Latest news with #AlphaCognition
Yahoo
10 hours ago
- Business
- Yahoo
Alpha Cognition Inc. Common Stock (ACOG): A Bull Case Theory
We came across a bullish thesis on Alpha Cognition Inc. Common Stock (ACOG) by anygal on r/investing on Reddit. In this article, we will summarize the bulls' thesis on ACOG. Alpha Cognition Inc. Common Stock (ACOG)'s share was trading at $9.33 as of 30th May. ACOG's forward P/E was 26.88 according to Yahoo Finance. A chemist in a laboratory analyzing data from the various therapeutic tests conducted. Alpha Cognition Inc. (NASDAQ: ACOG) represents a potentially overlooked opportunity in the Alzheimer's treatment space, having recently launched its oral drug, Zunveyl, at the end of March. With a current market cap of $150 million and $45 million in cash, the company is targeting the underserved segment of the Alzheimer's population—specifically, the 50% of patients in long-term care (LTC) not taking any current medications due to severe side effects. Unlike other galantamine-based drugs, Zunveyl significantly slows disease progression and improves short-term memory with a markedly better safety profile—only one serious side-effect case was reported in its Phase 3 trials, versus a 50% rate seen in traditional options. The drug's Medicare coverage further eases affordability, lowering monthly out-of-pocket costs to $30–$190. Initial demand appears promising, with nearly 500 patients starting treatment in the first two weeks of launch. Even a modest 1% market penetration into the LTC segment could yield $135 million in annual revenue, with $67.5 million in net income assuming 50% margins. A 5% penetration would put net income at $675 million, dwarfing the current valuation. Alpha Cognition has also secured a distribution deal with a major Chinese pharmaceutical firm, creating a royalty-based revenue stream in Asia. While the upside is substantial, key risks remain—most notably, the emergence of unforeseen serious side effects post-launch, which could lead to FDA scrutiny or suspension of sales. Still, the market's underreaction and the company's positioning as a safer, effective alternative in a high-need space make ACOG a high-upside, high-conviction bet for risk-tolerant investors. Previously, we have covered ACOG in March 2025 wherein we summarized a by BullishDoctor on Twitter. The user highlighted that Alpha Cognition Inc.'s drug ZUNVEYL addressed the major side effects of existing Alzheimer's treatments, making it highly tolerable and poised for adoption in long-term care facilities, a $2 billion market. The company was pre-revenue but launched in March 2025 with strong physician support, a nearly complete sales force, and promising catalysts like a Phase 4 study and sublingual formulation, projecting breakeven within three years. Since our last coverage, the stock is up 61% as of 30th May. Alpha Cognition Inc. Common Stock (ACOG) is not on our list of the 30 Most Popular Stocks Among Hedge Funds. As per our database, 8 hedge fund portfolios held ACOG at the end of the first quarter which was 10 in the previous quarter. While we acknowledge the potential of ACOG as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an extremely cheap AI stock that is also a major beneficiary of Trump tariffs and onshoring, see our free report on the best short-term AI stock. READ NEXT: 8 Best Wide Moat Stocks to Buy Now and 30 Most Important AI Stocks According to BlackRock. Disclosure: None. This article was originally published at Insider Monkey. Sign in to access your portfolio
Associated Press
19-05-2025
- Business
- Associated Press
Stonegate Capital Partners Updates Coverage on Alpha Cognition Inc. (ACOG) Q1 2025
Dallas, Texas--(Newsfile Corp. - May 19, 2025) - Alpha Cognition Inc. (NASDAQ: ACOG): Stonegate Capital Partners updates their coverage on Alpha Cognition Inc. (NASDAQ: ACOG). Alpha Cognition began 2025 by launching ZUNVEYL(R) (benzgalantamine) to the U.S. long-term care (LTC) market on March 17, 2025, delivering on its commercialization timeline and budget. Early clinician and patient feedback has been positive, citing successful initial patient outcomes and strong ordering momentum, with rapid product replenishment by wholesalers. The field team reported broad engagement across high-priority LTC accounts nationwide. Importantly, Medicare reimbursement was secured soon after launch, significantly improving access for patients in LTC settings. Management reiterated that all launch objectives remain on track and within budget, with commercial execution progressing as planned. To view the full announcement, including downloadable images, bios, and more, click here. Key Takeaways: [ This image cannot be displayed. Please visit the source: ] Click image above to view full announcement. About Stonegate Stonegate Capital Partners is a leading capital markets advisory firm providing investor relations, equity research, and institutional investor outreach services for public companies. Our affiliate, Stonegate Capital Markets (member FINRA) provides a full spectrum of investment banking services for public and private companies. Contacts: Stonegate Capital Partners (214) 987-4121 [email protected] Source: Stonegate, Inc. To view the source version of this press release, please visit
Yahoo
17-05-2025
- Business
- Yahoo
We Think Alpha Cognition (NASDAQ:ACOG) Can Easily Afford To Drive Business Growth
