issuance is June 3, 2024.
About Aeterna Zentaris Inc.
Aeterna is a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products focused on areas of significant unmet medical need. Aeterna’s lead 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). Aeterna 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.
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Aeterna 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 neuromyelitis optica spectrum disorder (NMOSD), Parkinson’s disease (PD), hypoparathyroidism and amyotrophic lateral sclerosis (ALS; Lou Gehrig’s disease).
For more information, please visit www.zentaris.com and connect with the Company on Twitter, LinkedIn and Facebook.
Forward-Looking Statements
This press release contains statements that may constitute forward-looking statements within the meaning of U.S. and Canadian securities legislation and regulations, and such statements are made pursuant to the safe-harbor provision of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements are frequently, but not always, identified by words such as “expects,” “aiming”, “anticipates,” “believes,” “intends,” “potential,” “possible,” and similar expressions. Such statements, based as they are on current expectations of management, inherently involve numerous risks, uncertainty and assumptions, known and unknown, many of which are beyond our control.
Forward-looking statements in this press release include, but are not limited to, those relating to Aeterna’s expectations regarding: the potential obtaining of an order from the Court via the Application; the timing for the Company’s annual meeting; the timing and location for the hearing of the Application; the ability of Aeterna and Ceapro to complete the Transaction on the terms described herein, or at all; the anticipated timeline for the completion of the Transaction; and receipt of final regulatory and stock exchange approvals with respect to the Transaction (including approval of the continued listing of the Common Shares on the Nasdaq and the TSX).
Forward-looking statements involve known and unknown risks and uncertainties, and other factors which may cause the actual results, performance or achievements stated herein to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Such risks and uncertainties include, among others, our reliance on the success of the DETECT clinical trial in the European Union and U.S. for Macrilen™ (macimorelin) in CGHD; results from our ongoing or planned pre-clinical studies and our DETECT clinical trial under development may not be successful or may not support advancing the product further in pre-clinical studies, to human clinical trials or regulatory approval; 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 global instability due to the global pandemic of COVID-19 and the war in the Ukraine, and their unknown potential effect on our planned operations; 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 continue to list our common shares on the NASDAQ; and the availability and timing of required stock exchange, regulatory and other approvals for the completion of the Transaction with Ceapro. 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 risks discussed in our Annual Report on Form 20-F under the caption “Risk Factors”. Given the uncertainties and risk factors, readers are cautioned not to place undue reliance on these forward-looking statements. We disclaim any obligation to update any such factors 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.
For a more detailed discussion of such risks and other factors that may affect Aeterna’s and ability to achieve the expectations set forth in the forward-looking statements contained in this news release, see Aeterna’s Annual Report on Form 20-F and MD&A filed under Aeterna’s profile on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov, as well as Aeterna’s other filings with the Canadian securities regulators and the Securities and Exchange Commission.
No securities regulatory authority has either approved or disapproved of the contents of this news release. The Toronto Stock Exchange accepts no responsibility for the adequacy or accuracy of this release.
Investor Contact:
Investor Relations
AZinfo@aezsinc.com
+1 843-900-3223
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Exhibit 99.6
Exhibit 99.7
