ACOG Alpha Cognition Inc

Alpha Cognition Inc. (TSX-V: ACOG) (OTCQB: ACOGF) (“Alpha Cognition”, or the “Company”), a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating neurodegenerative disorders, today reported financial results and provided a corporate update for the second quarter ended June 30, 2022.

"The Company released positive topline data from the ALPHA-1062 pivotal trial during the second quarter of 2022 which allows for the preparation of an NDA filing for the product. This NDA is on track to be submitted to the FDA in Q2 2023. The Company has advanced clinical start-up activities for the Phase 3 patient tolerability trial, RESOLVE up to the point of initiating enrollment. The objectives of the RESOLVE trial are to evaluate the tolerability profile of ALPHA-1062, and the potential for a faster titration in patients with Alzheimer's disease. Additionally, the Company has initiated a number of cost saving initiatives to extend cash runway and is exploring both partnership and other opportunities," said Michael McFadden, the Company’s Chief Executive Officer.

Recent Company Developments

• The Company elected to conduct this additional study which was designed to demonstrate pharmacokinetic (PK) equivalence between 5mg ALPHA-1062 delayed release tablets and 8 mg galantamine hydrobromide extended release (ER) capsules. These data, coupled with the positive pivotal data released in June, establish bioequivalence to both formulations of galantamine hydrobromide and strengthen the NDA application for ALPHA-1062 in mild-to-moderate AD, planned for Q2 2023.
• The Company has completed significant start-up activities in preparation to initiate the RESOLVE tolerability study to date. The Company is seeking additional capital to fund this study initiation and will commence the study within a quarter to securing the required funding.
• The Company has initiated cost cutting measures to lower its near term burn rate. The company streamlined R&D programs to focus on ALPHA-1062 and reduced headcount and other operating costs not essential to the ALPHA-1062 NDA file.
• The Company plans to request an FDA meeting to discuss the clinical development of intranasal ALPHA-1062 for the treatment of traumatic brain injury (TBI). It is anticipated that this meeting will take place in Q4 2022.

During the second quarter, the Company:

• Announced Positive Results from Pivotal Study with ALPHA-1062 in Development for Alzheimer’s Disease.
• Met with FDA regarding the ALPHA-1062 program for mild-to-moderate Alzheimer’s Disease. The Company received feedback regarding the ALPHA-1062 RESOLVE trial, labeling, and manufacturing.
• Received rare pediatric designation for ALPHA-0602 for treatment of spinal muscular atrophy. This designation allows for priority review.
• Announced Positive Data from Pre-Clinical Studies and Discovery of GEM Combinations with Potential for Neurodegenerative Disease Treatment.

Financial Highlights for Second Quarter 2022:

(Expressed in United States Dollars)

• Research and development (R&D) expenses were $3.0 million for the three months ended June 30, 2022, and $4.8 million for the six months ended June 30, 2022, up from $1.5 million and $3.2 million in the same periods in 2021, respectively. R&D expenses increased in 2022 primarily due to the additional costs associated with advancing ALPHA-1062 and ALPHA-0602 clinical and preclinical studies.
• General and administrative (G&A), excluding non-cash expenses relating to accretion, amortization, depreciation, and share-based compensation, were $0.9 million for the three months ended June 30, 2022, and $1.6 million for the six months ended June 30, 2022, up from $0.6 million and $0.9 million in the same periods of 2021. The increase in G&A expenses in 2022 primarily related to management, consulting and professional fees, and investor relations costs, supporting the growth in our operations.
• The Company recorded a gain on revaluation derivative liability for the three months ended June 30, 2021, of $1.3 million and $1.4 million for the six months ended June 30, 2022, compared to a gain of $2.4 million in the three months ended June 30, 2021, and a loss of $6.0 million in the six months ended June 30, 2021. The Company performs a revaluation each reporting period for the derivative liability relating to the convertible debentures and the recognition of a derivative liability on the transfer of warrants from Alpha Cognition Canada to Alpha Cognition Inc., with an exercise price in USD, pursuant to the Transaction, where Alpha Cognition Canada was acquired by and became a wholly owned subsidiary of Alpha Cognition Inc.
• The Company incurred nil in listing expenses in the three and six months ended June 30, 2022, compared to nil and $1.4 million in the three months and six months ended June 30 , 2021, related to the companies Q1 2021 public listing and reverse acquisition transaction.
• The second quarter 2022 net loss was $3.4 million, or a net loss of $0.05 per share, and for the six months ended June 30, 2022, net loss was $6.1 million, or a net loss of $0.09 per share, compared to the second quarter of 2021 net income of $0.1 million, or a net income of $0.00 per share, and for the six months year ended June 30, 2021, net loss of $12.1 million, or a net loss of $0.25 per share.
• Cash and cash equivalents as of June 30, 2022 were $6.0 million.
• Shares of common stock outstanding at June 30, 2022 were 61,023,450.

