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VANCOUVER, British Columbia, October 07, 2021--(BUSINESS WIRE)--Alpha Cognition Inc. (TSX-V: ACOG)(OTCQB: ACOGF)("Alpha Cognition", or the "Company"), a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating neurodegenerative disorders, has released the following business update by its CEO, Mr. Michael McFadden:
"As Chief Executive Officer of Alpha Cognition, I am pleased to provide an update regarding the Company’s accomplishments to date, and our milestones for the next year.
In mid-April, I was excited to take on the role as Alpha Cognition’s CEO. Over the past few months, the company has made tremendous progress and is in the process of executing a strategic change that we believe will add tremendous value for shareholders, healthcare professionals, patients, and caregivers.
Just before my arrival, the company entered the public markets on the TSX.V through an RTO with Crystal Bridge. The entry to public markets was a first for Alpha Cognition, Inc., which operated as a private biopharmaceutical company focused on the development of its clinical program for ALPHA-1062 with a goal of selling the approved asset to an integrated pharmaceutical company. Although ALPHA-1062 is the company’s most advanced product, there are a number of development compounds in the pipeline.
This summer, the company reviewed the asset portfolio, initiated market research with physicians, caregivers, and healthcare payers using leading market research firms to better understand the potential value drivers for the company and how to maximize the value of ALPHA-1062. We then discussed our findings with thought leaders in the Alzheimer’s, brain injury, and ALS segments. Based on this process, we believe the following:
- Data suggests that the market opportunity for ALPHA-1062 is much larger than originally thought.
- An approved drug with attributes similar to ALPHA-1062 can take a significant share in the US Alzheimer’s market.
- We can advance other portions of our pipeline efficiently to deliver robust inflection points for investors.
As a result, the company has re-invigorated its strategy that diversifies risk and offers additional upside opportunities for investors in 2022. It includes:
Create a diverse pipeline that advances the company’s lead compound, ALPHA-1062, with lean capital utilization to prepare for commercialization.
Advance ALPHA-1062 for mild-to-moderate Alzheimer’s program with an efficient use of capital. This includes a BABE study, supplemented with safety and tolerability data that supports differentiation in the commercial marketplace. Top-line data read-out from BABE study is scheduled for late Q1 2022.
Prepare to launch ALPHA-1062 with a focus on Neurologists and Long-Term Care physicians. The US Alzheimer’s prescription market is valued at $5B annually and we believe that we can commercialize the asset with a CNS specialty sales force. The company hired Lauren D’Angelo as Chief Commercial Officer to develop and prepare the company for commercialization.
Advance ALPHA-1062 intranasal formulation for mild traumatic brain injury (mTBI). There is currently no drug approved for mTBI. The company is currently planning to initiate an early-stage trial this fall with top-line data read-out in late Q1 2022.
Build a pipeline of lifecycle programs that will support a successful launch of ALPHA-1062 with other routes of delivery and alternative formulations.
The company has a combination program of ALPHA-1062 + memantine scheduled in 2024. This combination would be targeted toward moderate-to-severe Alzheimer’s patients. The market potential is estimated to be $3B in annual prescription value.
Sublingual formulation – the company can advance a sublingual formulation which could be utilized in the Long-Term Care market for patients who cannot swallow.
QD (once a day) formulation – the company can advance a once daily formulation to offer less frequent dosing. This formulation would offer additional choice to physicians and caregivers on medication management.
Diversify the pipeline with additional programs that focus on neurodegenerative diseases with limited or no treatments.
Advance ALPHA-0602 for amyotrophic lateral sclerosis (ALS). This product is a full-length progranulin gene therapy that has been studied for ALS, a deadly disease with no cure. The company will initiate an early-stage trial this fall with top-line data read-out in Q1 2022.
Optimize the company’s discovery program to identify new gene therapy compounds that the company can leverage for other neurodegenerative diseases.
Utilize shareholder capital efficiently for R&D and G&A strategies that return value to shareholders.
If successfully implemented, this strategy would provide Alpha Cognition with a robust and diverse multi-dimensional pipeline that brings new products to market and advances important compounds for diseases with limited or no approved treatments.
The company has made tremendous progress in 2021 and has accomplished the following items:
- The company has successfully positioned itself on a public exchange in Canada and has expanded its presence into the US by listing on the OTCQB Venture Market (trading symbol: ACOGF).
