Ault Global Holdings, Inc. (NYSE American: DPW) a diversified
holding company (the “Company”), announced today that
Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), a
preclinical stage biopharmaceutical company focused on developing
novel products for the treatment of neurodegenerative diseases and
psychiatric disorders, submitted an investigational new drug
(“IND”) application to the FDA for the initiation of a Phase
1 clinical study of AL001 on June 30, 2021. The Phase 1,
first-in-human study, is designed for the purpose of determining
potential clinically safe and appropriate AL001 dosing in future
studies. AL001 is a lithium-based ionic cocrystal oral therapy for
patients with dementia related to mild, moderate, and severe
cognitive impairment associated with Alzheimer’s disease.
Following completion of this initial study, Alzamend intends to
initiate a Phase 1/2a clinical trial designed to evaluate the
safety, tolerability, pharmacokinetics, pharmacodynamics, and
preliminary efficacy of AL001 in Alzheimer’s disease patients.
Presuming favorable data, a subsequent Phase 2b program is planned
to target appropriate doses for the pivotal Phase 3 safety/efficacy
clinical program required for regulatory approval.
“This IND submission represents a key milestone for Alzamend as
we continue to advance our proprietary pipeline. We believe AL001
could potentially provide clinicians with a major improvement over
current lithium-based treatments and may constitute a means of
treating Alzheimer’s disease and other neurodegenerative diseases
and psychiatric disorders. We look forward to providing more
details on the timeline and market opportunity following FDA
clearance of the IND, if obtained,” commented Stephan Jackman,
Chief Executive Officer of Alzamend.
Based on preclinical data, AL001 treatment prevents cognitive
deficits, depression, and irritability in APPSWE/PS1dE9 mice, and
has shown an improvement of associative learning and memory and
irritability compared with lithium carbonate treatments, supporting
the potential of this lithium formulation for the treatment of
Alzheimer’s disease and psychiatric disorders. Lithium has been
marketed for more than 35 years and human toxicology regarding
lithium use has been well characterized, potentially allowing
Alzamend to rely upon this existing data, potentially reducing the
regulatory burden for safety data.
Alzamend’s mission is to help the Alzheimer’s disease community
by supporting the full product development life cycle of treatment
and cures for dementia and Alzheimer’s disease driven by the belief
that strong support of research is the foundation for true
innovation. Dementia is not a normal part of aging, and there are
numerous symptoms that can indicate cognitive and neurological
impairments. Alzheimer’s disease is the most common form of
dementia. This disease robs people of their loved ones, as memories
are erased and personalities are diminished. Alzamend’s vision
statement nicely sums up their mission: “Together We Can ‘Make
Alzheimer’s Just a Memory!’™”.
The economic impact of Alzheimer’s disease can be as devastating
as the emotional stress. Over 47 million people in the world
currently live with Alzheimer’s disease or dementia, with over 6.2
million in the U.S. (two-thirds are women). The lifetime cost of
care for an Alzheimer’s disease patient is estimated at $374,000 in
the U.S. According to the Alzheimer’s Association, it is estimated
that Alzheimer’s and dementia deaths increased more than 16% in
2021 due to COVID-19. In 2021, Alzheimer’s and dementia will cost
the U.S. an estimated $355 billion with the costs expected to rise
into the trillions in the next 25 years. In, addition, Medicare and
Medicaid is expected to pay approximately $239 billion, or 67% of
the treatment and long-term care costs associated with Alzheimer’s
disease and dementia, with another $79 billion of out-of-pocket
costs. According to the Alzheimer’s Association, eleven million
Americans provide an estimated 15.3 billion hours of unpaid care
per year, valued at $257 billion, for these patients with
two-thirds of these being women, and one-third being daughters.
Milton “Todd” Ault, III, the Company’s Executive Chairman,
stated, “The Company is pleased that Alzamend has achieved this
milestone to further its commitment to develop treatments and cures
for Alzheimer’s, other neurodegenerative diseases and psychiatric
disorders.”
The Company has certain beneficial ownership and rights to
further invest in Alzamend as follows:
- The Company beneficially owns approximately 5.3 million shares
of Alzamend common stock held by its wholly owned subsidiary,
Digital Power Lending, LLC (“DPL”).
