ADDED
You should read this Annual Report and the documents that we reference in this Annual Report and have filed as exhibits to this Annual Report , completely and with the understanding that our actual future results may be materially different from what we expect.
BUSINESS Business Overview We are a 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.
We focus on the development of commercial manufacturing and commercial sales of ZUNVEYL oral tablet formulation.
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.
We launched ZUNVEYL on March 19, 2025 and 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.
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 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 to study a sublingual formulation for cognitive impairment with mTBI.
As the assets were pre-clinical and did not add material value to the Company, the Company did not develop these assets further and instead terminated its licensing agreement related to the assets but retained certain royalties and payments from the licensor in relation to any future developments of the assets.
The official commercial launch was announced on March 19, 2025 and ZUNVEYL is now available by prescription in pharmacies nationwide.
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.
REMOVED
You should read this Annual Report and the documents that we reference in this Annual Report and have filed as exhibits to the registration statement, of which this Annual Report is a part, completely and with the understanding that our actual future results may be materially different from what we expect.
(the Company, Alpha Cognition, we, or us ) 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.
On July 26, 2024, the Company received approval by the FDA of the Company s New Drug Application (the NDA ) for ZUNVEYL (benzgalantamine) previously known as ALPHA-1062 ( ZUNVEYL or ALPHA-1062 ) a delayed release oral tablet formulation indicated for the treatment mild to moderate dementia of the Alzheimer s type in adults (Alzheimer s disease).
The Company s current focus is on the commercial manufacturing and sales of ZUNVEYL oral tablet formulation.
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.
The Company intends to target large volume nursing homes specializing in Alzheimer s, to leverage an account based sales team with demonstrated success in LTC, in order to position ZUNVEYL with Medicare payors, and to work with strategic and clinical partnerships with consultant pharmacists and long term care pharmacies.
ZUNVEYL, is a patented next generation acetylcholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer s type in adults.
In addition to our approved oral formulation, ZUNVEYL is also in pre-clinical development (1) in combination with memantine to treat moderate to severe Alzheimer s disease, (2) alone as a with sublingual formulation for patients suffering from dysphagia, and (3) alone and referred to herein as ALPHA-1062IN that is intended to be out-licensed for pre-clinical development to study an intranasal formulation for cognitive impairment with mTBI.
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.
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.