Alpha Cognition Inc.

Previous wording

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed financial statements and the accompanying notes thereto included elsewhere in this Quarterly Report on Form 10-Q and with our audited financial statements and the accompanying notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2025, as previously filed with the Commission. This discussion and analysis contains forward-looking statements and forward-looking information that involve risks, uncertainties, and assumptions. Our actual results may differ materially from those anticipated in these forward-looking statements and information as a result of many factors. See section heading “Special Note Regarding Forward-Looking Statements.”

Current wording

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed financial statements and the accompanying notes thereto included elsewhere in this Quarterly Report on Form 10-Q and with our audited financial statements and the accompanying notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2025, as previously filed with the U.S. Securities and Exchange Commission. This discussion and analysis contains forward-looking statements and forward-looking information that involve risks, uncertainties, and assumptions. Our actual results may differ materially from those anticipated in these forward-looking statements and information as a result of many factors. See section heading “Special Note Regarding Forward-Looking Statements.”

Previous wording

The Company is a commercial stage biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer’s disease (“AD”), for which there are limited or no treatment options. The Company focuses on the commercial manufacturing and commercial sales of ZUNVEYL oral tablet formulation. The Company’s commercial program for ZUNVEYL is primarily focused on its 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.

Current wording

The Company is a commercial stage biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as AD, for which there are limited or no treatment options. The Company focuses on the commercial manufacturing and commercial sales of ZUNVEYL oral tablet formulation. The Company’s commercial program for ZUNVEYL is primarily focused on its 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.

Previous wording

The Company launched ZUNVEYL on March 19, 2025, and targets the largest volume nursing homes specializing in Alzheimer’s disease, leveraging an account-based sales team with demonstrated success in LTC, positioning ZUNVEYL with Medicare payors, and developing strategic and clinical partnerships with consultant pharmacists and long-term care pharmacies. Alpha Cognition has set the Wholesale Acquisition Cost (WAC) for its therapeutic product at $869.36 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 oral tablet (“ALPHA-1062IN”) formulation for treatment of mild-moderate Alzheimer’s disease and 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).

Current wording

The Company launched ZUNVEYL on March 19, 2025, and targets the largest volume nursing homes specializing in AD, leveraging an account-based sales team with demonstrated success in Long-term care (“LTC”), positioning ZUNVEYL with Medicare payors, and developing strategic and clinical partnerships with consultant pharmacists and long-term care pharmacies. Alpha Cognition has set the Wholesale Acquisition Cost (“WAC”) for its therapeutic product at $869.36 per bottle. 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 two additional pre-clinical development programs: (1) ZUNVEYL in combination with memantine for the treatment of moderate-to-severe AD and (2) ALPHA-1062 sublingual oral tablet (“ALPHA-1062IN”) formulation for treatment of mild-moderate AD and for the treatment of cognitive impairment with mild traumatic brain injury (mTBI; otherwise known as concussion).

Previous wording

ZUNVEYL, is a patented new innovative product being positioned 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 is in pre-clinical development for cognitive impairment with mTBI.

Current wording

ZUNVEYL is a patented new innovative product being positioned as a next generation acetylcholinesterase inhibitor for the treatment of AD, 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 AD, in pre-clinical development with sublingual formulation for patients suffering from dysphagia, and is in pre-clinical development for cognitive impairment with mTBI.

Previous wording

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 was voluntarily delisted from the CSE on December 17, 2024.

Current wording

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 Common Stock was 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 Common Stock was voluntarily delisted from the CSE on December 17, 2024.

Previous wording

As of June 30, 2026, the Company had an accumulated deficit of $112,374,533 which has been primarily financed by equity. The Company had $41,384,287 in cash and cash equivalents and $6,412,718 in current liabilities (of which $44,464 is payable from the Company’s available restricted cash balance) as of June 30, 2026. The Company’s continuing operations, as intended, are highly dependent upon its ability to obtain additional funding and eventually generate positive 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.

