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Alpha Cognition Inc.

Alpha Cognition Inc.ACOGEarnings & Financial Report

Nasdaq · Health Care · Biological Products, (No Diagnostic Substances)

What changed in Alpha Cognition Inc.'s 10-K — 2024 vs 2025

Top changes in Alpha Cognition Inc.'s 2025 10-K

498 paragraphs added · 579 removed · 384 edited across 6 sections

Item 1. Business

Business — how the company describes what it does

127 edited+22 added−21 removed220 unchanged
Indicated for mild-to-moderate and moderate-to-severe stages of Alzheimer’s disease 3) Galantamine (marketed under the brand names Reminyl and Razadyne/Razadyn ER by Janssen) a. Approved in 2001, 2004; generic b. Acetylcholinesterase inhibitor drug class, oral BID medication c. Indicated for mild-to-moderate stage of Alzheimer’s disease 4) Donepezil transdermal system (marketed under the brand name Adlarity by Corium) a.
Indicated for mild-to-moderate and moderate-to-severe stages of Alzheimer’s disease 3) Galantamine (marketed under the brand names Reminyl and Razadyne/Razadyn ER by Janssen) a. Approved in 2001, 2004; generic b. Acetylcholinesterase inhibitor drug class, oral BID medication c. Indicated for mild-to-moderate stage of Alzheimer’s disease 4 4) Donepezil transdermal system (marketed under the brand name Adlarity by Corium) a.
The NDA and patent holders may then initiate a patent infringement lawsuit in response to the notice of the paragraph IV certification.
The NDA and patent holders may then initiate a patent infringement lawsuit in response to the notice of paragraph IV certification.
Implications of Being a Smaller Reporting Company Rule 12b-2 of the Exchange Act defines a “smaller reporting company” as an issuer that is not an investment company, an asset-backed issuer, or a majority-owned subsidiary of a parent that is not a smaller reporting company and that: ● had a public float of less than $250 million as of the last business day of its most recently completed second fiscal quarter, computed by multiplying the aggregate worldwide number of shares of its voting and non-voting common equity held by non-affiliates by the price at which the common equity was last sold, or the average of the bid and asked prices of common equity, in the principal market for the common equity; or ● in the case of an initial registration statement under the Securities Act, or the Exchange Act of 1934, as amended, which we refer to as the Exchange Act, for shares of its common equity, had a public float of less than $250 million as of a date within 30 days of the date of the filing of the registration statement, computed by multiplying the aggregate worldwide number of such shares held by non-affiliates before the registration plus, in the case of a Securities Act registration statement, the number of such shares included in the registration statement by the estimated initial public offering price of the shares; or ● in the case of an issuer whose public float as calculated under the previous two bullet points was zero or less than $700 million, had annual revenues of less than $100 million during the most recently completed fiscal year for which audited financial statements are available.
Implications of Being a Smaller Reporting Company Rule 12b-2 of the Exchange Act defines a “smaller reporting company” as an issuer that is not an investment company, an asset-backed issuer, or a majority-owned subsidiary of a parent that is not a smaller reporting company and that: ● had a public float of less than $250 million as of the last business day of its most recently completed second fiscal quarter, computed by multiplying the aggregate worldwide number of shares of its voting and non-voting common equity held by non-affiliates by the price at which the common equity was last sold, or the average of the bid and asked prices of common equity, in the principal market for the common equity; or ● in the case of an initial registration statement under the Securities Act, or the Exchange Act of 1934, as amended, which we refer to as the Exchange Act, for stock of its common equity, had a public float of less than $250 million as of a date within 30 days of the date of the filing of the registration statement, computed by multiplying the aggregate worldwide number of such stock held by non-affiliates before the registration plus, in the case of a Securities Act registration statement, the number of such shares included in the registration statement by the estimated initial public offering price of the sstock; or ● in the case of an issuer whose public float as calculated under the previous two bullet points was zero or less than $700 million, had annual revenues of less than $100 million during the most recently completed fiscal year for which audited financial statements are available.
The Company elected to conduct this additional study which was designed to demonstrate pharmacokinetic (PK) equivalence between ALPHA-1062 5mg delayed release oral tablets and 8 mg galantamine hydrobromide extended release capsules, when dosed to steady state. Bioequivalence appeared to be established based on total drug exposure (AUC) and the Cmax was expectedly higher than that of the extended release reference.
The Company elected to conduct this additional study which was designed to demonstrate PK equivalence between ALPHA-1062 5mg delayed release oral tablets and 8 mg galantamine hydrobromide extended release capsules, when dosed to steady state. Bioequivalence appeared to be established based on total drug exposure (AUC) and the Cmax was expectedly higher than that of the extended release reference.
If a biological product designated as an orphan product receives marketing approval for an indication broader than what is designated, it may not be entitled to orphan product exclusivity. Expedited Development and Review Programs The FDA has a fast track designation program that is intended to expedite or facilitate the process for reviewing new drug products that meet certain criteria.
If a biological product designated as an orphan product receives marketing approval for an indication broader than what is designated, it may not be entitled to orphan product exclusivity. 23 Expedited Development and Review Programs The FDA has a fast track designation program that is intended to expedite or facilitate the process for reviewing new drug products that meet certain criteria.
Decreases in third-party reimbursement for any product or a decision by a third-party payor not to cover a product could reduce physician usage and patient demand for the product. At the state level, there are also new laws and ongoing ballot initiatives that create additional pressure on drug pricing and may affect how pharmaceutical products are covered and reimbursed.
Decreases in third-party reimbursement for any product or a decision by a third-party payor not to cover a product could reduce physician usage and patient demand for the product. 28 At the state level, there are also new laws and ongoing ballot initiatives that create additional pressure on drug pricing and may affect how pharmaceutical products are covered and reimbursed.
Approved in 2022, branded transdermal patch b. Acetylcholinesterase inhibitor drug class, once-weekly transdermal system c. Indicated for mild-to-moderate and moderate-to-severe stages of Alzheimer’s disease 10 5) Benzgalantamine (marketed under the brand name ZUNVEYL by Alpha Cognition) a. Approved in 2024, commercially available in Q1 2025 b. Acetylcholinesterase inhibitor drug class, oral BID medication c.
Approved in 2022, branded transdermal patch b. Acetylcholinesterase inhibitor drug class, once-weekly transdermal system c. Indicated for mild-to-moderate and moderate-to-severe stages of Alzheimer’s disease 5) Benzgalantamine (marketed under the brand name ZUNVEYL by Alpha Cognition) a. Approved in 2024, commercially available in Q1 2025 b. Acetylcholinesterase inhibitor drug class, oral BID medication c.
In addition, orphan drug exclusivity, as described above, may offer a seven-year period of marketing exclusivity, except in certain circumstances. 25 Other Healthcare Laws Pharmaceutical manufacturers are subject to additional healthcare laws, regulation, and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which they conduct their business.
In addition, orphan drug exclusivity, as described above, may offer a seven-year period of marketing exclusivity, except in certain circumstances. Other Healthcare Laws Pharmaceutical manufacturers are subject to additional healthcare laws, regulation, and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which they conduct their business.
The Company’s phone number is 1-858-344-4375. The Company’s website is www.alphacognition.com . Information contained on the Company’s website is not incorporated into this Annual Report. 29 Competition We face substantial competition from multiple sources, including large and specialty biotechnology and pharmaceutical companies, academic research institutions and governmental agencies and public and private research institutions.
The Company’s phone number is 1-858-344-4375. The Company’s website is www.alphacognition.com . Information contained on the Company’s website is not incorporated into this Annual Report. Competition We face substantial competition from multiple sources, including large and specialty biotechnology and pharmaceutical companies, academic research institutions and governmental agencies and public and private research institutions.
Notwithstanding the submission of any requested additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval. After the FDA evaluates an NDA, it will issue an approval letter or a Complete Response Letter. An approval letter authorizes commercial marketing of the drug with prescribing information for specific indications.
Notwithstanding the submission of any requested additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval. 22 After the FDA evaluates an NDA, it will issue an approval letter or a Complete Response Letter. An approval letter authorizes commercial marketing of the drug with prescribing information for specific indications.
The Company has completed sufficient planning and launched ZUNVEYL on March 19 th , 2025 using a specialty sales force that focuses on LTC physicians in the U.S. LTC physicians who treat elderly patients that reside in nursing homes also make pharmacologic decisions in concert with the LTC treatment team.
The Company has completed sufficient planning and launched ZUNVEYL on March 19, 2025 using a specialty sales force that focuses on LTC physicians in the U.S. LTC physicians who treat elderly patients that reside in nursing homes also make pharmacologic decisions in concert with the LTC treatment team.
We cannot predict whether any proposed legislation will become law and the effect of these possible changes on our business cannot be predicted at this time. 28 Specialized Skill and Knowledge The development of pharmaceutical products is a complex undertaking which requires many diverse skill sets.
We cannot predict whether any proposed legislation will become law and the effect of these possible changes on our business cannot be predicted at this time. Specialized Skill and Knowledge The development of pharmaceutical products is a complex undertaking which requires many diverse skill sets.
Alpha Cognition remains focused on optimizing patient access and formulary positioning to drive adoption and long-term revenue growth Competitive Conditions and ZUNVEYL Positioning Alzheimer’s disease symptomatic treatments are currently limited and perceived to provide limited symptom improvement and cause difficult to manage tolerability side effects.
Alpha Cognition remains focused on optimizing patient access and formulary positioning to drive adoption and long-term revenue growth. 3 Competitive Conditions and ZUNVEYL Positioning Alzheimer’s disease symptomatic treatments are currently limited and perceived to provide limited symptom improvement and cause difficult-to-manage tolerability side effects.
As a result, the Supreme Court did not rule on the constitutionality of the ACA or any of its provisions. There may be other efforts to challenge, repeal, or replace the ACA. If successful, such efforts may potentially impact our business in the future. President Joseph R.
As a result, the Supreme Court did not rule on the constitutionality of the ACA or any of its provisions. There may be other efforts to challenge, repeal, or replace the ACA. If successful, such efforts may potentially impact our business in the future. 29 President Joseph R.
Generally, before a new drug can be marketed, considerable data must be generated, which demonstrate the drug’s quality, safety, and efficacy. Such data must then be organized into a format specific for each regulatory authority, submitted for review and approved by the regulatory authority. U.S.
Generally, before a new drug can be marketed, considerable data must be generated, which demonstrate the drug’s quality, safety, and efficacy. Such data must then be organized into a format specific for each regulatory authority, submitted for review and approved by the regulatory authority. 20 U.S.
However, companies may share truthful and not misleading information that is otherwise consistent with a product’s FDA-approved labelling. 505(b)(2) NDAs The FDA is authorized to approve an alternative type of NDA under Section 505(b)(2) of the FDCA.
However, companies may share truthful and not misleading information that is otherwise consistent with a product’s FDA-approved labelling. 25 505(b)(2) NDAs The FDA is authorized to approve an alternative type of NDA under Section 505(b)(2) of the FDCA.
On average 40% of the final years of an Alzheimer’s disease patients (ages 70 to 80 years old) will be spent in the severe stage and the nature of the symptoms leads to the vast majority being admitted into a LTC facility.
On average 40% of the final years of Alzheimer’s disease patients (ages 70 to 80 years old) will be spent in the severe stage and the nature of the symptoms leads to the vast majority being admitted into a LTC facility.
Depending on the individual risk factors, time of diagnosis, and other factors, the length of time a patient is within each stage of the continuum will vary greatly. Alzheimer’s disease symptoms affect the whole patient: mind, body and behavior/personality.
Depending on the individual risk factors, time of diagnosis, and other factors, the length of time a patient is within each stage of the continuum will vary greatly. 8 Alzheimer’s disease symptoms affect the whole patient: mind, body and behavior/personality.
The Company exercised a reversion of rights for ALPHA-1062 for TBI, pancreatitis, and related conditions in January and has brought ALPHA-1062 Intranasal for mTBI and related conditions, ALPHA-1062 for Acute pancreatitis back to the Company to develop both compounds for said conditions. 1 Our Strategy The Company’s principal business objectives are to: 1) Obtain commercial success with the newly FDA-approved ZUNVEYL delayed release oral tablet formulation indicated for the treatment of mild to moderate dementia of the Alzheimer’s type in adults (Alzheimer’s disease).
The Company exercised a reversion of rights for ALPHA-1062 for TBI, pancreatitis, and related conditions in January 2025 and has brought ALPHA-1062 for mTBI and related conditions, ALPHA-1062 for Acute pancreatitis back to the Company to develop both compounds for said conditions. 1 Our Strategy The Company’s principal business objectives are to: 1) Obtain commercial success with the newly FDA-approved ZUNVEYL delayed release oral tablet formulation indicated for the treatment of mild to moderate dementia of the Alzheimer’s type in adults (Alzheimer’s disease).
Prescribing habits within long-term care physicians, seem to be well entrenched, and overall, physicians report feeling dissatisfied and/or apathetic about their symptomatic treatment options. Caregivers also expresses dissatisfaction with the currently approved symptomatic treatments options. Our solution: ZUNVEYL There is a significant unmet need for better treatment options for patients suffering from Alzheimer’s disease.
Prescribing habits within long-term care physicians seem to be well entrenched, and overall, physicians report feeling dissatisfied and/or apathetic about their symptomatic treatment options. Caregivers also express dissatisfaction with the currently approved symptomatic treatments options. Our solution: ZUNVEYL There is a significant unmet need for better treatment options for patients suffering from Alzheimer’s disease.
Common cognitive symptoms are memory loss, learning decline, challenges planning or solving problems, forming words/speaking and confusion with places or time. As symptoms become more severe, they affect daily activities, such as the ability going to the bathroom, eating and swallowing, drinking, and overall mobility. Alzheimer’s disease progresses within each person differently.
Common cognitive symptoms are memory loss, learning decline, challenges planning or solving problems, forming words/speaking and confusion with places or time. As symptoms become more severe, they affect daily activities, such as the ability to go to the bathroom, eating and swallowing, drinking, and overall mobility. Alzheimer’s disease progresses within each person differently.
DOI 10.1002/alz.13016. 2 Alzheimer’s disease symptomatic treatments are currently limited and perceived to provide limited symptom improvement and cause difficult to manage tolerability side effects. Symptomatic treatments are designed to improve the ability to learn, remember data, and function normally with daily tasks like toileting, cooking, or home care.
DOI 10.1002/alz.13016. 7 Alzheimer’s disease symptomatic treatments are currently limited and perceived to provide limited symptom improvement and cause difficult-to-manage tolerability side effects. Symptomatic treatments are designed to improve the ability to learn, remember data, and function normally with daily tasks like toileting, cooking, or home care.
CMS will be responsible for the regulatory, development, manufacturing, and commercialization of ZUNVEYL in the licensed territories. On January 14, 2025, the Company announced the strategic appointments of Jen Pesa, Vice President of Commercial; Jack Kelly, Head of Market Access; Rommel Fernandez, Vice President of Corporate Strategy and Operations; and Kurt Grady, Vice President of Medical Affairs.
CMSI will be responsible for the regulatory, development, manufacturing, and commercialization of ZUNVEYL in the licensed territories. On January 14, 2025, the Company announced the strategic appointments of Jen Pesa, Vice President of Commercial; Jack Kelly, Head of Market Access; Rommel Fernandez, Vice President of Corporate Strategy and Operations; and Kurt Grady, Vice President of Medical Affairs.
The CCPA requires covered companies to provide new disclosure to consumers about such companies’ data collection, use and sharing practices, provide such consumers new ways to opt-out of certain sales or transfers of personal information, and provide consumers with additional causes of action. Under the CCPA the California Attorney General may bring enforcement actions for violations of the CCPA.
The CCPA requires covered companies to provide new disclosures to consumers about such companies’ data collection, use and sharing practices, provide such consumers with new ways to opt-out of certain sales or transfers of personal information, and provide consumers with additional causes of action. Under the CCPA the California Attorney General may bring enforcement actions for violations of the CCPA.
On July 26, 2024, the Company received this FDA approval. The Company will now focus on the development of commercial manufacturing and commercial sales of ZUNVEYL oral tablet formulation. Even though ZUNVEYL was approved, it may not achieve commercial success. The Company hired its Commercial team, and 32 person salesforce in the first quarter 2025.
On July 26, 2024, the Company received this FDA approval. The Company will now focus on the development of commercial manufacturing and commercial sales of ZUNVEYL oral tablet formulation. Even though ZUNVEYL was approved, it may not achieve commercial success. The Company hired its commercial team, and salesforce in the first quarter 2025.
The official commercial launch was announced on March 19 th , 2025 and ZUNVEYL is now available by prescription in pharmacies nationwide.
The official commercial launch was announced on March 19, 2025 and ZUNVEYL is now available by prescription in pharmacies nationwide.
In the United States two patents are granted in this patent family that cover the corresponding method of treatment claims, one of which is directed to nasal administration of ALPHA-1062. A patent term extension (PTE) of U.S. 9,763,953 has been filed to potentially extend the term of this granted patent.
In the United States two patents are granted in this patent family that cover the corresponding method of treatment claims, one of which is directed to nasal administration. A patent term extension (PTE) of U.S. 9,763,953 has been filed to potentially extend the term of this granted patent.
Neurologists/Psychiatrists prescribe 27% of all Alzheimer’s disease Rxs and due to the large Alzheimer’s disease afflicted population within LTC facilities, these physicians prescribe 36% of the total Rxs. 4 Alzheimer’s disease caregivers carry a heavy burden People suffering from Alzheimer’s disease are not relegated only to the patients.
Neurologists/Psychiatrists prescribe 27% of all Alzheimer’s disease Rxs and due to the large Alzheimer’s disease afflicted population within LTC facilities, these physicians prescribe 36% of the total Rxs. 9 Alzheimer’s disease caregivers carry a heavy burden People suffering from Alzheimer’s disease are not relegated only to the patients.
Terms of the agreement total $44 million, which includes $6 million in total upfront payments split into tranches and development and commercial milestone payments. Additionally, ACI is eligible to receive royalties on net sales of ZUNVEYL in Asia (excluding Japan), Australia and New Zealand.
Terms of the agreement total $44 million, which includes $3 million in total upfront payments split into tranches and development and commercial milestone payments. Additionally, ACI is eligible to receive royalties on net sales of ZUNVEYL in Asia (excluding Japan), Australia and New Zealand.
Some studies state distress remains unchanged or even increases after a relative is admitted to a residential care facility. 5 Alzheimer’s disease was officially listed as the sixth-leading cause of death in the United States in 2019.
Some studies state distress remains unchanged or even increases after a relative is admitted to a residential care facility. 10 Alzheimer’s disease was officially listed as the sixth-leading cause of death in the United States in 2019.
Single-dose administration of ALPHA-1062 delayed release oral tablet formulation was well tolerated with no adverse events reported. 7 BABE Study vs. Extended Release During August 2022, the Company announced results from an additional bioequivalence study with ALPHA-1062.
Single-dose administration of ALPHA-1062 delayed release oral tablet formulation was well tolerated with no adverse events reported. 12 BABE Study vs. Extended Release During August 2022, the Company announced results from an additional bioequivalence study with ALPHA-1062.
ALPHA-1062IN significantly: ● Acutely limited the extent of motor deficit. ● Improved motor and sensory functional recovery measured by motor skill assessment, sensory/motor skill assessment, and Modified Neurological Severity Score which comprises motor, sensory, balance and reflex assessment. ● Improved cognitive functional recovery measured by tests which assess recognition memory, and spatial learning and memory.
