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Item 1. Business

2022-07-19 compared with 2021-07-29 · 582 added, 490 removed, 679 unchanged (61% of the section changed)

In this Annual Report,

unless the context requires otherwise, references to the “Company,”

“Alzamend,”

“we,”

“our company”

and “us”

refer to Alzamend Neuro, Inc., a Delaware corporation.

unless the context requires otherwise, references to the “Company,” “Alzamend,” “we,” “our company”

and “us” refer to Alzamend Neuro, Inc., a Delaware corporation.

Company Overview

are a preclinical stage biopharmaceutical company focused on developing novel products for the treatment of neurodegenerative diseases

and psychiatric disorders.

With our two current and future product candidates, we aim to bring treatments or cures to market at a reasonable

cost as quickly as possible.

Far too many individuals —

patients and caregivers —

suffer from the burden created by these

devastating, and often fatal, diseases.

Our primary target, Alzheimer’s, was among the most-feared diseases (second only to cancer)

among Americans, according to a 2011 survey by the Harvard School of Public Health.

Alzheimer’s is also the sixth leading cause

of death in the United States according to a 2021 report from the Alzheimer’s Association, a nonprofit that funds research.

Alzheimer’s treatments only temporarily relieve symptoms but do not slow or halt the underlying worsening of the disease, which

currently affects roughly 6.2 million Americans and that number is expected to grow to 13 million individuals by 2050.

Alzheimer’s

also impacts more than 11 million Americans who provide an estimated 15.3 billion hours of unpaid care per year, valued at $257 billion,

according to data provided by the Alzheimer’s Association.

In 2021, the estimated healthcare costs for treating individuals with

Alzheimer’s in the United States will be $355 billion, including $239 billion in Medicare and Medicaid payments, according to data

provided by the Alzheimer’s Association.

These costs could rise to as high as $1.1 trillion per year by 2050 if no permanent treatment

or cure for Alzheimer’s is found, the Alzheimer’s Association reported.

current pipeline consists of two novel therapeutic drug candidates:

(i) a patented ionic cocrystal technology delivering a therapeutic

combination of lithium, proline and salicylate, known as AL001 or LiProSal, through two royalty-bearing exclusive worldwide licenses from

the University of South Florida Research Foundation, Inc., as licensor, and (ii) 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,

known as AL002 or CA022W, through a royalty-bearing exclusive worldwide license from the same licensor.

lead product candidate that we have licensed and will initially move to clinical development in humans is an ionic cocrystal of lithium

for the treatment of Alzheimer’s and other neurodegenerative diseases and psychiatric disorders.

Based on our preclinical data,

AL001 treatment prevents cognitive deficits, depression and irritability in APPSWE/PS1dE9 mice, and is superior in improving associative

learning and memory and irritability compared with lithium carbonate treatments, supporting the potential of this lithium formulation

for the treatment of Alzheimer’s and psychiatric disorders in humans.

Lithium has been marketed for more than 35 years and human

toxicology regarding lithium use has been well characterized, potentially mitigating the regulatory burden for safety data.

results of randomized, placebo-controlled, clinical trials of lithium in the treatment of patients with Alzheimer’s dementia and

are an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease

(“Alzheimer’s”), bipolar disorder, major depressive disorder (“MDD”) and post-traumatic stress disorder

With our two product candidates, we aim to bring treatments or cures to market as quickly as possible.

individuals, patients and caregivers suffer from the burden created by these devastating, and often fatal, diseases.

Our primary target,

Alzheimer’s, was among the most-feared diseases (second only to cancer) among Americans, according to a 2011 survey by the Harvard

School of Public Health.

Alzheimer’s is also the sixth leading cause of death in the United States according to a 2021 report from

the Alzheimer’s Association, a nonprofit that funds research.

Existing Alzheimer’s treatments only temporarily relieve symptoms

but do not slow or halt the progression of the disease, which currently affects roughly 6.2 million Americans and that number is expected

to grow to 13 million individuals by 2050.

Alzheimer’s also impacts more than 11 million Americans who provide an estimated 16 billion

hours of unpaid care per year, valued at $272 billion, according to data provided by the Alzheimer’s Association.

In 2022, the estimated

healthcare costs for treating individuals with Alzheimer’s in the United States will be $321 billion, including $206 billion in

Medicare and Medicaid payments.

These costs could rise to as high as $1 trillion per year by 2050 if no permanent treatment or cure for

Alzheimer’s is found, the Alzheimer’s Association reported.

pipeline consists of two novel therapeutic drug candidates:

AL001 - A patented ionic cocrystal technology delivering a therapeutic combination of lithium, proline and

salicylate, known as AL001, through two royalty-bearing exclusive worldwide licenses from the University of South Florida Research Foundation,

Inc., as licensor (the “Licensor”);

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, known as AL002 or CA022W, through

a royalty-bearing exclusive worldwide license from the Licensor.

Our most advanced

product candidate (lead product) licensed and in clinical development in humans is an ionic cocrystal of lithium for the treatment of

Alzheimer’s, bipolar disorder, MDD and PTSD.

Based on our preclinical data, AL001 treatment prevents cognitive deficits, depression

and irritability in APPSWE/PS1dE9 mice, and is superior in improving associative learning and memory and irritability compared with lithium

carbonate treatments, supporting the potential of this lithium formulation for the treatment of Alzheimer’s, bipolar disorder, MDD

and PTSD in humans.

Lithium has been marketed for more than 35 years and human toxicology regarding lithium use has been well characterized,

potentially mitigating the regulatory burden for safety data.

results of randomized, placebo-controlled, clinical trials of lithium in the treatment of patients with Alzheimer’s dementia and

subjects with mild cognitive impairment have been widely published.

Clinical studies have indicated that lithium administered at doses

lower than those used for affective disorders can favorably impact Alzheimer’s outcomes.

A study by O.V.

Forlenza, et al., entitled

“Disease-Modifying Properties of Long-Term Lithium Treatment for Amnestic Mild Cognitive Impairment:

Randomized Controlled Trial,”

appearing in the British Journal of Psychiatry (2011) reported that lithium was superior to a placebo, evidencing a slower decline of

cognitive function as measured by the Alzheimer’s Disease Assessment Scale cognitive subscale.

Given the absence of adequate treatments

that can slow, halt or even reverse the decline of this highly prevalent disease, the potential efficacy of lithium in the long-term management

of Alzheimer’s may positively impact public health.

There is an unmet medical need for safe and effective Alzheimer’s treatments,

of Alzheimer’s may positively impact public health.

There is an unmet medical need for safe and effective Alzheimer’s treatments,

particularly for treatments with neuroprotective properties.

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suggest that lithium may exert some of its long-term beneficial effects in the treatment of affective disorders via underappreciated neuroprotective

Molecular biology and animal studies have also suggested that lithium may offer protection against Alzheimer’s.

absence of other adequate treatments, the potential efficacy of lithium in the long-term treatment of neurodegenerative disorders may

be warranted.

Phase III clinical trials in humans, we intend to seek approval to commercialize AL001 via a New Drug Application (“NDA”).

As one of the initial steps of the NDA process, we submitted a Pre-Investigational New Drug (“PIND”) briefing package to the

Food and Drug Administration (“FDA”) in July 2019 that argued against the need for any further preclinical safety studies.

In the FDA’s response to our PIND package, the FDA asked us to provide a scientific bridge to a listed drug to support the adequacy

of the nonclinical program.

According to the FDA, the adequacy of the nonclinical data will be a matter for review.

If the adequacy of

the nonclinical data is not sufficient for the FDA, we will then be required to conduct a clinical pharmacokinetics animal study (an expected

six week study) of AL001 to be considered for FDA approval.

We submitted an Investigational New Drug (“IND”) application to

the FDA on June 30, 2021.