Current wording

As of September 30, 2026, the Company had an accumulated deficit of $118,909,554 which has been primarily financed by equity. The Company had $37,801,828 in cash and cash equivalents and $8,037,719 in current liabilities (of which $44,464 is payable from the Company’s available restricted cash balance) as of September 30, 2026. The Company’s continuing operations, as intended, are highly dependent upon its ability to obtain additional funding and eventually generate positive 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.

Previous wording

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 for ZUNVEYL from the FDA. Any additional capital is expected to further support our planned costs for commercial activities.

Current wording

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 for ZUNVEYL from the US Food and Drug Administration (“FDA”). Any additional capital is expected to further support our planned costs for commercial activities.

Previous wording

Licensing 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.

Current wording

Licensing revenue consists of revenue from our License, Collaboration and Distribution Agreement with CMS International Development and Management Limited, “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.

Previous wording

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

Current wording

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.

Previous wording

Research and development expenses represent costs incurred to conduct research, such as the discovery and development of our product candidates. We recognize all research and development costs as they are incurred unless there is an alternative future use in other research and development projects or otherwise.

Current wording

R&D expenses represent costs incurred to conduct research, such as the discovery and development of our product candidates. We recognize all research and development costs as they are incurred unless there is an alternative future use in other research and development projects or otherwise.

Previous wording

Research and development expenses consists primarily of the following:

Current wording

R&D expenses consist primarily of the following:

Previous wording

The increase was primarily attributable to higher prescription volume resulting from increased utilization of ZUNVEYL. During the three months ended June 30, 2026, the increase in volume was 251% when compared to the three months ended June 30, 2025.

Current wording

The increase was primarily attributable to higher prescription volume resulting from increased utilization of ZUNVEYL. During the three months ended September 30, 2026, the increase in volume was 215% when compared to the three months ended September 30, 2025.

Previous wording

Product revenue was also positively impacted from the increase in WAC from its $749.00 launch price per bottle to $869.36 per bottle. The increase in WAC per bottle resulted in an increase of 14% in gross product sales.

Current wording

Product revenue was also positively impacted from the increase in average WAC from $788.83 per bottle to $869.36 per bottle. The increase in WAC per bottle resulted in an increase of 21% in gross product sales.

Previous wording

These increases were partially offset by higher GTN deductions, including government and commercial rebates, chargebacks, and distribution-related fees. GTN deductions represented 24.4% of gross product sales during the three months ended June 30, 2026 compared with 21.1% during the comparable prior period.

Current wording

These increases were partially offset by higher GTN deductions, including government and commercial rebates, chargebacks, and distribution-related fees. GTN deductions represented 25.5% of gross product sales during the three months ended September 30, 2026 compared with 21.9% during the comparable prior period.

Previous wording

Product revenue is presented net of estimated GTN deductions. GTN deductions increased from $418,902 during the three months ended June 30, 2025 to $1,931,799 during the current period.

Current wording

Product revenue is presented net of estimated GTN deductions. GTN deductions increased from $629,996 during the three months ended September 30, 2025 to $2,662,627 during the current period.

Previous wording

Comparison of Revenue for the Six Months Ended June 30, 2026 and 2025

Current wording

Comparison of Revenue for the Nine Months Ended September 30, 2026 and 2025

Previous wording

The increase was primarily attributable to higher prescription volume resulting from increased utilization of ZUNVEYL. During the six months ended June 30, 2026, the increase in volume was 367% when compared to the six months ended June 30, 2025.

Current wording

The increase was primarily attributable to higher prescription volume resulting from increased utilization of ZUNVEYL. During the nine months ended September 30, 2026, the increase in volume was 285% when compared to the nine months ended September 30, 2025.

Previous wording

Product revenue was also positively impacted from the increase in WAC from its $749.00 launch price per bottle to $869.36 per bottle. The increase in WAC per bottle resulted in an increase of 12% in gross product sales.

Current wording

Product revenue was also positively impacted from the increase in average WAC from $770.58 per bottle to $853.24 per bottle. The increase in average WAC per bottle resulted in an increase of 10% in gross product sales.

