ACOG 10-K & 10-Q changes, risk factors and insider trading

Risks Related to Our Common Shares and this OfferingStock

We are a commercial developmentbiopharmaceutical stage biopharmaceuticalcompany company in the early stages of commercial development of ourwith one product approved for commercial sale and have incurred significant losses since our inception. We expect to incur significant losses for the foreseeable future and our costs may increase substantially in the foreseeable future.

Since our inception, we have incurred significant net losses, and we expect to continue to incur significant expenses and operating losses for the foreseeable future. Our net losses were approximately $12.4 $20.6 million and $13.8$14.6 million for the years ended December 31, 2024, 2025, and 2023,2024, respectively. As of December 31, 2024,2025, we had an accumulated deficit of approximately $74$97.1 million. We have only one product, ZUNVEYL formerly known as ALPHA-1062, approved for planned commercialization and have never generated any revenue from product sales.commercialization.

We have devoted substantially all our financial resources and efforts to the commercialization of ZUNVEYL and development of our other product candidates, including conducting preclinical studies and clinical trials. We expect to continue to incur significant expenses and operating losses over the next several years.years We expect that it could be several years, if ever, beforeand we havecontinue athe commercial commercializedroll product.out of ZUNVEYL and pursue our other product candidates. Our net losses may fluctuate significantly from quarter to quarter and year to year. We anticipate that our expenses will increase substantially for the foreseeable future as we:

Our ability to continue to generate revenue and achieve profitability depends significantly on our ability to achieve commercial success with ZUNVEYL oral tablet formulation, our one FDA approved product, and continued development and commercialization of our other product candidates, if approved.

To date, we have not generated anyapproximately $6.8 million in revenue from the commercialization of our product candidates. We have only one product, ZUNVEYL oral tablets, approved for commercialization. To continue to generate revenue and become and remain profitable, we must succeed in the commercialization of ZUNVEYL and developing and eventually commercializing our other product candidates. This will require us to be successful in a range of challenging activities, including commercial manufacturing, marketing and sales of ZUNVEYL, completing preclinical testing and clinical trials of our other product candidates, obtaining regulatory approval of our other product candidates, and manufacturing, marketing and selling any other product candidates for which we may obtain regulatory approval, as well as discovering and developing additional product candidates. Outside of our commercial development activities for ZUNVEYL, we are only in the preliminary stages of most of these activities. We may never succeed in these activities and, even if we do, may never generate any revenue or revenue that is significant enough to achieve profitability. Even if we achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would depress the value of our Company and could impair our ability to raise capital, expand our business, maintain our development efforts, obtain product approvals, diversify our offerings or continue our operations. A decline in the value of our Company could also cause you to lose all or part of your investment.

We have a limited operating history and haveno noprior history of commercializing products, which may make it difficult for an investor to evaluate the success of our business to date date and to assess our future viability.

We commenced operations in 2014, and our operations to date have been largely focused on developing our clinical and preclinical product candidates, primarily ALPHA-1062. To date, we have successfully obtained regulatory approval for only one product, ZUNVEYL oral tablets, and have not demonstrated our abilitybegan to manufacture acommercialize productZUNVEYL onin a2025. commercial scale, or arrange for a third partyPrior to dobeginning socommercialization efforts onin our2025, behalf,we orhave conductno saleshistory andof marketingcommercializing activities necessary for successful commercialization.products. Consequently, any predictions made about our future success or viability may not be as accurate as they could be if we had a longer operating history or a history of successfully developing and commercializing products.

We will need substantial capital to meet our financial obligations and to pursue our business objectives, including the continued commercialization of ZUNVEYL oral tablet formulation. If If we are unable to raise capital when needed, we could be forced to delay, reduce and/or eliminate one or more of our research and drug development programs or future commercialization efforts.

Our operations have required substantial amounts of capital since inception, and we expect our expenses to increase significantly in the foreseeable future. Developing commercial manufacturing, marketing and sales is expensive and uncertain which could take a long time to complete. We may not achieve commercial success with ZUNVEYL. Similarly, identifying potential product candidates and conducting preclinical testing and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain regulatory approval and achieve product sales. We expect to continue to incur significant expenses and operating losses over the next several years as we complete continue our commercialization activities for ZUNVEYL and our ongoing clinical trials of our other product candidates, initiate future future clinical trials of our other product candidates, prepare for commercialization activities of our other product candidates and advance any of our other product candidates we may develop or otherwise acquire. In addition, our product candidates, if approved, may not achieve commercial success. Our revenue,revenue ifis any, will beprimarily derived from sales of ZUNVEYL followingas a result of our commercial development activities and our other products that we do not expect to be commercially available for the foreseeable future, if at all.activities. If we obtain marketing approval for any other product candidates that we develop or otherwise acquire, we expect to incur significant commercialization expenses related to product sales, marketing, distribution and manufacturing. We also expect an increase in our expenses associated with creating additional infrastructure to support operations as a public company.