On July 28, 2021 the FDA responded to our IND that we are safe to proceed and we will be able to commence Phase

I clinical trials in humans.

product can be designated as a breakthrough therapy if it is intended to treat a serious condition and preliminary clinical evidence indicates

that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

For purposes of

breakthrough therapy designation, a clinically significant endpoint generally refers to an endpoint that measures an effect on irreversible

morbidity or mortality (“IMM”), or on symptoms that represent serious consequences of the disease.

A clinically significant

endpoint can also refer to findings that suggest an effect on IMM or serious symptoms, including:

an effect on an established surrogate endpoint;

an effect on a surrogate endpoint or intermediate clinical endpoint considered reasonably likely to predict

a clinical benefit (i.e., the accelerated approval standard);

an effect on a pharmacodynamic biomarker (which is a measurable indicator of the disease state) that does

not meet criteria for an acceptable surrogate endpoint, but strongly suggests the potential for a clinically meaningful effect on the

underlying disease;

a significantly improved safety profile compared to available therapy (e.g., less dose-limiting toxicity

for an oncology agent), with evidence of similar efficacy.

on our preclinical data, AL001 has a positive effect on the pharmacodynamic biomarkers of Alzheimer’s.

As a result, if confirmed

clinically, we believe that AL001 is a candidate for breakthrough therapy designation because of its positive effect on a pharmacodynamic

biomarker (beta-amyloids) and potential for a clinically meaningful effect on Alzheimer’s.

Phase III clinical trials in humans, we intend to seek approval to commercialize AL001 via a New Drug Application (“NDA”).

As one of the initial steps of the NDA process, we submitted a pre-Investigational New Drug (“pre-IND”) briefing package to

Food and Drug Administration (“FDA”) in July 2019 that argued against the need for any further preclinical safety

We submitted an Investigational New Drug (“IND”) application to the FDA on June 30, 2021.

On July 28, 2021, the FDA

responded to our IND and stated that we may proceed with Phase I clinical trials in humans.

We initiated our Phase I clinical trial on

September 13, 2021.

We completed our Phase I clinical trial in March 2022 and initiated a Phase IIA clinical trial in May 2022.

The ongoing Phase IIA study

is evaluating the safety and tolerability of AL001 under multiple-dose, steady-state conditions and is determining the maximum tolerated

dose in patients diagnosed with mild to moderate Alzheimer’s.

The lithium and salicylate components of AL001 are to be given within

the amounts already approved for use in patients for other indications.

Up to 40 subjects will complete the Phase IIA trial.

tolerated dose will then be used for further studies.

Topline data are expected in December 2022 from this study.

Based on our preclinical

data, AL001 has a positive effect on the pharmacodynamic biomarkers of Alzheimer’s.

We propose to validate this clinically and if

confirmed, we believe that AL001 is a candidate for breakthrough therapy designation because of its positive effect on a pharmacodynamic

biomarker (beta-amyloids) and potential for a clinically meaningful effect on Alzheimer’s.

A drug that receives a breakthrough therapy

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commitment involving senior managers.

However, we have not received breakthrough therapy designation nor have we qualified for expedited

Our product candidate may not qualify for breakthrough therapy designation or, if it does qualify for breakthrough therapy

designation, it may not actually lead to faster development or expedited regulatory review and approval or necessarily increase the likelihood

that it will receive FDA approval.

However, we have not yet applied for breakthrough therapy designation nor have we received any official

designation for expedited development.

Our product candidate may not qualify for breakthrough therapy designation;

further, even if it

does qualify for breakthrough therapy designation, it may not actually lead to faster development or expedited regulatory review and approval

or necessarily increase the likelihood that it will receive FDA approval.

Additionally,

we believe that AL001 is positioned for an expedited Section 505(b)(2) regulatory pathway for new drug.

AL001’s active pharmaceutical

ingredients (lithium, proline and salicylate) are well documented and approved by the FDA.

The provisions of 505(b)(2) were created, in

part, to help avoid unnecessary duplication of studies already performed on a previously approved (“reference”

or “listed”)

part, to help avoid unnecessary duplication of studies already performed on a previously approved (“reference” or “listed”)

This section gives the FDA express permission to rely on data not developed by the NDA applicant.

This can result in a much less

expensive and much faster route to approval, compared with a traditional development path such as 505(b)(1), while creating new, differentiated

products with tremendous commercial value.

If we successfully obtain a breakthrough therapy designation and the Section 505(b)(2) regulatory

pathway for new drug approvals, we believe we can shorten the development timeline for AL001.

However, our product candidate may not qualify

for expedited development or, if it does qualify for expedited development, it may not actually lead to faster development or expedited

regulatory review and approval.

believe that our ability to re-engineer lithium solid dosage forms in order to optimize performance has the potential to address a wide

range of clinical applications ranging from neurodegenerative disorders, such as Alzheimer’s, amyotrophic lateral sclerosis (known

as ALS and Lou Gehrig’s disease), Huntington’s disease, multiple sclerosis, Parkinson’s disease and traumatic brain

injury, to more psychiatric conditions such as bipolar disorder, depression, mania, post-traumatic stress disorder and suicidality.

novel approach is intended to achieve the desired therapeutic outcome of enhanced penetration through the blood-brain barrier and sustained

brain lithium concentrations while systemic exposures (and toxicities) are mitigated for other organ systems.

The optimal modified-release

lithium dosing approach should avoid acutely toxic peak concentrations in blood, as well as in the brain, and should maintain such blood

concentrations for a predictable, clinically relevant time, with overall low systemic exposures that mitigate the potential for adverse

We anticipate that the lithium delivery system will be adaptable to a dosing regimen that maintains therapeutic brain lithium

concentrations consistently for the longest possible time while allowing only modest exposures and providing adequate recovery periods

between doses for other organ systems.

have an additional preclinical candidate for Alzheimer’s, AL002, which has transitioned from early-stage development to an extensive

program of preclinical study and evaluation, which was completed on May 31, 2021 and was followed by a comprehensive report prepared by

This process can result in a much

less expensive and much faster route to approval, compared with a traditional development path such as 505(b)(1), while creating new,

differentiated products with tremendous commercial value.

If we successfully obtain a breakthrough therapy designation and the Section

505(b)(2) regulatory pathway for new drug approvals, we believe we can shorten the development timeline for AL001.

However, our product

candidate may not qualify for expedited development or, if it does qualify for expedited development, it may not actually lead to faster

development or expedited regulatory review and approval.

We believe that

our ability to re-engineer lithium solid dosage forms in order to optimize performance has the potential to address a wide range of clinical

applications ranging from neurodegenerative disorders, not merely Alzheimer’s, but also amyotrophic lateral sclerosis (known as

ALS and Lou Gehrig’s disease), Huntington’s disease, multiple sclerosis, Parkinson’s disease and traumatic brain injury,

to more psychiatric conditions such as bipolar disorder, MDD, mania, PTSD and suicidality.

This novel approach is intended to achieve

the desired therapeutic outcome of enhanced penetration through the blood-brain barrier and sustained brain lithium concentrations while

systemic exposures (and toxicities) are mitigated for other organ systems.

The optimal modified-release lithium dosing approach should

avoid acutely toxic peak concentrations in blood, as well as in the brain, and should maintain such blood concentrations for a predictable,

clinically relevant time, with overall low systemic exposures that mitigate the potential for adverse events.

We anticipate that the lithium

delivery system will be adaptable to a dosing regimen that maintains therapeutic brain lithium concentrations consistently for the longest

possible time while allowing only modest exposures and providing adequate recovery periods between doses for other organ systems.

have an additional preclinical candidate for Alzheimer’s, AL002, which has transitioned from early-stage development to an extensive

program of preclinical study and evaluation that was completed on May 31, 2021, and was followed by a comprehensive report prepared by

Charles River Laboratories, Inc., an independent preclinical service provider, received on July 23, 2021.

