8-K
Alpha Cognition Inc. (ACOG)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the SecuritiesExchange Act of 1934
Date of report (Date of earliest event reported): August 12, 2024
ALPHA COGNITION INC.
(Exact name of registrant as specified in its charter)
| British Columbia | 333-278997 | N/A |
|---|---|---|
| (State or other jurisdiction<br><br> of incorporation) | (Commission File Number) | (IRS Employer<br><br> Identification No.) |
| 1200 – 750 West Pender StreetVancouver, British Columbia | V6C 2T8 | |
| --- | --- | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code:
604-564-9244
| (Former name or former address, if changed since last report) |
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act: None
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
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. ☐
Item 2.02 Results of Operation andFinancial Condition
On August 12, 2024, Alpha Cognition Inc. (the “Registrant” or “Company”) issued a press release announcing its financial and operational results for the quarter ended June 30, 2024 and providing a corporate update (the “Press Release”). A copy of the Press Release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
In accordance with General Instruction B.2 of Form 8-K, the information in this Form 8-K (including Exhibit 99.1) is being “furnished,” and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section nor shall they be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits
| 99.1 | Press Release dated August 12, 2024* |
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| 104 | Cover Page Interactive Data File––the cover page interactive data file does not appear<br>in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. |
| * | The Exhibit relating to Item 2.02 is intended to be furnished<br>to, not filed with, the SEC pursuant to Regulation FD. |
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SIGNATURE
Pursuant to the requirement 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.
| ALPHA COGNITION INC. | ||
|---|---|---|
| Date: August 12, 2024 | By: | /s/ Don Kalkofen |
| Name: | Don Kalkofen | |
| Title: | Chief Financial Officer |
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Exhibit 99.1
| Alpha Cognition Inc.CSE: ACOG1200-750 W Pender St,<br><br>Vancouver, BC V6C 2T8,<br><br>www.alphacognition.com<br><br>info@alphacognition.com |
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NEWS RELEASE
Alpha Cognition AnnouncesFinancial Results for the Second Quarter and Six Months Ended June 2024 and Provides Corporate Update
VANCOUVER, B.C., August 12, 2024. Alpha CognitionInc. (OTCQB: ACOGF) (CSE: ACOG) (“Alpha Cognition”, or the “Company”), a biopharmaceutical company developing novel therapeutics for debilitating neurodegenerative disorders, today reported financial results for the second quarter and six months ended June 30, 2024, and provided a corporate update.
“The FDA approval of ZUNVEYL represents an important breakthrough for patients with Alzheimer’s disease. This approval marks a pivotal moment for our company, demonstrating our commitment to innovation and our ability to deliver life-changing therapies to patients. The second oral therapy approved this decade, ZUNVEYL’s dual MOA was designed to eliminate drug absorption in the gastrointestinal (GI) tract, potentially addressing certain tolerability issues with leading Alzheimer’s disease medications, combined with a long-term efficacy profile. Over the coming months, we will focus attention on preparing for the commercial launch of ZUNVEYL and bringing this innovative treatment to patients,” said Michael McFadden, the Company’s Chief Executive Officer.
Second Quarter 2024 Business Accomplishmentsand Corporate Highlights
| ● | The<br> Company announced that the U.S. Food and Drug Administration (FDA) has granted approval for<br> ZUNVEYL® (benzgalantamine) previously known as ALPHA-1062, for the treatment of mild-to-moderate<br> Alzheimer’s disease (AD). AD is a progressive brain disorder that slowly destroys memory,<br> thinking skills, and eventually the ability to do simple tasks, like carry on a conversation.<br> AD is the most common form of dementia affecting nearly 7 million people, and is the leading<br> cause of nursing home admissions and deaths, with 70% of all nursing home residents suffering<br> with AD. |
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| ● | We<br> continued progress in a pre-clinical study in partnership with Seattle Institute for Biomedical<br> and Clinical Research to assess ALPHA-1062 intra nasal’s reduction of behavioral and<br> functional deficits and brain-wide burden of neuropathology following single or multiple<br> blasts compared to placebo and sham. |
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| ● | We<br> also, advanced our commercialization preparations for launching in the Long-Term Care (“LTC”)<br> market segment. Our research has indicated that the acetylcholinesterase inhibitor prescription<br> market in the U.S. from the LTC market is large, representing 36% of the over 11 million<br> prescriptions filled in pharmacies each year and is characterized by both patient and practitioner<br> dissatisfaction. |
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| Alpha Cognition Inc. CSE: ACOG 1200-750 W Pender St,<br><br> Vancouver, BC V6C 2T8,<br><br> www.alphacognition.com<br><br> info@alphacognition.com | |
