Alpha Cognition Inc. Reports Second Quarter 2025 Financial Results and Provides Operational Update

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2 days ago

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ZUNVEYL Launch Momentum: Completed the first quarter of ZUNVEYL commercialization, achieving approximately $2 million in net product revenues year-to-date.
Advancing ALPHA-1062: Completed pre-clinical Bomb Blast study in collaboration with the U.S. Department of Defense and the Seattle Institute of Biomedical and Clinical Research.
Strong Balance Sheet: Cash and cash equivalents of $39.4 million as of June 30, 2025, supporting an estimated cash runway of approximately two years at the current utilization rate.
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VANCOUVER, British Columbia & GRAPEVINE, Texas — Alpha Cognition Inc. (Nasdaq: ACOG) ('Alpha Cognition' or the 'Company') today announced its financial results for the second quarter ended June 30, 2025.
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'The initial ZUNVEYL launch has been met with strong interest from both healthcare providers and patients. Early adoption in nursing homes and by geriatric specialists has created a solid foundation for future growth,'
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said Michael McFadden, Chief Executive Officer of Alpha Cognition.
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'Clinician feedback continues to validate our belief that ZUNVEYL will become an important therapy in the long-term care segment.'
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Completed the first quarter of ZUNVEYL commercialization, achieving approximately $2 million in net product revenues year-to-date.
Received positive clinician feedback highlighting ZUNVEYL's impact on cognitive function, behavioral symptoms, and its safety profile.
Secured the Company's first national Medicare Part D contract with no prior authorization required, ahead of schedule.
Sales team engaged with more than 3,700 healthcare professionals and generated prescriptions in over 300 nursing homes.
Concluded the Bomb Blast Study, demonstrating that ALPHA-1062 reduced neuroinflammation and neuropathology associated with blast trauma.
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Second Quarter 2025 Financial Results:
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ZUNVEYL net product revenues of $1.6 million for the quarter ended June 30, 2025.
Research and development expenses for the three months ended June 30, 2025 were $317 thousand compared to $967 thousand for the same period in 2024.
Selling, general and administrative expenses for the three months ended June 30, 2025 were $6.5 million compared to $1.4 million for the same period in 2024, driven primarily by commercial-readiness activities.
Net operating loss for the three months ended June 30, 2025 were $5.7 million compared to $2.4 million for the same period in 2024.
Net loss for the for the three months ended June 30, 2025 were $10.5 million compared to $2.1 million for the same period in 2024, primarily due to a $5.2 million non-cash change in the value of warrant liabilities.
Cash and cash equivalents of $39.4 million as of March 31, 2025 compared to $48.6 million as of December 31, 2024. At current utilization rate, the Company expects a cash runway of approximately two years.
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Following the release, management will host a conference call to review financial and operating results.
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About Alpha Cognition Inc.
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Alpha Cognition Inc. is a commercial 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.
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ZUNVEYL is a patented drug approved as a new generation acetylcholinesterase inhibitor for the treatment of Alzheimer's disease, with expected minimal gastrointestinal side effects. 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. 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.
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ZUNVEYL is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer's type in adults.
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IMPORTANT SAFETY INFORMATION
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CONTRAINDICATIONS
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ZUNVEYL is contraindicated in patients with known hypersensitivity to benzgalantamine, galantamine, or to any inactive ingredients in ZUNVEYL. Serious skin reactions have occurred.
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WARNINGS AND PRECAUTIONS
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Serious Skin Reactions
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: Serious skin reactions (Stevens-Johnson syndrome and acute generalized exanthematous pustulosis) have been reported in patients receiving galantamine (the active metabolite of ZUNVEYL tablets). If signs or symptoms suggest a serious skin reaction, use of this drug should not be resumed, and alternative therapy should be considered.
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Anesthesia
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: See Drug Interactions Section
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Cardiovascular Conditions:
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Cholinesterase inhibitors, including ZUNVEYL, have vagotonic effects on the sinoatrial and atrioventricular nodes, leading to bradycardia and AV block. Bradycardia and all types of heart block have been reported in patients taking cholinesterase inhibitors, both with and without known underlying cardiac conduction abnormalities. Therefore, all patients should be considered at risk for adverse effects on cardiac conduction.
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Patients treated with galantamine up to 24 mg/day using the recommended dosing schedule showed a dose-related increase in risk of syncope.
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Gastrointestinal Conditions
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: Cholinesterase inhibitors, including ZUNVEYL, may increase gastric acid secretion. Patients should be monitored closely for active or occult gastrointestinal bleeding, especially those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs). Clinical studies of galantamine have shown no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding.
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Galantamine has been shown to produce nausea, vomiting, diarrhea, anorexia, and weight loss. Monitor the patient's weight during therapy with ZUNVEYL.
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Genitourinary Conditions:
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Although this was not observed in clinical trials with galantamine, cholinesterase inhibitors, including ZUNVEYL, may cause bladder outflow obstruction.
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Neurological Conditions:
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Cholinesterase inhibitors are believed to have some potential to cause generalized convulsions. Seizure activity may also be a manifestation of Alzheimer's disease. Patients with Alzheimer's disease should be monitored closely for seizures while taking ZUNVEYL.
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Pulmonary Conditions:
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Cholinesterase inhibitors, including ZUNVEYL, should be prescribed with care to patients with a history of severe asthma or obstructive pulmonary disease. Monitor for respiratory adverse reactions.
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ADVERSE REACTIONS
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The most common adverse reactions with galantamine tablets (≥5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite.
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DRUG INTERACTIONS
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Use with Anticholinergics:
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Galantamine has the potential to interfere with the activity of anticholinergic medications.
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Use with Cholinomimetics and Other Cholinesterase Inhibitors:
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A synergistic effect is expected when cholinesterase inhibitors are given concurrently with succinylcholine, other cholinesterase inhibitors, similar neuromuscular blocking agents or cholinergic agonists such as bethanechol.
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USE IN SPECIFIC POPULATIONS
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Pregnancy:
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Based on animal data may cause fetal harm.
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Hepatic Impairment:
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In patients with moderate hepatic impairment, a decrease in clearance of galantamine was observed; therefore, a dosage adjustment is recommended. Use of ZUNVEYL in patients with severe hepatic impairment is not recommended.
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Renal Impairment:
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In patients with a creatinine clearance of 9 to 59 mL/min, an increase in exposure of galantamine was observed; therefore, a dosage adjustment is recommended. Use of ZUNVEYL in patients with creatinine clearance less than 9 mL/min is not recommended.
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These are not all of the possible side effects of ZUNVEYL. You can report side effects to the FDA. Visit www.fda.gov/MedWatch or call 1‑800‑FDA‑1088. Please click here for Full Prescribing Information.
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Forward-looking Statements
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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. 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. 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 most recent Annual Report on Form 10-K filed with the SEC on March 31, 2025 and the Company's other filings with the SEC 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.
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