As of December 31, 2024,2025, we had approximately $48.6 $66.1 million in unrestricted cash and cash equivalents and have not generated positive cash flows from operations. Based on our current business plans, we believe our existing cash and cash equivalents, will be sufficient for us to fund our ongoing operating expenses, pre-NDA approval commercialization expenses, and capital expenditures requirements through at least the next 12 months. We may need to raise additional capital to fund our operations and commercial plans after 12 months. Full commercial launch of ZUNVEYL is expected to require substantial capital to continue our commercialization efforts and bring the product to market in the US. We have based these estimates on assumptions that may prove to be incorrect or require adjustment as a result of business decisions, and we could utilize our available capital resources sooner than we currently expect.

We are proceeding with our commercial launch of our ZUNVEYL oral tablet product, where we expect to raise substantial additional capital to continue our commercialization efforts and bring the product to market in the US and continue development of our product candidates. We expect to incur significant commercialization expenses related to product manufacturing, sales, marketing, distribution, and continued R&D.D of ZUNVEYL.

We incur expenses in U.S. dollars, Canadian dollars, and EUROsEuros but our financial statements are denominated in U.S. dollars. Accordingly, we face exposure to adverse movements in currency exchange rates. Our foreign operations that are contracted in foreign currencies will be exposed to foreign exchange rate fluctuations as the financial results are translated from the local currency into U.S. dollars upon consolidation.dollars. Specifically, the U.S. dollar cost of our operations in Canada, API manufacturing in Taiwan and conductingmanufacturing clinicalof trialsZUNVEYL in India is influenced by any movements in the currency exchange rate. Such movements in the currency exchange rate may have a negative effect on our financial results. IfCurrently, our revenue generating agreements are settled in U.S. dollars, however, we may in the future enter into revenue contracts in foreign currencies if and when we expand commercialization of ZUNVEYL. The extent contracts related to our operating costs or revenue are settled in a foreign currency, if the U.S. dollar weakens against foreign currencies, the translation of these foreign currency denominated transactions will could result in increased revenue,revenue decreased operating expenses and increased net income.income (decreased net loss). Similarly, if the U.S. dollar strengthens against foreign currencies, the translation of these foreign currency denominated transactions will could result in decreased revenue, increased operating expenses and decreased net income.income (increased net loss). As exchange rates vary, sales and other operating results, when translated, may differ materially from our or the capital market’s expectations.

Our business is heavily dependent on the successfulcommercial commercializationsuccess of ZUNVEYL oral tablet formulation, our only FDA approved product, and the development and commercialization of any future product candidates that we may develop or acquire.

The NDA for ZUNVEYL oral tablets was approved by the FDA on July 26, 2024, but all our other product candidates are in the pre-clinical stage. The success of our business, including our ability to finance our Company and generate revenue in the future, will primarily depend on the successfulcommercial commercialization success of ZUNVEYL, our only FDA approved and commercially produced product, and the development, regulatory approval and commercialization of our other product candidates. We cannot cannot be certain that ZUNVEYL canwill beexperience successfullycommercial commercializedsuccess or that our other product candidates will receive regulatory approval or be successfully commercialized even if we receive regulatory approval.

The commercial success of ZUNVEYL and the clinical and commercial success of ZUNVEYL and any future product candidates that we may develop or acquire will depend on a number of factors, including the following:

Efforts by biopharmaceutical and pharmaceutical companies in treating Alzheimer’s disease have seen limited success in drug development. Biogen’s Aduhelm, a monoclonal antibody administered via infusion, received accelerated approval from the FDA on June 7, 2021, but Biogen has announced that it will discontinue marketing marketing AdelheimAduhelm by the end of 2024. Adlarity, transdermal formulation of donepezil from the markers of Corium, was the most recently FDA approved symptomatic treatment in 8 years, in March 2022. We cannot be certain that our oral, small-molecule approach will lead to the development of further approvable or marketable products. Since 2003, over 500 clinical studies in Alzheimer’s have have been completed and only Aduhelm, Adlarity and now our product ZUNVEYL have been approved by the FDA, compared to higher success rates for all other drug candidates.

Any government investigation of alleged violations of law could require us to expend significant time and resources in response and could generate negative publicity. The occurrence of any event or penalty described above may inhibit ourthe abilitycommercial tosuccess commercializeof ZUNVEYL and adversely affect our business, financial condition, results of operations and prospects.