Our preclinical program included

a toxicologic evaluation, histopathology study and brain beta amyloid analysis and, after we received additional financing in March 2021,

was expanded to include an immunoglobulin analysis and biodistribution study.

We submitted a pre-IND meeting

request for AL002 and supporting briefing documents to the Center for Biological Evaluation and Research of the FDA on July 30, 2021.

We received a written response to relating to the pre-IND from the FDA providing a path for Alzamend’s planned clinical development

of AL002 on September 30, 2021.

The FDA agreed to allow Alzamend to submit an IND to conduct a combined Phase I/II study.

We anticipate

submitting an IND to initiate a Phase I/II study for AL002 in September 2022.

Our Business Strategy

intend to develop and commercialize therapeutics with the potential to significantly improve the lives of individuals afflicted by Alzheimer’s

and other neurodegenerative diseases and psychiatric disorders.

We intend to develop

and commercialize therapeutics that are better than existing treatments and have the potential to significantly improve the lives of individuals

afflicted by Alzheimer’s, bipolar disorder, MDD and PTSD.

To achieve these goals, we are pursuing the following key business strategies:

Advance clinical development of AL001 and AL002 for Alzheimer’s treatment .

• Advance clinical development of AL001 and AL002 for Alzheimer’s treatment .

For our lead candidate,

AL001, we have submitted a PIND briefing package to the FDA with proposed testing parameters and on June 30, 2021 have submitted an IND

On July 28, 2021 the FDA responded to our IND that we are safe to proceed and we will be able to commence Phase I clinical

trials in humans.

Our preclinical candidate, AL002, is in an earlier stage of development.

We completed our preclinical study and evaluation

of AL002 on May 31, 2021.

AL001, we completed our Phase I clinical trial in March 2022 and initiated a Phase IIA clinical trial in May 2022.

We anticipate topline

data in December 2022 from our ongoing Phase IIA multiple ascending dose (“MAD”) clinical trial for AL001 treatment of dementia

related to Alzheimer’s.

We completed our preclinical study and evaluation of AL002 on May 31, 2021, and anticipate submitting an

IND to initiate a Phase I/II study in September 2022;

• Expand our pipeline of pharmaceuticals to include additional indications for AL001 and delivery methods.

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candidates through clinical development for the treatment of a variety of indications.

In addition to treating Alzheimer’s, AL001

has the potential to treat a wide range of neurodegenerative diseases and psychiatric disorders.

We plan to pursue the treatment of bipolar

disorder, depression, and post-traumatic stress disorder.

We also plan to explore different formulations (liquid, immediate release and

sprinkle capsules) to deliver AL001.

disorder, MDD, and PTSD with AL001, and in May 2022, we submitted a pre-IND meeting request to the FDA for these indications and received

a written response from the FDA in July 2022.

Based on the written response from the FDA, we plan to submit separate INDs for bipolar

disorder, MDD, and PTSD after completion of the current Phase II MAD clinical trial, which would allow us to initiate Phase II studies

in each of those indications.

We also plan to explore different formulations (liquid, immediate release and sprinkle capsules) to deliver

• Focus on translational and functional endpoints to efficiently develop product candidates.

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for breakthrough therapy designations because of their positive effects on a pharmacodynamic biomarker (beta-amyloids) and potential for

a clinically meaningful effect on Alzheimer’s, making them eligible to receive assistance from the FDA throughout the development

process that may shorten the development timelines.

However, we have not received breakthrough therapy designation nor qualified for expedited

development, and no assurance can be given that we will be able to do so.

However, we have neither received breakthrough therapy designation nor have we qualified

for expedited development, and no assurance can be given that we will.

Even if we qualify for breakthrough therapy designation or expedited

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directly into the marketplace, though we may do so depending on market conditions.

Our focus is to strategically effect partnering transactions

which will provide distribution and marketing capabilities for the sale of our products into the marketplace.

Our focus is expected to concentrate on entering into

strategical transactions with established distributors and producers, which will provide distribution and marketing capabilities for the

sale of our products into the marketplace.

Our Development Pipeline

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AL001 Drug Candidate

lead product candidate that we have licensed and will first move to clinical development in humans is an ionic cocrystal of lithium for

the treatment of Alzheimer’s and other neurodegenerative diseases and psychiatric disorders.

Lithium salts have a long history of

human consumption beginning in the 1800s.

In psychiatry, they have been used to treat mania and as a prophylactic for depression since

the mid-20th century.

Today, lithium salts are used as a mood stabilizer for the treatment of bipolar disorder.

Although the FDA has approved

no medications as safe and effective treatments for suicidality, lithium has proven to be the only drug that consistently reduces suicidality

in patients with neuropsychiatric disorders.

Despite these effective medicinal uses, current FDA-approved lithium pharmaceutics (lithium

carbonate and lithium citrate) are limited by a narrow therapeutic window that requires regular blood monitoring of plasma lithium levels

and blood chemistry by a clinician to mitigate adverse events.

Because conventional lithium salts (carbonate and citrate) are eliminated

relatively quickly, multiple administrations throughout the day are required to safely reach therapeutic plasma concentrations.

lithium drugs, such as lithium chloride and lithium carbonate, suffer from chronic toxicity, poor physicochemical properties and poor

brain bioavailability.

Because lithium is so effective at reducing manic episodes in patients with bipolar disorder, it is still used

clinically despite its narrow therapeutic index.

lead product candidate that we have licensed and have begun clinical development in humans is an ionic cocrystal of lithium for the treatment

of Alzheimer’s, bipolar disorder, MDD and PTSD.

Lithium salts have a long history of human consumption beginning in the 1800s.

psychiatry, they have been used to treat mania and as a prophylactic for depression since the mid-20th century.

Today, lithium salts are

used as a mood stabilizer for the treatment of bipolar disorder.

Although the FDA has approved no medications as safe and effective treatments

for suicidality, lithium has proven to be the only drug that consistently reduces suicidality in patients with neuropsychiatric disorders.

Despite these effective medicinal uses, current FDA-approved lithium pharmaceutics (lithium carbonate and lithium citrate) are limited

by a narrow therapeutic window that requires regular blood monitoring of plasma lithium levels and blood chemistry by a clinician to mitigate

adverse events.

Because conventional lithium salts (carbonate and citrate) are eliminated relatively quickly, multiple administrations

throughout the day are required to safely reach therapeutic plasma concentrations.

Existing lithium drugs, such as lithium chloride and

lithium carbonate, suffer from chronic toxicity, poor physicochemical properties and poor brain bioavailability.

Because lithium is so

effective at reducing manic episodes in patients with bipolar disorder, it is still used clinically despite its narrow therapeutic index.

This has led researchers to begin to look for alternatives to lithium with similar bioactivities.

from the University of South Florida have developed a new lithium cocrystal composition and method of preparation that, under certain

clinical and/or testing conditions, have been shown to allow for lower dosages to achieve therapeutic brain levels of lithium for psychiatric

disorders, which could lead to a broadening of lithium’s therapeutic index.

Our studies and/or testing have indicated that the compound

offers improved physiochemical properties compared to existing forms of lithium, giving it the potential to be developed as an anti-suicidal

drug or for use against mood disorders.

evidence suggests that lithium may be efficacious for both the treatment and prevention of Alzheimer’s.

Scientists from

the University of South Florida have developed a new lithium cocrystal composition and method of preparation that, under certain clinical

and/or testing conditions, have been shown to allow for lower dosages to achieve therapeutic brain levels of lithium for psychiatric disorders,

which could lead to a broadening of lithium’s therapeutic index.