We can readily understand why investors are attracted to unprofitable companies. For example, although software-as-a-service business lost money for years while it grew recurring revenue, if you held shares since 2005, you'd have done very well indeed. But while history lauds those rare successes, those that fail are often forgotten; who remembers So, the natural question for Alpha Cognition (NASDAQ:ACOG) shareholders is whether they should be concerned by its rate of cash burn. In this report, we will consider the company's annual negative free cash flow, henceforth referring to it as the 'cash burn'. The first step is to compare its cash burn with its cash reserves, to give us its 'cash runway'. AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. A cash runway is defined as the length of time it would take a company to run out of money if it kept spending at its current rate of cash burn. When Alpha Cognition last reported its March 2025 balance sheet in May 2025, it had zero debt and cash worth US$46m. In the last year, its cash burn was US$7.4m. Therefore, from March 2025 it had 6.1 years of cash runway. Notably, however, analysts think that Alpha Cognition will break even (at a free cash flow level) before then. In that case, it may never reach the end of its cash runway. You can see how its cash balance has changed over time in the image below. See our latest analysis for Alpha Cognition Whilst it's great to see that Alpha Cognition has already begun generating revenue from operations, last year it only produced US$2.9m, so we don't think it is generating significant revenue, at this point. Therefore, for the purposes of this analysis we'll focus on how the cash burn is tracking. With cash burn dropping by 15% it seems management feel the company is spending enough to advance its business plans at an appropriate pace. Clearly, however, the crucial factor is whether the company will grow its business going forward. So you might want to take a peek at how much the company is expected to grow in the next few years. Even though it has reduced its cash burn recently, shareholders should still consider how easy it would be for Alpha Cognition to raise more cash in the future. Generally speaking, a listed business can raise new cash through issuing shares or taking on debt. One of the main advantages held by publicly listed companies is that they can sell shares to investors to raise cash and fund growth. By looking at a company's cash burn relative to its market capitalisation, we gain insight on how much shareholders would be diluted if the company needed to raise enough cash to cover another year's cash burn. Alpha Cognition has a market capitalisation of US$139m and burnt through US$7.4m last year, which is 5.4% of the company's market value. That's a low proportion, so we figure the company would be able to raise more cash to fund growth, with a little dilution, or even to simply borrow some money. As you can probably tell by now, we're not too worried about Alpha Cognition's cash burn. In particular, we think its cash runway stands out as evidence that the company is well on top of its spending. Its weak point is its cash burn reduction, but even that wasn't too bad! One real positive is that analysts are forecasting that the company will reach breakeven. After considering a range of factors in this article, we're pretty relaxed about its cash burn, since the company seems to be in a good position to continue to fund its growth. On another note, we conducted an in-depth investigation of the company, and identified 5 warning signs for Alpha Cognition (2 are potentially serious!) that you should be aware of before investing here. Of course, you might find a fantastic investment by looking elsewhere. So take a peek at this free list of companies with significant insider holdings, and this list of stocks growth stocks (according to analyst forecasts) Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
National Post
15-05-2025
- Business
- National Post
Alpha Cognition Inc. Reports First Quarter 2025 Financial Results and Operating Overview
Article content Launched ZUNVEYL (benzgalantamine) to US market on March 17, 2025 Secured business development licensing revenues of $2.6M for partnership with CMS Pharma Cash and cash equivalents of $45.5 million as of March 31, 2025, compared to $48.6 million as of December 31, 2024. At current cash utilization rates, the Company expects a cash runway of approximately two years. Article content Article content VANCOUVER, British Columbia — Alpha Cognition Inc. (Nasdaq: ACOG) ('Alpha Cognition', or the 'Company') today announced its financial results for the first quarter ended March 31, 2025. Article content 'We closed the quarter on a strong note, launching ZUNVEYL ® to the long-term care market,' said Michael McFadden, Chief Executive Officer. 'We feel that the company is operating at a high level and are on schedule and within budget on all of our launch plans. Early market feedback on ZUNVEYL utilization reinforces our belief that ZUNVEYL can be a disruptive product for the Alzheimer's segment. The team is reporting successful patient stories that fuel our passion to tell more health care providers about ZUNVEYL.' Article content Alpha Cognition launched ZUNVEYL to long term care market on time and within budget. Early clinician feedback underscores ZUNVEYL's positive impact on cognitive function, established safety profile, and convenient administration. Medicare reimbursement secured shortly after launch, expanding access for long-term care patients. Robust initial demand reflected in broad ordering activity and early product replenishment by wholesalers. Order momentum is building, with many accounts already submitting reorders. Field team actively engaging the majority of high-priority long-term care targets nationwide. Article content Strengthened Intellectual Property Portfolio: Article content The Company secured