The Company is a biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer’s disease (“Alzheimer’s disease” or “AD”), for which there are limited or no treatment options. On July 26, 2024, the Company received approval by the FDA of the Company’s New Drug Application (the “NDA”) for ZUNVEYL™ (benzgalantamine) previously known as ALPHA-1062 (“ZUNVEYL” or “ALPHA-1062”) a delayed release oral tablet formulation indicated for the treatment mild to moderate dementia of the Alzheimer’s type in adults (Alzheimer’s disease). The Company will now focus on the commercial manufacturing and sales of ZUNVEYL oral tablet formulation. The Company’s commercial development program for ZUNVEYL is primarily focused on building a long term care commercial team that can focus on providing key points of differentiation, exploiting key issues with existing Acetylcholinesterase inhibitors (“AChEI”) treatments, and seeking potential licensing partners for other additional indications and new formulations. The Company intends to target large volume nursing homes specializing in Alzheimer’s, to leverage an account based sales team with demonstrated success in long-term care (“LTC”), in order to position ZUNVEYL with Medicare payors, and to work with strategic and clinical partnerships with consultant pharmacists and long term care pharmacies. The Company has five additional pre-clinical development programs: (1) ZUNVEYL in combination with memantine for the treatment of moderate-to-severe Alzheimer’s disease, (2) ALPHA-1062 sublingual formulation, (3) ALPHA-1062 intranasal (“ALPHA-1062IN”) formulation for the treatment of cognitive impairment with mild traumatic brain injury (mTBI; otherwise known as concussion), (4) ALPHA-0602, and (5) ALPHA-0702 & ALPHA-0802, the latter two programs also referred to as ‘Progranulin’ and ‘Progranulin GEM’s’, respectively, for the treatment of neurodegenerative diseases including amyotrophic lateral sclerosis (ALS) or Lou Gehrig’s disease and spinal muscular atrophy (SMA). ZUNVEYL, is a patented next generation acetylcholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type in adults. ZUNVEYL’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. In addition to our approved oral formulation, ZUNVEYL is also in pre-clinical development (1) in combination with memantine to treat moderate to severe Alzheimer’s disease, (2) alone as a with sublingual formulation for patients suffering from dysphagia, and (3) alone and referred to herein as “ALPHA-1062IN” that is intended to be out-licensed for pre-clinical development to study an intranasal formulation for cognitive impairment with mTBI. Our other pre-clinical assets include ALPHA-0602 and ALPHA-0702 & ALPHA-0802 (Progranulin and Progranulin GEM’s). In general, progranulin is a protein expressed in several cell types in the central nervous system and in peripheral tissues that promote cell survival, regulate certain inflammatory processes, and play 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. Orphan Drug Designation was provided for ALPHA-0602 by the Office of Orphan Drug Products, FDA on February 2020 based on the Federal Food Drug, and Cosmetic Act, whereby the ALPHA-0602 met the criteria designated in Section 526 of such Act. The Orphan Drug Designation allows for exclusivity provisions provided the drug is approved first for indication: treatment of amyotrophic lateral sclerosis ALPHA-0702 and ALPHA-0802 are Granulin Epithelin Motifs, (“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 result with potentially lower toxicity, and greater therapeutic effect than full length progranulin. As the assets are pre-clinical and do not add material value to the Company, the Company will not develop these assets further and instead will seek to out-license the assets to interested third parties. Given the early stage of discussion with third parties, the Company cannot assess value to a license agreement. --- We were incorporated on November 15, 2017 under the Business Corporations Act (British Columbia) (“BCBCA”) under the name “Crystal Bridge Enterprises Inc.” as a Canadian Capital Pool Company. A Canadian Capital Pool Company is a special purpose acquisition company organized for the purposes of completing acquisition transactions, known as “qualifying transactions,” with operating companies for the purposes of taking the operating companies public in Canada. Qualifying transactions are subject to Canadian securities laws and exchange listing requirements. We completed our qualifying transaction with Alpha Cognition Canada Inc. on March 18, 2021, and changed our name to Alpha Cognition Inc. As a result of the qualifying transaction, Alpha Cognition Canada Inc. became the Company’s wholly-owned subsidiary. Our principal executive offices are located at 1200 – 750 West Pender Street, Vancouver, British Columbia. Our offices in the United States are located at 20073 Fiddler’s Green, Frisco, Texas.
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Here are 1-2 brief analogies to describe Alpha Cognition (ACOG):
An early-stage Biogen, but exclusively focused on neurodegenerative diseases like Alzheimer's.
Like a startup Eli Lilly, developing treatments for Alzheimer's and other neurological conditions.
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- ALPHA-1062 (Oral): An investigational drug candidate being developed for the treatment of Alzheimer's disease.
- ALPHA-1062 (Intranasal): An investigational drug candidate focused on treating traumatic brain injury (TBI) and post-concussion syndrome (PCS).
- ALPHA-0602: An investigational drug candidate for the treatment of amyotrophic lateral sclerosis (ALS).