Our studies and/or testing have indicated that the compound offers

improved physiochemical properties compared to existing forms of lithium, giving it the potential to be developed as an anti-suicidal

drug and for use against mood disorders.

evidence suggests that lithium may be efficacious for both the treatment and prevention of Alzheimer’s.

Unlike traditional medications

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Results from recent clinical studies suggest that lithium

treatment may reduce dementia development while preserving cognitive function and reducing biomarkers associated with Alzheimer’s.

novel ionic cocrystal of lithium (AL001), which was designed, synthesized and characterized by a team of inventors from the University

of South Florida has been shown to exhibit improved nonclinical pharmacokinetics compared to current FDA-approved lithium products, and

is also bioactive in many in vitro models of Alzheimer’s.

AL001 may constitute a means of treating Alzheimer’s and other neurodegenerative

diseases and psychiatric disorders.

Our preclinical studies encompassed the treatment of 28 transgenic (or genetically modified) and 10

non-transgenic mice with lithium carbonate and AL001.

In particular, female APPSWE/PS1dE9 mice at 4 months of age were fed with either

regular chow (Tg-Ctrl,n= 8) or chow that contained lithium carbonate (LC, 0.05% equivalent to 83 mg/kg/day, n = 6), or lithium salicylate

(LS, 0.20% equivalent to 325 mg/kg/day, n = 6), or lithium salicylate proline co-crystal, AL001 (AL001, 0.35% equivalent to 583 mg/kg/day,

n = 8) for 9 months.

In addition, aged-matched non- transgenic background control mice (B6C3F1/J, Non-Tg Ctrl, n = 10) were fed regular

chow for 9 months as control.

Each treatment group was subject to a battery of behavioral tests at 12 months of age and mice were sacrificed

at 13 months of age.

The results of our preclinical studies, conducted from May 2016 to June 2017, are summarized below:

treatment may reduce dementia development while preserving cognitive function and reducing biomarkers associated with Alzheimer’s.

The novel ionic

cocrystal of lithium (AL001), which was designed, synthesized and characterized by a team of inventors from the University of South Florida

has been shown to exhibit improved nonclinical pharmacokinetics compared to currently FDA-approved lithium products and is also bioactive

in many in vitro models of Alzheimer’s.

AL001 may constitute a means of treating Alzheimer’s, bipolar disorder, MDD and PTSD.

Our preclinical studies encompassed the treatment of 28 transgenic (or genetically modified) and 10 non-transgenic mice with lithium carbonate

In particular, female APPSWE/PS1dE9 mice at 4 months of age were fed with either regular chow (Tg-Ctrl, n=8) or chow that contained

lithium carbonate (LC, 0.05% equivalent to 83 mg/kg/day, n=6), or lithium salicylate (LS, 0.20% equivalent to 325 mg/kg/day, n=6), or

lithium salicylate proline co-crystal, AL001 (AL001, 0.35% equivalent to 583 mg/kg/day, n=8) for 9 months.

In addition, aged-matched non-

transgenic background control mice (B6C3F1/J, Non-Tg-Ctrl, n=10) were fed regular chow for 9 months as control.

Each treatment group was

subject to a battery of behavioral tests at 12 months of age and mice were sacrificed at 13 months of age.

The results of our preclinical

studies, conducted from May 2016 to June 2017, are summarized below:

• AL001 treatment improved cognitive function by 50% (Tg-Ctrl vs.

p<0.01), in comparison with

the control group, through behavioral tests administered to mice with Alzheimer’s.

The tests resulted in 50% lower escape latency

p < 0.01) during the training and probe trial of the Morris water maze test and 50% longer contextual freezing

time (Tg-Ctrl vs.

p<0.01) during the training and probe trial of the Morris water maze test and 50% longer contextual freezing time

p<0.05) during the fear conditioning test;

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p<0.05) and in reducing irritability

p < 0.01), supporting the potential of this lithium formulation for the treatment of Alzheimer’s.

p<0.01), supporting the potential of this lithium formulation for the treatment of Alzheimer’s;

• AL001 had no effect on renal COX2 activity (Tg-Ctrl vs.

p>0.05), a biomarker of renal toxicity,

while markedly reducing abnormal biomarkers associated with Alzheimer’s by 50%, in particular beta-amyloid pathology, tau phosphorylation

and neuro-inflammation (Tg-Ctrl vs.

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In contrast, equimolar doses (using a similar structure of moles but different active

pharmaceutical ingredient) of lithium carbonate enhanced renal COX2 expression while having little or no impact on Alzheimer’s pathology

• AL001, at the effective dose, yielded 50% higher lithium levels (LC vs.

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is less than or equal to 0.05, the outcome is considered statistically significant.

The FDA’s evidentiary standard of efficacy generally

relies on a p-value of less than or equal to 0.05.

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all of the results of our preclinical studies were statistically significant compared to the control group.

product can be designated as a breakthrough therapy if it is intended to treat a serious condition and preliminary clinical evidence indicates

that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

For purposes of

breakthrough therapy designation, clinically significant endpoint generally refers to an endpoint that measures an effect on irreversible

morbidity or mortality (“IMM”), or on symptoms that represent serious consequences of the disease.

A clinically significant

endpoint can also refer to findings that suggest an effect on IMM or serious symptoms, including:

On September 13,

2021, we initiated a randomized, balanced, Phase I, single-dose, open-label, two-treatment, two-period, two- sequence, crossover, relative

bioavailability study to investigate lithium pharmacokinetics and safety of AL001 formulation compared to a marketed immediate release

lithium carbonate formulation in healthy subjects.

The primary objective of this study was to assess the relative bioavailability of the

AL001 lithium formulation relative to a marketed lithium carbonate formulation in healthy subjects for the purpose of determining potential

clinically safe and effective AL001 dosing in future studies.

Additionally, we wanted to characterize safety and tolerability of the tested

formulations under the conditions of this study.

This was a first-in-human study of the AL001 formulation;

this trial was designed to

assess the relative bioavailability of the AL001 lithium formulation compared to a marketed lithium carbonate formulation in at least

24 completed healthy subjects (30 subjects were to be enrolled) for the purpose of determining potential clinically safe and effective

AL001 dosing in future studies.

The AL001 lithium content was nearly half of the reference lithium carbonate capsule dosage as it was

expected that treatment of frail Alzheimer’s patients will require half the lithium dose used for treatment of bipolar/affective

Lithium carbonate 300 mg (Reference product) was given as a single dose in this study;

this is often used as a starting dose

for treatment of bipolar/affective disorders when given three times daily.

The shape of the AL001 lithium plasma concentration versus

time curve was unknown prior to this study.

Also unknown were the AL001 rate and extent of lithium absorption.

The Phase I study was completed

in March 2022 with the following results:

· AL001 was shown to be safe and well-tolerated

in healthy adult subjects;

· No serious adverse events and no deaths were

reported during the trial;

· The safety profiles of both AL001 and the marketed

lithium carbonate capsule were benign;

· No clinically significant abnormal findings in

electrocardiograms were noted during the trial;

· AL001 salicylate plasma concentrations were observed

to be well tolerated and consistently within safe limits;

· Dose-adjusted relative bioavailability

analyses of the rate and extent of lithium absorption in plasma indicated that AL001 1050 mg (lithium content equivalent to 150 mg

lithium carbonate) is bioequivalent to a marketed 300 mg lithium carbonate capsule and the shapes of the lithium plasma

concentration versus time curves are similar.