ALPHA-1062 significantly: ● Acutely limited the extent of motor deficit. ● Improved motor and sensory functional recovery measured by motor skill assessment, sensory/motor skill assessment, and Modified Neurological Severity Score which comprises motor, sensory, balance and reflex assessment. ● Improved cognitive functional recovery measured by tests which assess recognition memory, and spatial learning and memory.
Two drug products are recognized to be bioequivalent if the 90% confidence interval of the ratio of geometric means of the primary pharmacokinetic (PK) responses (after log-transformation) is within the bioequivalence limits of 80% and 125%. A secondary objective of the studies was to evaluate the safety and tolerability of single-dose administration of ALPHA-1062 5mg delayed release oral tablet formulation.
Two drug products are recognized to be bioequivalent if the 90% confidence interval of the ratio of geometric means of the primary pharmacokinetic (“PK”) responses (after log-transformation) are within the bioequivalence limits of 80% and 125% A secondary objective of the studies was to evaluate the safety and tolerability of single-dose administration of ALPHA-1062 5mg delayed release oral tablet formulation.
Our other pre-clinical assets include ALPHA-0602 and ALPHA-0702 & ALPHA-0802 (Progranulin and Progranulin GEM’s), which are expressed in several cell types in the central nervous system and in peripheral tissues, promotes cell survival, regulates certain inflammatory processes, and play a significant role in regulating lysosomal function and microglial responses to disease.
Our other pre-clinical assets previously included ALPHA-0602 and ALPHA-0702 & ALPHA-0802 (Progranulin and Progranulin GEM’s), which are expressed in several cell types in the central nervous system and in peripheral tissues, promotes cell survival, regulates certain inflammatory processes, and play a significant role in regulating lysosomal function and microglial responses to disease.
Indicated for mild-to-moderate stage of Alzheimer’s disease The FDA approved Aducanumab (marketed under the branded name Adulhelm by Biogen) in 2021 and lecanemab (marketed under the branded name Leqembi by Easai) for mild-to-moderate Alzheimer’s disease.
Indicated for mild-to-moderate stage of Alzheimer’s disease The FDA approved Aducanumab (marketed under the branded name Adulhelm by Biogen) in 2021 and lecanemab (marketed under the branded name Leqembi by Eisai) for mild-to-moderate Alzheimer’s disease.
We will need to seek and obtain regulatory approval through the processes in each of the above mentioned jurisdictions, which will take additional time and resource.
We will need to seek and obtain regulatory approval through the processes in each of the above-mentioned jurisdictions, which will take additional time and resources.
There were minimal adverse events ( 6 The following table summarizes the results of each of the two ZUNVEYL, formerly known as ALPHA-1062 delayed release oral tablet formulation, Pivotal Studies (fed and fasted) — Bioequivalence/Bioavailability (“BABE”) Study vs. Immediate Release (“IR”) (completed in June 2022) and an additional BABE Study vs. Extended Release (“ER”) (completed in August 2022).
There were minimal adverse events ( The following table summarizes the results of each of the two ZUNVEYL, formerly known as ALPHA-1062 delayed release oral tablet formulation, Pivotal Studies (fed and fasted) — Bioequivalence/Bioavailability (“BABE”) Study vs. Immediate Release (“IR”) (completed in June 2022) and an additional BABE Study vs.
It is expected that coverage and utilization may be better for Leqembi than Adulhelm, but this will only be apparent after several quarters of commercialization. It is important to note that DMT agents will not be a competitor to the current standard of care, the AChEI class.
Leqembi is indicated for the treatment of Alzheimer’s disease. It is expected that coverage and utilization may be better for Leqembi than Adulhelm, but this will only be apparent after several quarters of commercialization. It is important to note that DMT agents will not be a competitor to the current standard of care, the AChEI class.
Any agency or judicial enforcement action could have a material adverse effect on us. 19 The process required by the FDA before a drug may be marketed in the United States generally involves the following: ● completion of nonclinical laboratory tests, animal studies, and formulation studies in accordance with FDA’s good laboratory requirements and other applicable regulations; ● submission to the FDA of an IND, which must become effective before human clinical trials may begin; ● approval by an independent Institutional Review Board ethics committee, either centralized or with respect to each clinical site, before each clinical trial may be initiated; ● performance of adequate and well-controlled human clinical trials in accordance with GCP requirements to establish the safety and efficacy of the proposed drug for its intended use; ● submission to the FDA of an NDA after completion of all pivotal trials; ● determination by the FDA within 60 days of its receipt of an NDA to accept the filing for substantive review; ● satisfactory completion of an FDA advisory committee review, if applicable; ● satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the drug is produced to assess compliance with current good manufacturing practice (“cGMP”) requirements to ensure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality, and purity, and of selected clinical investigation sites to assess compliance with GCP; ● FDA review and approval of the NDA to permit commercial marketing of the product for particular indications for use in the United States; ● compliance with any post-approval requirements, including potential requirements to conduct any post-approval studies required by the FDA or the potential requirement to implement risk evaluation and mitigation strategies (“REMS”); and ● compliance with the United States Pediatric Research Equity Act of 2003 (“PREA”), which requires either exemption from the requirements or may require conducting clinical research in a pediatric population.
The process required by the FDA before a drug may be marketed in the United States generally involves the following: ● completion of nonclinical laboratory tests, animal studies, and formulation studies in accordance with FDA’s good laboratory requirements and other applicable regulations; ● submission to the FDA of an IND, which must become effective before human clinical trials may begin; ● approval by an independent Institutional Review Board ethics committee, either centralized or with respect to each clinical site, before each clinical trial may be initiated; ● performance of adequate and well-controlled human clinical trials in accordance with GCP requirements to establish the safety and efficacy of the proposed drug for its intended use; ● submission to the FDA of an NDA after completion of all pivotal trials; ● determination by the FDA within 60 days of its receipt of an NDA to accept the filing for substantive review; ● satisfactory completion of an FDA advisory committee review, if applicable; ● satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the drug is produced to assess compliance with current good manufacturing practice (“cGMP”) requirements to ensure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality, and purity, and of selected clinical investigation sites to assess compliance with GCP; ● FDA review and approval of the NDA to permit commercial marketing of the product for particular indications for use in the United States; ● compliance with any post-approval requirements, including potential requirements to conduct any post-approval studies required by the FDA or the potential requirement to implement risk evaluation and mitigation strategies (“REMS”); and ● compliance with the United States Pediatric Research Equity Act of 2003 (“PREA”), which requires either exemption from the requirements or may require conducting clinical research in a pediatric population. 21 During the development of a new drug, sponsors are given opportunities to meet with the FDA at certain points.
Primary endpoints of these studies were to evaluate bioavailability and bioequivalence by comparative measurements of peak plasma concentration (Cmax), and area under the plasma concentration-time curve from time zero to infinity (AUC0-inf.). Secondary endpoints were to measure adverse events and safety outcomes. Thirty-six healthy subjects were enrolled in each trial.
Primary endpoints of these studies were to evaluate bioavailability and bioequivalence by comparative measurements of peak plasma concentration (“Cmax”), and area under the plasma concentration-time curve from time zero to infinity (“AUC0-inf”). Secondary endpoints were to measure adverse events and safety outcomes. Thirty-six healthy subjects were enrolled in each trial.
Our research has indicated that the acetylcholinesterase inhibitor (AChEI) prescription market in the U.S. from the LTC market is large, representing 36% of the over 11 million prescriptions filled in pharmacies each year. The AChEI class includes Aricept, Exelon, Exelon Patch, Razadyne, Adlarity, Namzaric, and generic versions of the AChEIs.
Third party prescribing data has indicated that the acetylcholinesterase inhibitor (AChEI) prescription market in the U.S. from the LTC market is large, representing 36% of the over 11 million prescriptions filled in pharmacies each year. The AChEI class includes Aricept, Exelon, Exelon Patch, Razadyne, Adlarity, Namzaric, and generic versions of the AChEIs.
The Company expects to initiate the additional pre-clinical toxicity and manufacturing work in the future. The Company would then be in the position to file an IND for ALPHA-1062IN. In December 2021, the Company announced functional data from an animal study under the ALPHA-1062 TBI program.
The Company expects to initiate the additional pre-clinical toxicity and manufacturing work in the future. The Company would then be in the position to advanceALPHA-1062. In December 2021, the Company announced functional data from an animal study under the ALPHA-1062 TBI program.
The formulation is in early development stages and further development will be contingent upon the Company obtaining additional capital resources through financing and further alignment with the FDA on the scope and requirements of a development program. Traumatic Brain Injury: ALPHA-1062 Intranasal Formulation mTBI: The Company has completed a pre-clinical study of ALPHA-1062IN in mTBI.
The formulation is in early development stages and further development will be contingent upon the Company obtaining additional capital resources through financing and further alignment with the FDA on the scope and requirements of a development program. 15 ALPHA-1062 mTBI: The Company has completed a pre-clinical study of ALPHA-1062 in mTBI.
On January 8, 2025, the Company announced an exclusive licensing agreement with China Medical System Holdings Limited (CMS) for the development, manufacturing and commercialization of ZUNVEYL (benzgalantamine) in Asia (excluding Japan), Australia and New Zealand. ZUNVEYL is a next generation acetylcholinesterase inhibitor approved in the US for the treatment of mild-to-moderate Alzheimer’s disease.
On January 8, 2025, the Company announced an exclusive licensing agreement with CMS International Development and Management Limited (“CMSI”) for the development, manufacturing and commercialization of ZUNVEYL (benzgalantamine) in Asia (excluding Japan), Australia and New Zealand. ZUNVEYL is a next generation acetylcholinesterase inhibitor approved in the US for the treatment of mild-to-moderate Alzheimer’s disease.
We have included our website address as an inactive textual reference only. 31
We have included our website address as an inactive textual reference only. 33
Jurisdiction Patent/Application number Status Estimated Expiry Date (20-year term) United States US 11,795,176 18/463,157 Granted Pending Continuation (Allowed) 01/13/2042 Europe 21152317.0 22738869.1 Priority Pending Pending 01/13/2042 Singapore 11202304626U Pending 01/13/2042 Russia 2023121087 Pending 01/13/2042 Mexico MX/a/2023/008276 Pending 01/13/2042 Korea 10-2023-7024970 Pending 01/13/2042 Japan 2023-565641 Pending 01/13/2042 Israel 303907 Pending 01/13/2042 China 2022800098271 Pending 01/13/2042 62024086161.2 Pending 01/13/2042 Hong Kong 62024091747.1 Pending 01/13/2042 Canada 3,205,859 Pending 01/13/2042 Brazil BR 11 2023 013926 0 Pending 01/13/2042 Australia 2022208641 Pending 01/13/2042 This invention is based on the discovery and isolation of multiple unique crystalline forms of the ALPHA-1062 gluconate salt.
Jurisdiction Patent/Application number Status Estimated Expiry Date (20-year term) United States 11,795,176 12,157,743 18/965,776 19/247,344 Granted Granted Pending Pending 01/13/2042 Europe 22738869.1 Pending 01/13/2042 Singapore 11202304626U Pending 01/13/2042 Russia 2023121087 Pending 01/13/2042 Mexico MX/a/2023/008276 Pending 01/13/2042 Korea 10-2023-7024970 Pending 01/13/2042 Japan 2023-565641 Pending 01/13/2042 Israel 303907 Pending 01/13/2042 China 2022800098271 Pending 01/13/2042 Hong Kong 62024086161.2 Pending 01/13/2042 62024091747.1 Pending 01/13/2042 Canada 3,205,859 Pending 01/13/2042 Brazil BR 11 2023 013926 0 Pending 01/13/2042 Australia 2022208641 Pending 01/13/2042 This invention is based on the discovery and isolation of multiple unique crystalline forms of the ALPHA-1062 gluconate salt.
The Company is encouraged by the preclinical data and met with the FDA in Q2 2023 to discuss IND submission and gain alignment with FDA on further clinical plans.
The Company is encouraged by the preclinical data and met with the FDA in Q2 2023 to discuss program advancement and gain alignment with FDA on further clinical plans.
BABE Study vs. Immediate Release The primary objective of both the fed and fasted studies was to evaluate the relative bioavailability of a single-dose of ALPHA-1062 (or benzgalantamine) 5mg delayed release oral tablet formulation compared to galantamine hydrobromide tablet 4mg immediate release — the reference drug.
Extended Release (“ER”) (completed in August 2022). 11 BABE Study vs. Immediate Release The primary objective of both the fed and fasted studies was to evaluate the relative bioavailability of a single-dose of ALPHA-1062 (or benzgalantamine) 5mg delayed release oral tablet formulation compared to galantamine hydrobromide tablet 4mg immediate release — the reference drug.
Adulhelm was the first disease modifying treatment (DMT), but due to several issues associated with the drug, including CMS restricting overage, it was not easily accessible and was only covered for qualified clinical trial patients. Biogen has announced that it is discontinuing sale of Adulhelm by the end of 2024. Leqembi is indicated for the treatment of Alzheimer’s disease.
Adulhelm was the first disease modifying treatment (DMT), but due to several issues associated with the drug, including Centers of Medicare and Medicaid Services (“CMS”) restricting overage, it was not easily accessible and was only covered for qualified clinical trial patients. Biogen has announced that it is discontinuing sale of Adulhelm by the end of 2024.
By way of example, the ACA increased the minimum level of Medicaid rebates payable by manufacturers of brand name drugs from 15.1% to 23.1%; it required collection of rebates for drugs paid by Medicaid managed care organizations; imposed a non-deductible annual fee on pharmaceutical manufacturers or importers who sell certain “branded prescription drugs” to specified federal government programs; it implemented a new methodology under which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted, or injected; it expanded the eligibility criteria for Medicaid programs; it created a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research; and it established a Center for Medicare Innovation at the Centers for Medicare & Medicaid Services (“CMS”), to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending. 27 Since its enactment, there have been executive, judicial and Congressional challenges to certain aspects of the ACA, and we expect there will be additional challenges and amendments to the ACA in the future.
By way of example, the ACA increased the minimum level of Medicaid rebates payable by manufacturers of brand name drugs from 15.1% to 23.1%; it required collection of rebates for drugs paid by Medicaid managed care organizations; imposed a non-deductible annual fee on pharmaceutical manufacturers or importers who sell certain “branded prescription drugs” to specified federal government programs; it implemented a new methodology under which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted, or injected; it expanded the eligibility criteria for Medicaid programs; it created a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research; and it established a Center for Medicare Innovation at the CMS, to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending.
The Company may pursue new business opportunities for commercial and/or development partners both domestically and internationally. ● Commercialization - The Company completed commercialization preparations for ZUNVEYL in Q1 2025 and initiated commercialization on March 19 th , 2025.
The Company may pursue new business opportunities for commercial and/or development partners both domestically and internationally. ● Commercialization – The Company completed commercialization preparations for ZUNVEYL in the first quarter of 2025 and initiated commercial launch on March 19, 2025.
These provisions include, but are not limited to: ● being permitted to present only two years of audited financial statements, in addition to any required unaudited interim financial statements, with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure in this prospectus; ● not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended; ● reduced disclosure obligations regarding executive compensation in our periodic reports, proxy statements and registration statements; ● exemption from certain executive compensation disclosure provisions requiring a pay-for-performance graph and CEO pay ratio disclosure; and ● exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved. 30 We elected to take advantage of all of these reduced reporting requirements and exemptions, including the longer phase-in periods for the adoption of new or revised financial accounting standards under §107 of the JOBS Act.
These provisions include, but are not limited to: ● being permitted to present only two years of audited financial statements, in addition to any required unaudited interim financial statements, with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure in this prospectus; ● not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended; ● reduced disclosure obligations regarding executive compensation in our periodic reports, proxy statements and registration statements; ● exemption from certain executive compensation disclosure provisions requiring a pay-for-performance graph and CEO pay ratio disclosure; and ● exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved.
Other potential consequences include, among other things: ● restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls; ● fines, warning letters, or untitled letters; ● clinical holds on post-approval or Phase IV clinical studies, if applicable; ● refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of product license approvals; ● product seizure or detention, or refusal to permit the import or export of products; ● consent decrees, corporate integrity agreements, debarment, or exclusion from federal healthcare programs; and ● mandated modification of promotional materials and labeling and the issuance of corrective information. 23 Under the PREA, an NDA must contain data to assess the safety and efficacy of the applicant product for indications in applicable pediatric populations.
Other potential consequences include, among other things: ● restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls; ● fines, warning letters, or untitled letters; ● clinical holds on post-approval or Phase IV clinical studies, if applicable; ● refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of product license approvals; ● product seizure or detention, or refusal to permit the import or export of products; ● consent decrees, corporate integrity agreements, debarment, or exclusion from federal healthcare programs; and ● mandated modification of promotional materials and labeling and the issuance of corrective information.
Alzheimer’s disease is a significant societal and healthcare burden due to the large and growing at-risk patient population, physician perceived limited effectiveness of current treatments and a shortage of drug innovation.
Alzheimer’s disease is a significant societal and healthcare burden due to the large and growing at-risk patient population, physician perceived limited effectiveness of current treatments and a shortage of drug innovation. Adapted from Alzheimer’s Facts and Figures, 2023, page 30.
Even if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened. We may explore some of these opportunities for our product candidates as appropriate.
Even if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened.
The Company’s commercial development program for ZUNVEYL is primarily focused on building a long term care (“LTC”) commercial team that can focus on providing key points of differentiation, exploiting key issues with existing Acetylcholinesterase inhibitors (“AChEI”) treatments, and seeking potential licensing partners for other additional indications and new formulations.
Our commercial development program for ZUNVEYL is primarily focused on building a long-term care (“LTC”) commercial team that can focus on providing key points of differentiation, exploiting key issues with existing Acetylcholinesterase inhibitors (“AChEI”) treatments, and franchising potential additional indications and new products.
Jurisdiction Patent number Status Expiry Date Canada CA 2,721,007 Granted 04/14/2028 China CN 102007129 Granted 04/14/2028 Europe (11 European Patent Convention member states) EP 2137192 Granted 04/14/2028 United States US 9,763,953 US 10,265,325 Granted Granted 12/1/2026 09/22/2026 In Europe, China and Canada, this patent protects the therapeutic use of ALPHA-1062 to treat a variety of neurodegenerative, psychiatric or neurological diseases with a cholinergic deficit.
Jurisdiction Patent number Status Expiry Date United States US 9,763,953 Granted 12/1/2026 US 10,265,325 Granted 09/22/2026 China CN 102007129 Granted 04/14/2028 In China, this patent protects the therapeutic use of ALPHA-1062 to treat a variety of neurodegenerative, psychiatric or neurological diseases with a cholinergic deficit.
These groups make up 36% of all Rx within the Alzheimer’s disease market. The Company will promote awareness and educate on differentiating features of its marketed treatments The sales force approach will consist of long-term care home materials, peer-to-peer learning programs, partnerships with Alzheimer’s disease and long-term care societies and associations.
The Company will promote awareness and educate on differentiating features of its marketed treatments The sales force approach will consist of long-term care home materials, peer-to-peer learning programs, partnerships with Alzheimer’s disease and long-term care societies and associations.
These sanctions could include the FDA’s refusal to approve pending applications, withdrawal of an approval, a clinical hold, warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement, or civil or criminal penalties.
These sanctions could include the FDA’s refusal to approve pending applications, withdrawal of an approval, a clinical hold, warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement, or civil or criminal penalties. Any agency or judicial enforcement action could have a material adverse effect on us.
