- Alzamend recently announced partnership with Massachusetts
General Hospital for five phase II clinical trials of AL001,
involving healthy human subjects and patients with Alzheimer’s, BD,
MDD and PTSD
- Alzamend has executed an agreement to provide sufficient
capital over the next 18 months to finance the initiation and
progression of AL001 and ALZN002 clinical trials
Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), a
clinical-stage biopharmaceutical company focused on developing
novel products for the treatment of Alzheimer’s disease
(“Alzheimer’s”), bipolar disorder (“BD”), major
depressive disorder (“MDD”) and post-traumatic stress
disorder (“PTSD”), today shared a letter from its Chief
Executive Officer, Stephan Jackman.
Dear Stockholders,
I am reaching out to share an update about our clinical programs
and the outlook for the future.
Planned Clinical Trials
The heart of Alzamend’s mission lies in pioneering breakthroughs
that have the potential to transform lives. I am thrilled to share
that our planned clinical trials are currently on pace to make
significant progress over the next year. The dedication of our
research and development partners, in collaboration with experts in
the field, has propelled us closer to potentially achieving
significant milestones.
AL001
Our lead therapeutic drug candidate, AL001, is a novel
lithium-delivery system that has the potential to deliver benefits
of marketed lithium salts while mitigating or avoiding currently
experienced toxicities associated with lithium. Our preclinical
data for AL001 treatment showed prevention of cognitive deficits,
depression and irritability in mice models, and has shown to be
superior in improving associative learning, memory, and
irritability, compared with lithium carbonate treatments. In March
2022, we announced that full data sets from our Phase I
bioequivalent study affirmed that the extent of lithium absorption
in plasma indicated that AL001 at 150 mg dosage is bioequivalent to
the marketed 300 mg lithium carbonate product. In June 2023, we
announced topline data from our Phase IIA multiple-ascending dose
study in Alzheimer’s and healthy patients, which initiated in May
2022. Results from the Phase IIA study identified a maximum
tolerated dose (“MTD”), as assessed by an independent safety
review committee. This MTD, providing lithium at a lithium
carbonate equivalent dose of 240 mg 3-times daily (“TID”),
is designed to be unlikely to require therapeutic drug monitoring
(“TDM”). Moreover, this dose is designed to distribute more
lithium to the brain but at lower systemic exposure, resulting in
an improved safety profile compared to currently marketed lithium
salts and thereby avoiding clinical disadvantages.
In the latter half of 2023, Alzamend submitted and received
"Study May Proceed" letters from the United States Food and Drug
Administration (“FDA”) encompassing three additional
investigational new drug (“IND”) applications for AL001 in
BD, MDD, and PTSD. Alzamend recently announced it reached a
partnership agreement with Massachusetts General Hospital to serve
as its contract research organization (“CRO”) in connection
with five Phase II clinical trials, one for healthy human subjects,
and one each in patients with Alzheimer’s, BD, MDD and PTSD. The
clinical trials will be designed to determine relative increased
lithium levels in the brain of AL001 compared to a marketed lithium
salt.
One of Alzamend’s goals is to replace a 300 mg TID lithium
carbonate dose for treatment of BD with a 240 mg TID AL001 lithium
equivalent, which represents a daily decrease of 20% of lithium
given to a patient. Lithium is a commonly prescribed drug for manic
episodes in BD type 1 as well as maintenance therapy of BD in
patients with a history of a manic episode. Lithium was the first
mood stabilizer approved by the FDA and is still a first-line
treatment option (considered the “gold standard”) and is utilized
off-label for MDD and PTSD. Alzamend believes these programs may
qualify for the 505(b)(2) pathway for FDA approval, which is
available to new formulations of an approved drug. Alzamend
anticipates initiating all five of these studies in the first half
of 2025, with exact dates to be announced before the end of
2024.
ALZN002
Our secondary therapeutic drug candidate, ALZN002, is a
proprietary “active” immunotherapy product, which means it is
produced by each patient’s immune system.
The proposed mechanism of action is through the pulsed-Dendritic
Cell (“DC”) activation of T-cells that stimulates the immune
system, resulting in the clearance of brain amyloid. As people age,
their immune systems may degrade, and some people may be unable to
produce natural beta-amyloid antibodies, the absence of which leads
to the plaque build-up causing Alzheimer’s. ALZN002 is intended to
elicit an immune response to produce anti-amyloid antibodies, which
can then neutralize circulated beta-amyloids and prevent additional
plaque build-up. The goal of this treatment approach is to foster
tolerance to treatment for safety purposes while stimulating the
immune system to reduce the brain’s beta-amyloid protein burden,
resulting in reduced Alzheimer’s signs and symptoms.