- The Company has the right to acquire 1.35 million shares of
Alzamend common stock upon the exercise of warrants beneficially
owned by DPL.
- In March 2021, Alzamend entered into a securities purchase
agreement with DPL pursuant to which Alzamend agreed to sell an
aggregate of 6.7 million shares of its common stock for an
aggregate of $10 million, or $1.50 per share, which sales will be
made in tranches. Alzamend further agreed to issue to DPL warrants
to purchase such number of shares of its common stock equal to 50%
of the shares of common stock purchased under the securities
purchase agreement at an exercise price of $3.00 per share. On
March 9, 2021, the Company purchased 2.7 million shares of Alzamend
common stock (included in the 5.3 million shares of Alzamend common
stock held by DPL described above) upon closing of the first
tranche of $4 million. Under the terms of the securities purchase
agreement, DPL may purchase an additional 4.0 million shares.
- Finally, Alzamend agreed that for a period of 18 months
following the date of the payment of the final tranche of $4
million, DPL will have the right to invest an additional $10
million on the same terms, except that no specific milestones have
been determined with respect to the additional $10 million.
Should the Company exercise all warrants and options to invest,
it would own approximately 22.6 million shares with an average cost
of $2.27 per share of common stock, representing 22% of Alzamend’s
issued and outstanding common stock.
For more information on Ault Global Holdings and its
subsidiaries, the Company recommends that stockholders, investors
and any other interested parties read the Company’s public filings
with the SEC, available at www.sec.gov, and press releases
available under the Investor Relations section at
www.AultGlobal.com.
About Ault Global Holdings, Inc.
Ault Global Holdings, Inc. is a diversified holding company
pursuing growth by acquiring undervalued businesses and disruptive
technologies with a global impact. Through its wholly and
majority-owned subsidiaries and strategic investments, the Company
provides mission-critical products that support a diverse range of
industries, including defense/aerospace, industrial, automotive,
telecommunications, medical/biopharma, and textiles. In addition,
the Company extends credit to select entrepreneurial businesses
through a licensed lending subsidiary. Ault Global Holdings’
headquarters are located at 11411 Southern Highlands Parkway, Suite
240, Las Vegas, NV 89141; www.AultGlobal.com.
About Alzamend Neuro
Alzamend Neuro, Inc. (“Alzamend”) (www.Alzamend.com), is a
Delaware corporation with its corporate headquarters in Tampa,
Florida. The mission of Alzamend is to help the Alzheimer’s
community by supporting the full product development life cycle of
treatment and cures of neurodegenerative diseases and psychiatric
disorders, including Alzheimer’s disease. With Alzamend’s two
current and future product candidates, Alzamend aims to bring
treatments or cures to market at a reasonable cost as quickly as
possible. Alzamend’s current pipeline consists of two novel
therapeutic drug candidates, AL001 - a patented ionic cocrystal
technology delivering a therapeutic combination of lithium,
proline, and salicylate, and AL002 - a patented method using a
mutant-peptide sensitized cell as a cell-based therapeutic vaccine
that seeks to restore the ability of a patient’s immunological
system to combat Alzheimer’s disease. Both of Alzamend’s product
candidates are licensed from the pursuant to royalty-bearing
exclusive worldwide licenses from the University of South Florida.
www.Alzamend.com
Forward-Looking Statements
This press release contains “forward looking statements” within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. These forward-looking statements generally include
statements that are predictive in nature and depend upon or refer
to future events or conditions, and include words such as
“believes,” “plans,” “anticipates,” “projects,” “estimates,”
“expects,” “intends,” “strategy,” “future,” “opportunity,” “may,”
“will,” “should,” “could,” “potential,” or similar expressions.
Statements that are not historical facts are forward-looking
statements. Forward-looking statements are based on current beliefs
and assumptions that are subject to risks and uncertainties.
Forward-looking statements speak only as of the date they are made,
and the Company undertakes no obligation to update any of them
publicly in light of new information or future events. Actual
results could differ materially from those contained in any
forward-looking statement as a result of various factors. More
information, including potential risk factors, that could affect
the Company’s business and financial results are included in the
Company’s filings with the U.S. Securities and Exchange Commission,
including, but not limited to, the Company’s Forms 10-K, 10-Q and
8-K. All filings are available at www.sec.gov and on the Company’s
website at www.AultGlobal.com.
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