UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31,2024
or
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission file number:001-42403
Alpha Cognition Inc.
(Exact Name of Registrant as Specified in its Charter)
| British Columbia | N/A |
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| (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
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| 1200 - 750 West Pender Street |
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| Vancouver, British Columbia | V6C |
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| (Address of Principal Executive Offices) | (Zip Code) |
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(604) 564-9244
(Registrant’s Telephone Number, including Area Code)
Securities registered pursuant to Section 12(b) of the Act: None
| Title of each class: | Trading Symbol | Name of each exchange on which registered: |
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| Common Shares, no par value | ACOG | The Nasdaq Stock Market LLC |
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Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes☐ No ☒
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes☐ No ☒
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act:
| Large Accelerated Filer ☐ | Accelerated Filer ☐ | Non-Accelerated Filer ☒ |
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| Smaller Reporting Company ☒ | Emerging Growth Company ☒ | |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.☐
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act): Yes☐ No☒
State the aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which the common equity was last sold, or the average bid and asked price of such common equity, as of the last business day of the registrant’s most recently completed second fiscal quarter: $62,829,984.
The number of shares of Registrant’s Common Stock outstanding as of March 31, 2025 was 16,019,787.
DOCUMENTS INCORPORATED BY REFERENCE
To the extent herein specifically referenced in Part III, portions of the Registrant’s Definitive Proxy Statement on Schedule 14A for the 2025 Annual Meeting of Stockholders are incorporated herein. See Part III.
| Auditor Firm Id: | 1524 | Auditor Name: | Manning Elliot LLP | Auditor Location: | Vancouver, British Columbia |
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TABLE OF CONTENTS
| Page |
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| PART I |
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| ITEM 1. BUSINESS | 1 |
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| ITEM 1A. RISK FACTORS | 32 |
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| ITEM 1B. UNRESOLVED STAFF COMMENTS | 87 |
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| ITEM 1C. CYBERSECURITY | 87 |
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| ITEM 2. PROPERTIES | 88 |
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| ITEM 3. LEGAL PROCEEDINGS | 88 |
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| ITEM 4. MINE SAFETY DISCLOSURES | 88 |
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| PART II |
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| ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKERHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES | 89 |
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| ITEM 6. [RESERVED] | 91 |
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| ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDIITION AND RESULTS OF OPERATIONS | 92 |
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| ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLSOURES ABOUT MARKET RISK | 109 |
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| ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA | F-1 |
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| ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE | 110 |
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| ITEM 9A. CONTROLS AND PROCEDURES | 110 |
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| ITEM 9B. OTHER INFORMATION | 110 |
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| ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS | 110 |
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| PART III |
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| ITEM 10. DIRECTORS, EXECUTIVE OFFIERS AND CORPORATE GOVERNANCE | 111 |
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| ITEM 11. EXECUTIVE COMPENSATION | 111 |
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| ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS | 111 |
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| ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE | 111 |
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| ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES | 111 |
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| PART IV |
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| ITEM 15. EXHIBITS AND FINANCIAL STATEMENTS SCHEDULES | 112 |
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| SIGNATURES | 114 |
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K contains forward-looking statements concerning our business, operations and financial performance, as well as our plans, objectives and expectations for our business operations and financial performance and condition. All statements other than statements of historical facts included in this Annual Report are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. In addition, statements that “we believe” or similar statements reflect our beliefs and opinions on the relevant subject.