Blood Brain Barrier VII (BBB VII): ALPHA-1062 for Treating Post Concussive Syndrome (PCS) Jurisdiction Application number Status Estimated Expiry Date (20-year term) PCT application PCT/CA2024/050691 Pending (not published) 5/24/2044 This invention is based on treating cognitive impairment in patients with persistent post-concussion symptoms (PCS) after TBI, using ALPHA 1062.
Blood Brain Barrier VII (BBB VII): ALPHA-1062 for Treating Post Concussive Syndrome (PCS) (PCT application PCT/CA2024/050691) Jurisdiction Application number Status Estimated Expiry Date (20-year term) Europe EP24809904.6 Pending 5/24/2044 China 2024800336565 Pending 5/24/2044 United States 19/486,720 Pending est. 5/24/2044 This invention is based on treating cognitive impairment in patients with persistent post-concussion symptoms (PCS) after TBI, using ALPHA 1062.
The Company intends to develop a detailed commercialization plan for ZUNVEYL in the United States. The Company also intends to identify pharmaceutical distribution partners to enter the markets in Asia, European Union, and/or LATAM (Mexico, Central and South America).
The Company intends to develop a detailed commercialization plan for ZUNVEYL in the United States. The Company also intends to identify pharmaceutical distribution partners to enter the markets in Asia, European Union, and/or LATAM (Mexico, Central and South America). The Company is in discussions with several pharmaceutical distributors with respect to LATAM and select Asian countries.
The Company has six additional pre-clinical development programs: (1) ZUNVEYL in combination with memantine for the treatment of moderate-to-severe Alzheimer’s disease, (2) ALPHA-1062 sublingual formulation, (3) ALPHA-1062 intranasal (“ALPHA-1062IN”) formulation for the treatment of cognitive impairment with mild traumatic brain injury (mTBI; otherwise known as concussion), (4) ALPHA-0602, and (5) ALPHA-0702 & ALPHA-0802, the latter two programs also referred to as ‘Progranulin’ and ‘Progranulin GEM’s’, respectively, for the treatment of neurodegenerative diseases including amyotrophic lateral sclerosis (ALS) or Lou Gehrig’s disease and spinal muscular atrophy (SMA) , and (6) ALPHA-1062 for the treatment of acute pancreatitis.
We have three additional pre-clinical development programs: ZUNVEYL in combination with memantine for the treatment of moderate-to-severe Alzheimer’s disease, ALPHA-1062 sublingual formulation, ALPHA-1062 sublingual formulation for the treatment of cognitive impairment with mild traumatic brain injury (mTBI; otherwise known as concussion), and ALPHA-0602, ALPHA-0702 & ALPHA-0802, the latter two programs 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).
Adapted from Alzheimer’s Facts and Figures, 2023, page 30 3 Symptoms There are 5 main stages of severity on the Alzheimer’s disease continuum, which are defined by brain changes and the resulting symptoms that affect a patient’s daily life.
Symptoms There are 5 main stages of severity on the Alzheimer’s disease continuum, which are defined by brain changes and the resulting symptoms that affect a patient’s daily life.
The Company believes that we can differentiate ZUNVEYL based on several potential advantages to Alzheimer’s disease patients: ● Established efficacy of galantamine with cognitive and functional improvement results ● Clinical data published in Neurology in April 2021, supports significant risk reduction in risk of developing severe dementia and strongest effect on cognition ● Dual mechanism of action, enhancing the acetylcholine levels and nicotinic receptor sensitivity ● Enteric-coated tablet that passes through the GI tract as an inactive compound to potentially minimize GI side effects ((nausea, vomiting, and diarrhea)) ● No incidence of insomnia in the FDA approved label for ZUNVEYL According to primary market research conducted by and for the Company, including a report prepared by a third-party paid for by the Company in October 2021, we believe the market research confirms that based on the product attributes listed above, 88% of LTC prescribers are likely to prescribe ZUNVEYL, with a 29% preference share.
The Company believes that we can differentiate ZUNVEYL based on several potential advantages to Alzheimer’s disease patients: ● Established efficacy of galantamine with cognitive, behavioral symptom and functional improvement results ● Clinical data published in Neurology in April 2021, supports significant risk reduction in risk of developing severe dementia and strongest effect on cognition ● Dual mechanism of action, enhancing the acetylcholine levels and nicotinic receptor sensitivity ● Enteric-coated tablet that passes through the GI tract as an inactive compound to potentially minimize GI side effects (nausea, vomiting, and diarrhea) ● No incidence of insomnia in the FDA approved label for ZUNVEYL According to primary market research conducted by and for the Company, including a report prepared by a third-party paid for by the Company in October 2021, we believe the market research confirms that based on the product attributes listed above, 88% of LTC prescribers are likely to prescribe ZUNVEYL, with a 29% preference share. 6 ZUNVEYL, also known as ALPHA-1062 Delayed Release Oral Tablet Formulation, Manufacturing With respect to the manufacturing of ZUNVEYL, the Company has entered into agreements with specialized contract manufacturing organizations located in Taiwan for the manufacturing of the ZUNVEYL active pharmaceutical ingredient, and with manufacturing companies located in the United States specialized in the production of oral tablets and nasal spray formulations.
Post-Approval Requirements Any products manufactured or distributed by us pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to record-keeping, reporting of adverse experiences, periodic reporting, product sampling and distribution, and advertising and promotion of the product.
We may explore some of these opportunities for our product candidates as appropriate. 24 Post-Approval Requirements Any products manufactured or distributed by us pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to record-keeping, reporting of adverse experiences, periodic reporting, product sampling and distribution, and advertising and promotion of the product.
In fact, many say the distress is unchanged or even increases. 12 Our Product and Approach to Treatment The Company plans to develop ALPHA-1062+ memantine, to simplify the co-administration of these drugs by a patient or caregiver with the goal of increasing compliance and adherence to the prescribed regimen.
Our Product and Approach to Treatment The Company plans to develop ALPHA-1062+ memantine, to simplify the co-administration of these drugs by a patient or caregiver with the goal of increasing compliance and adherence to the prescribed regimen.
Distributors often have a deep understanding of local market dynamics, including regulatory requirements, distribution channels, and consumer preferences. Partnering with a local distributor should allow the Company to leverage this expertise and navigate the complexities of entering a new market more effectively. FDA regulatory approval does not guarantee regulatory approval for distribution in other territories.
Partnering with a local distributor should allow the Company to leverage this expertise and navigate the complexities of entering a new market more effectively. FDA regulatory approval does not guarantee regulatory approval for distribution in other territories.
As a result of the Qualifying Transaction Alpha Canada became the Company’s wholly-owned subsidiary. Alpha Canada was a privately held company incorporated pursuant to the BCBCA on May 16, 2014, under the name “Neurodyn Cognition Inc.”.
(formerly Alpha Cognition Inc.) (“Alpha Canada” or “ACI Canada”) on March 18, 2021, and changed its name to Alpha Cognition Inc. As a result of the Qualifying Transaction Alpha Canada became the Company’s wholly owned subsidiary. Alpha Canada was a privately held company incorporated pursuant to the BCBCA on May 16, 2014, under the name “Neurodyn Cognition Inc.”.
The risk of our being found in violation of these or other laws and regulations is increased by the fact that many have not been fully interpreted by the regulatory authorities or the courts and their provisions are open to various interpretations.
New legislation proposed or enacted in various other states will continue to shape the data privacy environment nationally. 27 The risk of our being found in violation of these or other laws and regulations is increased by the fact that many have not been fully interpreted by the regulatory authorities or the courts and their provisions are open to various interpretations.
Alzheimer’s Disease Moderate-To-Severe Stage Program Disease and Market Overview Our second program is a combination oral product of benzgalantamine and memantime for moderate-to-severe Alzheimer’s disease. The product is in formulation and pre-clinical development. The Company believes combining ALPHA-1062 with previous FDA approved NMDA receptor memantine would provide differentiating efficacy and an attractive tolerability profile to patients within these advance stages.
The product is in formulation and pre-clinical development. The Company believes combining ALPHA-1062 with previous FDA approved NMDA receptor memantine would provide differentiating efficacy and an attractive tolerability profile to patients within these advance stages. Moderate Alzheimer’s disease and severe Alzheimer’s disease affects a total of ~1.4M patients in the United States.
As long-term care settings predominate in the provision of care to moderately-to-severely affected patients, the Company will also raise awareness of the compelling results from the Swedish Dementia Registry that demonstrated that galantamine had the strongest effect on cognitive improvement and was the only drug to demonstrate a significant reduction in the risk of developing severe dementia, and a lower risk of death as compared to other evaluated acetylcholinesterase inhibitors.
As long-term care settings predominate in the provision of care to moderately-to-severely affected patients, the Company will also raise awareness of the compelling results from the Swedish Dementia Registry that demonstrated that galantamine had the strongest effect on cognitive improvement and was the only drug to demonstrate a significant reduction in the risk of developing severe dementia, and a lower risk of death as compared to other evaluated acetylcholinesterase inhibitors. 14 Should both ALPHA-1062 and the combination therapy (ALPHA-1062+memantine) ultimately be approved for commercialization, the Company would be able to offer a solution that treats all the stages of Alzheimer’s disease.
In addition, new government requirements, including those resulting from new legislation, may be established, or the FDA’s policies may change, which could impact the timeline for regulatory approval or otherwise impact ongoing development programs. 21 Orphan Drug Designation Under the Orphan Drug Act, the FDA may grant ODD, to a drug or therapeutic biological product intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the United States and for which there is no reasonable expectation that the cost of developing and making a biological product available in the United States for this type of disease or condition will be recovered from sales of the product.
Orphan Drug Designation Under the Orphan Drug Act, the FDA may grant ODD, to a drug or therapeutic biological product intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the United States and for which there is no reasonable expectation that the cost of developing and making a biological product available in the United States for this type of disease or condition will be recovered from sales of the product.
To the extent that we continue to qualify as a “smaller reporting company,” as such term is defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended, after we cease to qualify as an emerging growth company, certain of the exemptions available to us as an emerging growth company may continue to be available to us as a smaller reporting company, including: (i) not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes Oxley Act; (ii) scaled executive compensation disclosures; and (iii) the requirement to provide only two years of audited financial statements, instead of three years.
However, if certain events occur prior to the end of such five-year period, including if we become a “large accelerated filer,” our annual gross revenues exceed $1.235 billion or we issue more than $1 billion of non-convertible debt in any three-year period, we will cease to be an emerging growth company prior to the end of such five-year period. 32 To the extent that we continue to qualify as a “smaller reporting company,” as such term is defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended, after we cease to qualify as an emerging growth company, certain of the exemptions available to us as an emerging growth company may continue to be available to us as a smaller reporting company, including: (i) not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes Oxley Act; (ii) scaled executive compensation disclosures; and (iii) the requirement to provide only two years of audited financial statements, instead of three years.
Patient willingness to try multiple therapeutics provides an opportunity for ZUNVEYL to take market share in the overall AChEI market. The sales force will message potential key points of label differentiation and exploit key issues with existing AChEI medications. The Company will attempt to secure product coverage with U.S. payors.
Patient willingness to try multiple therapeutics provides an opportunity for ZUNVEYL to take market share in the overall AChEI market. The sales force executes potential key points of label differentiation and exploit key issues with existing AChEI medications. The Company is actively engaged in securing formulary coverage for ZUNVEYL with U.S. payors and negotiating agreements with pharmacy benefit managers.
The caregiver burden also increases during this stage, as many activities (dressing, bathing, bathroom) require assistance and management. In the severe stage of the disease, patients will experience more robust and debilitating symptoms. The complete deterioration of cognition and functional abilities require round-the-clock care, eating and drinking prove difficult, and they usually become bed bound.
In the severe stage of the disease, patients will experience more robust and debilitating symptoms. The complete deterioration of cognition and functional abilities require round-the-clock care, eating and drinking prove difficult, and they usually become bed bound.
Smaller or early-stage companies may also prove to be significant competitors, particularly through sizeable collaborative arrangements with established companies. These competitors also compete with us in recruiting and retain qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.
These competitors also compete with us in recruiting and retain qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.
A stable, highly soluble polymorph form was identified, which shows improved stability and solubility over other crystalline forms and is intended for use in the drug product. An international PCT application and parallel U.S. application were filed January 13, 2022, the European priority application also remains pending.
A stable, highly soluble polymorph form was identified, which shows improved stability and solubility over other crystalline forms and is intended for use in the drug product. An international PCT application and parallel U.S. application were filed January 13, 2022. The Canadian Intellectual Property Office (CIPO) has acknowledged novelty and inventive step of the claims of the PCT application.
The Company believes that it has sufficient capital to break even in year three, provided the Company executes it’s commercial plan in Long Term Care market and does not advance compounds in the pipeline. 2) Pursue its pre-clinical assets when the timing and costs to the Company permit.
The Company believes that it has sufficient capital to achieve operating profitability by 2027, provided the Company executes its commercial plan in LTC market and does not advance compounds in the pipeline. 2) Pursue its pre-clinical assets when the timing and costs to the Company permit.
ZUNVEYL, is a patented next generation acetylcholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type in adults. ZUNVEYL’s active metabolite is differentiated from donepezil and rivastigmine in that it binds neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition.
ZUNVEYL, is a patented new innovative product being developed 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.
It must also contain information to support dose administration for pediatric populations where the drug may be utilized. FDA has the ability to grant complete waivers, partial waivers, or deferrals for compliance with PREA.
Under the PREA, an NDA must contain data to assess the safety and efficacy of the applicant product for indications in applicable pediatric populations. It must also contain information to support dose administration for pediatric populations where the drug may be utilized. FDA has the ability to grant complete waivers, partial waivers, or deferrals for compliance with PREA.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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We anticipate that our expenses will increase substantially for the foreseeable future as we: ● establish a commercialization infrastructure and scale up external manufacturing and distribution capabilities to commercialize ZUNVEYL oral tabulation formulation formerly known as ALPHA-1062 and any other product candidates for which we may obtain regulatory approval; ● conduct our ongoing and planned clinical trials of ALPHA-1062, as well as initiate and complete additional clinical trials; ● continue our clinical validation of ALPHA-1062 for moderate-to-severe Alzheimer’s disease and explore the potential of ALPHA-1062IN related to mTBI; ● adapt our regulatory compliance efforts to incorporate requirements applicable to marketed products; ● maintain, expand and protect our intellectual property portfolio; ● hire additional clinical, manufacturing and scientific personnel; ● add operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts; ● incur additional legal, accounting and other expenses in operating as a public company; and ● scale up our clinical and regulatory capabilities.
We anticipate that our expenses will increase substantially for the foreseeable future as we: ● continue establish a commercialization infrastructure and scale up external manufacturing and distribution capabilities to commercialize ZUNVEYL oral tabulation formulation formerly known as ALPHA-1062 and any other product candidates for which we may obtain regulatory approval; ● conduct our ongoing and planned clinical trials of ALPHA-1062, as well as initiate and complete additional clinical trials; ● continue our clinical validation of ALPHA-1062 for moderate-to-severe Alzheimer’s disease and explore the potential of ALPHA-1062IN related to mTBI; ● adapt our regulatory compliance efforts to incorporate requirements applicable to marketed products; ● maintain, expand and protect our intellectual property portfolio; ● hire additional clinical, manufacturing and scientific personnel; ● add operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts; ● incur additional legal, accounting and other expenses in operating as a public company; and ● scale up our clinical and regulatory capabilities.
We may seek an accelerated approval pathway for our one or more of our product candidates.
We may seek an accelerated approval pathway for one or more of our product candidates.
Dollar denominated functional currency could result in a significant risk of loss at the date of valuing the risk and cause the Company to incur a significant non-cash derivative liability depending on the exchange rate and share price volatility, share price, risk-free interest rate, and remaining life of the Canadian Dollar denominated warrants.
Dollar denominated functional currency could result in a significant risk of loss at the date of valuing the risk and cause the Company to incur a significant non-cash derivative liability depending on the exchange rate and share price volatility, share price, risk-free interest rate, and remaining life of the Canadian Dollar denominated warrants.
Our future success is dependent on our ability to successfully develop, obtain regulatory approval for and then successfully commercialize our product candidates, and we may experience delays or fail to do so for many reasons, including the following: ● our product candidates may not successfully complete preclinical studies or clinical trials; ● receipt of feedback from regulatory authorities that requires us to modify the design of our clinical trials; ● clinical trial observations or results that require us to modify the design of our clinical trials; ● the number of patients required for clinical trials being larger than anticipated, enrollment in these clinical trials being slower than anticipated or participants dropping out of these clinical trials at a higher rate than anticipated; ● the suspension or termination of our clinical trials for various reasons, including non-compliance with regulatory requirements or a finding that our product candidates have undesirable side effects or other unexpected characteristics or risks; ● negative or inconclusive clinical trial results that may require us to conduct additional clinical trials or abandon certain drug development programs; ● the cost of clinical trials of our product candidates being greater than anticipated; ● a product candidate may on further study be shown to have harmful side effects or other characteristics that indicate it does not meet applicable regulatory criteria; ● any changes to our manufacturing process that may be necessary or desired; ● third-party contractors not performing data collection or analysis in a timely or accurate manner; ● third-party contractors becoming debarred or suspended or otherwise penalized by the FDA or other government or regulatory authorities for violations of regulatory requirements, in which case we may need to find a substitute contractor, and we may not be able to use some or all of the data produced by such contractors in support of our marketing applications; ● our competitors may develop therapeutics that render our product candidates obsolete or less attractive; ● the market for a product candidate may change so that the continued development of that product candidate is no longer reasonable or commercially attractive; ● a product candidate may not be capable of being produced in commercial quantities at an acceptable cost, or at all; ● if a product candidate obtains regulatory approval, we may be unable to establish sales and marketing capabilities, or successfully market such approved product candidate; and ● a product candidate may not be accepted as safe and effective by patients, the medical community or third-party payors.
Our future success is dependent on our ability to successfully develop, obtain regulatory approval for and then successfully commercialize our product candidates, and we may experience delays or fail to do so for many reasons, including the following: ● our product candidates may not successfully complete preclinical studies or clinical trials; ● receipt of feedback from regulatory authorities that requires us to modify the design of our clinical trials; 57 ● clinical trial observations or results that require us to modify the design of our clinical trials; ● the number of patients required for clinical trials being larger than anticipated, enrollment in these clinical trials being slower than anticipated or participants dropping out of these clinical trials at a higher rate than anticipated; ● the suspension or termination of our clinical trials for various reasons, including non-compliance with regulatory requirements or a finding that our product candidates have undesirable side effects or other unexpected characteristics or risks; ● negative or inconclusive clinical trial results that may require us to conduct additional clinical trials or abandon certain drug development programs; ● the cost of clinical trials of our product candidates being greater than anticipated; ● a product candidate may on further study be shown to have harmful side effects or other characteristics that indicate it does not meet applicable regulatory criteria; ● any changes to our manufacturing process that may be necessary or desired; ● third-party contractors not performing data collection or analysis in a timely or accurate manner; ● third-party contractors becoming debarred or suspended or otherwise penalized by the FDA or other government or regulatory authorities for violations of regulatory requirements, in which case we may need to find a substitute contractor, and we may not be able to use some or all of the data produced by such contractors in support of our marketing applications; ● our competitors may develop therapeutics that render our product candidates obsolete or less attractive; ● the market for a product candidate may change so that the continued development of that product candidate is no longer reasonable or commercially attractive; ● a product candidate may not be capable of being produced in commercial quantities at an acceptable cost, or at all; ● if a product candidate obtains regulatory approval, we may be unable to establish sales and marketing capabilities, or successfully market such approved product candidate; and ● a product candidate may not be accepted as safe and effective by patients, the medical community or third-party payors.