Previous wording

These increases were partially offset by higher GTN deductions, including government and commercial rebates, chargebacks, and distribution-related fees. GTN deductions represented 24.6% of gross product sales during the six months ended June 30, 2026 compared with 20.5% during the comparable prior period.

Current wording

These increases were partially offset by higher GTN deductions, including government and commercial rebates, chargebacks, and distribution-related fees. GTN deductions represented 25.2% of gross product sales during the nine months ended September 30, 2026 compared with 19.6% during the comparable prior period.

Previous wording

Product revenue is presented net of estimated GTN deductions. GTN deductions increased from $494,432 during the six months ended June 30, 2025 to $3,121,666 during the current period.

Current wording

Product revenue is presented net of estimated GTN deductions. GTN deductions increased from $1,040,593 during the nine months ended September 30, 2025 to $5,826,630 during the current period.

Previous wording

Licensing revenue was $2,663,001 during the six months ended June 30, 2025 compared to $81,445 during the six months ended June 30, 2026. The decrease of $2,581,556 was primarily due to the recognition of $2,396,600 during the six months ended June 30, 2025 related to the one-time transfer of intellectual property to CMSI.

Current wording

Licensing revenue was $3,169,637 during the nine months ended September 30, 2025 compared to $108,488 during the nine months ended September 30, 2026. The decrease of $3,061,149 was primarily due to the recognition of $2,396,600 during the nine months ended September 30, 2025 related to the one-time transfer of intellectual property to CMSI.

Previous wording

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

Current wording

Cost of product sales increased by $209,320, or 129%, from $162,777 for the three months ended September 30, 2025 to $372,097 for the three months ended September 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.

Previous wording

Cost of licensing revenue decreased by $53,756, or 58%, from $93,118 for the three months ended June 30, 2025 to $39,362 for the three months ended June 30, 2026. The decrease is from a reduction of royalty payments and 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.

Current wording

Cost of licensing revenue decreased by $442,958, or 95%, from $465,284 for the three months ended September 30, 2025 to $22,326 for the three months ended September 30, 2026. The decrease is from a reduction of royalty payments and 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.

Previous wording

Comparison of Cost of Sales and Cost of Licensing Revenue for the Six Months Ended June 30, 2026 and 2025

Current wording

Comparison of Cost of Sales and Cost of Licensing Revenue for the Nine Months Ended September 30, 2026 and 2025

Previous wording

Cost of product sales increased by $394,424, or 299%, from $131,895 for the six months ended June 30, 2025 to $526,319 for the six 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

Current wording

Cost of product sales increased by $603,744, or 205%, from $294,672 for the nine months ended September 30, 2025 to $898,416 for the nine months ended September 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.

Previous wording

Cost of licensing revenue decreased by $840,833, or 93%, from $903,118 for the six months ended June 30, 2025 to $62,285 for the six months ended June 30, 2026. The decrease is from a reduction of royalty payments and 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.

Current wording

Cost of licensing revenue decreased by $1,283,791, or 94%, from $1,368,402 for the nine months ended September 30, 2025 to $84,611 for the nine months ended September 30, 2026. The decrease is from a reduction of royalty payments and 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.

Previous wording

Research and development expenses increased by $2,298,619, or 285%, from $806,556 for the six months ended June 30, 2025, to $3,105,175 for the six months ended June 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 studies.

Current wording

Research and development expenses increased by $831,164, or 162%, from $513,783 for the three months ended September 30, 2025, to $1,344,947 for the three months ended September 30, 2026. The increase was attributable to time allocated in employee and management costs incurred for the development of the dissolvable tablet and clinical studies.

Previous wording

Comparison of Research and Development for the Six Months Ended June 30, 2026 and 2025

Current wording

Comparison of Research and Development for the Nine Months Ended September 30, 2026 and 2025

Previous wording

Research and development expenses increased by $1,602,730, or 395%, from $406,140 for the three months ended June 30, 2025, to $2,008,870 for the three months ended June 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 studies.