a new composition of matter patent in the U.S., covering the tablet formulation of benzgalantamine. This patent extends ZUNVEYL's U.S. protection through 2044 and global protection through 2041, enhancing Alpha Cognition's long-term competitive position. The Company received notice from FDA regarding an extension of a method of use patent. The final extension date is expected to be provided by the agency in Q3 2025. Article content First Quarter 2025 Financial Results: Article content Zunveyl net product revenues of $347 thousand for the quarter ended March 31, 2025. Licensing revenue of $2.6M for the quarter ended March 31, 2025. Research and development expenses for the three months ended March 31, 2025 were $408 thousand compared to $917 thousand for the same period in 2024. Selling, general and administrative expenses for the three months ended March 31, 2025 were $5.4 million compared to $3.5 million for the same period in 2024, driven primarily by commercial-readiness activities. Net loss for the for the three months ended March 31, 2025 were $2.0 million compared to $5.0 million for the same period in 2024 Cash and cash equivalents of $45.5 million as of March 31, 2025 compared to $48.6 million as of December 31, 2024. At current cash utilization rates, the Company expects a cash runway of approximately two years. Article content 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. Article content 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. Article content ZUNVEYL is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer's type in adults. Article content CONTRAINDICATIONS Article content ZUNVEYL is contraindicated in patients with known hypersensitivity to benzgalantamine, galantamine, or to any inactive ingredients in ZUNVEYL. Serious skin reactions have occurred. Article content Serious Skin Reactions: 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. Article content Cardiovascular Conditions: 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. Article content Patients treated with galantamine up to 24 mg/day using the recommended dosing schedule showed a dose-related increase in risk of syncope. Article content Gastrointestinal Conditions: 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. Article content Galantamine has been shown to produce nausea, vomiting, diarrhea, anorexia, and weight loss. Monitor the patient's weight during therapy with ZUNVEYL. Article content Genitourinary Conditions: Although this was not observed in clinical trials with galantamine, cholinesterase inhibitors, including ZUNVEYL, may cause bladder outflow obstruction. Article content Neurological Conditions: 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. Article content Pulmonary Conditions: 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. Article content ADVERSE REACTIONS The most common adverse reactions with galantamine tablets (≥5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite. DRUG INTERACTIONS Use with Anticholinergics: Galantamine has the potential to interfere with the activity of anticholinergic medications. Use with Cholinomimetics and Other Cholinesterase Inhibitors: 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. USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data may cause fetal harm. Hepatic Impairment: 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. Renal Impairment: 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. Article content These are not all of the possible side effects of ZUNVEYL. You can report side effects to the FDA. Visit or call 1‑800‑FDA‑1088. Please click here for Full Prescribing Information. Article content 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. Forward‐looking statements may include statements regarding the potential benefits of the licensing agreement for the development and commercialization of ZUNVEYL in Asia (excluding Japan), Australia and New Zealand, the Company's timing and planned activities to launch ZUNVEYL in the U.S. and China, the timing for the Company's planned corporate update call, the potential timing for the availability of ZUNVEYL in the U.S. and China, the potential future developments of ZUNVEYL in China, the potential market size for ZUNVEYL in China, the Company's business strategy for the launch of ZUNVEYL in China, the market size and demand for ZUNVEYL in China, the Company's potential growth opportunities in China, the timing and results of the Company's milestone payments for China, the Company's regulatory submissions in China, and the potential regulatory approval and commercialization of the Company's products in China. 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 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 Form S-1/A registration statement as filed with the SEC on November 6, 2024 and available at 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. Article content Article content Article content Article content Article content Article content
Business Wire
15-05-2025
- Business
- Business Wire
Alpha Cognition Inc. Reports First Quarter 2025 Financial Results and Operating Overview