These factors include those discussed in this “Risk Factors” section of this Annual Report and others such as: ● results from, and any delays in, our current and future clinical trials with ZUNVEYL or any other future clinical development programs, including any delays related to the COVID-19 pandemic; ● announcements of the regulatory approval of ZUNVEYL or approval or disapproval for any future product candidates; ● failure or discontinuation of any of our research and development programs; ● the termination of any future collaborations or license agreements; ● delays in the commercialization of ZUNVEYL or any future product candidates; ● public misperception regarding the use of our product candidates; ● acquisitions and sales of new products or product candidates, technologies or businesses; ● manufacturing and supply issues related to our product candidates for clinical trials or future product candidates for commercialization; ● quarterly variations in our results of operations or those of our competitors; ● changes in coverage and recommendations by securities analysts; ● announcements by us or our competitors of new products or product candidates, significant contracts, commercial relationships, acquisitions or capital commitments; ● developments with respect to intellectual property rights; ● our commencement of, or involvement in, litigation; ● changes in financial estimates or guidance; ● any major changes in our board of directors or management; ● new legislation or regulation in the United States relating to the sale or pricing of pharmaceuticals; ● FDA or other U.S. or foreign regulatory actions affecting us or our industry; ● product liability claims or other litigation or public concern about the safety of our product candidates; ● market conditions in the biopharmaceutical sectors; ● general economic conditions in the United States and abroad; and ● other events or factors, including those resulting from pandemics, natural disasters, war, including the ongoing conflict in Ukraine, acts of terrorism or responses to these events.
These factors include those discussed in this “Risk Factors” section of this Annual Report and others such as: ● results from, and any delays in, our current and future clinical trials with ZUNVEYL or any other future clinical development programs, including any delays related to the COVID-19 pandemic; ● announcements of the regulatory approval of ZUNVEYL or approval or disapproval for any future product candidates; ● failure or discontinuation of any of our research and development programs; ● the termination of any future collaborations or license agreements; ● delays in the commercialization of ZUNVEYL or any future product candidates; ● public misperception regarding the use of our product candidates; ● acquisitions and sales of new products or product candidates, technologies or businesses; ● manufacturing and supply issues related to our product candidates for clinical trials or future product candidates for commercialization; ● quarterly variations in our results of operations or those of our competitors; ● changes in coverage and recommendations by securities analysts; ● announcements by us or our competitors of new products or product candidates, significant contracts, commercial relationships, acquisitions or capital commitments; ● developments with respect to intellectual property rights; ● our commencement of, or involvement in, litigation; ● changes in financial estimates or guidance; 85 ● any major changes in our board of directors or management; ● new legislation or regulation in the United States relating to the sale or pricing of pharmaceuticals; ● FDA or other U.S. or foreign regulatory actions affecting us or our industry; ● product liability claims or other litigation or public concern about the safety of our product candidates; ● market conditions in the biopharmaceutical sectors; ● general economic conditions in the United States and abroad; and ● other events or factors, including those resulting from pandemics, natural disasters, war, including the ongoing conflict in Ukraine, acts of terrorism or responses to these events.
The following examples are illustrative: ● others may be able to make product that is similar to product candidates we intend to commercialize that is not covered by the patents that we own; ● we, or any collaborators might not have been the first to make or reduce to practice the inventions covered by the issued patents or pending patent applications that we own; ● we or any collaborators might not have been the first to file patent applications covering certain of our inventions; ● others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; ● it is possible that our pending patent applications will not lead to issued patents; ● issued patents that we own may not provide us with any competitive advantages, or may be held invalid or unenforceable as a result of legal challenges; ● our competitors might conduct research and development activities in the United States and other countries that provide a safe harbor from patent infringement claims for certain research and development activities, as well as in countries where we do not have patent rights, and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; and we may not develop additional proprietary technologies that are patentable; ● third parties performing manufacturing or testing for us using our products or technologies could use the intellectual property of others without obtaining a proper license; ● parties may assert an ownership interest in our intellectual property and, if successful, such disputes may preclude us from exercising exclusive rights over that intellectual property; ● we may not develop additional proprietary technologies that are patentable; ● we may not be able to obtain and maintain necessary licenses on commercially reasonable terms, or at all; and ● the patents of others may harm our business.
The following examples are illustrative: ● others may be able to make product that is similar to product candidates we intend to commercialize that is not covered by the patents that we own; ● we, or any collaborators might not have been the first to make or reduce to practice the inventions covered by the issued patents or pending patent applications that we own; ● we or any collaborators might not have been the first to file patent applications covering certain of our inventions; ● others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; ● it is possible that our pending patent applications will not lead to issued patents; ● issued patents that we own may not provide us with any competitive advantages, or may be held invalid or unenforceable as a result of legal challenges; ● our competitors might conduct research and development activities in the United States and other countries that provide a safe harbor from patent infringement claims for certain research and development activities, as well as in countries where we do not have patent rights, and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; and we may not develop additional proprietary technologies that are patentable; 73 ● third parties performing manufacturing or testing for us using our products or technologies could use the intellectual property of others without obtaining a proper license; ● parties may assert an ownership interest in our intellectual property and, if successful, such disputes may preclude us from exercising exclusive rights over that intellectual property; ● we may not develop additional proprietary technologies that are patentable; ● we may not be able to obtain and maintain necessary licenses on commercially reasonable terms, or at all; and ● the patents of others may harm our business.
Applications for our product candidates could fail to receive regulatory approval for many reasons, including the following: ● the FDA or other comparable foreign regulatory authorities may disagree with the design, implementation or results of our clinical trials; ● the FDA or other comparable foreign regulatory authorities may determine that our product candidates are not safe and effective, are only moderately effective or have undesirable or unintended side effects, toxicities or other characteristics that preclude our obtaining marketing approval or prevent or limit commercial use; ● the population studied in the clinical trial may not be sufficiently broad or representative to assure efficacy and safety in the full population for which we seek approval; ● the FDA or other comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials; ● we may be unable to demonstrate to the FDA or other comparable foreign regulatory authorities that our product candidate’s risk-benefit ratio for its proposed indication is acceptable; ● the FDA or other comparable foreign regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and ● the approval policies or regulations of the FDA or other comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval 70 This lengthy approval process, as well as the unpredictability of the results of clinical trials, may result in our failing to obtain regulatory approval to market any of our product candidates, which would significantly harm our business, results of operations and prospects.
Applications for our product candidates could fail to receive regulatory approval for many reasons, including the following: ● the FDA or other comparable foreign regulatory authorities may disagree with the design, implementation or results of our clinical trials; ● the FDA or other comparable foreign regulatory authorities may determine that our product candidates are not safe and effective, are only moderately effective or have undesirable or unintended side effects, toxicities or other characteristics that preclude our obtaining marketing approval or prevent or limit commercial use; ● the population studied in the clinical trial may not be sufficiently broad or representative to assure efficacy and safety in the full population for which we seek approval; ● the FDA or other comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials; ● we may be unable to demonstrate to the FDA or other comparable foreign regulatory authorities that our product candidate’s risk-benefit ratio for its proposed indication is acceptable; ● the FDA or other comparable foreign regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and ● the approval policies or regulations of the FDA or other comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval This lengthy approval process, as well as the unpredictability of the results of clinical trials, may result in our failing to obtain regulatory approval to market any of our product candidates, which would significantly harm our business, results of operations and prospects.
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: ● successfully commercializing ZUNVEYL, either independently or with marketing service providers; ● the effectiveness of our sales and marketing strategy and operations, and obtaining market acceptance of ZUNVEYL, including garnering market share from existing and future treatment alternatives; ● maintaining compliance with all regulatory requirements applicable to ZUNVEYL and our commercial activities, including the post-marketing requirements and post-marketing commitments required by the FDA; ● the continued acceptability of the safety profile of ZUNVEYL and the occurrence of any unexpected side effects, adverse reactions or misuse, including potential business impact such as the need to withdraw the product (either voluntarily or as mandated by the FDA), loss of support by the advocacy communities or loss of positive corporate reputation resulting in related unfavorable media coverage in these areas; ● our ability to raise any additional required capital on acceptable terms, or at all; ● our ability to complete an IND enabling studies and successfully submit INDs or comparable applications; ● initiation and timely completion of our preclinical studies and clinical trials, which may be significantly slower or cost more than we currently anticipate and will depend substantially upon the performance of third-party contractors; ● delays or difficulties in enrolling and retaining patients in our clinical trials; ● whether we are required by the FDA, or similar foreign regulatory agencies to conduct additional clinical trials or other studies beyond those planned to support the approval and commercialization of our product candidates or any future product candidates; ● acceptance of our proposed indications and primary endpoint assessments relating to the proposed indications of our product candidates by the FDA and similar foreign regulatory authorities; ● our ability to demonstrate to the satisfaction of the FDA and similar foreign regulatory authorities the safety, efficacy and acceptable risk to benefit profile of our product candidates or any future product candidates; ● the prevalence, duration and severity of potential side effects or other safety issues experienced with our product candidates or future approved products, if any; ● achieving and maintaining, and, where applicable, ensuring that our third-party contractors achieve and maintain, compliance with our contractual obligations and with all regulatory requirements applicable to our product candidates or any future product candidates or approved products, if any; ● the ability of third parties with whom we contract to manufacture adequate clinical trial and commercial supplies of our product candidates or any future product candidates remain in good standing with regulatory agencies and develop, validate and maintain commercially viable manufacturing processes that are compliant with current good manufacturing practices, or cGMPs; ● the convenience of our treatment or dosing regimen; ● the timely receipt of necessary marketing approvals from the FDA and similar foreign regulatory authorities; ● acceptance by physicians, payors and patients of the benefits, safety and efficacy of our product candidates or any future product candidates, if approved, including relative to alternative and competing treatments; ● the willingness of physicians, operators of clinics and patients to utilize or adopt any of our product candidates or any future product candidates, if approved; 39 ● our ability to achieve sufficient market acceptance, coverage and adequate reimbursement from third-party payors and adequate market share and revenue for any approved products; ● our ability to expand our products, including ZUNVEYL into multiple indications; ● the COVID-19 pandemic, which may result in clinical site closures, delays to patient enrollment, patients discontinuing their treatment or follow up visits or changes to trial protocols; ● our ability to successfully develop a commercial strategy and thereafter commercialize our other product candidates or any future product candidates in the United States and internationally, if approved for marketing, reimbursement, sale and distribution in such countries and territories, whether alone or in collaboration with others; ● patient demand for our product candidates, if approved, including patients’ willingness to pay out-of-pocket for any approved products in the absence of coverage and/or adequate reimbursement from third-party payors; ● the actual market-size, ability to identify patients and the demographics of patients eligible for our product candidates, which may be different than expected; ● a continued acceptable safety profile following any marketing approval; ● our ability to compete with other therapies; ● our ability to establish and enforce intellectual property rights in and to our product candidates or any future product candidates; and ● our ability to avoid third-party patent interference, intellectual property challenges or intellectual property infringement claims.
The commercial success of ZUNVEYL and the clinical and commercial success of any future product candidates that we may develop or acquire will depend on a number of factors, including the following: ● the continued commercial success of ZUNVEYL, either independently or with marketing service providers; ● the effectiveness of our sales and marketing strategy and operations, and obtaining market acceptance of ZUNVEYL, including garnering market share from existing and future treatment alternatives; ● maintaining compliance with all regulatory requirements applicable to ZUNVEYL and our commercial activities, including the post-marketing requirements and post-marketing commitments required by the FDA; ● the continued acceptability of the safety profile of ZUNVEYL and the occurrence of any unexpected side effects, adverse reactions or misuse, including potential business impact such as the need to withdraw the product (either voluntarily or as mandated by the FDA), loss of support by the advocacy communities or loss of positive corporate reputation resulting in related unfavorable media coverage in these areas; 46 ● our ability to raise any additional required capital on acceptable terms, or at all; ● our ability to complete an IND enabling studies and successfully submit INDs or comparable applications; ● initiation and timely completion of our preclinical studies and clinical trials, which may be significantly slower or cost more than we currently anticipate and will depend substantially upon the performance of third-party contractors; ● delays or difficulties in enrolling and retaining patients in our clinical trials; ● whether we are required by the FDA, or similar foreign regulatory agencies to conduct additional clinical trials or other studies beyond those planned to support the approval and commercialization of our product candidates or any future product candidates; ● acceptance of our proposed indications and primary endpoint assessments relating to the proposed indications of our product candidates by the FDA and similar foreign regulatory authorities; ● our ability to demonstrate to the satisfaction of the FDA and similar foreign regulatory authorities the safety, efficacy and acceptable risk to benefit profile of our product candidates or any future product candidates; ● the prevalence, duration and severity of potential side effects or other safety issues experienced with our product candidates or future approved products, if any; ● achieving and maintaining, and, where applicable, ensuring that our third-party contractors achieve and maintain, compliance with our contractual obligations and with all regulatory requirements applicable to our product candidates or any future product candidates or approved products, if any; ● the ability of third parties with whom we contract to manufacture adequate clinical trial and commercial supplies of our product candidates or any future product candidates remain in good standing with regulatory agencies and develop, validate and maintain commercially viable manufacturing processes that are compliant with current good manufacturing practices, or cGMPs; ● the convenience of our treatment or dosing regimen; ● the timely receipt of necessary marketing approvals from the FDA and similar foreign regulatory authorities; ● acceptance by physicians, payors and patients of the benefits, safety and efficacy of our product candidates or any future product candidates, if approved, including relative to alternative and competing treatments; ● the willingness of physicians, operators of clinics and patients to utilize or adopt any of our product candidates or any future product candidates, if approved; ● our ability to achieve sufficient market acceptance, coverage and adequate reimbursement from third-party payors and adequate market share and revenue for any approved products; ● our ability to expand our products, including ZUNVEYL into multiple indications; ● the COVID-19 pandemic, which may result in clinical site closures, delays to patient enrollment, patients discontinuing their treatment or follow up visits or changes to trial protocols; ● our ability to successfully develop a commercial strategy and thereafter commercialize our other product candidates or any future product candidates in the United States and internationally, if approved for marketing, reimbursement, sale and distribution in such countries and territories, whether alone or in collaboration with others; 47 ● patient demand for our product candidates, if approved, including patients’ willingness to pay out-of-pocket for any approved products in the absence of coverage and/or adequate reimbursement from third-party payors; ● the actual market-size, ability to identify patients and the demographics of patients eligible for our product candidates, which may be different than expected; ● a continued acceptable safety profile following any marketing approval; ● our ability to compete with other therapies; ● our ability to establish and enforce intellectual property rights in and to our product candidates or any future product candidates; and ● our ability to avoid third-party patent interference, intellectual property challenges or intellectual property infringement claims.
In addition, the government may assert that a claim including items and services resulting from a violation of the U.S. federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act; ● HIPAA, which imposes criminal and civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement, in connection with the delivery of, or payment for, healthcare benefits, items or services; similar to the U.S. federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation; 74 ● HIPAA, as amended by the HITECH and its implementing regulations, which also imposes certain obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information without appropriate authorization by covered entities, such as health plans, healthcare clearinghouses and healthcare providers, as well as their business associates that perform certain services involving the use or disclosure of individually identifiable health information; ● federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers; ● the U.S.
In addition, the government may assert that a claim including items and services resulting from a violation of the U.S. federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act; ● HIPAA, which imposes criminal and civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement, in connection with the delivery of, or payment for, healthcare benefits, items or services; similar to the U.S. federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation; ● HIPAA, as amended by the HITECH and its implementing regulations, which also imposes certain obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information without appropriate authorization by covered entities, such as health plans, healthcare clearinghouses and healthcare providers, as well as their business associates that perform certain services involving the use or disclosure of individually identifiable health information; 79 ● federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers; ● the U.S.
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.
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 common stock.
For example, because many of these stockholders purchased their shares at prices substantially below the current market price of our common stock and have held their shares for a longer period, they may be more interested in selling our Company to an acquirer than other investors, or they may want us to pursue strategies that deviate from the interests of other stockholders.
For example, because many of these stockholders purchased their stock at prices substantially below the current market price of our common stock and have held their stock for a longer period, they may be more interested in selling our Company to an acquirer than other investors, or they may want us to pursue strategies that deviate from the interests of other stockholders.
As a consequence of these and other factors, our patent applications may fail to result in issued patents with claims that cover our product candidates in the United States or in other countries. Such a loss of patent protection could harm our business. 68 Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
As a consequence of these and other factors, our patent applications may fail to result in issued patents with claims that cover our product candidates in the United States or in other countries. Such a loss of patent protection could harm our business. Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
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 Adelheim by the end of 2024.
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 Aduhelm by the end of 2024.
If we fail to maintain the patents and patent applications covering any of our product candidates, our competitors might be able to enter the market earlier than anticipated, which would harm our business. We may need to license intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.
If we fail to maintain the patents and patent applications covering any of our product candidates, our competitors might be able to enter the market earlier than anticipated, which would harm our business. 66 We may need to license intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.
As a result, these persons, acting together, would be able to significantly influence all matters requiring stockholder approval, including the election and removal of directors, any merger, consolidation, sale of all or substantially all of our assets, or other significant corporate transactions. 82 Some of these persons or entities may have interests different than yours.
As a result, these persons, acting together, would be able to significantly influence all matters requiring stockholder approval, including the election and removal of directors, any merger, consolidation, sale of all or substantially all of our assets, or other significant corporate transactions. Some of these persons or entities may have interests different than yours.
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. 36 We may encounter unforeseen expenses, difficulties, complications, delays and other known or unknown factors in achieving our business objectives.
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 may encounter unforeseen expenses, difficulties, complications, delays and other known or unknown factors in achieving our business objectives.
For these reasons, we may not be able to utilize a material portion of the NOLs reflected on our balance sheet, even if we attain profitability. 83 We do not currently intend to pay dividends on our common stock, and, consequently, your ability to achieve a return on your investment will depend on appreciation in the price of our common stock.
For these reasons, we may not be able to utilize a material portion of the NOLs reflected on our balance sheet, even if we attain profitability. We do not currently intend to pay dividends on our common stock, and, consequently, your ability to achieve a return on your investment will depend on appreciation in the price of our common stock.
If one or more of these analysts cease coverage of us or fail to publish reports on us regularly, we could lose visibility in the financial markets, which in turn could cause our stock price or trading volume to decline. We may be subject to securities litigation, which is expensive and could divert our management’s attention.
If one or more of these analysts cease coverage of us or fail to publish reports on us regularly, we could lose visibility in the financial markets, which in turn could cause our stock price or trading volume to decline. 90 We may be subject to securities litigation, which is expensive and could divert our management’s attention.
We will need substantial capital to meet our financial obligations and to pursue our business objectives, including the commercialization of ZUNVEYL oral tablet formulation. 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.
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 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.
Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business. 63 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.
Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business. 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.
If reimbursement is not available or is available only at limited levels, we may not be able to successfully commercialize our product candidates and may not be able to obtain a satisfactory financial return on our investment in the development of product candidates. 56 There is significant uncertainty related to the insurance coverage and reimbursement of newly-approved products.
If reimbursement is not available or is available only at limited levels, we may not be able to successfully commercialize our product candidates and may not be able to obtain a satisfactory financial return on our investment in the development of product candidates. There is significant uncertainty related to the insurance coverage and reimbursement of newly-approved products.
We expect to continue to incur significant expenses and operating losses over the next several years as we complete our commercialization activities for ZUNVEYL and our ongoing clinical trials of our other product candidates, initiate 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.