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Financial Highlights for Second Quarter andSix Months ended June 30, 2024 (Expressed in United States Dollars and prepared in conformity with U.S. Generally Accepted AccountingStandards) (Unaudited)
| ● | Research<br> and development (R&D) expenses were $0.9 million for the three months ended<br> June 30, 2024, and $1.9 million for the six months ended June 30, 2024, compared to $1.3<br> million and $2.4 million in the same periods in 2023, respectively. R&D expenses decreased<br> from the prior year primarily due to the completion of the main clinical trails for ZUNVEYL<br> in AD and the majority of the NDA filing expenditures having been incurred during 2023. |
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| ● | General<br> and administrative (G&A), excluding non-cash expenses relating to accretion, amortization,<br> depreciation, and share-based compensation, were $1.2 million for the three months<br> ended June 30, 2024, and $4.4 million for the six months ended June 30, 2024, compared<br> to $0.6 million and $1.3 million in the same periods of 2023 respectively. The increases<br> in G&A expenses for both the three and the six months ended June 30, 2024, compared to<br> the same periods in 2023 was primarily related to increased consulting fee costs, which included<br> $2.3 million recognized for shares issued for services under the Spartan Capital consulting<br> agreement, management fees and salaries and professional fees. |
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| ● | Share-based<br> compensation included in G&A was $0.2 million for the three months ended June 30, 2024,<br> and $0.5 million for the full six months ended June 30, 2024, compared to $0.8 million and<br> $1.0 million in the same periods of 2023, respectably. The higher share-based compensation<br> during 2023 was primarily related to new stock option grants issued during that period, the<br> repricing of previously issued stock options during the first quarter of 2023, and related<br> fluctuations in the Company’s stock price over such periods. |
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| ● | On<br> August 31, 2023, the Company’s functional currency changed to the USD from the CAD;<br> as such, the Company recorded a derivative liability on the warrants outstanding with previously<br> issued CAD exercises prices. This derivative liability is being revalued at each reporting<br> period. |
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| ● | During<br> the first quarter of 2024, 9,420,050 warrants were re-priced from CAD to USD denominated<br> exercise price which resulted in $3,942,575 of the derivative liability being reclassified<br> to equity. As of June 30, 2024, the Company revalued the derivative liability to $946,105<br> and recorded a gain on revaluation of $187,056 for the three months ended June 30, 2024,<br> and related loss for the six months ended June 30, 2024, of $432,933. |
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| ● | The<br> Company reported Grant Income and Grant Expense of $138,561 and $272,340 for the three and<br> six months ended June 30, 2024, respectively. No Grant Income or Grant Expenses were incurred<br> during the same period of 2023. |
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| ● | The<br> second quarter of 2024 net loss was $2.1 million, or a net loss of $0.01 per share, and for<br> the full six months ended June 30, 2024, net loss was $7.1 million, or a net loss of $0.05<br> per share, compared to the second quarter of 2023 net loss of $2.8 million, or a net loss<br> of $0.03 per share, and for the full six months ended June 30, 2023, a net loss of $4.7 million,<br> or a net loss of $0.05 per share. |
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| ● | Cash<br> and cash equivalents at June 30, 2024 were $1.0 million, excluding restricted cash. |
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| ● | Shares<br> of common stock outstanding at June 30, 2023 were 150,505,536. |
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About Alpha CognitionInc.
Alpha Cognition Inc. is a development stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as AD and Cognitive Impairment with mild Traumatic Brain Injury (“mTBI”), for which there are currently no approved treatment options.
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| Alpha Cognition Inc. CSE: ACOG 1200-750 W Pender St,<br><br> Vancouver, BC V6C 2T8,<br><br> www.alphacognition.com<br><br> info@alphacognition.com |
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ZUNVEYL, previously ALPHA-1062, is a novel patented oral Alzheimer’s disease therapy with a dual mechanism of action designed to eliminate drug absorption in the GI tract, potentially addressing certain tolerability issues with leading AD medications, combined with the efficacy and long-term benefit profile of galantamine. As a new generation acetylcholinesterase inhibitor, it was developed to demonstrate a potentially improved GI side effect profile and has a CNS safety profile that includes no incidence of insomnia. While precise mechanism of action is not known, it is believed that ZUNVEYL works through two distinct pathways to enhance neurotransmitter activity and protect neuronal health, leading to improved cognitive and functional outcomes.