VANCOUVER, British Columbia--(BUSINESS WIRE)--Alpha Cognition Inc. (Nasdaq: ACOG) ('Alpha Cognition', or the 'Company') today announced its financial results for the first quarter ended March 31, 2025. 'We closed the quarter on a strong note, launching ZUNVEYL ® to the long-term care market,' said Michael McFadden, Chief Executive Officer. 'We feel that the company is operating at a high level and are on schedule and within budget on all of our launch plans. Early market feedback on ZUNVEYL utilization reinforces our belief that ZUNVEYL can be a disruptive product for the Alzheimer's segment. The team is reporting successful patient stories that fuel our passion to tell more health care providers about ZUNVEYL.' Recent Business and Operational Highlights: Commercial Readiness: Alpha Cognition launched ZUNVEYL to long term care market on time and within budget. Early clinician feedback underscores ZUNVEYL's positive impact on cognitive function, established safety profile, and convenient administration. Medicare reimbursement secured shortly after launch, expanding access for long-term care patients. Robust initial demand reflected in broad ordering activity and early product replenishment by wholesalers. Order momentum is building, with many accounts already submitting reorders. Field team actively engaging the majority of high-priority long-term care targets nationwide. Strengthened Intellectual Property Portfolio: The Company secured a new composition of matter patent in the U.S., covering the tablet formulation of benzgalantamine. This patent extends ZUNVEYL's U.S. protection through 2044 and global protection through 2041, enhancing Alpha Cognition's long-term competitive position. The Company received notice from FDA regarding an extension of a method of use patent. The final extension date is expected to be provided by the agency in Q3 2025. First Quarter 2025 Financial Results: Zunveyl net product revenues of $347 thousand for the quarter ended March 31, 2025. Licensing revenue of $2.6M for the quarter ended March 31, 2025. Research and development expenses for the three months ended March 31, 2025 were $408 thousand compared to $917 thousand for the same period in 2024. Selling, general and administrative expenses for the three months ended March 31, 2025 were $5.4 million compared to $3.5 million for the same period in 2024, driven primarily by commercial-readiness activities. Net loss for the for the three months ended March 31, 2025 were $2.0 million compared to $5.0 million for the same period in 2024 Cash and cash equivalents of $45.5 million as of March 31, 2025 compared to $48.6 million as of December 31, 2024. At current cash utilization rates, the Company expects a cash runway of approximately two years. About Alpha Cognition Inc. 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. 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. INDICATION AND USAGE ZUNVEYL is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer's type in adults. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS ZUNVEYL is contraindicated in patients with known hypersensitivity to benzgalantamine, galantamine, or to any inactive ingredients in ZUNVEYL. Serious skin reactions have occurred. WARNINGS AND PRECAUTIONS Serious Skin Reactions: 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. Anesthesia: See Drug Interactions Section Cardiovascular Conditions: 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. Patients treated with galantamine up to 24 mg/day using the recommended dosing schedule showed a dose-related increase in risk of syncope. Gastrointestinal Conditions: 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. Galantamine has been shown to produce nausea, vomiting, diarrhea, anorexia, and weight loss. Monitor the patient's weight during therapy with ZUNVEYL. Genitourinary Conditions: Although this was not observed in clinical trials with galantamine, cholinesterase inhibitors, including ZUNVEYL, may cause bladder outflow obstruction. Neurological Conditions: 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. Pulmonary Conditions: 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. ADVERSE REACTIONS The most common adverse reactions with galantamine tablets (≥5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite. DRUG INTERACTIONS Use with Anticholinergics: Galantamine has the potential to interfere with the activity of anticholinergic medications. Use with Cholinomimetics and Other Cholinesterase Inhibitors: 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. USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data may cause fetal harm. Hepatic Impairment: 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. Renal Impairment: 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. These are not all of the possible side effects of ZUNVEYL. You can report side effects to the FDA. Visit or call 1‑800‑FDA‑1088. Please click here for Full Prescribing Information. Forward-looking Statements 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. Forward‐looking statements may include statements regarding the potential benefits of the licensing agreement for the development and commercialization of ZUNVEYL in Asia (excluding Japan), Australia and New Zealand, the Company's timing and planned activities to launch ZUNVEYL in the U.S. and China, the timing for the Company's planned corporate update call, the potential timing for the availability of ZUNVEYL in the U.S. and China, the potential future developments of ZUNVEYL in China, the potential market size for ZUNVEYL in China, the Company's business strategy for the launch of ZUNVEYL in China, the market size and demand for ZUNVEYL in China, the Company's potential growth opportunities in China, the timing and results of the Company's milestone payments for China, the Company's regulatory submissions in China, and the potential regulatory approval and commercialization of the Company's products in China. 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 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 Form S-1/A registration statement as filed with the SEC on November 6, 2024 and available at 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.