In April 2023, we announced the initiation of a Phase I/IIA
clinical trial for ALZN002. The purpose of this trial is to assess
the safety, tolerability, and efficacy of multiple ascending doses
of ALZN002 compared with that of placebo in 20-30 subjects with
mild to moderate morbidity. In February 2024, we received notice
from our CRO on the clinical trial that it was terminating our
contract with them. We are currently pursuing the engagement of a
replacement CRO and anticipate that the study will resume in the
fourth quarter of 2024.
Financial Condition
In an ever-evolving industry, financial prudence remains a
cornerstone of our strategic approach. Our disciplined cost
management, prudent resource allocation, and strategic investments
in high-potential areas have collectively contributed to our
financial resilience. We believe that this approach not only
fortifies our foundation but also preserves our ability to achieve
growth in the years ahead.
We raised capital through an at-the-market sales agreement in
the fourth quarter of 2023 through the first quarter of 2024, which
we strategically utilized from time to time with a goal of not
disrupting the market. We also entered into two separate securities
purchase agreements in 2024. The first one with an entity
associated with our founder and largest stockholder, pursuant to
which we have received $2.1 million in gross proceeds to date, and
which the investor has the right to purchase up to an additional
$3.9 million of securities through March 31, 2025. The second
agreement with an outside investor, pursuant to which we have
received $7.0 million in gross proceeds to date. Under the second
agreement, the investor is obligated to purchase, subject to
certain conditions, up to an additional $18.0 million of securities
through January 2026. Please see our Securities and Exchange
Commission filings for additional information regarding the
securities purchase agreements described above and the terms of
such financing transactions.
We remain grateful for the support from our investors as we
continue to apply those strategic investments to drive our
anticipated future growth. Our strategic roadmap includes further
optimizing operational efficiencies, expanding our footprint within
the industry, and deepening our commitment to bringing our
therapeutics to the market. As we progress through 2024 and into
2025, we look forward to sharing with you updates on our clinical
progress.
Nasdaq Compliance
In April 2024, we announced that a Nasdaq Hearings Panel granted
Alzamend’s request to continue its listing on The Nasdaq Capital
Market (“Nasdaq”), subject to Alzamend demonstrating
compliance, on or before September 23, 2024, with Listing Rule
5550(b)(1), which requires stockholder equity of at least $2.5
million (the “Stockholder Equity Rule”) and satisfying all
applicable requirements for continued listing on Nasdaq. We believe
that the capital raises from the securities purchase agreements
described above will enable us to achieve compliance with the
Stockholder Equity Rule within the timeframe required by
Nasdaq.
I want to express my sincere gratitude for your continued trust
and support. I fully understand that the market has not been kind
these past few years. Our stockholders play a pivotal role in our
journey, and we remain dedicated to delivering long-term value
through prudent fiscal management and pioneering advancements in
biotechnology.
We eagerly anticipate the opportunities that lie ahead and are
confident in our ability to create lasting value for all
stockholders.
Sincerely,
Stephan Jackman Chief Executive Officer, Alzamend Neuro
About Alzamend Neuro
Alzamend Neuro is a clinical-stage biopharmaceutical company
focused on developing novel products for the treatment of
Alzheimer’s, BD, MDD and PTSD. Our mission is to rapidly develop
and market safe and effective treatments. Our current pipeline
consists of two novel therapeutic drug candidates, AL001 - a
patented ionic cocrystal technology delivering lithium via a
therapeutic combination of lithium, salicylate and L-proline, and
ALZN002 - 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.
Both of our product candidates are licensed from the University of
South Florida Research Foundation, Inc. pursuant to royalty-bearing
exclusive worldwide licenses.
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 Alzamend 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
Alzamend’s business and financial results are included in
Alzamend’s filings with the U.S. Securities and Exchange
Commission. All filings are available at www.sec.gov and on
Alzamend’s website at www.Alzamend.com.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240826123586/en/
Email: Info@Alzamend.com or call: 1-844-722-6333
Alzamend Neuro (NASDAQ:ALZN)
Historical Stock Chart
From Oct 2024 to Nov 2024
Alzamend Neuro (NASDAQ:ALZN)
Historical Stock Chart
From Nov 2023 to Nov 2024