- We are advancing important research programs with ALPHA-1062 and the company expects to complete the pivotal trial by the end of the year. Top line data readout is scheduled to occur in late Q1 2022. We are also initiating an early stage mTBI trial to advance ALPHA-1062 intranasal program. Results from this study are scheduled for read-out in late Q1 2022.
- We are advancing our progranulin gene therapy program with an early-stage trial and expect to have this complete in Q1 2022 with top-line data readout the same quarter.
- We have established a scientific advisory board with top experts in neurology and psychiatry in the US and around the world. These experts provide relevant expertise as we further the development of our clinical pipeline and get closer to commercialization.
- We are building critical infrastructure to prepare to scale the company as programs progress, while managing company resources efficiently.
In summary, we believe we are off to a very good start, the team continues to deliver, and we are looking forward to the months ahead as we focus on furthering ALPHA-1062 and ALPHA-0602 drug development. I pledge to keep you updated as we progress towards our important and exciting goals.
Michael McFadden, CEO"
About Alpha Cognition Inc.
Alpha Cognition Inc. is a clinical stage, biopharmaceutical company dedicated to developing treatments for under-served neurodegenerative diseases, such as Alzheimer's Dementia and Amyotrophic Lateral Sclerosis (ALS).
ALPHA-1062, is a patented new chemical entity that has demonstrated safety and improved tolerability in human clinical trials. It is being developed as a new generation acetylcholinesterase inhibitor for the treatment of Alzheimer's disease, with minimal gastrointestinal side effects and novel routes of administration. ALPHA-1062's active metabolites are differentiated from donepezil and rivastigmine in that they may sensitize neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition. ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer's dementia and in a nasal spray formulation to treat traumatic brain injury.
ALPHA-0602 (Progranulin) is expressed in several cell types in the central nervous system and in peripheral tissues, regulates cell survival and certain inflammatory processes, and plays a major role in regulating lysosomal function and microglial responses to disease. Its use for the treatment of neurodegenerative diseases has been patented by the Company and granted an Orphan Drug Designation.
Neither TSX Venture Exchange (the "TSX-V"), OTC Markets Group, nor the TSX-V’s Regulation Services Provider (as that term is defined in policies of the TSX-V) accepts responsibility for the adequacy or accuracy of this release.
This news release is not, and under no circumstances is to be construed as, an advertisement or a public offering of securities. No securities commission or similar authority in Canada or in any other jurisdiction has reviewed or in any way passed upon this news release or the merits of the securities described herein and any representation to the contrary is an offence.
This news release includes forward-looking statements within the meaning of applicable securities laws. Except for statements of historical fact, any information contained in this news release may be a forward‐looking statement that reflects the Company’s current views about future events and are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Forward‐looking statements can be identified by the words "may," "might," "will," "could," "would," "should," "expect," "intend," "plan," "objective," "anticipate," "believe," "estimate," "predict," "project," "potential," "target," "seek," "contemplate," "continue" and "ongoing," or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward‐looking statements in this news release include statements regarding the Company’s business strategy, market size, potential growth opportunities, capital requirements, clinical development activities, the timing and results of clinical trials, regulatory submissions, potential regulatory approval and commercialization of the technology. Although the Company believes that we have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. The Company cannot assure that the actual results will be consistent with these forward-looking statements as a result of known and unknown risks, uncertainties, assumptions and other factors. These risks, uncertainties, assumptions and other factors include those associated with clinical studies and manufacturing, as well as development and commercialization of the Company’s products; the need for additional financing to maintain operations; risks posed by the economic and political environments in which the Company operates and intends to operate; market instability due to the COVID-19 pandemic; the potential for losses arising from the expansion of operations into new markets; increased competition; assumptions regarding market trends and the expected demand and desires for the Company’s products and proposed products; reliance on industry manufacturers, suppliers and key personnel; the failure to adequately protect intellectual property; a failure to adequately manage future growth; adverse market conditions; and failure to satisfy ongoing regulatory requirements or obtain regulatory approvals. These forward‐looking statements speak only as of the date of this news release and, other than as required by applicable securities laws, the Company undertakes no obligation to revise or update any forward‐looking statements, even if new information becomes available in the future.
This news release may also contain estimates and other statistical, market and industry data from independent parties or made by the Company relating to our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. We cannot guarantee the accuracy and completeness of information from third party sources.
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