Current wording

Research and development expenses increased by $2,048,077, or 155%, from $1,320,339 for the nine months ended September 30, 2025, to $3,368,416 for the nine months ended September 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 studies.

Previous wording

Selling, general and administrative expenses increased by $1,954,088 or 21%, from $9,494,966 for the three months ended June 30, 2025, to $11,449,054, for the three months ended June 30, 2026. In support of the Company’s expansion in commercial operations and launch of ZUNVEYL, there has been an increase of $2.5 million in employee costs due to the increase in sales representatives and administrative support; an increase of $1.4 million in marketing and commercial operations due to increased sales activity and implementation of the speaker bureau program; an increase in regulatory costs of approximately $337,000 for the FDA user fees; an increase of $345,000 in other general and administrative 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.

Current wording

Selling, general and administrative expenses increased by $7,267,179 or 142%, from $5,113,159 for the three months ended September 30, 2025, to $12,380,338, for the three months ended September 30, 2026. In support of the Company’s expansion in commercial operations and launch of ZUNVEYL, there has been an increase of $2.4 million in employee costs due to the increase in sales representatives and administrative support; an increase of $1.6 million in marketing and commercial operations due to increased sales activity and implementation of the speaker bureau program; an increase in regulatory costs of approximately $0.3 million for the FDA user fees; an increase of $1.0 million in other general and administrative expenses due to increased sales activity; and an increase of $2.0 million in stock-based compensation due to graded vesting nature of equity awards issued during the 2025 and 2026 fiscal years.

Previous wording

Comparison of Selling, General and Administrative Expenses for the Six Months Ended June 30, 2026 and 2025

Current wording

Comparison of Selling, General and Administrative Expenses for the Nine Months Ended September 30, 2026 and 2025

Previous wording

Selling, general and administrative expenses increased by $7,119,373 or 49%, from $14,586,238 for the six months ended June 30, 2025, to $21,705,611, for the six months ended June 30, 2026. In support of the Company’s expansion in commercial operations and launch of ZUNVEYL, there has been an increase of $5.8 million in employee costs due to the increase in sales representatives and administrative support; an increase of $2.3 million in marketing, sales and commercial operations due to increased sales activity and implementation of the speaker bureau program; an increase in regulatory costs of approximately $690,000 for the FDA user fees; an increase of $920,000 in other general and administrative expenses due to increased sales activity; and a decrease of $3.0 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.

Current wording

Selling, general and administrative expenses increased by $14,386,552 or 73%, from $19,699,397 for the nine months ended September 30, 2025, to $34,085,949, for the nine months ended September 30, 2026. In support of the Company’s expansion in commercial operations and launch of ZUNVEYL, there has been an increase of $8.3 million in employee costs due to the increase in sales representatives and administrative support; an increase of $4.0 million in marketing, sales and commercial operations due to increased sales activity and implementation of the speaker bureau program; an increase in regulatory costs of approximately $1.0 million for the FDA user fees; an increase of $1.6 million in other general and administrative expenses due to increased sales activity; $0.4 million increase in manufacturing related costsand a decrease of $1.0 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 and 2026 fiscal years.

Previous wording

Interest income had a net change of $44,935 or 11% from interest income of $425,670 for the three months ended June 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 $887,539 for the six months ended June 30, 2025.

Current wording

Interest income had a decrease of $19,678 or 5% from interest income of $377,671 for the three months ended September 30, 2025, to interest income, net of $357,993 for the three months ended September 30, 2026. Interest income had a net change of $20,426 or 2% from interest income of $1,265,210 for the nine months ended September 30, 2025, to interest income, net of $1,244,784 for the nine months ended September 30, 2026.

Previous wording

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

Current wording

During the three months ended September 30, 2026, the change in the fair value of the Company’s warrant liabilities resulted in a loss of $1,523,393 compared to a gain of $3,671,758 during the three months ended September 30, 2025. For both periods, the change in fair value primarily resulted from changes in the Company’s Common Stock price during the respective quarter.