Clinical trials are expensive and can take many years to complete, and the outcome is inherently uncertain. The historical failure rate for product candidates in our industry is high. We cannot guarantee guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all. A failure of one or more clinical trials can occur at any stage and our future clinical trials may not be successful. Clinical trials can be delayed or terminated for a variety of reasons. Further, even once completed the process to receive aan NDA can be delayed or unsuccessful.

We have conducted clinical trials of our product candidates outside the United States, and plan to continue to do so in the future. For example, we initially conducted our bioavailability and bioequivalence pivotal clinical trials of ALPHA-1062 in collaboration with Vimta Labs, Inc in Hyperabad,Hyderabad, India. In addition, the Phase 1 single and multiple ascending dose studies of ALPHA-1062 in healthy volunteers were conducted at the Centre for Human Disease Research (CHDR) in the Netherlands. The acceptance of future study data from clinical trials conducted outside the United States or another jurisdiction by the FDA, any comparable foreign regulatory authority may be subject to certain conditions or may not be accepted at all. In cases where data from foreign clinical trials are intended to serve as the basis for marketing approval in the United States, the FDA will generally not approve the application on the basis of foreign data alone unless:

If we are unable to obtain and maintain sufficient product liability insurance at an acceptable cost and scope of coverage to protect against potential product liability claims, the commercialization of of our currentZUNVEYL or any future product candidates we develop could be inhibited or prevented. We currently carry product liability insurance covering covering our clinical trials. Although we maintain such insurance, any claim that may be brought against us could result in a court judgment or or settlement in an amount that is not covered, in whole or in part, by our insurance or that is in excess of the limits of our insurance coverage. Our insurance policies also have various exclusions and deductibles, and we may be subject to a product liability claim for which we have no coverage. We will have to pay any amounts awarded by a court or negotiated in a settlement that exceedexceeds our coverage limitations limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient funds to pay such amounts. Moreover, in the future, we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses. Following the marketing approval of ZUNVEYL (which was received on July 26, 2024) or if and when we obtain approval for marketing any of our future product candidates, we intend to expand our insurance coverage to include the sale of such product candidate; however, we may be unable to obtain this liability insurance on commercially reasonable terms or at all.

Research and development of pharmaceuticals is a lengthy and inherently risky. We cannot give any assurance that our future product candidates will receive regulatory approval.

If the patent applications we hold with respect to our development programs and product candidates fail to issue, if their breadth or strength of protection is threatened, or if they fail to provide meaningful exclusivity for any of our product candidates, it could dissuade companies from collaborating with us to develop product candidates, and threaten our ability to commercialize, future products. Our pending applications cannot be enforced against third parties practicing the technology claimed in such applications unless and until a patent issuesis issued from such applications. Any such outcome could harm our business.

Moreover, patents have a limited lifespan. In the United States, the natural expiration of a patent is generally 20 years after the earliest filed application in a family. Various extensions may be available; however, the life of a patent, and the protection it affords, is limited. We note that certain of our U.S. patents directed toward ZUNVEYL and ALPHA-0602 are set to expire in 2026. In relation to these particular expiring patents patents, we have other patents which we believe are sufficient to cover our patent protection needs in relation to ZUNVEYL and ALPHA-0602. However, we may be wrong in this assessment or face unforeseen difficulties in relation to our patent coverage with could adversely impact the Company.

Moreover, a third party may challenge the current patents, or patents that may issuebe issued in the future, within our portfolio which could result in the invalidation of some or all of the patents that might otherwise be eligible for listing in the Orange Book for one of our products. If a third party successfully challenges all of the patents that might otherwise be eligible for listing in the Orange Book for one of our products, we will not be entitled to the 30-month stay of FDA approval upon the filing of an ANDA for a generic drug containing any of our product candidates, and relies in whole or in part on studies conducted by or for us.

Some of our competitors may be able to sustain the costs of complex intellectual property litigation more effectively than we can because they have substantially greater resources. In addition, intellectual property litigation, regardless of its outcome, may cause negative publicity, adversely impact prospective customers, cause product shipment delays, or prohibit us from manufacturing, marketing or otherwise commercializing our products, services and technology. Any uncertainties resulting from the initiation and continuation of any litigation could adversely impact our ability to raise additional funds or otherwise harm our business, results of operation, financial condition or cash flows. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements of the results of hearings, motions or other interim proceedings or developments, which could adversely impact the price of our common sharesstock and warrants. If securities analysts or investors perceive these results to be negative, it could adversely impact the price of our common sharesstock and warrants. The occurrence of any of these events may harm our business, results of operation, financial condition or cash flows.