We expect to continue to incur significant expenses and operating losses over the next several years as we continue our commercialization activities for ZUNVEYL and our ongoing clinical trials of our other product candidates, initiate 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.
We did not receive any FDA exclusivity associated with the approval of our NDA 218549 for ZUNVEYL. The validity, scope and enforceability of any patents listed in the Orange Book that cover our product candidates including our lead product ZUNVEYL can be challenged by third parties.
We did not receive any FDA exclusivity associated with the approval of our NDA 218549 for ZUNVEYL. 65 The validity, scope and enforceability of any patents listed in the Orange Book that cover our product candidates including our lead product ZUNVEYL can be challenged by third parties.
Our potential inability to integrate any business, products or technologies effectively may adversely affect our business, results of operations and financial condition. We will incur increased costs and demands upon management as a result of being a public company in the United States.
Our potential inability to integrate any business, products or technologies effectively may adversely affect our business, results of operations and financial condition. 84 We will incur increased costs and demands upon management as a result of being a public company in the United States.
Opposition or cancellation proceedings may be filed against our trademarks, and our trademarks may not survive such proceedings. 69 Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively and our business may be adversely affected.
Opposition or cancellation proceedings may be filed against our trademarks, and our trademarks may not survive such proceedings. Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively and our business may be adversely affected.
If regulatory sanctions are applied or if regulatory approval is withdrawn, the value of our Company and our operating results will be adversely affected. Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.
If regulatory sanctions are applied or if regulatory approval is withdrawn, the value of our Company and our operating results will be adversely affected. 76 Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.
Risks Related to Our Common Shares Our stock price may be volatile and you may not be able to resell common shares at or above the price you paid. The trading price of our common shares could be highly volatile and could be subject to wide fluctuations in response to various factors, some of which are beyond our control.
Risks Related to Our Common Stock Our stock price may be volatile and you may not be able to resell common stock at or above the price you paid. The trading price of our common stock could be highly volatile and could be subject to wide fluctuations in response to various factors, some of which are beyond our control.
We do not know whether any clinical trials we may conduct will demonstrate consistent or adequate efficacy and safety sufficient to obtain approval to market any of our product candidates. We rely on third parties in the conduct of all of our clinical trials.
We do not know whether any clinical trials we may conduct will demonstrate consistent or adequate efficacy and safety sufficient to obtain approval to market any of our product candidates. 52 We rely on third parties in the conduct of all of our clinical trials.
Even if we are successful in defending against any such actions that may be brought against us, our business may be impaired. 75 Inadequate funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
Even if we are successful in defending against any such actions that may be brought against us, our business may be impaired. 80 Inadequate funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
Further, pursuant to Rule 144, non-affiliate stockholders may sell freely after six months, subject only to the current public information requirement. Affiliates may sell after six months, subject to the Rule 144 volume, manner of sale (for equity securities), current public information, and notice requirements.
Pursuant to Rule 144, non-affiliate stockholders may sell freely after six months, subject only to the current public information requirement. Affiliates may sell after six months, subject to the Rule 144 volume, manner of sale (for equity securities), current public information, and notice requirements.
If the top-line data that we report differ from final results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, product candidates may be harmed, which could significantly harm our business, financial condition, results of operations and prospects. 46 We have conducted, and in the future plan to conduct, clinical trials for product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials.
If the top-line data that we report differ from final results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, product candidates may be harmed, which could significantly harm our business, financial condition, results of operations and prospects. 54 We have conducted, and in the future plan to conduct, clinical trials for product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials.
Failure to obtain or maintain coverage and adequate reimbursement for our product candidates, if approved, could limit our ability to market those drugs and decrease our ability to generate revenue. 33 ● We currently have no sales organization.
Failure to obtain or maintain coverage and adequate reimbursement for our product candidates, if approved, could limit our ability to market those drugs and decrease our ability to generate revenue. ● We currently have no sales organization.
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.
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 our common stock sold at such discount.
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, or if the exercise prices of the options that they hold are significantly below the market price of our common stock. 77 Competition for qualified personnel in the biopharmaceutical field is intense due to the limited number of individuals who possess the skills and experience required by our industry.
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 stock, or if the exercise prices of the options that they hold are significantly below the market price of our common stock. 82 Competition for qualified personnel in the biopharmaceutical field is intense due to the limited number of individuals who possess the skills and experience required by our industry.
Any violations of the laws and regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, the loss of export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm and other consequences. 76 Risks Related to Employee Matters and Growth Management We will need to increase the size of our organization, and we may experience difficulties in managing growth.
Any violations of the laws and regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, the loss of export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm and other consequences. 81 Risks Related to Employee Matters and Growth Management We will need to increase the size of our organization, and we may experience difficulties in managing growth.
Any failure to report our financial results on an accurate and timely basis could result in sanctions, lawsuits, delisting of our shares from the Nasdaq or other adverse consequences that would materially and adversely affect our business, financial condition, results of operations and prospects. Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
Any failure to report our financial results on an accurate and timely basis could result in sanctions, lawsuits, delisting of our stock from the Nasdaq or other adverse consequences that would materially and adversely affect our business, financial condition, results of operations and prospects. Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
Any of these events, even if we were ultimately to prevail, could require us to divert substantial financial and management resources that we would otherwise be able to devote to our business. 64 We may become involved in lawsuits to protect or enforce our patents or our other intellectual property rights, which could be expensive, time consuming and unsuccessful.
Any of these events, even if we were ultimately to prevail, could require us to divert substantial financial and management resources that we would otherwise be able to devote to our business. 68 We may become involved in lawsuits to protect or enforce our patents or our other intellectual property rights, which could be expensive, time consuming and unsuccessful.
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 shares is uncertain. In addition, the Inflation Reduction Act of 2022 includes provisions that impact the U.S. federal income taxation of corporations.
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 stock is uncertain. In addition, the Inflation Reduction Act of 2022 includes provisions that impact the U.S. federal income taxation of corporations.
Shares eligible for future sale may adversely affect the market. From time to time, certain of our stockholders may be eligible to sell all or some of their common shares by means of ordinary brokerage transactions in the open market pursuant to effective resale registration statements and Rule 144 promulgated under the Securities Act, subject to certain limitations.
Stock eligible for future sale may adversely affect the market. From time to time, certain of our stockholders may be eligible to sell all or some of their common stock by means of ordinary brokerage transactions in the open market pursuant to effective resale registration statements and Rule 144 promulgated under the Securities Act, subject to certain limitations.
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 have no history of commercializing products, which may make it difficult for an investor to evaluate the success of our business to date and to assess our future viability.
A decline in the value of our Company could also cause you to lose all or part of your investment. 43 We have a limited operating history and no prior history of commercializing products, which may make it difficult for an investor to evaluate the success of our business to date and to assess our future viability.
We may not be successful in accomplishing these required tasks. 78 Establishing an internal sales or marketing team with technical expertise and supporting distribution capabilities to commercialize our product candidates will be expensive and time-consuming and will require significant attention of our executive officers to manage.
We may not be successful in accomplishing these required tasks. 83 Establishing an internal sales or marketing team with technical expertise and supporting distribution capabilities to commercialize our product candidates will be expensive and time-consuming and will require significant attention of our executive officers to manage.
If we are unable to successfully identify, acquire, develop and commercialize additional product candidates, our commercial opportunities may be limited. 40 We have initially concentrated our research and development efforts on the treatment of Alzheimer’s Disease, a disease that has seen limited success in drug development.
If we are unable to successfully identify, acquire, develop and commercialize additional product candidates, our commercial opportunities may be limited. 48 We have initially concentrated our research and development efforts on the treatment of Alzheimer’s Disease, a disease that has seen limited success in drug development.
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. Additionally, states in which we operate or own assets may impose new or increased taxes.
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 stock. Additionally, states in which we operate or own assets may impose new or increased taxes.
Risks Related to Commercialization and Manufacturing ● ZUNVEYL oral tablet formulation may fail to achieve the broad degree of adoption and use by physicians, patients, hospitals, healthcare payors and others in the medical community necessary for commercial success. ● The market opportunities for ZUNVEYL oral tablet formulation may be smaller than we anticipate. ● We rely on third-party suppliers to manufacture our product candidates, and we intend to rely on third parties to produce commercial supplies of ZUNVEYL and any other approved product.
Summary of Risk Factors Risks Related to Commercialization and Manufacturing ● ZUNVEYL oral tablet formulation may fail to achieve the broad degree of adoption and use by physicians, patients, hospitals, healthcare payors and others in the medical community necessary for commercial success. ● The market opportunities for ZUNVEYL oral tablet formulation may be smaller than we anticipate. ● We rely on third-party suppliers to manufacture our product candidates, and we intend to rely on third parties to produce commercial supplies of ZUNVEYL and any other approved product.
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, India.
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 Hyderabad, India.
We currently rely on third parties at key stages in our supply chain. For instance, the supply chains for our lead product candidate involves several manufacturers that specialize in specific operations of the manufacturing process, specifically, raw materials manufacturing, drug substance manufacturing and drug product manufacturing.
We currently rely on third parties at key stages in our supply chain. For instance, the supply chains for our lead product candidate involve several manufacturers that specialize in specific operations of the manufacturing process, specifically, raw materials manufacturing, drug substance manufacturing and drug product manufacturing.
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 shares and warrants. If securities analysts or investors perceive these results to be negative, it could adversely impact the price of our common shares and warrants.
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 stock and warrants. If securities analysts or investors perceive these results to be negative, it could adversely impact the price of our common stock and warrants.
If our existing stockholders sell, or indicate an intention to sell, substantial amounts of our common shares in the public market after any legal restrictions on resale discussed in this Annual Report lapse, the trading price of our common shares could decline.
If our existing stockholders sell, or indicate an intention to sell, substantial amounts of our common stock in the public market after any legal restrictions on resale discussed in this Annual Report lapse, the trading price of our common stock could decline.
If any of our other product candidates receive regulatory approval, wWe expect to expand our sales organization with technical expertise and supporting distribution capabilities to commercialize each such product candidate, which will be expensive and time consuming.
If any of our other product candidates receive regulatory approval, we expect to expand our sales organization with technical expertise and supporting distribution capabilities to commercialize each such product candidate, which will be expensive and time consuming.
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.
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 stock.
If such post-approval studies fail to confirm the drug’s clinical benefit, the FDA may withdraw its approval of the drug. 72 Prior to seeking such accelerated approval, we will seek feedback from the FDA and will otherwise evaluate our ability to seek and receive such accelerated approval.
If such post-approval studies fail to confirm the drug’s clinical benefit, the FDA may withdraw its approval of the drug. 77 Prior to seeking such accelerated approval, we will seek feedback from the FDA and will otherwise evaluate our ability to seek and receive such accelerated approval.
We will have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage 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.
We will have to pay any amounts awarded by a court or negotiated in a settlement that exceeds our coverage 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.
Congress, including changes in U.S. tax law, may adversely impact us and the value of our Common Shares. Changes to U.S. tax laws (which changes may have retroactive application) could adversely affect us or holders of the common shares.
Congress, including changes in U.S. tax law, may adversely impact us and the value of our Common Stock. Changes to U.S. tax laws (which changes may have retroactive application) could adversely affect us or holders of the common stock.
Risks including periodic foreign economic downturns and political instability, which may adversely affect the Company’s ability to obtain materials and conduct business in Taiwan. ● Our product candidates have never been manufactured on a commercial scale, and there are risks associated with scaling up manufacturing to commercial scale.
Risks including periodic foreign economic downturns and political instability, which may adversely affect the Company’s ability to obtain materials and conduct business in Taiwan. ● Our product candidates have not previously been manufactured on a commercial scale, and there are risks associated with scaling up manufacturing to commercial scale.
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.
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, 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.
In such cases, we may decide that the more prudent course of action is to simply monitor the situation or seek some other non-litigious action or solution. Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of our common shares to decline.
In such cases, we may decide that the more prudent course of action is to simply monitor the situation or seek some other non-litigious action or solution. 69 Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of our common stock to decline.
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 shares generally must include as ordinary income each year the excess of the fair market value of the common shares over the taxpayer’s basis therein. 81 Proposed legislation in the 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 stock generally must include as ordinary income each year the excess of the fair market value of the common stock over the taxpayer’s basis therein. Proposed legislation in 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. It may be difficult to enforce judgments or bring actions outside the United States against us and certain of our directors.
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 stock. 87 It may be difficult to enforce judgments or bring actions outside the United States against us and certain of our directors.
Our product candidates have never been manufactured on a commercial scale, and there are risks associated with scaling up manufacturing to commercial scale including, among others, cost overruns, potential problems with process scale-up, process reproducibility, stability issues, lot consistency and timely availability of raw materials.
Our product candidates have not previously been manufactured on a commercial scale, and there are risks associated with scaling up manufacturing to commercial scale including, among others, cost overruns, potential problems with process scale-up, process reproducibility, stability issues, lot consistency and timely availability of raw materials.
If following marketing approval of ZUNVEYL (which was received on July 26, 2024) or of any of our future product candidates, we or others later identify undesirable and unforeseen side effects caused by such product, a number of potentially significant negative consequences could result, including but not limited to: ● regulatory authorities may suspend, limit or withdraw approvals of such product, or seek an injunction against its manufacture or distribution; ● we may be required to conduct additional clinical trials or post-approval studies; ● we may be required to recall a product or change the way such product is administered to patients; ● additional restrictions may be imposed on the marketing of the particular product or the manufacturing processes for the product or any component thereof; 45 ● regulatory authorities may require the addition of labeling statements, such as a “black box” warning or a contraindication, or issue safety alerts, Dear Healthcare Provider letters, press releases or other communications containing warnings or other safety information about the product; ● we may be required to implement a Risk Evaluation and Mitigation Strategy, or REMS, or create a Medication Guide outlining the risks of such side effects for distribution to patients, a communication plan for healthcare providers and/or other elements to assure safe use; ● we could be sued and held liable for harm caused to patients; ● we may be subject to fines, injunctions or the imposition of criminal penalties; ● the product may become less competitive; and ● our reputation may suffer.
Further, clinical trials may not be sufficient to determine the effect and safety consequences of taking our product candidates over a multi-year period. 53 If following marketing approval of ZUNVEYL (which was received on July 26, 2024) or of any of our future product candidates, we or others later identify undesirable and unforeseen side effects caused by such product, a number of potentially significant negative consequences could result, including but not limited to: ● regulatory authorities may suspend, limit or withdraw approvals of such product, or seek an injunction against its manufacture or distribution; ● we may be required to conduct additional clinical trials or post-approval studies; ● we may be required to recall a product or change the way such product is administered to patients; ● additional restrictions may be imposed on the marketing of the particular product or the manufacturing processes for the product or any component thereof; ● regulatory authorities may require the addition of labeling statements, such as a “black box” warning or a contraindication, or issue safety alerts, Dear Healthcare Provider letters, press releases or other communications containing warnings or other safety information about the product; ● we may be required to implement a Risk Evaluation and Mitigation Strategy, or REMS, or create a Medication Guide outlining the risks of such side effects for distribution to patients, a communication plan for healthcare providers and/or other elements to assure safe use; ● we could be sued and held liable for harm caused to patients; ● we may be subject to fines, injunctions or the imposition of criminal penalties; ● the product may become less competitive; and ● our reputation may suffer.
An inactive market may also impair our ability to raise capital by selling shares and may impair our ability to acquire other product candidates, businesses or technologies using our shares as consideration.
An inactive market may also impair our ability to raise capital by selling stock and may impair our ability to acquire other product candidates, businesses or technologies using our stock as consideration.
If securities analysts or investors perceive these results to be negative, it could harm the price of our common shares and warrants.
If securities analysts or investors perceive these results to be negative, it could harm the price of our common stock and warrants.
The degree of market acceptance of our product candidates, if approved for commercial sale, will depend on a number of factors, including: ● the clinical indications for which the product is approved and patient demand for approved products that treat those indications; ● the safety and efficacy of our product as compared to other available therapies; ● the availability of coverage and adequate reimbursement from governmental healthcare plans or third party payors for any of our product candidates that may be approved; ● acceptance by physicians, operators of clinics and patients of the product as a safe and effective treatment; ● physician and patient willingness to adopt a new therapy over other available therapies to treat approved indications; ● overcoming any biases physicians or patients may have toward particular therapies for the treatment of approved indications; ● proper training and administration of our product candidates by physicians and medical staff; ● public misperception regarding the use of our therapies, if approved for commercial sale; ● patient satisfaction with the results and administration of our product candidates and overall treatment experience, including, for example, the convenience of any dosing regimen; ● the cost of treatment with our product candidates in relation to alternative treatments and reimbursement levels, if any, and willingness to pay for the product, if approved, on the part of insurance companies and other third-party payors, physicians and patients; ● the revenue and profitability that our products may offer a physician as compared to alternative therapies; ● limitations or warnings contained in the FDA-approved labeling for our products; ● any FDA requirement to undertake a REMS; ● the effectiveness of our sales, marketing and distribution efforts; ● adverse publicity about our products or favorable publicity about competitive products; and ● potential product liability claims.
The degree of market acceptance of our product candidates, if approved for commercial sale, will depend on a number of factors, including: ● the clinical indications for which the product is approved and patient demand for approved products that treat those indications; ● the safety and efficacy of our product as compared to other available therapies; ● the availability of coverage and adequate reimbursement from governmental healthcare plans or payors for any of our product candidates that may be approved; ● acceptance by physicians, operators of clinics and patients of the product as a safe and effective treatment; ● physician and patient willingness to adopt a new therapy over other available therapies to treat approved indications; ● overcoming any biases physicians or patients may have toward particular therapies for the treatment of approved indications; ● proper training and administration of our product candidates by physicians and medical staff; ● public misperception regarding the use of our therapies, if approved for commercial sale; ● patient satisfaction with the results and administration of our product candidates and overall treatment experience, including, for example, the convenience of any dosing regimen; ● the cost of treatment with our product candidates in relation to alternative treatments and reimbursement levels, if any, and willingness to pay for the product, if approved, on the part of insurance companies and other third-party payors, physicians and patients; ● the revenue and profitability that our products may offer a physician as compared to alternative therapies; ● limitations or warnings contained in the FDA-approved labeling for our products; ● any FDA requirement to undertake a REMS; ● the effectiveness of our sales, marketing and distribution efforts; ● adverse publicity about our products or favorable publicity about competitive products; and ● potential product liability claims. 38 We cannot assure you that our current or future product candidates, if approved, will achieve broad market acceptance among physicians, patients, healthcare payors and others in the medical community.
Summary of Risk Factors Risks Related to Our Financial Position ● We are a commercial development stage biopharmaceutical company in the early stages of commercial development of our one product approved for commercial sale and have incurred significant losses since our inception.
Risks Related to Our Financial Position ● We are a commercial stage biopharmaceutical company in the early stages of commercial development of our one product approved for commercial sale and have incurred significant losses since our inception.
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 our ability to commercialize ZUNVEYL and adversely affect our business, financial condition, results of operations and prospects.
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 the commercial success of ZUNVEYL and adversely affect our business, financial condition, results of operations and prospects.
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.
If we sell our common stock in future financings, stockholders may experience immediate dilution and, as a result, our stock price may decline.
Additionally, geopolitical tensions and ongoing conflicts in the Middle East, particularly between Israel and Hamas and Israel and Hezbollah, may lead to global economic instability and fluctuating energy prices that could materially affect our business.