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Alpha Cognition (ACOG) is a clinical-stage biopharmaceutical company focused on developing therapies for neurological diseases, such as Alzheimer's disease and ALS. As such, its primary activities are research and development (R&D) and conducting clinical trials for its drug candidates.
Given its stage of development, Alpha Cognition does not currently have commercialized products generating sales, and therefore, it does not have "major customers" in the traditional sense that purchase its products or services.
The company's business model revolves around advancing its drug candidates through various phases of clinical trials with the aim of:
- Eventually licensing its drug candidates to larger pharmaceutical companies for further development, regulatory approval, and commercialization, or
- Potentially bringing approved drugs to market itself (though this is less common for clinical-stage companies without established commercial infrastructure).
In the event of commercialization, the ultimate purchasers and distributors of its drugs would typically be healthcare providers, pharmaceutical distributors, pharmacies, and potentially government health programs or insurance companies (indirectly). However, these are potential future partners/customers, not current major customers for Alpha Cognition's business operations.
Therefore, at this stage, Alpha Cognition does not have a list of current customer companies or categories of individual customers to report.
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Michael McFadden, CEO and Director
Mr. McFadden brings over 30 years of successful leadership experience, spanning pre-IND drug discovery through commercialization, and has launched more than a dozen therapies in neurology, psychiatry, endocrinology, and urology. He has over 16 years of experience in Neuroscience. His previous leadership roles include Chief Commercial Officer at MPower Health, Chief Commercial Officer at Urovant Sciences (Nasdaq: UROV), and Senior Vice President of Sales and Marketing at Avanir Pharmaceuticals (Nasdaq: AVNR). Mr. McFadden also held leadership positions at Amylin Pharmaceuticals (Nasdaq: AMLN) and Pharmacia. Before his roles directly within pharmaceutical companies, Mr. McFadden was a managing director in Marsh's Private Equity and Mergers Practice and later joined the private equity group of insurance broker Lockton Cos. as an executive vice president, specializing in M&A and insurance consulting for private equity transactions, demonstrating involvement with private equity-backed companies in an advisory capacity.
Henry Du, Vice President, Finance and Accounting and Interim Chief Financial Officer
Mr. Du brings over 15 years of experience to Alpha Cognition in leadership roles in both finance and accounting. He currently serves as the Vice President of Finance and Accounting and interim Chief Financial Officer at Alpha Cognition Inc. since October 2024. Prior to this, he was the Senior Vice President of Accounting and Administration at Amplify Surgical, a medical device company, where he managed finance, accounting, HR, payroll, compliance, corporate legal, and investor relations. Mr. Du also served as VP of Finance and Senior Corporate Controller at HUYABIO International and held leadership roles at Eledon Pharmaceuticals (formerly Novus Therapeutics), United Auto Credit, and Avanir Pharmaceuticals. In past management consulting and corporate strategy experience, he has been recognized as a trusted partner by senior management and private equity sponsors, indicating a pattern of managing or advising companies backed by private equity firms.
Lauren D'Angelo, Chief Operating Officer
Ms. D'Angelo possesses 25 years of experience in pharmaceuticals marketing, sales, and operations, with extensive clinical experience across 15 products in nine therapeutic areas. She has significant expertise in transitioning organizations from pre-commercialization to launch and post-launch phases, successfully developing and leading over 20 launch plans and executing 15 product launches, new indications, and line extensions. Previously, Ms. D'Angelo served as Vice President, Marketing and Commercial Strategy at Urovant Sciences, where she was instrumental in the commercial launch of GEMTESA®. Her career also includes leadership positions in commercial development, marketing, operations, and sales at Avanir Pharmaceuticals, Medivation, Genentech, and AstraZeneca. She has been recognized as a 2023 PharmaVoice Top 100 Industry Leader, Medical Marketing & Media's (MM+M) 2022 Woman of Distinction, MM+M's 2017 Woman to Watch, and was selected as one of Pharmaceutical Executive's Emerging Pharma Leaders for 2020.
Dr. Denis Kay, Chief Scientific Officer
Dr. Kay is a co-founder of Neurodyn Life Sciences (NLS), established in August 2006, where he served as Chief Scientific Officer. In 2017, he assumed the role of Chief Scientific Officer at Alpha Cognition Inc. He brings more than 30 years of experience in the development and characterization of animal models of neurological diseases, coupled with 7 years of early-stage Central Nervous System clinical development experience. Dr. Kay is a grant recipient of the Michael J. Fox Foundation and has secured funding from various agencies for research and product development programs.
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The emergence and increasing adoption of disease-modifying therapies (DMTs) for Alzheimer's disease, such as lecanemab (Leqembi) and the anticipated approval of donanemab, represent a significant paradigm shift in the treatment approach. These therapies target the underlying pathology of Alzheimer's rather than just managing symptoms. As these DMTs become more established and widely adopted in clinical practice, they pose a clear threat to Alpha Cognition's lead candidate, ALPHA-1062, which is a prodrug of a symptomatic cholinesterase inhibitor (galantamine). The market's shift towards disease modification could diminish the clinical relevance and market opportunity for a therapy focused solely on symptomatic improvement, even if it offers improved tolerability.