Even if we establish infringement, the court may decide not to grant an injunction against further infringing activity and instead award only monetary damages, which may or may not be an adequate remedy. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could harm the price of our common sharesstock and warrants.

Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of our common sharesstock to decline.

During the course of any intellectual property litigation, there could be public announcements of the initiation of the litigation as well as results of hearings, rulings on motions, and other interim proceedings in the litigation. If securities analysts or investors regard these announcements as negative, the perceived value of our existing products, programs or intellectual property could be diminished. Accordingly, the market price of our common shares stock may decline. Such announcements could also harm our reputation or the market for our future products, which could have a material adverse effect on our business.

Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses, and could distract our technical and management personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments, and if securities analysts or investors perceive these results to be negative, it could adversely impact the price of our common shares.stock. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. We may not have sufficient financial or other resources to conduct such litigation or proceedings adequately. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources. Accordingly, despite our efforts, we may not be able to prevent third parties from infringing upon or misappropriating our intellectual property. In addition, the uncertainties associated with litigation could compromise our ability to raise the funds necessary to continue our clinical trials and internal research programs. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could compromise our ability to compete in the marketplace, including compromising our ability to raise the funds necessary to continue our clinical trials, continue our research programs, license necessary technology from third parties, or enter into development collaborations that would help us commercializemanufacture ZUNVEYL or commercialize our future product candidates, if approved.

Where possible, we plan to pursue accelerated development strategies in areas of high unmet need. We may seek an accelerated approval pathway for our one or more of our product candidates. Under the accelerated approval provisions in the Federal Food, Drug, and Cosmetic Act, and the FDA’s implementing regulations, the FDA may grant accelerated approval to a product candidate designed to treat a serious or life-threatening condition that provides meaningful therapeutic benefit over available therapies upon a determination that the product candidate has an effect on a surrogate endpoint or intermediate clinical endpoint that is reasonably likely to predict clinical benefit. The FDA considers a clinical benefit to be a positive therapeutic effect that is clinically meaningful in the context of a given disease, such as irreversible morbidity or mortality. For the purposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit. An intermediate clinical endpoint is a clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit. The accelerated approval pathway may be used in cases in which the advantage of a new drug over available therapy may not be a direct therapeutic advantage, but is a clinically important improvement from a patient and public health perspective. If granted, accelerated approval is usually contingent on the sponsor’s agreement to conduct, in a diligent manner, additional post-approval confirmatory studies to verify and describe the drug’s clinical benefit. If such post-approval studies fail to confirm the drug’s clinical benefit, the FDA may withdraw its approval of the drug.

As of March 28,30, 2025,2026, we had 5272 full-time employees and 21 part-time contractorscontractor in total. We will need to continue to expand our managerial, operational, finance and other resources in order to manage our operations and clinical trials, continue our development activities and commercialize ZUNVEYL, our lead product candidate, or any future product candidates. Our management and personnel, systems and facilities currently in place may not be adequate to support this future growth. Our need to effectively execute our growth strategy requires that we:

In addition, employment candidates and existing employees often consider the value of the stock awards they receive in connection with their employment. If the perceived benefits of our stock awards decline, either because we are a public company or for other reasons, it may harm our ability to recruit and retain highly skilled employees. Our employees may be more likely to leave us if the shares they own have significantly appreciated in value relative to the original purchase prices of the shares,stock, or if the exercise prices of the options that they hold are significantly below the market price of our common stock.

Risks Related to Our Common SharesStock

Our stock price may be volatile and you may not be able to resell common sharesstock at or above the price you paid.

The trading price of our common sharesstock could be highly volatile and could be subject to wide fluctuations in response to various factors, some of which are beyond our control. In particular, the trading prices for biopharmaceutical companies have been highly volatile as a result of the COVID-19 pandemic and world events. These factors include those discussed in this “Risk Factors” section of this Annual Report and others such as:

In addition, the stock markets in general, and the markets for biopharmaceutical stocks in particular, have experienced extreme volatility that may have been unrelated to the operating performance of the Company. These broad market fluctuations may adversely affect the trading price or liquidity of our common shares.stock.

An active, liquid and orderly market for our common sharesstock may not develop, and you may not be able to resell your common sharesstock at or above the initial public offering price.

There has been limited trading of our common shares stock on the OTCQB and CSE exchanges. Although our common sharesstock are now listed on the Nasdaq Capital Market an active trading market may not develop or, if it is developed, may not be sustained. The lack of an active market may impair your ability to sell your common shares stock at the time you wish to sell them or at a price that you consider reasonable. An inactive market may also impair our ability to raise capital by selling shares stock and may impair our ability to acquire other product candidates, businesses or technologies using our shares stock as consideration.