Additionally, geopolitical tensions and ongoing conflicts in the Middle East, particularly between the United States, Israel and Iran, Israel and Hamas and Israel and Hezbollah, may lead to global economic instability and fluctuating energy prices that could materially affect our business.
Our pending applications cannot be enforced against third parties practicing the technology claimed in such applications unless and until a patent issues from such applications. Any such outcome could harm our business.
Our pending applications cannot be enforced against third parties practicing the technology claimed in such applications unless and until a patent is issued from such applications. Any such outcome could harm our business.
We cannot give any assurance that any of our product candidates will receive regulatory approval. ● Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business. ● Failure to comply with health and data protection laws and regulations could lead to government enforcement actions and civil or criminal penalties, private litigation or adverse publicity and could negatively affect our operating results and business. ● Even if the product candidates that we develop receive regulatory approval in the United States or another jurisdiction, they may never receive approval in other jurisdictions, which would limit market opportunities for our product candidates and adversely affect our business. ● We face significant competition in an environment of rapid technological and scientific change, and there is a possibility that our competitors may achieve regulatory approval before us or develop therapies that are safer, more advanced or more effective than ours, which may negatively impact our ability to successfully market or commercialize any product candidates we may develop and ultimately harm our financial condition.
We cannot give any assurance that any of our product candidates will receive regulatory approval. ● Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business. ● Failure to comply with health and data protection laws and regulations could lead to government enforcement actions and civil or criminal penalties, private litigation or adverse publicity and could negatively affect our operating results and business. ● Even if the product candidates that we develop receive regulatory approval in the United States or another jurisdiction, they may never receive approval in other jurisdictions, which would limit market opportunities for our product candidates and adversely affect our business. ● We face significant competition in an environment of rapid technological and scientific change, and there is a possibility that our competitors may achieve regulatory approval before us or develop therapies that are safer, more advanced or more effective than ours, which may negatively impact our ability to successfully market or commercialize any product candidates we may develop and ultimately harm our financial condition. 35 Risks Related to Our Intellectual Property ● Our success depends on our ability to obtain and maintain patent protection for our technology and product candidates including our lead product, ALPHA-1062.
If we are a PFIC for any year during a U.S. taxpayer’s holding period of common shares, then such U.S. taxpayer generally will be required to treat any gain realized upon a disposition of the common shares, as applicable, or any so-called ‘‘excess distribution’’ received on its common shares, as applicable, as ordinary income, and to pay an interest charge on a portion of such gain or distribution.
If we are a PFIC for any year during a U.S. taxpayer’s holding period of common stock, then such U.S. taxpayer generally will be required to treat any gain realized upon a disposition of the common stock, as applicable, or any so-called “excess distribution” received on its common stock, as applicable, as ordinary income, and to pay an interest charge on a portion of such gain or distribution.
Our future capital requirements will depend on many factors, including, but not limited to: ● the scope, progress, costs and results of our ongoing support and commercialization of ZUNVEYL, including manufacturing, distribution, marketing and sales, obtaining favorable insurance coverage and reimbursement decisions from governmental and third-party payors, as well as the associated costs, including any unforeseen costs we may incur as a result of additional preclinical study or clinical trials that may be required, or other delays; ● the scope, progress, costs and results of preclinical development, laboratory testing and clinical trials for any future product candidates we may decide to pursue; ● the extent to which we develop, in-license or acquire other product candidates and technologies; ● the costs and timing of process development and manufacturing scale-up activities associated with our product candidates and other programs we advance them through preclinical and clinical development; ● the number and development requirements of other product candidates that we may pursue; ● the extent to which we acquire or in-license other product candidates and technologies; ● the costs, timing and outcome of regulatory review of our product candidates; 37 ● the costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution, for any of our other product candidates for which we receive marketing approval; ● the effect of competing products that may limit market penetration of our products; ● the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval; ● our ability to establish collaborations to commercialize ZUNVEYL or any of our other product candidates outside the United States; ● the timing, receipt and amount of sales of, or milestone payments related to or royalties on, our current or future product candidates, if any; ● the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; ● the extent to which we acquire or invest in businesses, products, or technologies; and ● the additional costs we may incur as a result of operating as a public company, including our efforts to enhance operational systems and hire additional personnel, including enhanced internal controls over financial reporting.
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. 44 Our future capital requirements will depend on many factors, including, but not limited to: ● the scope, progress, costs and results of our ongoing support and commercialization of ZUNVEYL, including manufacturing, distribution, marketing and sales, obtaining favorable insurance coverage and reimbursement decisions from governmental and third-party payors, as well as the associated costs, including any unforeseen costs we may incur as a result of additional preclinical study or clinical trials that may be required, or other delays; ● the scope, progress, costs and results of preclinical development, laboratory testing and clinical trials for any future product candidates we may decide to pursue; ● the extent to which we develop, in-license or acquire other product candidates and technologies; ● the costs and timing of process development and manufacturing scale-up activities associated with our product candidates and other programs we advance them through preclinical and clinical development; ● the number and development requirements of other product candidates that we may pursue; ● the extent to which we acquire or in-license other product candidates and technologies; ● the costs, timing and outcome of regulatory review of our product candidates; ● the costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution, for any of our other product candidates for which we receive marketing approval; ● the effect of competing products that may limit market penetration of our products; ● the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval; ● our ability to establish collaborations to commercialize ZUNVEYL or any of our other product candidates outside the United States; ● the timing, receipt and amount of sales of, or milestone payments related to or royalties on, our current or future product candidates, if any; ● the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; ● the extent to which we acquire or invest in businesses, products, or technologies; and ● the additional costs we may incur as a result of operating as a public company, including our efforts to enhance operational systems and hire additional personnel, including enhanced internal controls over financial reporting.
We are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, and we intend to take advantage of some of the exemptions from reporting requirements that are applicable to other public companies that are not emerging growth companies, including: ● not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting; ● not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements; ● reduced disclosure obligations regarding executive compensation in our periodic reports, proxy statements and registration statements; and ● not being required to hold a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.
We are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, and we intend to take advantage of some of the exemptions from reporting requirements that are applicable to other public companies that are not emerging growth companies, including: ● not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting; ● not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements; ● reduced disclosure obligations regarding executive compensation in our periodic reports, proxy statements and registration statements; and ● not being required to hold a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. 86 We cannot predict if investors will find our common stock less attractive because we will rely on these exemptions.
Following the marketing approval of ZUNVEYL 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.
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.
The success of our business, including our ability to finance our Company and generate revenue in the future, will primarily depend on the successful commercialization of ZUNVEYL, our only FDA approved product, and the development, regulatory approval and commercialization of our product candidates.
The success of our business, including our ability to finance our Company and generate revenue in the future, will primarily depend on the commercial success of ZUNVEYL, our only FDA approved and commercially produced product, and the development, regulatory approval and commercialization of our other product candidates.
Many similar privacy laws have been proposed at the federal level and in other states. 50 Foreign data protection laws, including Regulation 2016/679, known as the General Data Protection Regulation, or GDPR, may also apply to health-related and other personal information data subjects in the EU or the United Kingdom, or UK.
Many similar privacy laws have been proposed at the federal level and in other states. Foreign data protection laws, including Regulation 2016/679, known as the General Data Protection Regulation, or GDPR, may also apply to health-related and other personal information data subjects in the EU or the United Kingdom, or UK. The GDPR went into effect on May 25, 2018.
The GDPR went into effect on May 25, 2018. Companies that must comply with the GDPR face increased compliance obligations and risk, including robust regulatory enforcement of data protection requirements as well as potential fines for noncompliance of up to €20 million or 4% of annual global revenue of the noncompliance company, whichever is greater.
Companies that must comply with the GDPR face increased compliance obligations and risk, including robust regulatory enforcement of data protection requirements as well as potential fines for noncompliance of up to €20 million or 4% of annual global revenue of the noncompliance company, whichever is greater.
If we are not successful in identifying, developing, in-licensing, acquiring or/and commercializing additional product candidates, our ability to expand our business and achieve our strategic objectives would be impaired. ● We may encounter substantial delays in our preclinical studies and clinical trials or may not be able to conduct or complete our preclinical studies or clinical trials on the timelines we expect, if at all. ● Use of our therapeutic candidates could be associated with side effects, adverse events or other properties or safety risks, which could delay or preclude approval, cause us to suspend or discontinue clinical trials, abandon a therapeutic candidate, limit the commercial profile of an approved label or result in other significant negative consequences that could severely harm our business, prospects, operating results and financial condition. ● Interim “top-line” and preliminary data from studies or trials that we announce or publish from time to time may change as more data becomes available and are subject to audit and verification procedures that could result in material changes in the final data. 32 ● We have conducted all of our clinical trials to date outside of the United States, and in the future plan to conduct clinical trials for product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials. ● If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our current or future product candidates.
If we are not successful in identifying, developing, in-licensing, acquiring or/and commercializing additional product candidates, our ability to expand our business and achieve our strategic objectives would be impaired. ● We may encounter substantial delays in our preclinical studies and clinical trials or may not be able to conduct or complete our preclinical studies or clinical trials on the timelines we expect, if at all. ● Use of our therapeutic candidates could be associated with side effects, adverse events or other properties or safety risks, which could delay or preclude approval, cause us to suspend or discontinue clinical trials, abandon a therapeutic candidate, limit the commercial profile of an approved label or result in other significant negative consequences that could severely harm our business, prospects, operating results and financial condition. ● Interim “top-line” and preliminary data from studies or trials that we announce or publish from time to time may change as more data becomes available and are subject to audit and verification procedures that could result in material changes in the final data. ● We have conducted all of our clinical trials to date outside of the United States, and in the future plan to conduct clinical trials for product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials. ● If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our current or future product candidates. ● We identified material weaknesses in our internal control over financial reporting which are in the process of being remediated, and if we fail to maintain an effective system of disclosure controls and internal control over financial reporting, our ability to produce timely and accurate financial statements or comply with applicable laws and regulations could be impaired.
Our ability to use our net operating loss carryforwards to offset future taxable income may be subject to certain limitations. At December 31, 2024, the Company had, for Canadian tax purposes, non-capital losses aggregating approximately $51,884,000 million.
Our ability to use our net operating loss carryforwards to offset future taxable income may be subject to certain limitations. At December 31, 2025, the Company had, for Canadian tax purposes, non-capital losses aggregating approximately $57 million.
We currently carry product liability insurance covering our clinical trials. Although we maintain such insurance, any claim that may be brought against us could result in a court judgment 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.
Although we maintain such insurance, any claim that may be brought against us could result in a court judgment 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.
These losses are available to reduce taxable income earned by the Alpha Cognition Canada Inc. in future years and expire between 2035 and 2044. Additionally, as of December 31, 2024, the Company had, for United States of America tax purposes, non-capital losses aggregating approximately $9,000.
These losses are available to reduce taxable income earned by the Company and Alpha Cognition Canada Inc. in future years and expire between 2035 and 2045. Additionally, as of December 31, 2025, the Company had, for United States of America tax purposes, non-capital losses aggregating approximately $11 million.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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We also maintain cybersecurity insurance. Our assessment and management of material risks from cybersecurity threats are taken into account in our overall risk management processes.
We also maintain cybersecurity insurance. 92 Our assessment and management of material risks from cybersecurity threats are taken into account in our overall risk management processes.
We use third-party service providers to assist management to identify, assess, and manage material risks from cybersecurity threats, including for example, a managed security provider and professional services firms, including outside legal counsel. 87 We use third-party service providers to perform a variety of functions throughout our business, including, for example, application providers, hosting companies, contract research organizations, and contract manufacturing organizations.
We use third-party service providers to assist management to identify, assess, and manage material risks from cybersecurity threats, including for example, a managed security provider and professional services firms, including outside legal counsel.
Added
We use third-party service providers to perform a variety of functions throughout our business, including, for example, application providers, hosting companies, contract research organizations, and contract manufacturing organizations.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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However, from time to time, we may become involved in other litigation or legal proceedings relating to claims arising from the ordinary course of business
However, from time to time, we may become involved in other litigation or legal proceedings relating to claims arising from the ordinary course of business ITEM 4. MINE SAFETY DISCLOSURES Not applicable. 93 PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Residents should consult their own legal, accounting and tax advisors regarding such tax consequences under United States, state, local or foreign tax law regarding the acquisition or disposition of our common shares or other securities, in particular, the tax consequences of the Company possibly being a PFIC within the meaning of Section 1297 of the United States Internal Revenue Code.
Residents should consult their own legal, accounting and tax advisors regarding such tax consequences under United States, state, local or foreign tax law regarding the acquisition or disposition of our common stock or other securities, in particular, the tax consequences of the Company possibly being a PFIC within the meaning of Section 1297 of the United States Internal Revenue Code.
However, members of, or holders of, an interest in such entities that hold common shares may be entitled to the benefits of the Convention for income derived through such entities. Such members or holders should consult their own tax advisors in this regard.
However, members of, or holders of, an interest in such entities that hold common stock may be entitled to the benefits of the Convention for income derived through such entities. Such members or holders should consult their own tax advisors in this regard.
Comment is restricted to holders of common shares each of whom, at all material times for the purposes of the Canadian Tax Act and the Convention: (i) is resident solely in the United States; (ii) is entitled to the benefits of the Convention; (iii) holds all common shares as capital property; (iv) holds no common shares that are “taxable Canadian property” (as defined in the Canadian Tax Act) of the holder; (v) deals at arm’s length with and is not affiliated with Vista; (vi) does not and is not deemed to use or hold any common shares in a business carried on in Canada; and (vii) is not an insurer that carries on business in Canada and elsewhere; (each such holder, a “U.S.
Comment is restricted to holders of common stock each of whom, at all material times for the purposes of the Canadian Tax Act and the Convention: (i) is resident solely in the United States; (ii) is entitled to the benefits of the Convention; (iii) holds all common stock as capital property; (iv) holds no common stock that are “taxable Canadian property” (as defined in the Canadian Tax Act) of the holder; (v) deals at arm’s length with and is not affiliated with Alpha Cognition; (vi) does not and is not deemed to use or hold any common stock in a business carried on in Canada; and (vii) is not an insurer that carries on business in Canada and elsewhere; (each such holder, a “U.S.
See the section “Item 1A. – Risk Factors – The Company is possibly a “passive foreign investment company,” which would likely have adverse U.S. federal income tax consequences for U.S. shareholders” above.
See the section “Item 1A. – Risk Factors – The Company is possibly a “passive foreign investment company,” which would likely have adverse U.S. federal income tax consequences for U.S. shareholders” above. ITEM 6. [RESERVED]
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKERHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information On November 12, 2024, our common shares began trading on the Nasdaq under the symbol “ACOG”. Our common shares were previously traded on the CSE, but were voluntarily delisted on December 17, 2024.
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information On November 12, 2024, our common stock began trading on the Nasdaq under the symbol “ACOG”. Our common stock were previously traded on the CSE, but were voluntarily delisted on December 17, 2024.
The discussion below is qualified accordingly. A U.S. Resident Holder who disposes or is deemed to dispose of one or more common shares generally should not thereby incur any liability for Canadian federal income tax in respect of any capital gain arising as a consequence of the disposition. A U.S.
Resident Holder who disposes or is deemed to dispose of one or more common stock generally should not thereby incur any liability for Canadian federal income tax in respect of any capital gain arising as a consequence of the disposition. A U.S.
Resident Holder to whom Vista pays or is deemed to pay a dividend on the holder’s common shares will be subject to Canadian withholding tax, and Vista will be required to withhold the tax from the dividend and remit it to the CRA for the holder’s account.
Resident Holder to whom Alpha Cognition pays or is deemed to pay a dividend on the holder’s common stock will be subject to Canadian withholding tax, and Alpha Cognition will be required to withhold the tax from the dividend and remit it to the CRA for the holder’s account.
Certain Canadian Federal Income Tax Considerations for U.S. Residents The following summarizes certain Canadian federal income tax consequences generally applicable under the Income Tax Act (Canada) and the regulations enacted thereunder (collectively, the “Canadian Tax Act”) and the Canada-United States Income Tax Convention (1980) (the “Convention”) to the holding and disposition of common shares.
Residents The following summarizes certain Canadian federal income tax consequences generally applicable under the Income Tax Act (Canada) and the regulations enacted thereunder (collectively, the “Canadian Tax Act”) and the Canada-United States Income Tax Convention (1980) (the “Convention”) to the holding and disposition of common stock.
Generally, a holder’s common shares will be considered to be capital property of the holder provided that the holder is not a trader or dealer in securities, did not acquire, hold or dispose of the common shares in one or more transactions considered to be an adventure or concern in the nature of trade and does not hold the common shares as inventory in the course of carrying on a business. 90 Generally, a holder’s common shares will not be “taxable Canadian property” of the holder at a particular time at which the common shares are listed on a “designated stock exchange” (which currently includes the TSX) unless both of the following conditions are met at any time during the 60-month period ending at the particular time: (i) the holder, persons with whom the holder does not deal at arm’s length, or any partnership in which the holder or persons with whom the holder did not deal at arm’s length holds a membership interest directly or indirectly through one or more partnerships, alone or in any combination, owned 25% or more of the issued shares of any class of the capital stock of Vista; and (ii) more than 50% of the fair market value of the common shares was derived directly or indirectly from, or from any combination of, real or immovable property situated in Canada, “Canadian resource properties” (as defined in the Canadian Tax Act), “timber resource properties” (as defined in the Canadian Tax Act), or options in respect of or interests in such properties.
Generally, a holder’s common stock will not be “taxable Canadian property” of the holder at a particular time at which the common stock are listed on a “designated stock exchange” (which currently includes the TSX) unless both of the following conditions are met at any time during the 60-month period ending at the particular time: (i) the holder, persons with whom the holder does not deal at arm’s length, or any partnership in which the holder or persons with whom the holder did not deal at arm’s length holds a membership interest directly or indirectly through one or more partnerships, alone or in any combination, owned 25% or more of the issued stock of any class of the capital stock of Alpha Cognition; and (ii) more than 50% of the fair market value of the common stock was derived directly or indirectly from, or from any combination of, real or immovable property situated in Canada, “Canadian resource properties” (as defined in the Canadian Tax Act), “timber resource properties” (as defined in the Canadian Tax Act), or options in respect of or interests in such properties.
Resident Holder who beneficially owns the dividend will generally be subject to Canadian withholding tax at the rate of 15 % (or 5%, if the U.S. Resident Holder who beneficially owns the dividend is a company that is not fiscally transparent and which owns at least 10% of the voting stock of Vista) of the gross amount of the dividend.
Resident Holder who beneficially owns the dividend will generally be subject to Canadian withholding tax at the rate of 15 % (or 5%, if the U.S.
Exchange Controls There are no governmental laws, decrees or regulations in Canada that restrict the export or import of capital, including foreign exchange controls, or that affect the remittance of dividends, interest, or other payments to non-resident holders of the securities of Vista, other than Canadian withholding tax. See “Certain Canadian Federal Income Tax Considerations for U.S. Residents” below.
As of December 31, 2025 the Company has approximately $55.16 million of the net proceeds remaining in the bank. 94 Exchange Controls There are no governmental laws, decrees or regulations in Canada that restrict the export or import of capital, including foreign exchange controls, or that affect the remittance of dividends, interest, or other payments to non-resident holders of the securities of Alpha Cognition, other than Canadian withholding tax.
Except as otherwise expressly provided, this summary does not take into account any provincial, territorial or foreign tax considerations, which may differ materially from those set out herein.
Except as otherwise expressly provided, this summary does not take into account any provincial, territorial or foreign tax considerations, which may differ materially from those set out herein. 95 This summary is of a general nature only, is not exhaustive of all possible Canadian federal income tax considerations and is not intended to be and should not be construed as legal or tax advice to any particular U.S.