Forward-looking statements may include, but are not limited to, statements with respect to:
| ● | financial and other projections, future plans, objectives, performance, revenues, growth, profits or operating expense; |
| ● | the use of available funds; |
| ● | plans to research, develop, implement, adopt, market and sell new technology or products, including continued research, development and commercialization regarding the Company’s products and proposed products; |
| ● | estimates and projections regarding the industry in which the Company operates or will operate, including the global pharmaceutical and biotechnology markets, and expectations relating to trends and the adoption of new products; |
| ● | requirements for additional capital and future financing options; |
| ● | plans to launch new products and identify qualified distribution partners; |
| ● | expansion and acceptance of the Company’s products in different markets; |
| ● | manufacturing, license and distribution partnerships and agreements; |
| ● | plans to identify, pursue, negotiate and/or complete strategic acquisitions; |
| ● | the timing and possible outcome of regulatory and legislative matters, including, without limitation, planned FDA, EU and other regulatory approval processes; |
| ● | future plans, objectives or economic performance, or the assumption underlying any of the foregoing; and |
| ● | other expectations of the Company. |
| ● | All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed in, or implied by these, forward-looking statements and therefore, you should not unduly rely on such statements, including, but not limited to: |
| ● | risks related to early stage of development and significant history of losses; |
| ● | risks related to our ability to generate revenue and achieve profitability; |
| ● | risks related to our lack of history in commercializing products; |
| ● | risks related to our need for substantial additional capital; |
| ● | risks related to fluctuations in currency exchange rates; |
| ● | risks related to our reliance on the successful development, regulatory approval and commercialization of ZUNVEYL formerly known as ALPHA-1062; |
| ● | risks related to our ability to successfully expand our pipeline of product candidates; |
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| ● | risks related to our focus on treatments for Alzheimer’s disease; |
| ● | risks related to substantial delays in our preclinical and clinical trials; |
| ● | risks related to the outcome of preclinical testing and early clinical trials not being predictive of later clinical trials; |
| ● | risks related to our reliance on third-parties to conduct our clinical trials; |
| ● | risks related to use of our therapeutic candidates being associated with side effects, adverse events or other properties or safety risks; |
| ● | risks related to preliminary data from studies or trials we announce changing as more data becomes available and are subject to audit and verification processes; |
| ● | risks related to foreign jurisdictions not accepting the data from our trials in the United States; |
| ● | risks related to product liability; |
| ● | risks related to our information systems; |
| ● | risks related to research and development of pharmaceuticals being lengthy and inherently risky; |
| ● | risks related to disruptions at the FDA; |
| ● | risks related to our failure to comply with health and data protection laws; |
| ● | risks related to approval in foreign jurisdictions; |
| ● | risks related to competition in our industry; |
| ● | risks related to commercialization and manufacturing; |
| ● | risks related to our market opportunity being smaller than we anticipate; |
| ● | risks related to our reliance on third-party suppliers; |
| ● | risks related to supply chain risks; |
| ● | risks related to our products never having been manufactured on a commercial scale; |
| ● | risks related to the complexity of manufacturing drugs; |
| ● | risks related to the successful commercialization of our product being dependent on governmental authorities and health insurers establishing adequate coverage, reimbursement levels and pricing policies; |
| ● | risks related to our lack of a sales organization; |
| ● | risks related to our ability to obtain and maintain patent protection for our technology and product candidates; |
| ● | risks related to protecting our intellectual property rights throughout the world; |
| ● | risks related to obtaining protection under Hatch-Waxman Amendments; |
| ● | risks related to the validity, scope and enforcement of any patents listed in the Orange Book; |
| ● | risks related to maintaining our patent protections; |
| ● | risks related to our need to license intellectual property from third parties; |
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| ● | risks related to third party claims of infringement; |
| ● | risks related to our ability to identify third-party patents to avoid infringement; |
| ● | risks related to lawsuits to protect and enforce our patents; |
| ● | risks related to unfavorable publicity; |
| ● | risks related to intellectual property litigation using substantial resources and distracting personnel; |
| ● | risks related to changes in U.S. patent law; |
| ● | risks related to sharing our trade secrets; |
| ● | risks related to claims that our employees, consultants or independent contractors have wrongfully used confidential information of former employers; |
| ● | risks related to claims we wrongfully hired employees; |
| ● | risks related to claims challenging inventorship; |
| ● | risks related to trademarks; |
| ● | risks related to regulatory approval processes being lengthy, time consuming and unpredictable; |
| ● | risks related to our products remaining subject to regulatory scrutiny; |
| ● | risks related to obtaining and maintaining regulatory approval in multiple jurisdictions; |
| ● | risks related to using accelerated pathways to FDA approval; |
| ● | risks related to healthcare legislation including unfavorable pricing; |
| ● | risks related to our business exposing us to regulatory penalties; |
| ● | risks related to our ability to comply with environmental, health and safety laws and regulations; |
| ● | risks related to U.S. foreign export and import laws; |
| ● | risks related to our need to increase the size of our organization; |
| ● | risks related to our need to attract and retain management and key scientific personnel; |
| ● | risks related to our employees or contractors violating the law or engaging in misconduct; |
| ● | risks related to establishing sales and marketing personnel; |
| ● | risks related to exploring strategic collaborations; |
| ● | risks related to acquisitions and related integrations; and |
| ● | risks related to our common shares. |
We have based these forward-looking statements largely on our current expectations, estimates, forecasts and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Annual Report, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur at all. You should refer to the section entitled “Risk Factors” and elsewhere in this Annual Report for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. Except as required by law, including applicable Canadian laws, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
You should read this Annual Report and the documents that we reference in this Annual Report and have filed as exhibits to the registration statement, of which this Annual Report is a part, completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of the forward-looking statements in this Annual Report by these cautionary statements.
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