We believe we were a “passive foreign investment company” (a “PFIC”) within the meaning of Section 1297 of the U.S. Internal Revenue Code of 1986, as amended (the “Code”) for our most recently completed taxable year and based on current business plans and financial expectations, we expect to be a PFIC for our current taxable year and may be a PFIC in subsequent tax years. If we are a PFIC for any year during a U.S. taxpayer’s holding period of common shares,stock, then such U.S. taxpayer generally will be required to treat any gain realized upon a disposition of the common shares,stock, as applicable, or any so-called ‘‘“excess distribution’’distribution” received on its common shares, stock, as applicable, as ordinary income, and to pay an interest charge on a portion of such gain or distribution. In certain circumstances, the sum of the tax and the interest charge may exceed the total amount of proceeds realized on the disposition, or the amount of excess distribution distribution received, by the U.S. taxpayer. Subject to certain limitations, these tax consequences may be mitigated if a U.S. taxpayer makes a timely and effective QEF Election (as defined below) or a Mark-to-Market Election (as defined below). In addition, U.S. taxpayers should should be aware that there can be no assurances that we will satisfy the record keeping requirements that apply to a QEF (as defined below), or that we will supply U.S. taxpayers with information that such U.S. taxpayers are required to report under the QEF rules, in the event that we are a PFIC. Thus, U.S. Holders may not be able to make a QEF Election. A U.S. taxpayer who makes a Mark-to-Market Election with respect to the common sharesstock generally must include as ordinary income each year the excess of the fair market value of the common sharesstock over the taxpayer’s basis therein.

Proposed legislation in the U.S. Congress, including changes in U.S. tax law, may adversely impact us and the value of our Common Shares.Stock.

Changes to U.S. tax laws (which changes may have retroactive application) could adversely affect us or holders of the common shares.stock. In recent years, many changes to U.S. federal income tax laws have been proposed and made, and additional changes to U.S. federal income tax laws are likely to continue to occur in the future.

The U.S. Congress is currently considering numerous items of legislation which may be enacted prospectively or with retroactive effect, which legislation could adversely impact our financial performance and the value of the common shares.stock. Additionally, states in which we operate or own assets may impose new or increased taxes. If enacted, most of the proposals would be effective for the current or later years. The proposed legislation remains subject to change, and its impact on us and purchasers of the common sharesstock is uncertain.

In addition, the Inflation Reduction Act of 2022 includes provisions that impact the U.S. federal income taxation of corporations. Among other items, this legislation includes provisions that impose a minimum tax on the book income of certain large corporations and an excise tax on certain corporate stock repurchases that are imposed on the Corporation repurchasing such stock. It remains unclear in certain respects how this legislation will be implemented by the U.S. Department of the Treasury and we cannot predict how this legislation or any future changes in tax laws might affect us or purchasers of the common shares. stock.

If we sell shares of our common stock in future financings, stockholders may experience immediate dilution and, as a result, our stock price may decline.

Because we expect our expenses to increase significantly in the foreseeable future and because, based on our current business plans, our existing cash, cash equivalents and marketable securities, will be insufficient for us to fund our planned operating and capital expenditures beyond the date that is just several months after the date of this Annual Report, we may from time to time issue additional shares of common stock. These issuances may be at a discount from the current trading price of our common stock. As a result, our stockholders would experience immediate dilution upon the purchase of any shares of our common stock sold at such discount. In addition, as opportunities present themselves, we may enter into financing or similar arrangements in the future, including the issuance of debt securities, preferred stock or common stock. If we issue common stock or securities convertible into common stock, our common stockholders will experience additional dilution and, as a result, our stock price may decline.

The Company is a commercial stage 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. The Company will focuses on the development of commercial manufacturing and commercial sales of ZUNVEYL oral tablet formulation. The Company’s commercial developmentprogram program for ZUNVEYL is primarily focused on building aits long-term care commercial team that can focus on providing key points of differentiation, exploiting key issues with existing AChEI treatments, and franchising potential additional indications and new products.

