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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 July 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):
On July 16, 2024, Aeterna Zentaris Inc. (“Aeterna”, “we”, “our” or the “Company”) issued a news release announcing the voting results of its Annual General and Special Meeting of Shareholders held on July 16, 2024 (the “Annual Meeting”), a copy of which is attached hereto as Exhibit 99.1 and is 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and shall be deemed to be a part thereof from the date on which this Report on Form 6-K is furnished, to the extent not superseded by documents or reports subsequently filed or furnished.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.
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
| Exhibit | Description | |
| 99.1 | Aeterna Zentaris Announces Results of Virtual 2024 Meeting of Shareholders |
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: July 16, 2024 | By: | /s/ Giuliano La Fratta |
| Giuliano La Fratta | ||
| Chief Financial Officer | ||
Exhibit 99.1
Aeterna Zentaris Announces Results of Virtual 2024 Meeting of Shareholders
TORONTO, ONTARIO, July 16, 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 and active ingredients for healthcare and cosmetics industries, today announced the voting results on the items of business considered at the virtual annual general and special meeting of shareholders of the Company (the “AGSM”) held today.
Results of the AGSM
The results of the vote in respect of the election of directors of the Company are set out below:
| Name of Nominee | Votes For | % For | Votes Against | % Against | ||||||||||||
| Ronald W. Miller (Chair) | 668,451 | 84.64 | % | 121,280 | 15.36 | % | ||||||||||
| Carolyn Egbert | 491,197 | 62.20 | % | 298,534 | 37.80 | % | ||||||||||
| Geneviève Foster | 667,668 | 84.54 | % | 122,063 | 15.46 | % | ||||||||||
| Gilles Gagnon | 404,154 | 51.18 | % | 385,577 | 48.82 | % | ||||||||||
| Ulrich Kosciessa | 638,832 | 80.89 | % | 150,899 | 19.11 | % | ||||||||||
| William Li | 670,416 | 84.89 | % | 119,315 | 15.11 | % | ||||||||||
| Dennis Turpin | 300,528 | 38.05 | % | 489,203 | 61.95 | % | ||||||||||
Although he did not receive a majority of votes cast for his re-election, as provided in the Canada Business Corporations Act and in order to facilitate a seamless transition, Mr. Turpin has graciously agreed to continue as a member of the Company’s board of directors (the “Board”) and in his role as Chair of the Audit Committee for 90 days from today or, if earlier, when his successor is appointed.
Prior to the AGSM, Peter G. Edwards resigned as a director of the Company and therefore did not stand for re-election at the AGSM, resulting in the nomination of seven directors to the Board (as opposed to eight directors, as was set out in the management information circular of the Company dated June 13, 2024 (the “Management Information Circular”)). The Company does not currently anticipate appointing any director to fill the vacancy created by Mr. Edwards’ resignation.
In addition, at the AGSM, Deloitte LLP was appointed as the Company’s auditor, and the Name Change Resolution (as defined and described in the Management Information Circular) was approved. The new name of the Company, COSCIENS Biopharma Inc., is expected to be implemented in the coming weeks.
The Company 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 from Section 613 of the TSX Company Manual, the effect of which is that, subject to the satisfaction of certain conditions prescribed by the Toronto Stock Exchange, the Company will not have to comply with certain Canadian requirements in connection with the Company’s long-term incentive plan (the “Exemption”). As a result, shareholders were not asked to approve the unallocated entitlements under the Company’s long-term incentive plan at the AGSM.
For full voting details, please see the report of voting results filed on SEDAR+ at www.sedarplus.ca and EDGAR at www.sec.gov.
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 July 16, 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 remaining tenure of Mr. Turpin as a director and transition to a successor; the Company’s appointment of a director to fill the vacancy created by Mr. Edwards’ resignation; matters related to the Name Change Resolution, including the anticipated name change of the Company and the receipt of related regulatory approvals for same; and the satisfaction of Toronto Stock Exchange conditions related to the Company’s reliance on the Exemption.
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 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.
Investor Contact:
Jenene Thomas
JTC Team
T: +1 (833) 475-8247
E: aezs@jtcir.com