May 5, 2022, we initiated a multiple-dose, steady-state, double-blind, ascending dose safety, tolerability, pharmacokinetic study (www.clinicaltrials.gov,

NCT05363293) of AL001 in patients with mild to moderate Alzheimer’s with the following objectives:

To evaluate the safety and tolerability

of AL001 under multiple-dose, steady-state conditions in Alzheimer’s patients;

To characterize the maximum

tolerated dose (MTD) of AL001 in patients with mild to moderate Alzheimer’s;

· Exploratory:

Determination of qualitative

and quantitative evaluations of AD patient desirable characteristics for future Phase 2 and 3 clinical studies in order to:

o Facilitate recruitment into subsequent AL001 clinical trials;

o Facilitate trial-adherence to completion of study requirements including treatment adherence.

product can be designated as a breakthrough therapy if it is intended to treat a serious condition (for which the FDA considers Alzheimer’s)

and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically

significant endpoint(s).

For purposes of breakthrough therapy designation, a clinically significant endpoint generally refers to an endpoint

that measures an effect on irreversible morbidity or mortality (“IMM”), or on symptoms that represent serious consequences

of the disease.

A clinically significant endpoint can also refer to findings that suggest an effect on IMM or serious symptoms, including:

• an effect on an established surrogate endpoint;

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a clinical benefit (i.e., the accelerated approval standard);

an effect on a pharmacodynamic biomarker that does not meet criteria for an acceptable surrogate endpoint,

but strongly suggests the potential for a clinically meaningful effect on the underlying disease;

• an effect on a pharmacodynamic biomarker (which is a measurable indicator of the disease state) that does

not meet criteria for an acceptable surrogate endpoint, but strongly suggests the potential for a clinically meaningful effect on the

underlying disease;

• a significantly improved safety profile compared to available therapy (e.g., less dose-limiting toxicity

for an oncology agent), with evidence of similar efficacy.

on our preclinical data, AL001 has a positive effect on the pharmacodynamic biomarkers of Alzheimer’s.

As a result, we believe that

AL001 is candidate for breakthrough therapy designation because of its positive effect on a pharmacodynamic biomarker (beta-amyloids)

and potential for a clinically meaningful effect on Alzheimer’s.

A drug that receives a breakthrough therapy designation is eligible

for fast- track designation features, intensive guidance on an efficient drug development program and FDA organizational commitment involving

senior managers.

However, we have not received breakthrough therapy designation or have qualified for expedited development.

candidate may not qualify for breakthrough therapy designation or, if it does qualify for breakthrough therapy designation, it may not

actually lead to faster development or expedited regulatory review and approval or necessarily increase the likelihood that it will receive

FDA approval.

if the data from AL001 in the aforementioned Phase II study provides confirmation of the pre-clinical data, i.e., positive effect on a

pharmacodynamic biomarker (beta-amyloids) and potential for a clinically meaningful effect on Alzheimer’s, AL001 will be a candidate

for breakthrough therapy designation.

If breakthrough therapy designation is granted, it would be eligible for intensive guidance on an

efficient drug development program and FDA organizational commitment involving senior managers.

However, we have neither received breakthrough

therapy designation nor have we qualified for expedited development.

Our product candidate may not qualify for breakthrough therapy designation;

further, even if it does qualify for breakthrough therapy designation, it may not actually lead to faster development or expedited regulatory

review and approval or necessarily increase the likelihood that it will receive FDA approval.

Additionally,

we believe that AL001 is positioned for an expedited Section 505(b)(2) regulatory pathway for new drug.

AL001’s active pharmaceutical

ingredients (lithium, proline and salicylate) are well documented and approved by the FDA.

The provisions of Section 505(b)(2) were created,

in part, to help avoid unnecessary duplication of studies already performed on a previously approved (“reference”

or “listed”)

in part, to help avoid unnecessary duplication of studies already performed on a previously approved (“reference” or “listed”)

This section gives the FDA express permission to rely on data not developed by the NDA applicant.

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development or expedited regulatory review and approval.

will require extensive clinical evaluation, regulatory review and approval, significant marketing efforts and substantial investment before

it or any successors are likely to provide us with any revenue.

As a result, if we do not successfully develop, achieve regulatory approval

for and commercialize AL001, our long-term business plans will not be met, and we will be unable to generate the revenue we have forecast

AL001 will require

extensive clinical evaluation, regulatory review and approval, significant marketing efforts and substantial investment before it or any

successors are likely to provide us with any revenue.

As a result, if we do not successfully develop, achieve regulatory approval for

and commercialize AL001, our long-term business plans will not be met, and we will be unable to generate the revenue we have forecast

for the foreseeable future, if any.

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or acquire additional intellectual property, we will not become profitable with this therapeutic drug candidate, and we will be unable

to continue our operations at the currently planned pace.

to continue our operations at the currently planned pace, if at all.

AL002 Drug Candidate

other product candidate that we have licensed to clinically develop in humans is AL002, a patented method using a mutant peptide sensitized

cell as a cell-based therapeutic vaccine which seeks to restore the ability of the patient’s immunological system to combat Alzheimer’s.

The proposed mechanism of action is through the pulsed-Dendritic Cell (“DC”) activation of T-cells that stimulates the immune

cell as a cell-based therapeutic vaccine which seeks to restore the ability of the patient’s immunological system to combat Alzheimer’s.

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.

Preclinical studies conducted from April 2005 to July 2010 suggest that the infusion

of transgenic (or genetically modified) mice with AL002-pulsed DCs is associated with lower amyloid burden and improved neurobehavioral

of transgenic (or genetically modified) mice with AL002-pulsed DCs is associated with lower amyloid burden and improved neuro-behavioral

This is likely to be mediated by an anti-inflammatory effect in addition to the immunogenicity of this therapy.

is based on the theory that Alzheimer’s symptoms may be caused in large part by plaque deposits that can cluster in the brain composed

of protein fragments called beta-amyloids that build up between nerve cells.

One hypothesis is that a special type of immune cell, natural

beta-amyloid antibodies, may play a role in preventing plaque build-up in people without Alzheimer’s.

As people age, their immune

system may degrade, and some people may be unable to produce natural beta-amyloid antibodies which leads to the plaque build-up causing

Alzheimer’s.

is intended to elicit an immune response to product anti-amyloid antibodies, which can then neutralize circulated beta-amyloids and prevent

additional plaque build-up.

The mutant antigen within AL002 was selected specifically for its high HLA binding affinity, thereby avoiding

the need for an adjuvant, which may cause an adverse (Th1) immune response.

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.

AL002 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 mutant antigen within AL002 was selected specifically for its high HLA binding affinity, thereby avoiding the need

for an adjuvant, which may cause an adverse (Th1) immune response.

is an autologous modified DC treatment.

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The DCs are incubated with a modified amyloid beta (Aβ) peptide

(“AL002 peptide”) to sensitize them, and then administered to the same patient.

evidence has accumulated recently suggesting that immunotherapy is a highly promising modality of treatment in Alzheimer’s.

(“AL002 peptide”) to sensitize them, and then administered to the same patient.

evidence has accumulated recently suggesting that immunotherapy is a highly promising modality of treatment in Alzheimer’s.

current immune-based active investigations are focused on passive immunization by pre-prepared Aβ antibody administration.

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Further, preliminary evidence suggests a recurrence of the amyloid accumulation after clearance with the immunoglobulins.

A prior attempt at engaging the immune system to treat Alzheimer’s was conducted using the immunization with pre-aggregated synthetic

Aβ (AN-1792) combined with the immunogenic adjuvant QS-21.

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in the vaccine formulation.

July 23, 2021 we announced that Alzamend received positive toxicology results for AL002 in a good laboratory practices (“GLP”)

toxicology study using a transgenic mouse model of Alzheimer’s disease.

July 23, 2021, we announced that Alzamend received positive toxicology results for AL002 in a good laboratory practices (“GLP”)

toxicology study using a transgenic mouse model of Alzheimer’s.

