VANCOUVER, British Columbia--(BUSINESS WIRE)--Alpha Cognition Inc. (NASDAQ: ACOG) (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 September 30, 2024, and provided a corporate update.
“The FDA approval of ZUNVEYL represents an important breakthrough for patients with Alzheimer’s disease. Alpha Cognition is focused on commercial preparation in the US market and ex-US licensing opportunities to bring this important therapy to market. The team is adding important expertise in marketing, sales, product reimbursement, and medical to bring ZUNVEYL to patients in Q1, 2025” said Michael McFadden, the Company’s Chief Executive Officer.
Third Quarter 2024 Business Accomplishments and Corporate Highlights
- The Company raised $4.5M gross proceeds in a bridge financing. Use of proceeds will be to build commercial supply and prepare for commercialization.
- Manufacturing stability tests were successful, which will extend the commercial shelf life of ZUNVEYL to 24 months.
- The Company continued progress in a pre-clinical study in partnership with Seattle Institute for Biomedical and Clinical Research to assess ALPHA-1062 intra nasal’s reduction of behavioral and functional deficits and brain-wide burden of neuropathology following single or multiple blasts compared to placebo and sham. The Company expects the results of this study in the fourth quarter.
- The Company completed preparation to list on the NASDAQ exchange, filing an S1, securing banking partner to complete a necessary capital raise to fund it’s commercialization strategy.
- The Company advanced commercialization preparation for our Q1 2025 launch into the Long-Term Care (“LTC”) market segment. The acetylcholinesterase inhibitor prescription market in the U.S. from the LTC market is large, representing 36% of the over 11 million prescriptions filled in pharmacies each year and is characterized by both patient and physician dissatisfaction.
“The company is excited to launch ZUNVEYL and bring this much-needed treatment option to patients suffering from Alzheimer's disease. The team is working diligently to prepare for this launch, ensuring that healthcare providers have the information and patients have the resources and support they need. ZUNVEYL offers dual-action benefits with the established efficacy of galantamine and no insomnia. It was uniquely designed to bypass the gut with the potential of minimizing GI side effects. We believe that ZUNVEYL’s unique combination of these attributes will make a meaningful difference in the lives of those affected by this debilitating disease. The team is preparing for a successful rollout and broad accessibility for ZUNVEYL” said Lauren D’Angelo, the company’s Chief Operating Officer.
Financial Highlights for Third Quarter and Nine Months ended September 30, 2024 (Expressed in United States Dollars and prepared in conformity with U.S. Generally Accepted Accounting Standards) (Unaudited)
- Research and development (R&D) expenses were $1.0 million for the three months ended September 30, 2024, and $2.9 million for the nine months ended September 30, 2024, compared to $1.4 million and $3.8 million in the same periods in 2023, respectively. R&D expenses decreased from the prior year primarily due to the completion of the main clinical trails for ZUNVEYL in AD and the majority of the NDA filing expenditures having been incurred during 2023.
- General and administrative (G&A), excluding non-cash expenses relating to accretion, amortization, depreciation, and share-based compensation, were $1.2 million for the three months ended September 30, 2024, and $5.7 million for the nine months ended September 30, 2024, compared to $0.8 million and $2.2 million in the same periods of 2023 respectively. The increases in G&A expenses for both the three and the nine months ended September 30, 2024, compared to the same periods in 2023 was primarily related to increased consulting fee costs, which included $2.3 million recognized for shares issued for services under the Spartan Capital consulting agreement, management fees and salaries and professional fees.
- Share-based compensation included in G&A was $0.1 million for the three months ended September 30, 2024, and $0.6 million for the full nine months ended September 30, 2024, compared to $0.5 million and $1.5 million in the same periods of 2023, respectively. The higher share-based compensation during 2023 was primarily related to new stock option grants issued during that period, the repricing of previously issued stock options during the first quarter of 2023, and related fluctuations in the Company’s stock price over such periods.
- On August 31, 2023, the Company’s functional currency changed to the USD from the CAD; as such, the Company recorded a derivative liability on the warrants outstanding with previously issued CAD exercises prices. This derivative liability is being revalued at each reporting period.
- During the first quarter of 2024, 376,801 warrants were re-priced from CAD to USD denominated exercise price which resulted in $3.9 million of the derivative liability being reclassified to equity. As of September 30, 2024, the Company revalued the derivative liability to $0.7 million and recorded a gain on revaluation of $0.3 million for the three months ended September 30, 2024, and related loss for the nine months ended September 30, 2024, of $140 thousand.
- The Company reported Grant Income and Grant Expense of $61.1 thousand and $0.3 million for the three and nine months ended September 30, 2024, respectively, compared to $32.8 thousand for the same periods of 2023, respectively.
- The third quarter of 2024 net loss was $1.9 million, or a net loss of $0.31 per share, and for the full nine months ended September 30, 2024, net loss was $9.0 million, or a net loss of $1.51 per share, compared to the third quarter of 2023 net loss of $3.3 million, or a net loss of $0.84 per share, and for the full nine months ended September 30, 2023, a net loss of $8.0 million, or a net loss of $2.23 per share.
- Cash and cash equivalents at September 30, 2024 were $3.7 million, excluding restricted cash.
- On November 5, 2024, the Company completed a reverse stock split on the ratio of one share issued for every previously issued and outstanding twenty-five shares. All current and comparative references to the number and price per share for common shares, preferred shares, options, warrants, ACI Canada legacy performance options and weighted average number of shares, loss per share, have been restated to give effect to this reverse stock split.
- Shares of common stock outstanding at September 30, 2024 were 6,034,216.
About Alpha Cognition Inc.
Alpha Cognition Inc. is a commercial 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.
ZUNVEYL 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.
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.
| Condensed Consolidated Statements of Operations (Unaudited) | |||||||||||||
| (expressed in United States Dollars) | |||||||||||||
| Three months ended June 30, | Nine months ended September 30, | ||||||||||||
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||
| Total operating expenses | $ |
(2,487,784 |
) |
$ |
(2,765,913 |
) |
$ |
(9,320,513 |
) |
$ |
(7,518,042 |
) |
|
| Other income (expenses) |
|
627,878 |
|
|
(503,210 |
) |
|
342,384 |
|
|
(512,214 |
) |
|
| Net loss |
|
(1,859,906 |
) |
|
(3,269,123 |
) |
|
(8,978,129 |
) |
|
(8,030,256 |
) |
|
| Currency translation adjustment |
|
- |
|
|
(11,232 |
) |
|
- |
|
|
(19,573 |
) |
|
| Comprehensive loss | $ |
(1,859,906 |
) |
$ |
(3,280,355 |
) |
$ |
(8,978,129 |
) |
$ |
(8,049,829 |
) |
|
| Net loss per share, basic and diluted | $ |
(0.31 |
) |
$ |
(0.84 |
) |
$ |
(1.51 |
) |
$ |
(2.23 |
) |
|
| Weighted average shares used to compute net loss per sahre basic and diluted |
|
6,030,259 |
|
|
3,880,433 |
|
|
5,928,460 |
|
|
3,599,266 |
|
|
| Selected Consolidated Balance Sheet Data | |||||
| (expressed in United States Dollars) | |||||
| Unaudited | |||||
| September 30, | December 31, | ||||
|
2024 |
|
2023 |
|
|
| Cash and cash equivalents | $ |
3,666,389 |
$ |
1,404,160 |
|
| Working capital (deficiency) | $ |
1,508,496 |
$ |
(697,554 |
) |
| Total assets | $ |
5,028,072 |
$ |
2,452,170 |
|
| Total long-term liabilities | $ |
4,941,867 |
$ |
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”).