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Alpha Cognition (ACOG) is developing treatments for several neurodegenerative diseases. The addressable markets for their main products and pipeline candidates are as follows:
- ZUNVEYL (benzgalantamine) for mild to moderate Alzheimer's disease: The global Alzheimer's therapeutics market was estimated at USD 6.49 billion in 2025 and is projected to reach approximately USD 33.62 billion by 2034. North America held a 46.10% share of this market in 2024. Alpha Cognition is also specifically targeting the U.S. long-term care market for Alzheimer's, which is estimated to be a $3 billion market.
- ZUNVEYL in combination with memantine for moderate-to-severe Alzheimer's disease: The market for combination drugs treating severe Alzheimer's disease is estimated at $2 billion. This market size is likely global.
- ALPHA-1062 sublingual formulation for acute pancreatitis: Currently, there is no approved treatment for acute pancreatitis. The annual cost of acute pancreatitis in the U.S. is $3 billion, representing a significant potential market for a first-in-class therapy.
- ALPHA-1062 intranasal formulation for cognitive impairment with mild traumatic brain injury (mTBI): There is currently no known treatment for traumatic brain injury (TBI). The global mild cognitive impairment (MCI) market, which cognitive impairment from mTBI could address, was valued at USD 2.8 billion in 2023 across the seven major markets (7MM: United States, EU4, UK, and Japan). The U.S. alone accounted for approximately 52% of this market. The global MCI market is projected to grow from USD 2,325.85 million in 2024 to USD 3,553.24 million by 2032. North America accounts for approximately 45% of this market in 2024.
- ALPHA-0602, ALPHA-0702, and ALPHA-0802 programs for Amyotrophic Lateral Sclerosis (ALS): The global amyotrophic lateral sclerosis (ALS) treatment market was valued at USD 713.3 million in 2023 and is projected to grow to $1.80 billion by 2032. The North American ALS treatment market is expected to reach USD 515.6 million by the end of 2032.
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Alpha Cognition (symbol: ACOG) is expected to experience future revenue growth over the next 2-3 years driven by several key factors.
Here are 3-5 expected drivers of future revenue growth for Alpha Cognition:
- Ramp-up of ZUNVEYL Sales in the U.S. Long-Term Care Market: Alpha Cognition's primary commercial product, ZUNVEYL, an Alzheimer's therapy, launched in the U.S. long-term care (LTC) market in March 2024 (or April 2024). The company is focusing its commercial efforts on this segment, which represents a significant market opportunity. Initial clinician adoption metrics have been promising, with Medicare reimbursement secured and early reorder rates. Continued penetration and growth in prescriptions within the LTC market are expected to be a major revenue driver.
- Expansion of ZUNVEYL to New Markets and Payer Coverage: Beyond the initial LTC launch, Alpha Cognition plans to expand ZUNVEYL's commercialization to the broader neurology segment once comprehensive payer reimbursement is established. This expansion will allow the company to reach a wider patient population. Additionally, securing national PBM contracts and ongoing support for reimbursement and prior authorizations will enhance market access and drive sales.
- Launch of a Sublingual Formulation of ALPHA-1062: Alpha Cognition is developing a sublingual tablet formulation of ALPHA-1062 (ZUNVEYL) specifically for the approximately 20% of Alzheimer's patients who have difficulty swallowing pills. This new formulation is expected to be finalized by Q4 2025 or Q1 2026, offering a differentiated product that could capture a significant unmet need in the market and displace existing alternatives.
- International Market Expansion through Licensing Deals: The company has a strategic licensing agreement with CMS Pharmaceuticals for ZUNVEYL in China, Australia, and New Zealand, with an initial payment received in February 2025. Regulatory submission for approval in China is anticipated in Q4 2025, and modest royalty revenue from this deal is expected in 2026. Alpha Cognition is also in discussions for additional business development deals in other international territories in late 2025, which could generate further revenues in 2026.
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Share Issuance
- In October 2021, Alpha Cognition completed a public offering of units, generating gross proceeds of approximately C$14.4 million through the issuance of 9,602,500 Units at C$1.50 per Unit.
- In September 2025, the company announced the pricing of an oversubscribed underwritten public offering of 5,600,000 common shares at $6.25 per share, resulting in gross proceeds of approximately $35.0 million.
- In August 2025, Alpha Cognition filed a $250 million mixed shelf offering for various securities, including common shares, preferred shares, debt securities, and warrants.
Inbound Investments
- In the first quarter of 2025, Alpha Cognition recognized $2.6 million in business development licensing revenue from a partnership with CMS Pharma.
Capital Expenditures
- Specific dollar values for capital expenditures made or authorized are not explicitly reported in the provided financial overviews or news releases for Alpha Cognition within the last 3-5 years.