The study was conducted by Charles River Laboratories.

is 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.

five-dose GLP study with AL002-sensitized cells was completed using a transgenic (or genetically modified) mouse model of Alzheimer’s

disease to investigate the tolerability of AL002.

patient’s immunological system to combat Alzheimer’s.

five-dose GLP study with AL002-sensitized cells was completed using a transgenic (or genetically modified) mouse model of Alzheimer’s to investigate the tolerability of AL002.

Single injections were administered on days 1, 30, 50, 70, and 90.

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immune system to attack the target tissues with success.

Its use in Alzheimer’s therapeutics is relatively recent.

We are proposing

to conduct a first-in-human Phase I study of autologous DC, pulsed with a modified Aβ epitope.

Preclinical work supports that it

is associated with positive anti-inflammatory response and a decrease in brain amyloid contents.

product can be designated as a breakthrough therapy if it is intended to treat a serious condition and preliminary clinical evidence indicates

that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

A drug that receives

a breakthrough therapy designation is eligible for fast track designation features, intensive guidance on an efficient drug development

program and FDA organizational commitment involving senior managers.

We believe that AL002 is positioned for a breakthrough therapy designation

because of its positive effect on a pharmacodynamic biomarker (beta-amyloids) and potential for a clinically meaningful effect on Alzheimer’s.

to conduct a first-in-human Phase I/II study of autologous DC, pulsed with a modified Aβ epitope.

Preclinical work supports that

it is associated with positive anti-inflammatory response and a decrease in brain amyloid contents.

We anticipate submitting an IND to

initiate a Phase I/II study for AL002 in September 2022.

A product can be

designated as a breakthrough therapy if it is intended to treat a serious condition and preliminary clinical evidence indicates that the

drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

A drug that receives a breakthrough

therapy designation is eligible for fast-track designation features, intensive guidance on an efficient drug development program and FDA

organizational commitment involving senior managers.

We believe that AL002 is positioned for a breakthrough therapy designation because

of its positive effect on a pharmacodynamic biomarker (beta-amyloids) and potential for a clinically meaningful effect on Alzheimer’s.

If we successfully acquire a breakthrough therapy designation for new drug approvals, we believe we can shorten the development timeline

However, we have not received breakthrough therapy designation nor qualified for expedited development.

However, we have neither received breakthrough therapy designation nor qualified for expedited development.

Our product candidate

may not qualify for breakthrough therapy designation or, if it does qualify for breakthrough therapy designation, it may not actually

lead to faster development or expedited regulatory review and approval or necessarily increase the likelihood that it will receive FDA

may not qualify for breakthrough therapy designation;

further, even if it does qualify for breakthrough therapy designation, it may not

actually lead to faster development or expedited regulatory review and approval or necessarily increase the likelihood that it will receive

FDA approval.

will require extensive clinical evaluation, regulatory review and approval, significant marketing efforts and substantial investment before

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or acquire additional intellectual property, we will not become profitable with this therapeutic drug candidate, and we will be unable

to continue our operations at the currently planned pace.

to continue our operations at the currently planned pace, if at all.

Intellectual Property

and Licensing Agreements

May 1, 2016, we entered into a Standard Exclusive License Agreement with Sublicensing Terms with the University of South Florida Research

Foundation, Inc.

(the “Licensor”) pursuant to which the Licensor granted us a royalty bearing exclusive worldwide license

limited to the field of Alzheimer’s Immunotherapy and Diagnostics, under United States Patent No.

8,188,046, entitled “Amyloid

Beta Peptides and Methods of Use”

(AL002), filed April 7, 2009 and granted May 29, 2012.

addition to royalty payments of 4% on net sales of products developed from the licensed technology, we were required to pay a license

fee of $100,000 on each of June 25, 2016 and December 31, 2016.

As an additional licensing fee for the license of the AL001 technologies,

the licensor received 2,227,923 shares of our common stock.

Additionally, we are required to pay milestone payments on the due dates to

the Licensor for the license of the technology, as follows:

AL002 License:

January 1, 2022

On June 2, 2018, we entered into two Standard

Exclusive License Agreements with Sublicensing Terms for AL001 with the Licensor and its affiliate, the University of South Florida (the

“AL001 License Agreements”), pursuant to which the Licensor granted us a royalty bearing exclusive worldwide licenses limited

to the field of Alzheimer’s, under United States Patent Nos.

(i) 9,840,521, entitled “Organic Anion Lithium Ionic Cocrystal

Compounds and Compositions”, filed September 24, 2015 and granted December 12, 2017, and (ii) 9,603,869, entitled “Lithium

Co-Crystals for Treatment of Neuropsychiatric Disorders”, filed May 21, 2016 and granted March 28, 2017.

The AL001 License Agreements require that

we pay combined royalty payments of 4.5% on net sales of products developed from the licensed technology for AL001.

We have already paid

an initial license fee of $200,000 for AL001.

As an additional licensing fee for the license of the AL001 technologies, the Licensor received

2,227,923 shares of our common stock.

Minimum royalties for AL001 are $25,000 in 2023, $45,000 in 2024 and $70,000 in 2025 and every year

thereafter, for the life of the AL001 License Agreements.

On May 1, 2016,

we entered into a Standard Exclusive License Agreement with Sublicensing Terms for AL002 with the Licensor (the “AL002 License Agreement”),

pursuant to which the Licensor granted us a royalty bearing exclusive worldwide license limited to the field of Alzheimer’s Immunotherapy

and Diagnostics, under United States Patent No.

8,188,046, entitled “Amyloid Beta Peptides and Methods of Use”, filed April

7, 2009 and granted May 29, 2012.

The AL002 License

Agreement requires us to pay royalty payments of 4% on net sales of products developed from the licensed technology for AL002.

already paid an initial license fee of $200,000 for AL002.

As an additional licensing fee for the license of AL002, the Licensor received

3,601,809 shares of our common stock.

Minimum royalties for AL002 are $20,000 in 2022, $40,000 in 2023 and $50,000 in 2024 and every year

thereafter, for the life of the AL002 License Agreement.

On June 10, 2020, we entered

into two Standard Exclusive License Agreements with Sublicensing Terms for two additional indications of

AL001 with the Licensor (the “June AL001 License Agreements”), pursuant

to which the Licensor granted us a royalty bearing exclusive worldwide

licenses limited to the fields of (i) neurodegenerative diseases excluding Alzheimer’s and (ii) psychiatric diseases and disorders.

The June AL001 License Agreements require

us to pay royalty payments of 3% on net sales of products developed from the licensed technology for AL001 in those fields.

initial license fee of $20,000 for the additional indications.

These license agreements

have an indefinite term that continue until the later of the date no licensed patent under the applicable agreement remains a pending

application or enforceable patent, the end date of any period of market exclusivity granted by a governmental regulatory body, or the

date on which the licensee’s obligations to pay royalties expire under the applicable license agreement.

Under our various license

agreements, if we fail to meet a milestone by its specified date, Licensor may terminate the license agreement.

The Licensor was also

granted a preemptive right to acquire such shares or other equity securities that may be issued from time to time by us while the Licensor

remains the owner of any equity securities of our company.

Additionally, we are required to pay milestone

payments on the due dates to the Licensor for the license of the AL001 technologies and for the AL002 technology, as follows:

Original AL001 License:

Completed September 2019

Pre-IND meeting

Completed June 2021

IND application filing

Completed December 2021

Upon first dosing of patient in a clinical trial

Completed March 2022

Upon Completion of first clinical trial

12 months from completion of the first Phase II clinical trial

Upon first patient treated in a Phase III clinical trial

8 years from the effective date of the agreement

Upon FDA approval

*Milestone met and completed

AL002 License:

Completed January 2022

Upon IND application filing

12 months from IND application filing date

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Upon completion of first Phase I clinical trial

24 months from completion of first Phase I trial

24 months from completion of first Phase I clinical trial

Upon completion of first Phase II clinical trial

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7 years from the effective date of the agreement

Upon receipt of FDA BLA approval

Licensor was also granted a preemptive right to acquire such shares or other equity securities that may be issued from time to time by

us while Licensor remains the owner of any equity securities of our company.