The Company willlaunched targetZUNVEYL on March 19, 2025, and targets the largest volume nursing homes specializing in Alzheimer’s Disease,disease, leveraging an account-based sales team with demonstrated success in LTC, positioning positioning ZUNVEYL with Medicare payors, and developing strategic and clinical partnerships with consultant pharmacists and long-term care pharmacies. The company’s anticipated launch is in Q1 2025. Alpha Cognition has set the Wholesale Acquisition Cost (WAC) for its latesttherapeutic therapeutic product at $749$820 per month. This pricing reflects the company’s commitment to balancing patient access with the value of innovative healthcare solutions. By establishing a competitive WAC price, Alpha Cognition aims to enhance affordability and ensure patients can benefit from our advanced treatment options. Patients’ out-of-pocket cost for treatment with ZUNVEYL will depend on their length of treatment and their insurance. The Company has three 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,oral ALPHA-1062tablet intranasal (“ALPHA-1062IN”) formulation for the treatment of cognitive impairment with mild traumatic brain injury (mTBI; otherwise known as concussion) and (3) ALPHA-0602, ALPHA-0702 & ALPHA-0802, also referred to as ‘Progranulin’ and ‘Progranulin GEM’s’, for the treatment of neurodegenerative diseases including amyotrophic lateral sclerosis, otherwise known as ALS or Lou Gehrig’s disease and spinal muscular atrophy (SMA).

ZUNVEYL, is a patented new innovative product being developedpositioned as a next 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. ZUNVEYL is in pre-clinical development in combination with memantine to treat moderate to severe Alzheimer’s disease, in pre-clinical development with sublingual formulation for patients suffering from dysphagia, and ALPHA-1062IN is intended to be out-licensed forin pre-clinical development to study an intranasal formulation for cognitive impairment with mTBI.

The Company is the parent company of Alpha Cognition Canada Inc. (“Alpha Canada” or “ACI Canada”) which is the parent company of Alpha Cognition USA Inc. (“ACI USA”). As of May 1, 2023, the Company’s commonCommon sharesStock commenced trading on the CSE under the symbol “ACOG”, previously the Company’s shares stock were traded on the TSX-V until April 28, 2023, when the Company had them delisted. As of November 12, 2024, the Company’s Common common sharesStock commenced trading on The Nasdaq Capital Market under the symbol “ACOG”. The Company’s shares stock were voluntarily delisted from the CSE and OTCQB on December 17, 2024.

The Company has not generated revenues from its operations to date and asAs of December 31, 2024,2025, andthe Company had aan accumulated deficit of $76,285,038 (December 31, 2023 – $61,648,173)$97,106,775 which has been primarily financed by equity. The Company had $48,564,082$66,105,189 in cash and cash equivalents, including restricted cash, and $3,350,752$9,130,075 in current liabilities (of which $97,515$44,464 is payable from the Company’s available restricted cash balance) as of December 31, 2024.2025. The Company’s continuing operations, as intended, are highly dependent upon its ability to obtain additional funding and eventually positive generate cash flows. Management is of the opinion that it does have sufficient working capital to fully meet the Company’s liabilities and commitments as outlined and planned in the following discussion. Management is of the opinion it will need to raise additional capital to cover upcoming planned Research and Development (“R&D”), continued commercialization of ZUNVEYL and operating costs. Possible sources of such capital may come from our “at the market” facility and future private placementsplacements, and public offerings of the Company’s commonCommon sharesStock and funds received from the exercise of warrants and sharestock options. Additionally, the Company will also consider funding that may arise through partnership activities, including royalties, and debt. There is a risk that additional financing will not be available on a timely basis, on terms acceptable, or at all to the Company.

The Company is also contemplating raising capital by pursuing both dilutive and non-dilutive strategic sources of capital to fully execute its commercialization and operating plans followingfor receipt of the NDA approval for ZUNVEYL from the FDA. Any additional capital is expected to further support our planned costs tofor begin commercial activities including launching U.S. sales of ZUNVEYL in ADactivities.

Selling, General and administrativeAdministrative expenses

GeneralSelling, general and administrative expenses costs consist of personnel costs, other outside professional services including legal, human resources, audit and accounting services, consulting and pre-commercialization pre-commercialization expenses, including selling and marketing costs as well attendance to various conferences. Personnel costs consist of salaries, benefits, and share-based compensation. We expect to continue to incur expenses to support our continued operations as a public company, including expenses related to existing and future compliance with rules and regulations of the stock exchanges on which our securities are now traded, insurance expenses, investor relations, audit fees, professional services and general overhead and administrative costs.

ShareResults Basedof CompensationOperations

Interest income consists of interest earned and interest charges on our the Company’s cash and cash equivalents.

The Company is the parent company of Alpha Cognition Canada Inc. (“Alpha Canada” or “ACI Canada”) which is the parent company of Alpha Cognition USA Inc. (“ACI USA”). As of May 1, 2023, the Company’s Common Stock commenced trading on the CSE under the symbol “ACOG”, previously the Company’s stock were traded on the TSX-V until April 28, 2023, when the Company had them delisted. As of November 12, 2024, the Company’s Common Stock commenced trading on The Nasdaq Capital Market under the symbol “ACOG”. The Company’s stock werewas voluntarily delisted from the CSE on December 17, 2024.

