23:58:43 EDT Thu 16 May 2024
Enter Symbol
or Name
USA
CA



Alpha Cognition Inc
Symbol ACOG
Shares Issued 108,902,455
Close 2023-11-28 C$ 0.32
Market Cap C$ 34,848,786
Recent Sedar Documents

Alpha Cognition's Sept. 30 cash at $706,864 (U.S.)

2023-11-28 16:58 ET - News Release

Mr. Michael McFadden reports

ALPHA COGNITION ANNOUNCES THIRD QUARTER AND NINE MONTHS ENDED SEPTEMBER 30, 2023, RESULTS AND PROVIDES CORPORATE UPDATE

Alpha Cognition Inc. today released its financial results for the third quarter and nine months ended Sept. 30, 2023, and provided a corporate update.

"We recently achieved a significant milestone in our journey with the submission of our new drug application to the FDA at the end of September. Our dedicated team has tirelessly advanced our lead product, and we now stand on the cusp of a new chapter, confident in the strength of our data and the expertise that underpins our submission. The company expects FDA approval in the second half of 2024. We believe that Alpha-1062 will offer a meaningful differentiated therapy for patients with Alzheimer's dementia," said Michael McFadden, the company's chief executive officer.

Corporate updates

NDA submission

Alpha Cognition announced on Sept. 29, 2023, the submission of a new drug application (NDA) to the United States Food and Drug Administration (FDA) for Alpha-1062, a proprietary, patented, delayed release oral tablet formulation in development for the treatment of mild-to-moderate Alzheimer's disease. This submission marks a significant milestone in the company's continuing commitment to advancing patient care for patients suffering from Alzheimer's disease.

Issued patent

Alpha Cognition received from the U.S. patent office issued patent No. 11,795,176 titled "Solid Forms of Alpha-1062 Gluconate" which includes claims for crystalline solid forms of Alpha-1062 and will bolster existing patents that the company holds. The company expects to file additional patents for Alpha-1062 within the quarter, which will build on the robust patent portfolio the company already holds.

Awarded Department of Defense $750,000 R&D (research and development) grant

On June 5, 2023, the company was awarded a $750,000 research and development grant from the Army Medical Research and Material Command for a preclinical study on the use of the Alpha-1062IN to reduce blast mTBI (mild traumatic brain injury) induced functional deficit and brain abnormalities. The study grant is issued in collaboration with the Seattle Institute of Biomedical and Clinical Research and is endorsed by the Department of Defense. Researchers initiated the study in Q3 2023 and the company expects to report initial findings in Q2 2024.

PPM financing

On May 30, 2023, the company announced a best efforts private placement offering to raise gross proceeds of up to $6.5-million (U.S.) of units at a price of 22 cents per unit. Each unit consists of one common share and one-half of a common share purchase warrant. Each whole warrant will entitle the holder to purchase an additional common share of the company at a price of 31 U.S. cents per share for a period of three years from the closing date. The company expects to use the net proceeds from the offering for research and development, general and administrative matters, and working capital. The company has $3.8-million (U.S.) remaining of the $6.5-million (U.S.) of units to be issued in the private placement, as of the date of this press release.

TBI out-licensing plan

The company continued its work to out-license to a newly formed private entity, Alpha Seven Therapeutics Inc., which will develop Alpha-1062Intranasal (IN) for applications in traumatic brain injury. Alpha Seven will focus on the advancement of Alpha-1062IN initially for the treatment of cognitive impairment with mTBI using an intra-nasal formulation, including advancing clinical trials with the goal of FDA approval. The establishment of Alpha Seven Therapeutics is expected to provide for separate funding and advancement of the TBI applications of Alpha-1062IN while permitting Alpha Cognition to remain focused on advancing Alpha-1062 for use in the treatment of symptoms of Alzheimer's disease. If successful, the Alpha Seven's advancement of this program in 2023 will allow for potential upcoming inflection points including IND acceptance and first patient enrolled in Ph2 trial during 2H 2024, followed by initial phase 2 clinical results.