AL001 License:

are certain license fees and milestone payments required to be paid for the licensing of the AL001 technology, pursuant to the terms of

the Standard Exclusive License Agreements with Sublicensing Terms, both effective July 2, 2018 (the “AL001 License Agreements”)

with the licensor and the University of South Florida.

In addition, a royalty payment of 3% is required pursuant to License #18110 while

License #18111 requires a royalty payment of 1.5% on net sales of products developed from the licensed technology.

For the two AL001 licenses,

in the aggregate, we paid initial license fees of $200,000.

As an additional licensing fee, the Licensor is entitled to receive that number

of shares of common stock equal to 3% of the sum of the total number of issued and outstanding shares.

Additionally, we are required to

pay milestone payments on the due dates to the licensor for the license of the technology, as follows:

Pre-IND meeting

IND application filing

12 months from IND filing date

Upon first dosing of patient in a clinical trial

12 months from first patient dosing

Upon completion of first clinical trial

24 months from completion of the first clinical trial

Upon first patient treated in a Phase III clinical trial

8 years from the effective date of the agreement

Upon FDA approval

have met the Pre-IND meeting and IND application filing milestones encompassing AL001.

If we fail to meet a milestone payment by its specified

date, the Licensor may terminate the License Agreement.

On June 10, 2020,

we obtained two additional royalty-bearing exclusive worldwide licenses from the Licensor to a therapy named AL001.

One of the additional

licenses is for the treatment of neurodegenerative diseases excluding Alzheimer’s and the other license is for the treatment of

psychiatric diseases and disorders.

There are certain license fees and milestone payments required to be paid pursuant to the terms of

the Standard Exclusive License Agreements with Sublicensing Terms, both dated June 10, 2020 and effective as of November 1, 2019, with

the Licensor and the University of South Florida (the “June AL001 License Agreements”).

Under each of the June AL001 License

Agreements, a royalty payment of 3% is required on net sales of products developed from the licensed technology.

For the two additional

AL001 licenses, in the aggregate, we paid initial license fees of $20,000.

Additionally, under each of the June AL001 License Agreements,

we are required to pay milestone payments on the due dates to the Licensor for the license of the technology, as follows:

Upon FDA Biologics License Application (“BLA”) approval

Milestone met and completed

AL001 Licenses:

Upon first pre-IND meeting

Pre-IND meeting

December 31, 2022

Upon IND application filing

IND application filing

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Upon first patient treated in a Phase III clinical trial

August 1, 2029

8 years from the effective date of the agreement

First commercial sale

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remains a pending application or enforceable patent, the end date of any period of market exclusivity granted by a governmental regulatory

body, or the date on which the licensee’s obligations to pay royalties expire under the applicable license agreement.

Market Opportunity

Alzheimer’s Association estimates that the cost of caring for people with Alzheimer’s and other dementias will reach $355

billion in 2021, including $239 billion in Medicare and Medicaid payments, and that by 2050, these costs may rise as high as $1.1 trillion

Currently, Alzheimer’s is the sixth leading cause of death in the U.S.

and when extrapolated globally, the market for

preventions, treatments, and cures of this crippling disease is massive.

We were formed to develop and commercialize patented intellectual

property and treatments for Alzheimer’s, by funding it from preclinical through clinical trials and ultimately, if successful, make

it available to the global market.

Additionally, we are supporting ongoing research at the USF Health College of Medicine and plan to

support others with first rights of refusal on technologies for treating terminal diseases.

The Alzheimer’s

Association estimates that the cost of caring for people with Alzheimer’s and other dementias will reach $321 billion in 2022, including

$206 billion in Medicare and Medicaid payments, and that by 2050, these costs may rise as high as $1 trillion per year.

Alzamend was formed

to develop and commercialize patented intellectual property and treatments for Alzheimer’s, by funding it from preclinical through

clinical trials and ultimately, if successful, make it available to the global market.

Additionally, we are supporting ongoing research

at the USF Health College of Medicine and plan to support others with first rights of refusal on technologies for treating terminal diseases.

an article jointly issued on April 8, 2016, Allergan and Heptares cited currently significant unmet medical needs and a heavy economic

burden caused by cognitive impairment and dementia across multiple diseases, noting that currently available drugs for the treatment of

Alzheimer’s provide limited and transient effects on cognition.

They cite projections of healthcare costs, including nursing home

care, associated with Alzheimer’s and dementia (currently estimated to be in excess of $640 billion for North America, Western Europe,

and Asia-Pacific), that are continuing to grow based on data from the World Health Organization, Alzheimer’s International, the

care, associated with Alzheimer’s and dementia (currently estimated to be in excess of $640 billion for North America, Western Europe,

and Asia-Pacific), that are continuing to grow based on data from the World Health Organization, Alzheimer’s International, the

National Institute of Mental Health and the Lewy Body Dementia Association.

medical shortfall puts a spotlight on an urgent need for development of new therapies capable of treating the estimated more than 45 million

people worldwide suffering from Alzheimer’s today —

6.2 million in North America, 7.5 million in Western Europe and 3.6 million

in Asia-Pacific —

a number expected to increase to more than 130 million by 2050.

Alzheimer’s is the most common cause of

dementia, estimated to be associated with some 60 to 70% of cases.

An additional estimated 1.4 million patients in the United States suffer

from Lewy body dementia.

people worldwide suffering from Alzheimer’s today, 6.2 million in North America, 7.5 million in Western Europe and 3.6 million in

Asia-Pacific, a number expected to increase to more than 130 million by 2050.

Alzheimer’s is the most common cause of dementia,

estimated to be associated with some 60% to 70% of cases.

An additional estimated 1.4 million patients in the United States suffer from

Lewy body dementia.

We believe that the potential marketplace for a commercialized therapy or treatment would be tremendously significant

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Industry Overview

Alzheimer’s is the sixth leading cause of death in the United States and, when extrapolated globally, the market for preventions,

treatments and cures of this crippling disease is massive.

Since 1990, life expectancy has increased by six years and the worldwide average

continues to increase.

With the increase in the mean age of the population in developed countries, the prevalence of deteriorating neurological

diseases has also increased.

According to the Alzheimer’s Association, in the United States alone, 1 in 9 persons over the age of

65 have Alzheimer’s, with roughly 6.2 million Americans currently living with it.

It is estimated that this number will grow to

13 million by 2050 barring the development of medical breakthroughs to prevent, slow or cure the disease.

Many Alzheimer’s related

associations believe the actual number of adults with Alzheimer’s may be much higher since current statistics do not take in account

deaths from complications or from related diseases like pneumonia or heart attack.

These death certificates only list the most immediate

The fastest growing age group in the United States is the “over 85”

group within which one in three individuals have

Alzheimer’s.

deaths from other major causes have decreased significantly, official records indicate that deaths from Alzheimer’s have increased

Currently, Alzheimer’s

is the sixth leading cause of death in the United States and, when extrapolated globally, the market for preventions, treatments and cures

of this crippling disease is massive.

Since 1990, life expectancy has increased by six years and the worldwide average continues to increase.

With the increase in the mean age of the population in developed countries, the prevalence of deteriorating neurological diseases has

also increased.

According to the Alzheimer’s Association, in the United States alone, one of nine persons over the age of 65 have

Alzheimer’s, with roughly 6.2 million Americans currently living with it.

It is estimated that this number will grow to 13 million

by 2050 barring the development of medical breakthroughs to prevent, slow or cure the disease.

Many Alzheimer’s related associations

believe the actual number of adults with Alzheimer’s may be much higher since current statistics do not take in account deaths from

complications or from related diseases like pneumonia or heart attack.