As of MarchJune 31,30, 2026, the Company had an accumulated deficit of $103,584,793 $112,374,533 which has been primarily financed by equity. The Company had $54,248,275$41,384,287 in cash and cash equivalents and $5,425,117$6,412,718 in current liabilities (of which $44,464 is payable from the Company’s available restricted cash balance) as of MarchJune 31,30, 2026. The Company’s continuing operations, as intended, are highly dependent upon its ability to obtain additional funding and eventually generate positive generate cash flows. Management is of the opinion that it does have sufficient working capital to fully meet the Company’s liabilities and commitments as outlined and planned in the following discussion. Management is of the opinion it will need to raise additional capital to cover upcoming planned Research and Development (“R&D”), continued commercialization of ZUNVEYL and operating costs. Possible sources of such capital may come from our “at the market” facility and future private placements, and public offerings of the Company’s Common Stock and funds received from the exercise of warrants and stock options. Additionally, the Company will also consider funding that may arise through partnership activities, including royalties, and debt. There is a risk that additional financing will not be available on a timely basis, on terms acceptable, or at all to the Company.

LicenseLicensing revenue consists of revenue from our License, Collaboration and Distribution Agreement with CMS International Development and Management Limited, or CMSI (the “CMSI License Agreement”), including upfront payments, potential milestone and royalty payments, as well as revenue from the sale of active pharmaceutical ingredient (“API”), finished goods, and reimbursable costs.

Cost of product sales consists primarily of costs related to the manufacturing of ZUNVEYL, logistics costs, inventory impairment expense, and royalty payments under license or purchase agreements. agreements, and amortization of the Alpha-1062 intellectual property intangible asset.

Selling, general and administrative expenses costs consist of personnel costs, other outside professional services including legal, human resources, audit and accounting services, consulting and pre-commercialization expenses, including selling and marketing costs as well as attendance to various conferences. Personnel costs consist of salaries, benefits, and stock-based compensation. We expect to continue to incur expenses to support our continued operations as a public company, including expenses related to existing and future compliance with rules and regulations of the stock exchanges on which our securities are now traded, insurance expenses, investor relations, audit fees, professional services and general overhead and administrative costs.

Comparison of the Three Months Ended MarchJune 31,30, 2026 and 2025

Comparison of Revenue for the ThreeSix Months Ended MarchJune 31,30, 2026 and 2025

Comparison of Cost of Sales and Cost of Licensing Revenue for the Three Months Ended MarchJune 31,30, 2026 and 2025

Cost of product sales increased by $172,112, or 163%, from $105,354 for the three months ended June 30, 2025 to $277,466 for the three months ended June 30, 2026. The increase was primarily attributable to higher commercial sales volume of ZUNVEYL. The Company expects that cost of product sales will continue to increase over the year in relation to expected increased sales of ZUNVEYL as the Company expands its sales of ZUNVEYL Cost of licensing revenue decreased by $787,077, $53,756, or 97%,58%, from $810,000$93,118 for the three months ended MarchJune 31,30, 2025 to $22,923$39,362 for the three months ended MarchJune 31,30, 2026. The decrease is from a reduction of royalty payments and pass-through-costs,pass-through costs, such as consulting fees and active pharmaceutical ingredients, that were allocated to activities supporting the CMSI agreement. The Company expects that cost of licensing revenue will continue to decrease over the year until the requirements of the CMSI agreement have been fulfilled.

Comparison of Research and Development for the Three Months Ended March 31,June 30, 2026 and 2025

Research and development expenses increased by $695,889,$1,602,730, or 174%,395%, from $400,416 $406,140 for the three months ended MarchJune 31,30, 2025, to $1,096,305$2,008,870 for the three months ended MarchJune 31,30, 2026. The net change is due to increase in time allocated in employee and management costs for the development of the dissolvable tablet and clinical study.studies.

Comparison of Selling, General and Administrative Expenses for the Three Months Ended MarchJune 31,30, 2026 and 2025

Selling, general and administrative expenses increased by $5,165,285 $1,954,088 or 101%,21%, from $5,091,272$9,494,966 for the three months ended MarchJune 31,30, 2025, to $10,256,557,$11,449,054, for the three months ended MarchJune 31,30, 2026. In support of the Company’s expansion in commercial operations and launch of ZUNVEYL, there has been an increase of $3.3$2.5 million in management feesemployee costs due to the increase in sales representatives and salariesadministrative and employee costs,support; an increase of $822,074$1.4 million in marketing and commercial operations,operations due to increased sales activity and implementation of the speaker bureau program; an increase in regulatory costs of approximately $350,000,$337,000 andfor the FDA user fees; an increase of $384,000$345,000 in other general and administrative expenses.expenses due to increased sales activity; and a decrease of $2.7 million in stock-based compensation due to change of liability classified options to equity classified and graded vesting nature of equity awards issued during the 2025 fiscal year.

