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.
Sincerely,
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.
Forward-looking Statements
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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version on businesswire.com: https://www.businesswire.com/news/home/20211007005214/en/
Bristol Investor Relations Stefan Eftychiou 905 326 1888 ext 6
stefan@bristolir.com https://www.alphacognition.com/
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