Separately, ZUNVEYL is also being developed in combination with memantine to treat moderate-to-severe Alzheimer’s dementia, and as an intranasal formulation for Cognitive Impairment with mTBI. For more information about ZUNVEYL, please visit www.zunveyl.com or contact info@alphacognition.com and connect with us on Twitter and LinkedIn.
For further information:
Michael McFadden, CEO
Tel: 1-858-344-4375
info@alphacognition.com
https://www.alphacognition.com/
The Canadian Securities Exchange (the “CSE”)does not accept responsibility for the adequacy or accuracy of this release.
Forward-looking Statements
This news release includes forward-looking statements within the meaning of applicable United States and Canadian securities laws. Except for statements of historical fact, any information contained in this news release may be a forward-looking statement that reflects the Company’s current views about future events and are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward-looking statements by the words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “target,” “seek,” “contemplate,” “continue” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward-looking statements may include statements regarding the Company’s planned commercial development of ZUNVEYL, the anticipated long-term efficacy and tolerability profile of ZUNVEYL, plans regarding the development of ZUNVEYL in combination with memantine to treat moderate-to-severe AD, and as an intranasal formulation for Cognitive Impairment with mTBI, the Company’s business strategy, market size, potential growth opportunities, capital requirements, clinical development activities, the timing and results of clinical trials, regulatory submissions, potential regulatory approval and commercialization of the Company’s products. Although the Company believes to have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. The Company cannot assure that the actual results will be consistent with these forward-looking statements. These forward-looking statements are subject to certain risks, including risks regarding our ability to raise sufficient capital to implement our plans to commercialize ZUNVEYL , risks regarding the efficacy and tolerability of ZUNVEYL , risks related to ongoing regulatory oversight on the safety of ZUNVEYL, risk related to market adoption of ZUNVEYL, risks related to the Company’s intellectual property in relation to ZUNVEYL , risks related to the commercial manufacturing, distribution, marketing and sale of ZUNVEYL , risks related to product liability and other risks as described in the Company’s filings with Canadian securities regulatory authorities and available at www.sedar.com and the Company’s filings with the United States Securities and Exchange Commission (the “SEC”), including those risk factors under the heading “Risk Factors” in the Company’s Form S-1 registration statement as filed with the SEC on July 30, 2024 and available at www.sec.gov. These forward-looking statements speak only as of the date of this news release and the Company undertakes no obligation to revise or update any forward-looking statements for any reason, even if new information becomes available in the future, except as required by law.
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| Alpha Cognition Inc. CSE: ACOG 1200-750 W Pender St,<br><br> Vancouver, BC V6C 2T8,<br><br> www.alphacognition.com<br><br> info@alphacognition.com |
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Condensed Consolidated Statements of Operations (Unaudited)
(expressed in United States Dollars)
| Three months ended <br><br>June 30, | Six months ended <br><br>June 30, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |||||||||
| Total operating expenses | $ | (2,421,211 | ) | $ | (2,728,058 | ) | $ | (6,832,729 | ) | $ | (4,714,405 | ) |
| Other income (expenses) | 305,699 | (89,516 | ) | (285,494 | ) | (9,002 | ) | |||||
| Net loss | (2,115,512 | ) | (2,817,574 | ) | (7,118,223 | ) | (4,723,407 | ) | ||||
| Currency translation adjustment | - | 27,898 | - | (8,341 | ) | |||||||
| Comprehensive loss | $ | (2,115,512 | ) | $ | (2,789,676 | ) | $ | (7,118,223 | ) | $ | (4,731,748 | ) |
| Net loss per share, basic and diluted | $ | (0.01 | ) | $ | (0.03 | ) | $ | (0.05 | ) | $ | (0.05 | ) |
| Weighted average shares used to compute net loss per sahre basic and diluted | 150,234,327 | 94,604,510 | 146,925,149 | 86,273,053 |
Selected Consolidated Balance Sheet Data
(expressed in United States Dollars)
| Unaudited | ||||||
|---|---|---|---|---|---|---|
| June 30, | December 31, | |||||
| 2024 | 2023 | |||||
| Cash and cash equivalents | $ | 1,194,183 | $ | 1,494,573 | ||
| Working capital (deficiency) | $ | (57,156 | ) | $ | (697,554 | ) |
| Total assets | $ | 2,082,002 | $ | 2,452,170 | ||
| Total long-term liabilities | $ | 1,904,333 | $ | 4,539,872 |
Basis of Presentation – The Company financial statements are prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and the rules of the Securities and Exchange Commission (the “SEC”).
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