Interest income had a net change of $44,187$44,935 or 10% 11% from interest income of $506,056$425,670 for the three months ended MarchJune 31,30, 2025, to interest income, net of $380,735 for the three ended June 30, 2026. Interest income had a net change of $748 or 1% from interest income of $886,791 for the six months ended June 30, 2026, to interest income, net of $461,869$887,539 for the yearsix months ended March 31,June 30, 2025.

During the three months ended MarchJune 31,30, 2026, the change in the fair value of the Company’s warrant liabilities resulted in a gainloss of $1,124,072$1,414,267 compared to a gainloss of $1,147,882 $5,172,091 during the three months ended MarchJune 31,30, 2025. For both periods, the change in fair value primarily resulted from changes in the Company’s stock price during the respective quarter.

The Company does not have sufficient operating revenue to finance its existing obligations and has relied on external financing, such as debt and equity raises, since incorporation, to generate capital to maintain its capacity to meet working capital requirements. The Company has relied on debt and equity raises to finance its operating activities since incorporation. The Company has successfully raised funds that exceed the Company’s working capital requirements for the next 12 months from the date of issuance of the consolidated financial statements contained in this report. The Company expects to continue to rely on debt and the issuance of stock, and possibly other non-dilutive financing options to finance its ongoing operations and ongoing plans for commercialization of ZUNVEYL. However, there is a risk that additional financing will not be available on a timely basis or on terms acceptable to the Company.

In August 2025, the Company entered into an ATM agreement with H.C. WainrightWainwright & Co., LLC as the sales agent. The Company currently has not utilized the ATM facility.

Until such time, astime we can generate substantial product revenue, we expect to finance our operations through other capital sources, including current or potential future collaborations, licenses, royalties and other similar arrangements. We do not know what the terms of these future financings will be and whether they will be acceptable to the us Company or not and, therefore, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. To the extent we raise additional capital, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions, engaging in acquisitions, merger or collaboration transactions, selling or licensing our assets, making capital expenditures, redeeming our stock, making certain investments or declaring dividends. If we raise additional funds through collaborations or license agreements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves, or even cease operations.

On October 2, 2025, the Company completed a public offering of Common Stock by issuing 4,651,516 shares of Common Stock at a public offering price of $6.25 per share and 948,484 pre-funded warrants exercisable tointo Common Stock with an exercise price of $0.001 per share for total gross proceeds of approximately $35 million. In connection with this offering, the Company incurred underwriting fees of approximately $2.11 million.

The following table provides information regarding our cash flows for the threesix months ended MarchJune 31,30, 2026, and 2025:

Cash used in operating activities increased by $9,753,712 $10,472,932 to $11,797,992$18,656,708 for the threesix months ended MarchJune 31,30, 2026, from $2,044,280$8,183,776 for the comparative period. The increase is related to higher employee costs of approximately $3.4$6.1 million, and commercial, marketing and other general and administrative costs increased by approximately $1.5 million.$2.3 million and $2.0 million increase in research and development for the clinical studies.

Cash used in investing activities decreasedincreased by $61,948 $5,935,009 to $1,322$6,006,594 for the threesix months ended MarchJune 31,30, 2026 from $63,270$71,585 compared to the comparative period. During the threesix months ended March 31,June 2025,30, 2025 and 2026, investing activities consisted of acquiring computer equipment and software. During the six months ended June 30, 2026, the Company paid $5,906,702 for the acquisition of an intangible asset in connection with the Galantos Pharma royalty settlement.

Cash used in financing activities for the three six months ended MarchJune 31,30, 2026, decreasedincreased by $835,103$845,911 compared to the comparative period. During the threesix months ended MarchJune 31,30, 2025, financing activities primarily consisted,consisted of principal repayment of the promissory note of $911,463$911,463, proceeds of $25,823 from the exercise of warrants, and receiving $174,675 in government grant proceeds offset by $97,515$134,146 of related grant expenses. During the threesix months ended MarchJune 31,30, 2025,2026, financing activities was proceeds of $800 from the exercise of performance legacy options.

The Company did not have any contingencies as of MarchJune 31,30, 2026, or the date of this report.