About Alpha Cognition Inc.

Alpha Cognition Inc. is a clinical stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer's disease and Amyotrophic Lateral Sclerosis (ALS), for which there are limited 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 traumatic brain injury.

ALPHA-0602 (Progranulin) is expressed in several cell types in the central nervous system and in peripheral tissues, promotes cell survival, regulates certain inflammatory processes, and plays a significant role in regulating lysosomal function and microglial responses to disease. Its intended use for the treatment of neurodegenerative diseases has been patented by the Company and Alpha-0602 has been granted an Orphan Drug Designation for the treatment of ALS by the FDA. ALPHA-0702 and ALPHA-0802 are Granulin Epithelin Motifs, or GEMs, derived from full length progranulin which have therapeutic potential across multiple neurodegenerative diseases. GEMs have been shown to be important in regulating cell growth, survival, repair, and inflammation. Alpha-0702 and ALPHA-0802 are designed to deliver this with potentially lower toxicity, and greater therapeutic effect.

Neither TSX Venture Exchange (the “TSX-V”), OTC Markets Group, nor the TSX-V’s Regulation Services Provider (as that term is defined in policies of the TSX-V) accepts responsibility for the adequacy or accuracy of this release.

Forward-looking Statements

This news release is not, and under no circumstances is to be construed as, an advertisement or a public offering of securities. No securities commission or similar authority in Canada or in any other jurisdiction has reviewed or in any way passed upon this news release or the merits of the securities described herein and any representation to the contrary is an offence.

This news release includes forward-looking statements within the meaning of applicable 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. Forward‐looking statements can be identified 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 in this news release include statements regarding 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 technology. Although the Company believes that we 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 as a result of known and unknown risks, uncertainties, assumptions and other factors. These risks, uncertainties, assumptions and other factors include those associated with clinical studies and manufacturing, as well as development and commercialization of the Company’s products; the need for additional financing to maintain operations; risks posed by the economic and political environments in which the Company operates and intends to operate; market instability due to the COVID-19 pandemic; the potential for losses arising from the expansion of operations into new markets; increased competition; assumptions regarding market trends and the expected demand and desires for the Company’s products and proposed products; reliance on industry manufacturers, suppliers and key personnel; the failure to adequately protect intellectual property; a failure to adequately manage future growth; adverse market conditions; and failure to satisfy ongoing regulatory requirements or obtain regulatory approvals. These forward‐looking statements speak only as of the date of this news release and, other than as required by applicable securities laws, the Company undertakes no obligation to revise or update any forward‐looking statements, even if new information becomes available in the future.

This news release may also contain estimates and other statistical, market and industry data from independent parties or made by the Company relating to our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. We cannot guarantee the accuracy and completeness of information from third party sources.

Condensed Consolidated Statements of Operations (expressed in United States Dollars) Three months ended June 30, Six months ended June 30,

 

2022

 

 

2021

 

 

 

2022

 

 

2021

 

Operating expenses

$

(4,417,993

)

$

(2,267,844

)

$

(7,360,315

)

$

(4,723,909

)

Other income (expenses)

 

1,414,160

 

 

2,386,517

 

 

1,443,158

 

 

(7,382,366

)

Net (loss) income for the year

 

(3,003,833

)

 

118,673

 

 

(5,917,157

)

 

(12,106,275

)

Currency translation adjustment

 

(376,526

)

 

5,712

 

 

(176,449

)

 

5,712

 

Comprehensive (loss) income

$

(3,380,359

)

$

124,385

 

$

(6,093,606

)

$

(12,100,563

)

  Basic and diluted (loss) income per common share

$

(0.05

)

$

0.00

 

$

(0.09

)

$

(0.25

)

Weighted average shares

 

68,023,450

 

 

51,843,927

 

 

67,920,089

 

 

48,128,995

 

    Selected Consolidated Balance Sheet Data (expressed in United States Dollars) June 30, December 31,

 

2022

 

 

2021

 

Cash

$

5,975,457

 

$

11,301,793

 

Working capital (deficiency)

$

4,169,557

 

$

10,367,955

 

Total assets

$

6,840,674

 

$

12,880,388

 

Total long-term liabilities

$

675,983

 

$

2,048,127

 

 

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Bristol Investor Relations Stefan Eftychiou 905 326 1888 ext 6 stefan@bristolir.com https://www.alphacognition.com/