Previous wording

During the six months ended June 30, 2026, the change in the fair value of the Company’s warrant liabilities resulted in a loss of $290,195 compared to a loss of $4,024,209 during the six months ended June 30, 2025. For both periods, the change in fair value primarily resulted from changes in the Company’s stock price during the respective period.

Current wording

During the nine months ended September 30, 2026, the change in the fair value of the Company’s warrant liabilities resulted in a loss of $1,813,588 compared to a loss of $352,451 during the nine months ended September 30, 2025. For both periods, the change in fair value primarily resulted from changes in the Company’s Common Stock price during the respective period.

Previous wording

The Company uses various valuation models to estimate the fair value of its warrant liabilities. These models require the input of subjective assumptions including the expected term of the warrants and the expected volatility of the Company’s stock price during this term. Changes in the input assumptions can materially affect the fair value estimate and the Company’s net loss and liabilities.

Current wording

The Company uses various valuation models to estimate the fair value of its warrant liabilities. These models require the input of subjective assumptions including the expected term of the warrants and the expected volatility of the Company’s Common Stock price during this term. Changes in the input assumptions can materially affect the fair value estimate and the Company’s net loss and liabilities.

Previous wording

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 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 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.

Current wording

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 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 Common Stock, and possibly other non-dilutive financing options to finance its ongoing operations and 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.

Previous wording

We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we continue the commercialization of ZUNVEYL, following the start of sales in the first quarter of 2025, and potentially seek to discover and develop additional product candidates, conduct our ongoing and planned clinical trials and preclinical studies, continue our R&D activities, utilize third parties to manufacture ZUNVEYL, hire additional personnel, expand and protect our intellectual property, and incur additional costs associated with being a public company.

Current wording

We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we continue the commercialization of ZUNVEYL, following the start of sales in the first quarter of 2025, and potentially seek to discover and develop additional product candidates, conduct our ongoing and planned clinical trials and pre-clinical studies, continue our R&D activities, utilize third parties to manufacture ZUNVEYL, hire additional personnel, expand and protect our intellectual property, and incur additional costs associated with being a public company.

Previous wording

Based upon our current operating plan, we estimate that our existing cash and cash equivalents as of the date of this filing, will be sufficient to fund our projected base ongoing operating expenses, commercialization costs of ZUNVEYL in AD, ongoing CMC costs, pre-clinical formulation and study R&D work, and ongoing operating costs and capital expenditures through at least the next 12 months. We may choose to raise additional capital to continue to further advance our commercialization plans and ongoing operating costs. However, we may have based our estimates on assumptions that may prove to be wrong, and our operating plan may change as a result of many factors currently unknown to us. In addition, we could utilize our available capital resources sooner than we expected. The Company may also contemplate raising additional capital by pursuing both dilutive and non-dilutive strategic sources of capital to fully execute its commercial, R&D, and operating plans for ZUNVEYL. Any additional capital would further support our R&D and commercial activities related to U.S. sales of ZUNVEYL in AD.

Current wording

Based upon our current operating plan, we estimate that our existing cash and cash equivalents as of the date of this filing, will be sufficient to fund our projected base ongoing operating expenses, commercialization costs of ZUNVEYL in AD, ongoing chemistry, manufacturing, and control(s) (“CMC”) costs, pre-clinical formulation and study R&D work, and ongoing operating costs and capital expenditures through at least the next 12 months. We may choose to raise additional capital to continue to further advance our commercialization plans and ongoing operating costs. However, we may have based our estimates on assumptions that may prove to be wrong, and our operating plan may change as a result of many factors currently unknown to us. In addition, we could utilize our available capital resources sooner than we expected. The Company may also contemplate raising additional capital by pursuing both dilutive and non-dilutive strategic sources of capital to fully execute its commercial, R&D, and operating plans for ZUNVEYL. Any additional capital would further support our R&D and commercial activities related to U.S. sales of ZUNVEYL in AD.

Previous wording

Until such time 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 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.

Current wording

Until such time 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 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, engaging in acquisitions, merger or collaboration transactions, selling or licensing our assets, making capital expenditures, redeeming our Common 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.