Mr. Michael McFadden reports

ALPHA COGNITION PROVIDES BUSINESS UPDATE

Alpha Cognition Inc. has provided a business update on its ALPHA-1062 new drug application (NDA) filing for U.S. approval of mild-to-moderate Alzheimer's disease, commercialization strategy and a pipeline update.

The company completed a transformational year as it began the transition from a clinical research-focused company advancing toward a precommercial entity, following the filing of its new drug application for ALPHA-1062 for mild-to-moderate Alzheimer's disease. ALPHA-1062 is a next-generation acetylcholinesterase inhibitor, providing a much-needed treatment for the symptoms of Alzheimer's disease. The company filed an NDA for ALPHA-1062 and this was accepted for review by the Food and Drug Administration (FDA) Dec. 6, 2023. ALPHA-1062 has a Prescription Drug User Fee Act (PDUFA) date (drug approval date) in the United States for July 27, 2024. If approved, ALPHA-1062 would be the second oral therapy available for Alzheimer's patients in the past decade.

The mild-to-moderate Alzheimer's market in the U.S. is large, representing a $5.5-billion-per-year market opportunity, and affecting approximately 6.7 million people in the United States. Alzheimer's disease remains a market in need of new therapies, as market research indicates over 70 per cent of physicians are dissatisfied with current therapies. Over 50 per cent of patients discontinue their treatment within a year, primarily due to gastrointestinal side effects, insomnia or limited efficacy. ALPHA-1062 is uniquely designed to reduce adverse events, potentially leading to better outcomes for Alzheimer's patients.

Upon FDA approval, the company plans to launch commercially into the long-term care (LTC) market segment. The LTC market covers more than 35 per cent of the overall Alzheimer's disease market, representing a highly concentrated patient population with the lowest barriers to access. Alpha Cognition's commercialization strategy includes its initial commercial launch in LTC, followed by expansion to the neurology segment once payer reimbursement has been established.

The company remains focused on its pipeline, which includes the addition of a new formulation of ALPHA-1062 that it believes represents a significant additional market opportunity. The new formulation is a sublingual tablet that will be developed as an Alzheimer's treatment alternative for patients that are unable to swallow tablets. While in the early development stages, Alpha's new formulation has demonstrated active drug release in less than 30 seconds, 90-per-cent bioavailability, and a safe and well-tolerated compound. This formulation augments the company's ALPHA-1062/memantine combination which is being developed to treat moderate-to-severe Alzheimer's disease, another multibillion-dollar market opportunity.

For other Alpha Cognition programs the company will explore out-licensing its progranulin and granulin epithelin motifs (GEM) programs. For the traumatic brain injury program (mTBI), Alpha Cognition was awarded a grant from the Army Medical Research and Material Command (AMRMC) for a preclinical study on the use of ALPHA-1062IN (Intranasal) to reduce blast mTBI-induced functional deficit and brain abnormalities. The company initiated the study in the fourth quarter and expects to have interim results in Q3 of this year. Final study results will be completed in Q4 of 2024 and will be shared with Alpha Seven Therapeutics Inc., which is advancing ALPHA1062IN (intranasal) for traumatic brain injury and related disorders.

The company recently completed a private placement capital raise of $6.5-million along with the 30-per-cent overallotment. The funds from Alpha's capital raise efforts allow the company to continue toward the NDA approval and precommercialization activities for ALPHA-1062 in the U.S. market and seek out-licensing partners for other territories around the world.

In summary, the company successfully advanced its research priorities throughout 2023, is under review for the second oral therapy for Alzheimer's patients in a decade, and successfully improved its financial position by raising capital to advance NDA approval and precommercialization activities. It has introduced a new product to the pipeline that complements its Alzheimer's focus and has begun precommercialization strategic work for ALPHA-1062. The company believes that 2024 has the potential to be the most transformational year in company history and puts the company in a position to potentially help patients suffering from Alzheimer's disease.