Financial highlights for second quarter and nine months ended Sept. 30, 2023

(expressed in United States dollars)

  • Research and development (R&D) expenses were $1.5-million for the three months ended Sept. 30, 2023, and $3.9-million for the nine months ended Sept. 30, 2023, compared with $1.6-million and $6.4-million in the same periods in 2022, respectively. R&D expenses decreased from the prior year primarily due to the completion during 2022 of the main clinical trails for Alpha-1062.
  • General and administrative (G&A), excluding non-cash expenses relating to accretion, amortization, depreciation and share-based compensation, were $800,000 for the three months ended Sept. 30, 2023, and $2.2-million for the nine months ended Sept. 30, 2023, compared with from $1.0-million and $2.8-million in the same periods of 2022 respectively. The G&A expense decreases for both the three and nine months ended Sept. 30, 2023, was primarily related to lower management fees and salaries, investor relations expense, professional fees, financing costs, and subcontractors expenses, offset some by higher consulting fees. The overall G&A decrease year over year was due to the company's cost cutting efforts and focus on the advancement if its main asset, Alpha-1062 in AD.
  • The company recorded a loss on revaluation derivative liability for the three months ended Sept. 30, 2023, of $500,000 and $500,000 for nine months ended Sept. 30, 2023, compared with a gain of $300,000 and $1.7-million in the same periods of 2022 respectively. On Aug. 31, 2023, the company's functional currency changed to United States dollars from Canadian dollars; as such, the company recorded a derivative liability on the warrants outstanding with previously issued Canadian-dollar exercises prices and the derivative liability on warrants previously issued in United States dollars was derecognized. The company performs a revaluation each reporting period for its derivative liability and records the change in fair value of its warrants issued in a currency that differs from the functional currency at the end of each period.
  • Effective Aug. 31, 2023, the functional currency of the company was updated to United States dollars as management assessed that the currency of the primary economic environment in which the company operates changed to United States dollars on that date. The company reclassified its derivative liabilities upon the change in functional currency, which resulted in an increase of $4,189,576 in derivative liabilities with a corresponding increase in reserves of $351,969 and decrease in share capital of $4,541,545 at Aug. 31, 2023.
  • Share-based compensation under general and administrative was $500,000 for the three months ended Sept. 30, 2023, and $1.5-million for nine months ended Sept. 30, 2023, compared with $200,000 and $1.0-million in the same periods of 2022, respectively. The 2023 increases was primarily related to new stock option grants issued in 2023, the repricing of previously issued stock options during the first quarter of 2023, and related fluctuations in the company's stock price over the periods.
  • The company incurred foreign exchange gain/losses of nil in the three months ended Sept. 30, 2023, and nil for the full nine months ended Sept. 30, 2023, compared with a gain of $500,000 and $500,000 in the same periods of 2022, respectably.
  • The third quarter of 2023 net loss was $3.3-million, or a net loss of three cents per share, and for the nine months ended Sept. 30, 2023, net loss was $8.0-million, or a net loss of nine cents per share, compared with the third quarter of 2022 net loss of $2.8-million, or a net loss of four cents per share, and for the nine months ended Sept. 30, 2023, net loss of $8.8-million, or a net loss of 13 cents per share.
  • Cash and cash equivalents at Sept. 30, 2023, were $900,000, including $200,000 in restricted cash.
  • Shares of common stock outstanding at Sept. 30, 2023, were 101,064,722.

About Alpha Cognition Inc.

Alpha Cognition is a clinical-stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer's disease and cognitive impairment with mild traumatic brain injury (mTBI), for which there are currently no approved treatment options.

Alpha-1062 is a patented new chemical entity being developed as a new-generation acetylcholinesterase inhibitor for the treatment of Alzheimer's disease, with expected minimal gastrointestinal side effects. Alpha-1062's active metabolite is differentiated from donepezil and rivastigmine in that it binds neuronal nicotinic receptors, most notably the Alpha-7 subtype, which is known to have a positive effect on cognition. Alpha-1062 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.

We seek Safe Harbor.

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