Investors in Alpha Cognition’s securities cannot expect to receive a dividend in the foreseeable future, if at all.
Dividend Policy We have paid no dividends on the common stock to date and we do not expect to pay dividends on our common stock in the foreseeable future. Investors in Alpha Cognition’s securities cannot expect to receive a dividend in the foreseeable future, if at all.
Certain United States Federal Income Tax Considerations for U.S. Residents There may be material tax consequences to U.S. Residents in relation to an acquisition or disposition of common shares or other securities of the Company. U.S.
Residents in relation to an acquisition or disposition of common stock or other securities of the Company. U.S.
This number does not include an indeterminate number of stockholders whose shares are held by brokers in street name through depositaries, including CDS & Co and CEDE & Co. Dividend Policy We have paid no dividends on the common shares to date and we do not expect to pay dividends on our common shares in the foreseeable future.
Holders of Our Common Stock As of March 30, 2026, we had approximately 119 registered holders of our common stock. This number does not include an indeterminate number of stockholders whose stock are held by brokers in street name through depositaries, including CDS & Co and CEDE & Co.
On November 5, 2024, we completed a reverse stock split of our common shares with a stock split ratio of 1-for-25 (“Reverse Stock Split”). Holders of Our Common Stock As of March 31, 2025, we had approximately 16,019,787 registered holders of our common shares.
On November 5, 2024, we completed a reverse stock split of our common stock with a stock split ratio of 1-for-25 (“Reverse Stock Split”). On March 30, 2026, the closing price for our common stock in quoted on the Nasdaq was $5.32.
This summary is of a general nature only, is not exhaustive of all possible Canadian federal income tax considerations and is not intended to be and should not be construed as legal or tax advice to any particular U.S. Resident Holder. U.S. Resident Holders are urged to consult their own tax advisers for advice with respect to their particular circumstances.
Resident Holder. U.S. Resident Holders are urged to consult their own tax advisers for advice with respect to their particular circumstances. The discussion below is qualified accordingly. A U.S.
Removed
Recent Unregistered Sales of Equity Securities During the fiscal year ended December 31, 2024, we had the following sales of unregistered shares of equity securities: a) January 2024, the Company Issued 678,630 private placement units at a price of $5.50 for total proceeds of $3,732,469 with each unit consisting of one Common Share one warrant exercisable at a price of $5.75 per full warrant for a term of three years from each closing date.
Added
Recent Unregistered Sales of Equity Securities None Repurchases of Equity Securities by Our Company and Affiliated Purchasers None.
Removed
The Q2 2023 PP Offering was finalized on January 19, 2024. In connection with the Offering closing during 2024, the Company paid cash commissions of $342,320 and issued 41,493 agents warrants. Each agent warrant is exercisable into one Common Share of the Company at an exercise price of $5.75 for a term of 3 years.
Added
Use of Proceeds On October 1, 2025, the Company completed a public offering of common stock by issuing 4,651,516 common shares at a public offering price of $6.25 per share and pre-funded warrants to purchase up to 948,484 common shares at a public offering price of $6.249 per share for gross proceeds of approximately $35 million, after deducting discounts and commissions and estimated offering expenses payable by us, of approximately $32.8 million.
Removed
In connection with the final closing, Spartan Capital Securities, LLC (“Spartan”) received cash compensation of US$342,320 and was issued 41,493 compensation warrants of the Company, which may be exercised on the same terms as the private placement warrants.
Added
The public offering was completed pursuant to the Company’s registration statement on Form S-3 (333-289792) which was brought effective by the SEC on August 29, 2025. Titan Partners Group LLC, a division of American Capital Partners, LLC (“Titan Partners Group”) acted as the managing underwriter for the offering.
Removed
The Company also paid a consulting fee of US$320,000 and issued 582,331 common shares to Spartan pursuant to a Consulting Agreement (see the Company’s news release dated May 30, 2023).
Added
In connection with the offering, the Company paid Titan Partners Group an underwriting discount of approximately $2 million. We paid an aggregate total of approximately $341,250 in other expenses, including expense reimbursement to Titan Partners Group, legal and accounting fees, transfer agent fees and printing costs.
Removed
The Company also paid to certain finders aggregate cash commission of US$48,858, being 6% of the gross proceeds raised under the Offering from investors introduced to the Company by such finders. b) On September 24, 2024, the Company issued approximately $4.545 million of convertible notes and warrants to purchase 430,805 common shares.
Added
On November 13, 2024, the Company completed a public offering of common stock by issuing 8,695,653 common shares at a public offering price of $5.75 per share for gross proceeds of approximately $50 million and net proceeds, after deducting discounts and commissions and estimated offering expenses payable by us, of approximately $46.15 million.
Removed
The securities were issued to private investors pursuant to the exemption under Rule 506(b) of Regulation D based, in part, on the representations made by the investors. c) On November 13, 2024 in connection with the closing of its public offering, the Company issued 608,696 underwriter warrants.
Added
The initial public offering was completed pursuant to the Company’s registration statement on Form S-1 (333-280196) which was brought effective by the SEC on November 8, 2024, registering 8,695,653 common shares and pre-funded warrants to purchase up to 8,695,653 common shares to gross aggregated proceeds of $50 million. No pre-funded warrants were sold in the offering.
Removed
The underwriter warrants were issued pursuant to the terms of an underwriting agreement to the representative of the underwriters for services performed under the underwriting agreement.
Added
Titan Partners Group acted as the managing underwriter for the offering. In connection with the offering, the Company paid Titan Partners Group an underwriting discount of approximately $3 million and a non-accountable expense allowance of $500,000. We also paid Spartan Capital Partners, LLC an investment banking fee of $500,000.
Removed
The underwriter warrants were issued pursuant to the exemption provided by Section 4(a)(2). 89 d) On November 13, 2024, concurrently with the closing of its public offering, pursuant to the terms of the convertible notes, the Company’s convertible notes automatically converted into 801,412 common shares at a price of $5.75 per share.
Added
We paid an aggregate total of approximately $350,000 in other expenses, including expense reimbursement to Titan Partners Group, legal and accounting fees, transfer agent fees and printing costs.
Removed
The Company issued the common shares on conversion of the convertible notes pursuant to the exemption from the registration requirements of the Securities Act provided by Section 3(a)(9) thereof. e) Upon closing of its public offering on November 13, 2024, pursuant to the terms of the securities purchase agreement entered into on, each Buyer was issued an additional 50% of Warrants with identical terms to the initial warrants, as adjusted at the time of closing of the public offering.
Added
Consistent with the Company’s described use of proceeds in its registration statement, to date the Company has spent approximately $15.32 million of its net proceeds to begin our efforts toward our commercialization and launch of ZUNVEYL formerly known as ALPHA-1062 in Alzheimer’s disease; approximately $3.98 million for continued commercial CMC activities (chemistry, manufacturing, and controls); approximately $0.91 million on repayment of outstanding loan and approximately $8.49 million for working capital and general corporate purposes.
Removed
The Company issued 215,421 Warrants to the Buyers. The Warrants were issued pursuant to the exemption from the registration requirements of the Securities Act provided by Section 4(a)(2) thereof. f) On December 16, 2024, the Company issued a representative’s purchase warrant to purchase up to an aggregate of 34,196 common shares.
Added
See “Certain Canadian Federal Income Tax Considerations for U.S. Residents” below. Certain Canadian Federal Income Tax Considerations for U.S.
Removed
The representatives warrant may be exercised beginning on June 14, 2025 until November 8, 2029. The initial exercise price of each warrant is $7.18 per share. The warrants were issued pursuant to the exemption from the registration requirements of the Securities Act provided by Section 4(a)(2) thereof. Repurchases of Equity Securities by Our Company and Affiliated Purchasers None.
Added
Generally, a holder’s common stock will be considered to be capital property of the holder provided that the holder is not a trader or dealer in securities, did not acquire, hold or dispose of the common stock in one or more transactions considered to be an adventure or concern in the nature of trade and does not hold the common stock as inventory in the course of carrying on a business.
Added
Resident Holder who beneficially owns the dividend is a company that is not fiscally transparent and which owns at least 10% of the voting stock of Alpha Cognition) of the gross amount of the dividend. Certain United States Federal Income Tax Considerations for U.S. Residents There may be material tax consequences to U.S.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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General and administrative expenses 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 attendance to various conferences. Personnel costs consist of salaries, benefits, and share-based compensation.
Selling, General and Administrative expenses 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 attendance to various conferences. Personnel costs consist of salaries, benefits, and share-based compensation.
We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as our voting and non-voting common stock held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter, or our annual revenue is less than $100.0 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.
We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as our voting and non-voting Common Stock held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter, or our annual revenue is less than $100.0 million during the most recently completed fiscal year and our voting and non-voting Common Shares held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.
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 acquisition, merger or collaboration transactions, selling or licensing our assets, making capital expenditures, redeeming our stock, making certain investments or declaring dividends.
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.
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”), commercialization of ZUNVEYL and operating costs.
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.
Critical Accounting Policies and Estimates Our management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with US GAAP.
Critical Accounting Estimates Our management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with US GAAP.
ZUNVEYL, is a patented new innovative product being developed 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 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.
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDIITION AND RESULTS OF OPERATIONS The following discussion and analysis should be read in conjunction with our audited consolidated financial statements for the fiscal year ended December 31, 2024, and the related notes thereto, which have been prepared in accordance with generally accepted accounting principles in the United States.
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDIITION AND RESULTS OF OPERATIONS The following discussion and analysis should be read in conjunction with our audited consolidated financial statements for the fiscal year ended December 31, 2025, and the related notes thereto, which have been prepared in accordance with generally accepted accounting principles in the United States.
On December 12, 2024, the underwriter of the Company’s underwritten U.S. public offering partially exercised its over-allotment option to purchase an additional 488,506 common shares at the public offering price of $5.75 per share for additional gross proceeds of $2.8 million.
On December 12, 2024, the underwriter of the Company’s underwritten U.S. public offering partially exercised its over-allotment option to purchase an additional 488,506 common stock at the public offering price of $5.75 per share for additional gross proceeds of $2.8 million.
The notes were set to mature on September 24, 2026, had an aggregate face value of $4.545 million and bears interest at a rate of 10% per annum paid in common shares of the Company at the conversion price, subject to certain limitations.
The notes were set to mature on September 24, 2026, had an aggregate face value of $4.545 million and bears interest at a rate of 10% per annum paid in common stock of the Company at the conversion price, subject to certain limitations.
The notes were subject to mandatory conversion into common shares of the Company in conjunction with the closing of an offering of securities of the Company for at least $10 million in aggregate gross proceeds in coordination with the simultaneous uplisting of the common shares of the Company onto a United States national securities exchange (a “Qualified Offering”).
The notes were subject to mandatory conversion into common stock of the Company in conjunction with the closing of an offering of securities of the Company for at least $10 million in aggregate gross proceeds in coordination with the simultaneous uplisting of the common stock of the Company onto a United States national securities exchange (a “Qualified Offering”).
Each investor received warrants sufficient to purchase such number of common shares equal to the principal amount of notes such investor purchased divided by the conversion price of the notes. Each investor will receive an additional 50% of warrants with identical terms upon the closing of a Qualified Offering, as described above.
Each investor received warrants sufficient to purchase such number of common stock equal to the principal amount of notes such investor purchased divided by the conversion price of the notes. Each investor will receive an additional 50% of warrants with identical terms upon the closing of a Qualified Offering, as described above.
Alpha Cognition has set the Wholesale Acquisition Cost (WAC) for its latest therapeutic product at $749 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.
Alpha Cognition has set the Wholesale Acquisition Cost (WAC) for its therapeutic product at $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.
The notes were unsecured and rank senior to the Company’s other indebtedness. ● The notes were sold along with warrants to purchase common shares of the Company at an exercise price of $10.55 for a five-year term.
The notes were unsecured and rank senior to the Company’s other indebtedness. ● The notes were sold along with warrants to purchase common stock of the Company at an exercise price of $10.55 for a five-year term.
The completion of the public offering of common shares was a “Qualified Offering” under the Company’s convertible notes, which automatically converted into 801,413 common shares at closing of the public offering at a price of $5.75 per share, being the public offering price in the Qualified Offering.
The completion of the public offering of common stock was a “Qualified Offering” under the Company’s convertible notes, which automatically converted into 801,413 common stock at closing of the public offering at a price of $5.75 per share, being the public offering price in the Qualified Offering.
The Company expects to continue to rely on debt and the issuance of shares, and possibly other non-dilutive financing options to finance its ongoing operations and plans for commercialization of ZUNVEYL.
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.
We expect to look to raise additional capital to continue to further advance our commercialization plans and ongoing operating costs. However, we 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.
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.
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 following receipt of the NDA approval for ZUNVEYL from the FDA.
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 for ZUNVEYL from the FDA.
The timing and amount of our funding requirements will depend on many factors, including: ● the initiation, type, number, scope, progress, expansions, results, costs and timing of clinical trials and preclinical studies of ZUNVEYL and any future product candidates we may choose to pursue, including the costs of modification to clinical development plans based on feedback that we may receive from regulatory authorities and any third-party products used as combination agents in our clinical trials; ● the costs, timing and outcome of regulatory meetings and reviews of ZUNVEYL or any future product candidates, including requirements of regulatory authorities in any additional jurisdictions in which we may seek approval for ZUNVEYL and any future product candidates; ● the costs of obtaining, maintaining, enforcing and protecting our patents and other intellectual property and proprietary rights; ● our efforts to enhance operational systems and hire additional personnel to satisfy our obligations as a public company, including enhanced internal control over financial reporting; ● the costs associated with hiring additional personnel and consultants as our business grows, including additional executive officers and clinical development, regulatory, CMC quality and commercial personnel; ● the costs and timing of establishing or securing sales and marketing capabilities of any future product candidate approval; ● our ability to achieve sufficient market acceptance, coverage, and adequate reimbursement from third-party payors and adequate market share and revenue for any approved products; ● our ability and strategic decision to develop future product candidates other than ZUNVEYL, and the timing of such development, if any; ● patients’ willingness to pay out-of-pocket for any approved products in the absence of coverage and/or adequate reimbursement from third-party payors; ● the terms and timing of establishing and maintaining collaborations, licenses and other similar arrangements; and ● costs associated with any products or technologies that we may in-license or acquire.
The timing and amount of our funding requirements will depend on many factors, including: ● the costs associated with the production, distribution and sales of ZUNVEYL, including any future expansion of production capabilities, expansion of distribution networks, expansion of our sales force and increased expenses on advertising or related sale costs; ● the costs associated with our licensing arrangements for ZUNVEYL, including increased costs from such arrangements and increasing the number and types of licensing arrangements; ● the initiation, type, number, scope, progress, expansions, results, costs and timing of clinical trials and preclinical studies of ZUNVEYL and any future product candidates we may choose to pursue, including the costs of modification to clinical development plans based on feedback that we may receive from regulatory authorities and any third-party products used as combination agents in our clinical trials; ● the costs, timing and outcome of regulatory meetings and reviews of ZUNVEYL or any future product candidates, including requirements of regulatory authorities in any additional jurisdictions in which we may seek approval for ZUNVEYL and any future product candidates; ● the costs of obtaining, maintaining, enforcing and protecting our patents and other intellectual property and proprietary rights; ● our efforts to enhance operational systems and hire additional personnel to satisfy our obligations as a public company, including enhanced internal control over financial reporting; ● the costs associated with hiring additional personnel and consultants as our business grows, including additional executive officers and clinical development, regulatory, CMC quality and commercial personnel; ● the costs and timing of establishing or securing sales and marketing capabilities of any future product candidate approval; ● our ability to achieve sufficient market acceptance, coverage, and adequate reimbursement from third-party payors and adequate market share and revenue for any approved products; ● our ability and strategic decision to develop future product candidates other than ZUNVEYL, and the timing of such development, if any; ● patients’ willingness to pay out-of-pocket for any approved products in the absence of coverage and/or adequate reimbursement from third-party payors; ● the terms and timing of establishing and maintaining collaborations, licenses and other similar arrangements; and ● costs associated with any products or technologies that we may in-license or acquire.
The Company has three additional pre-clinical development programs: ZUNVEYL in combination with memantine for the treatment of moderate-to-severe Alzheimer’s disease, ALPHA-1062 sublingual formulation, ALPHA-1062 intranasal (“ALPHA-1062IN”) formulation for the treatment of cognitive impairment with mild traumatic brain injury (mTBI; otherwise known as concussion) and 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).
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 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).
See section heading “Special Note Regarding Forward-Looking Statements.” Overview The Company is a biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer’s disease (“Alzheimer’s disease” or “AD”), for which there are limited or no treatment options. The Company will focuses on the development of commercial manufacturing and commercial sales of ZUNVEYL oral tablet formulation.
See section heading “Special Note Regarding Forward-Looking Statements.” Overview 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.
We currently have two license agreements, ALPHA-1062 technology and ALPHA-602 technology, which are outlined below. We expect to enter into additional clinical development, contract research, clinical and commercial manufacturing, supplier, and collaborative research agreements in the future, which may require upfront payments and long-term commitments of capital resources.
We currently have three license agreements, the CMSI License Agreement, ALPHA-1062 technology and ALPHA-602 technology, which are outlined below. We expect to enter into additional clinical development, contract research, clinical and commercial manufacturing, supplier, and collaborative research agreements in the future, which may require upfront payments and long-term commitments of capital resources.
On September 24, 2024, the Company announced the closing of a $4.545 million bridge financing through the issuance of convertible notes and warrants led by existing investors and select new investors comprised of institutional funds and high-net-worth accredited investors. ● The notes are convertible into common shares of the Company at a conversion price of $10.55 per share.
Financing Activities Recent capital raising activities On September 24, 2024, the Company announced the closing of a $4.545 million bridge financing through the issuance of convertible notes and warrants led by existing investors and select new investors comprised of institutional funds and high-net-worth accredited investors. ● The notes are convertible into common stock of the Company at a conversion price of $10.55 per share.
However, there is a risk that additional financing will not be available on a timely basis or on terms acceptable to the Company. 100 Future Funding Requirements We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we continue the commercialization of ZUNVEYL, following the FDA’s approval in July 2024 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.
However, there is a risk that additional financing will not be available on a timely basis or on terms acceptable to the Company. 101 Future Funding Requirements 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.
To the extent we raise additional capital through the sale of equity or convertible debt securities, 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.
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.
See “Note 13 – Commitments and Contingencies” of the accompanying financial statements for a discussion of our contractual obligations and long-term commitments. Contingencies The Company did not have any contingencies as of December 31, 2024, or the date of this report.
See “Note 14 – Commitments and Contingencies” of the accompanying consolidated financial statements for a discussion of our contractual obligations and long-term commitments. Contingencies The Company did not have any contingencies as of December 31, 2025, or the date of this report.
Liquidity and Capital Resources Sources of Liquidity The Company does not have operating revenue to finance its existing obligations and therefore must continue to rely on external financing 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.
Liquidity and Capital Resources Sources of Liquidity 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, 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.
We will continue to remain an emerging growth company until the earliest of the following: (1) the last day of the fiscal year following the fifth anniversary of the date of the effectiveness of the Registration Statement on Form S-1 of which this prospectus form a part; (2) the last day of the fiscal year in which our total annual gross revenue is equal to or more than $1.235 billion; (3) the date on which we have issued more than $1.0 billion in nonconvertible debt during the previous three years; or (4) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.
We will continue to remain an emerging growth company until the earliest of the following: (1) December 31, 2029; (2) the last day of the fiscal year in which our total annual gross revenue is equal to or more than $1.235 billion; (3) the date on which we have issued more than $1.0 billion in nonconvertible debt during the previous three years; or (4) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.
Possible sources of such capital may come from private placements and public offerings of the Company’s common shares and funds received from the exercise of warrants and share options. Additionally, the Company will also consider funding that may arise through partnership activities, including royalties, and debt.
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.
Until such time, if ever, we can generate substantial product revenue, we expect to finance our operations through equity offerings, debt financings, or other capital sources, including current or potential future collaborations, licenses, royalties and other similar arrangements.
Until such time, as we can generate substantial product revenue, we expect to finance our operations other capital sources, including current or potential future collaborations, licenses, royalties and other similar arrangements.
Change in Fair Value of Derivative Liabilities and Conversion of Convertible Debt The Company used the Monte Carlo Simulation to determine the fair value of the conversion feature liability and warrants liability for recognition and subsequent conversion of the convertible debentures.
Change in Fair Value of Derivative Liabilities and Conversion of Convertible Debt The Company used the Monte Carlo Simulation to determine the fair value of the initial recognition of the convertible debentures and conversion feature liability in the 2024 year end.
Additionally, as a result of the closing of the Qualified Offering, the Company issued an additional 215,418 warrants exercisable to acquire 215,421 Common Shares with an exercise price of $7.19 per share and the exercise price of the Company’s existing 430,835 warrants issued in connection with the offering of the convertible notes was repriced from $10.55 per share to $7.19 per share.
The amount converted consisted of the converted principal amount of convertible notes and interest through November 13, 2024. 103 Additionally, as a result of the closing of the Qualified Offering, the Company issued an additional 215,421 warrants exercisable to acquire 215,421 Common Stock with an exercise price of $7.19 per share and the exercise price of the Company’s existing 430,835 warrants issued in connection with the offering of the convertible notes was repriced from $10.55 per share to $7.19 per share.
The Company will target 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. The company’s anticipated launch is in Q1 2025.
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.
In addition, we could utilize our available capital resources sooner than we expected. The Company is also contemplating raising additional capital by pursuing both dilutive and non-dilutive strategic sources of capital; to fully execute its commercial and operating plans following receipt of the NDA approval for ZUNVEYL from the FDA.
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.
Based upon our current operating plan, we estimate that our existing cash, cash equivalents and marketable securities as of the date of this filing, will be sufficient to fund our projected base ongoing operating expenses, the initial costs to prepare for commercialization of ZUNVEYL in AD, planned CMC costs, ongoing operating costs and capital expenditures through at least the next 24 months.
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 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.
Research and Development 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.
The Company had $48,564,082 in cash and cash equivalents, including restricted cash, and $3,350,752 in current liabilities (of which $97,515 is payable from the Company’s available restricted cash balance) as of December 31, 2024. The Company’s continuing operations, as intended, are highly dependent upon its ability to obtain additional funding and eventually generate cash flows.
The Company had $66,105,189 in cash and cash equivalents, including restricted cash, and $9,130,075 in current liabilities (of which $44,464 is payable from the Company’s available restricted cash balance) as of December 31, 2025. The Company’s continuing operations, as intended, are highly dependent upon its ability to obtain additional funding and eventually positive generate cash flows.
The Company uses the Black-Scholes Option Pricing Model to determine the fair value of stock options, standalone share purchase warrants issued and derivative liability. This model requires the input of subjective assumptions including expected share price volatility, interest rate, and forfeiture rate.
Changes in the input assumptions can materially affect the fair value estimate and the Company’s net loss and liabilities. The Company uses the Black-Scholes Option Pricing Model to determine the fair value of stock options, and derivative liabilities. This model requires the input of subjective assumptions including expected share price volatility, interest rate, and forfeiture rate.
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 for pre-clinical development to study an intranasal formulation for cognitive impairment with mTBI.
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. The Company is the parent company of Alpha Cognition Canada Inc.
The exercise price of the warrants is subject to adjustment upon the completion of a Qualified Offering to the lower of (i) the then existing exercise price, (ii) the exercise price of any common share purchase warrants issued in the Qualified Offering or (iii) if no common share purchase warrants are issued in the Qualified Offering, the closing price of the common shares on the Canadian Securities Exchange (as converted into U.S. dollars) immediately prior to the pricing news release of the Qualified Offering. 103 On November 13, 2024, the Company completed a public offering of common shares by issuing 8,695,653 common shares at a public offering price of $5.75 per share for gross proceeds of approximately $50 million.
The exercise price of the warrants is subject to adjustment upon the completion of a Qualified Offering to the lower of (i) the then existing exercise price, (ii) the exercise price of any common stock purchase warrants issued in the Qualified Offering or (iii) if no common stock purchase warrants are issued in the Qualified Offering, the closing price of the common stock on the Canadian Securities Exchange (as converted into U.S. dollars) immediately prior to the pricing news release of the Qualified Offering.
The Company’s commercial development program for ZUNVEYL is primarily focused on building a long-term care commercial team that can focus on providing key points of differentiation, exploiting key issues with existing AChEI treatments, and franchising potential additional indications and new products.
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. 96 For additional details regarding our business, see the discussion under “ Business ” in Item 1 of Part I of this Annual Report on Form 10-K.
As of May 1, 2023, the Company’s common shares commenced trading on the CSE under the symbol “ACOG”, previously the Company’s shares 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 shares commenced trading on The Nasdaq Capital Market under the symbol “ACOG”.
(“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.
Cash used in investing activities Cash used in investing activities increased by $26,701 to $26,701 for the year ended December 31, 2024 from $nil compared to the comparative period. During the year ended December 31, 2024, investing activities consisted of acquiring equipment.
During the year ended December 31, 2025, investing activities consisted of acquiring computer equipment and software. Cash provided by financing activities Cash provided by financing activities for the year ended December 31, 2025, decreased by $16,636,901 compared to the comparative period.
During the year ended December 31, 2024, financing activities primarily consisted of raising proceeds of $3,732,469 from units issued for cash, raising proceeds of $4,545,000 from the issuance of convertible debentures, raising proceeds of $52,808,915 from shares issued from the US listing, $300,000 from the exercise of warrants, and receiving $373,825 in government grant proceeds offset by $466,366 of related grant expenses.
During the year ended December 31, 2024, financing activities primarily consisted of raising proceeds of $56,541,384 from stock and units issued for cash, proceeds $4,545,000 from the issuance of convertible debentures offset by issuance costs of $459,360, proceeds of $300,000 from the exercise of warrants and receiving $373,825 in government grant proceeds offset by $446,366 of related expenses. 104 Contractual Obligations and Other Commitments In the normal course of business, we enter into agreements with contract service providers to assist in the performance of R&D and clinical and commercial manufacturing activities.
The loss of $3,164,707 for the year ended December 31, 2024 for the fair value of the warrant liabilities was a net change of $920,577, or 23%, compared to a loss of $4,085,284 for the year ended December 3, 2023.
Changes in the input assumptions can materially affect the fair value estimate and the Company’s net loss and equity reserves. The gain of $88,155 for the year ended December 31, 2025, for the fair value of the warrant liabilities was a net change of $3,252,862, or 103%, compared to a loss of $3,164,707 for the year ended December 31, 2024.
In connection with the US public offering, the Company’s Common Shares began trading on The Nasdaq Capital Market on November 12, 2024.
On November 13, 2024, the Company completed a public offering of common stock by issuing 8,695,653 common stock at a public offering price of $5.75 per share for gross proceeds of approximately $50 million. In connection with the US public offering, the Company’s Common Stock began trading on The Nasdaq Capital Market on November 12, 2024.
The Company’s shares were voluntarily delisted from the CSE and OTCQB on December 17, 2024. Operations The Company has not generated revenues from its operations to date and as of December 31, 2024, and had a deficit of $76,285,038 (December 31, 2023 – $61,648,173) which has been primarily financed by equity.
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 were voluntarily delisted from the CSE on December 17, 2024. Operations As of December 31, 2025, the Company had an accumulated deficit of $97,106,775 which has been primarily financed by equity.
Interest income increased $154,860, or 2,276%, from $6,804 for the year ended December 30, 2023, to $161,664 for the year ended December 31, 2024.
Interest income had a net change of $1,737,706 or 1,075% from interest income, net of $161,664 for the year ended December 31, 2024, to interest income, net of $1,899,370 for the year ended December 31, 2025.
The following table includes our cash flow data for the periods indicated: Cash Flows The following table provides information regarding our cash flows for the years ended December 31, 2024, and 2023: For the year ended December 31, Dollar Percentage 2024 2023 Change Change Consolidated Statement of Cash Flows Data Cash used in operating activities $ (7,755,654 ) $ (8,799,565 ) $ 1,043,911 (12 )% Cash provided by investing activities $ (26,701 ) $ - $ (26,701 ) 100 % Net cash provided by financing activities $ 54,851,864 $ 8,230,015 $ 46,621,849 566 % Share-based compensation $ 979,799 $ 2,369,585 $ (1,389,786 ) (59 )% Cash used in operating activities Cash used in operating activities decreased by $1,043,911 to $7,755,654 for the year ended December 31, 2024, from $8,799,565 for the comparative period.
On October 17, 2025, the underwriter of the Company’s public offering exercised its over-allotment option in full to purchase an additional 840,000 of Common Stock at the public offering price of $6.25 per share for additional gross proceeds of approximately $5.25 million and underwriting fees of $341,250 The following table includes our cash flow data for the periods indicated: Cash Flows The following table provides information regarding our cash flows for the years ended December 31, 2025, and 2024: For the Year Ended December 31, Dollar Percentage 2025 2024 Change Change Consolidated Statement of Cash Flows Data Cash used in operating activities $ (20,380,367 ) $ (7,755,654 ) $ (12,624,713 ) 163 % Cash used in investing activities $ (293,489 ) $ (26,701 ) $ (266,788 ) 999 % Net cash provided by financing activities $ 38,214,963 $ 54,851,864 $ (16,636,901 ) (30 )% Cash used in operating activities Cash used in operating activities increased by $12,624,713 to $20,380,367 for the year ended December 31, 2025, from $7,755,654 for the comparative period.
Comparison of General and Administrative Expenses for the Three Months ended December 31, 2024 and 2023 General and administrative expenses increased by $191,586 or 15%, from $1,309,958 for the three months ended December 31, 2023, to $1,501,544, for the three months ended December 31, 2024.
Cost of Product Sales and Cost of Licensing Revenue Comparison of Cost of Sales and Cost of Licensing Revenue for the Year Ended December 31, 2025 and 2024 Cost of product sales increased by $474,006, or 100%, from $0 for the year ended December 31, 2024 to $474,006 for the year ended December 31, 2025.
Removed
For additional details regarding our business, see the discussion under “ Business ” in Item 1 of Part I of this Annual Report on Form 10-K.
Added
Any additional capital is expected to further support our planned costs for commercial activities. Components of our Results of Operations Revenue The Company generates revenue from product sales and licensing arrangements. Product Sales, Net Product revenue consists primarily of sales of the Company’s commercial product to wholesalers and pharmacies.
Removed
Our other pre-clinical stage assets include ALPHA-0602, ALPHA-0702 & ALPHA-0802 (Progranulin and Progranulin GEM’s), which are expressed in several cell types in the central nervous system and in peripheral tissues, promotes cell survival, regulates certain inflammatory processes, and play a significant role in regulating lysosomal function and microglial responses to disease.
Added
Revenue is recognized at a point in time when control of the product transfers to the customer. Product revenue is recorded net of variable consideration, including expected prompt pay discounts, chargebacks, product returns, recalls, rebates, and consideration payable to customers.
Removed
Its intended use for the treatment of neurodegenerative diseases has been patented by the Company and ALPHA-0602 has been granted an Orphan Drug Designation for the treatment of ALS by the FDA.
Added
Consideration payable to customers includes fees paid to distributors, which are generally calculated as a percentage of product sales and are recognized as a reduction of revenue when the related services are not distinct from the Company’s promise to transfer the product.
Removed
Orphan Drug Designation was provided for ALPHA-0602 by the Office of Orphan Drug Products, FDA on February 2020 based on the Federal Food Drug, and Cosmetic Act, whereby the ALPHA-0602 met the criteria designated in Section 526 of such Act. For a further description see the section entitled “ Business — Government Regulation — Orphan Drug Designation ”.
Added
These deductions represent estimates of the related obligations and, as such, knowledge and judgment are required when estimating the impact of these revenue deductions on gross sales for a reporting period.
Removed
The Orphan Drug Designation allows for exclusivity provisions provided the drug is approved first for indication: treatment of amyotrophic lateral sclerosis ALPHA-0702 and ALPHA-0802 are Granulin Epithelin Motifs, (“GEMs”), derived from full length progranulin which have therapeutic potential across multiple neurodegenerative diseases. GEMs have been shown to be important in regulating cell growth, survival, repair, and inflammation.
Added
The amount of variable consideration can vary from period to period due to fluctuations in these deductions. 97 Licensing Revenue License 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.
Removed
ALPHA-0702 and ALPHA-0802 are designed to deliver this with potentially lower toxicity, and greater therapeutic effect. As the assets are pre-clinical assets and do not add material value to the Company, the Company will not develop these assets further and instead will seek to out-license the assets to interested third parties.
Added
Our revenue to date has been generated primarily from the upfront payment received from CMSI under the CMSI License Agreement. In addition to the upfront payment, we may also be entitled to development, regulatory, and sales milestone payments, as well as royalties on net sales, upon achieving predefined objectives. We recognize license revenue when the related performance obligations are satisfied.
Removed
Given the early stage of discussion with third parties, the Company cannot assess value to a license agreement. 92 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”).
Added
If achievement of a milestone is considered probable and it is probable that a significant revenue reversal will not occur, the associated milestone amount is included in the transaction price.
Removed
Any additional capital is expected to further support our planned costs to begin commercial activities including launching U.S. sales of ZUNVEYL in AD Reverse Stock Split On November 5, 2024, we completed a reverse stock split of our common shares with a stock split ratio of 1 -for-25 (“Reverse Stock Split”).
Added
License revenue also includes revenue from the sale of API and finished goods to CMSI, which are generally priced at cost plus a margin, as well as certain reimbursable pass-through costs. These amounts are recognized on a gross basis and are generally recognized upon shipment or delivery, depending on the applicable shipping terms.
Removed
Except as otherwise indicated, all references to our common shares, share data, per share data and related information depict the effect of the Reverse Stock Split as if it had occurred at the beginning of the earliest period presented.
Added
We expect that license revenue under the CMSI License Agreement, and from any potential future licensing arrangements, will fluctuate based on the timing and amount of upfront, milestone, and royalty payments, as well as the level of API sales and reimbursable activities.
Removed
The Reverse Stock Split combined each twenty five shares of our outstanding common shares into one common share, without any change in the par value per share which will remain no par value, and the Reverse Stock Split correspondingly adjusted, among other things, the number of common shares issuable upon exercise of outstanding options and warrants and the exercise price of such options and warrants and shares issuable upon conversion of preferred stock and other convertible securities.
Added
Cost of Product Sales 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. Prior to receiving FDA approval in July 2024, costs associated with the manufacturing of ZUNVEYL were expensed as research and development expenses.
Removed
No fractional shares will be issued in connection with the Reverse Stock Split, and any fractional shares resulting from the Reverse Stock Split were rounded to the nearest whole share. 93 Components of our Results of Operations Research and development Research and development expenses represent costs incurred to conduct research, such as the discovery and development of our product candidates.
Added
Cost of Licensing Revenue Cost of licensing revenue consists primarily of costs incurred to support the Company’s licensing arrangements, including the cost of API and finished goods sold to CMSI, as well as other costs associated with fulfilling obligations under the CMSI License Agreement, including reimbursable pass-through costs.
Removed
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.
Added
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. 98 Results of Operations Comparison of the Year Ended December 31, 2025 and 2024 For the Year Ended December 31, Dollar Percentage 2025 2024 Change Change Revenue Product sales, net $ 6,792,024 $ - $ 6,792,024 100 % Licensing 3,428,251 - 3,428,251 100 Total revenue 10,220,275 - 10,220,275 100 Operating Expenses Cost of product sales, excluding amortization of intangible asset 474,006 - 474,006 100 Cost of licensing revenue 1,441,317 - 1,441,317 100 Amortization of intangible assets 21,546 79,875 (58,329 ) (73 ) Research and development 1,867,972 3,920,412 (2,052,440 ) (52 ) Selling, general and administrative expenses 29,076,123 8,012,230 21,063,893 263 Total operating expenses 32,880,964 12,012,517 20,868,447 174 Loss from operations (22,660,689 ) (12,012,517 ) (10,648,172 ) 89 Other income (expense) Interest income 1,899,370 161,664 1,737,706 (1,075 ) Grant income 81,095 463,881 (382,786 ) (83 ) Gain (loss) from change in fair value of warrant liabilities 88,155 (3,164,707 ) 3,252,862 (103 ) Other expenses (77,806 ) (237,048 ) 159,242 (67 ) Total other income (expense) 1,990,814 (2,776,210 ) 4,767,024 (172 ) Net loss and comprehensive loss $ (20,669,875 ) $ (14,788,727 ) (5,881,148 ) 40 Net loss per share, basic $ (1.17 ) $ (2.04 ) $ 0.87 (43 ) Weighted-average outstanding stock, basic 17,680,597 7,247,864 10,432,733 144 Adjusted net loss, diluted $ (20,846,806 ) $ (14,788,727 ) $ (6,058,079 ) (41 ) Weighted-average outstanding stock, diluted 17,681,429 7,247,864 10,433,565 144 Net loss per share, diluted $ (1.18 ) $ (2.04 ) $ 0.86 (42 ) 99 Revenue Comparison of Revenue for Year Ended December 31, 2025 and 2024 Revenue increased by $10,220,275, or 100%, from $0 for the year ended December 31, 2024 to $10,220,275 for the year ended December 31, 2025.
Removed
Foreign exchange gain (loss) The foreign exchange gain (loss) amount consists of changes in the value of the Canadian Dollar compared to the U.S. Dollar throughout the year. Liability-Based Awards Bonus right awards that include cash settlement features are accounted for as liability-based awards in accordance with ASC 718, Compensation — Share Based Compensation.
Added
The increase is due to the start of commercial sales of ZUNVEYL in the first quarter of 2025 and the Company’s entrance into the License, Collaboration and Distribution agreement with CMSI (the “CMSI License Agreement”) pursuant to which the Company received a non-creditable upfront payment of $3 million in January 2025, of which approximately $179,000 has been deferred.
Removed
The fair value of the bonus right awards is estimated using a Black-Scholes option-pricing model and is revalued on each reporting date, based on the probability of the expected awards to vest, until settlement.
Added
The Company expects that revenue from commercial sales of ZUNVEYL will continue to grow year over year as the Company expands its sale force and implements its sale strategy in the coming fiscal year.
Removed
Changes in the estimated fair value of the bonus right awards are recognized within general and administrative expense in the consolidated statement of operations and comprehensive loss over the vesting period. Key assumptions in the calculation of the fair value of the bonus right awards include expected volatility, risk-free interest rate, expected life, and fair value per award.
Added
The Company is also eligible to receive up to $11 million in development and regulatory milestone payments with CMSI, as well as up to $30 million sales milestone payments.
Removed
Share Based Compensation Share-based compensation cost is recorded for all option grants and awards of non-vested stock based on the grant date fair value of the award using the Black-Scholes option-pricing model and is recognized over the service period required for the award.

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