These death certificates only list the most immediate cause.

fastest growing age group in the United States is the “over 85” group within which one in three individuals have Alzheimer’s.

deaths from other major causes have decreased significantly, official records indicate that deaths from Alzheimer’s have increased

significantly.

Between 2000 and 2019, the number of deaths from Alzheimer’s as recorded on death certificates has more than doubled,

increasing 145.2%, while the number of deaths from the number one cause of death (heart disease) decreased 7.3%.

65 seconds, someone in the United States develops Alzheimer’s.

Of the ten most fatal diseases in the United States, Alzheimer’s

is the only one with no cure, no known way of deceleration and no known means of prevention.

We were formed to commercialize patented

intellectual property in this space, by funding it from its present state through human clinical trials administered by the FDA and ultimately,

if successful, potentially make it available to the global market.

Alzheimer’s

average annual incidence for individuals ages 65 to 74 was 0.4%.

Every 65 seconds,

someone in the United States develops Alzheimer’s.

Of the 10 most fatal diseases in the United States, Alzheimer’s is the

only one with no cure, no known way of deceleration and no known means of prevention.

Alzamend was formed to commercialize patented intellectual

property in this space, by funding it from its present state through human clinical trials administered by the FDA and ultimately, if

successful, potentially making it available to the global market.

average annual incidence for individuals aged 65 to 74 was 0.4%.

In individuals ages 75 to 84, the annual incidence was 3.2%, and for

ages 85 and older (the “oldest-old”), the incidence was 7.6%.

It is estimated that the cost of caring for people with Alzheimer’s

ages 85 and older (the “oldest-old”), the incidence was 7.6%.

It is estimated that the cost of caring for people with Alzheimer’s

and other dementias will increase from an estimated $305 billion in 2020 to a projected $1.1 trillion per year by 2050 with Medicare and

Medicaid covering approximately 70% of such costs.

Over 11 million Americans provide unpaid care for people with Alzheimer’s or

other dementias.

The Alzheimer’s Association estimates that, in 2021, caregivers to individuals with Alzheimer’s will provide

15.3 billion hours of care valued at $257 billion.

cause and progression of Alzheimer’s are not well understood.

Through 2020, more than 2,444 clinical trials have been or are being

conducted to find ways to treat the disease, but it is unknown if any of the tested treatments will work.

to the Alzheimer’s Association, it is widely accepted that, with the increasing trend towards a longer lifespan coupled with the

baby-boomer population approaching retirement, the incidence of Alzheimer’s is likely to double in the next 30 years.

The cause and progression

of Alzheimer’s are not well understood.

Through May 2022, more than 3,793 clinical trials have been or are being conducted to find

ways to treat the disease, but it is unknown if any of the tested treatments will work.

to the Alzheimer’s Association, it is widely accepted that, with the increasing trend towards a longer lifespan coupled with the

baby-boomer population approaching retirement, the incidence of Alzheimer’s is likely to double in the next 30 years.

The exponential

increase in the expected number of patients presenting with Alzheimer’s not only represents a major area of unmet medical need,

but it also constitutes a significant market opportunity for diagnostics for this disease.

Alzheimer’s biomarker sales in 2011 were

reported at $1.5 billion but are expected have doubled in 2018 to over $3 billion.

(BCC research 2013, “Advances in biomarker and

monitoring diagnostics:

Great markets, not so great health effects”

by Bjørn Hofmann PhD and H.

Great markets, not so great health effects” by Bjørn Hofmann PhD and H.

Gilbert Welch MD, MPH, 2017).

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However, to our knowledge, no accurate and convenient tools are available

today for pre-dementia diagnosis of Alzheimer’s to support these efforts.

Currently, Alzheimer’s is diagnosed using a process

today for pre-dementia diagnosis of Alzheimer’s to support these efforts.

Currently, Alzheimer’s is diagnosed using a process

that combines cognition assessments with imaging and spinal-fluid tests.

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combined with advanced statistical tools/algorithms to develop disease-specific diagnostic models.

Alzheimer’s

Therapeutic Landscape

to the Alzheimer’s Association, the following is a pictorial representation of the more recent published data encompassing the Alzheimer’s

therapeutics landscape.

are currently several experimental therapeutic agents for Alzheimer’s in various stages of development with clinical testing directed

towards amyloid-beta, or Aβ, clearance, and inhibition of Tau protein aggregation or phosphorylated-Tau, or pTau, clearance.

clinical failures involving Aβ clearance highlight the incomplete understanding of the pathological processes in Alzheimer’s

and clearly demonstrate the need for novel strategies to fight the disease.

2021, the FDA approved Biogen’s Alzheimer’s drug aducanumab, also known as Aduhelm, making it the first medication cleared

regulators to reduce amyloid plaques in people living with Alzheimer’s and the first new medication for the disease in nearly

There were previously no drugs cleared by the FDA that can slow the mental decline from Alzheimer’s, which is the sixth-leading

cause of death in the United States.

The FDA approved Biogen’s Alzheimer’s drug Aduhelm, aimed at helping symptoms, not actually

slowing the disease itself.

Recent clinical failures involving Aβ clearance highlight the incomplete understanding of the pathological

processes in Alzheimer’s and clearly demonstrate the need for novel strategies to fight the disease.

Clinical Management

have retained TAMM Net, Inc., a ten-year old consulting firm based in Georgia for project management experienced with GMP to lead, develop

and manage our preclinical and clinical efforts, extending from the current status of each product candidate through the exit or commercialization

of the technologies that we have licensed.

We may retain experienced Canadian and European Union consulting firms to commercialize these

same technologies for those geographic markets.

have retained Rio Pharmaceutical Services and TAMM Net, Inc., to lead, develop and manage our preclinical and clinical efforts, extending

from the current status of each product candidate through the exit or commercialization of the technologies that we have licensed.

may retain experienced Canadian and European Union consulting firms to commercialize these same technologies for those geographic markets.

Manufacturing

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to third party contractors, with special capabilities to manufacture chemical drugs and biologic drug candidates for submission and clinical

testing under FDA guidelines and, for AL001, have received GMP material manufactured for clinical trial.

There are several sources of

manufacturing available once a therapy or treatment can achieve Phase II study as identified in a publication by Pharma.org released in

2013 (http://www.phrma.org/sites/default/files/Alzheimer’s%202013.pdf).

testing under FDA guidelines and, for AL001, have received Good Manufacturing Practices, or GMP, material manufactured for clinical trial.

There are several sources of manufacturing available once a therapy or treatment can achieve Phase II study as identified in a publication

by Pharma.org released in 2013 (http://www.phrma.org/sites/default/files/Alzheimer’s%202013.pdf).

Distribution and Marketing

intend to develop AL001 and AL002 through successive de-risking milestones towards regulatory approval and seek marketing approval of

AL001 and AL002, or entering into partnering transactions with biopharmaceutical companies seeking to strategically fortify pipelines

and, in turn, receiving funding for the costly later-stage clinical development required to achieve successful commercialization.

not anticipate selling products directly into the marketplace, though we may do so depending on market conditions.

Our focus is to strategically

effect partnering transactions which will provide distribution and marketing capabilities to sell products into the marketplace.

We intend to develop

AL001 and AL002 through successive de-risking milestones towards regulatory approval and seek marketing approval of AL001 and AL002 or

enter into partnering transactions with biopharmaceutical companies seeking to strategically fortify pipelines and, in turn, receiving

funding for the costly later-stage clinical development required to achieve successful commercialization.

We do not anticipate selling

products directly into the marketplace, though we may do so depending on market conditions.

Our focus is to strategically effect partnering

transactions which will provide distribution and marketing capabilities to sell products into the marketplace.

Government Regulation

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Health Product Regulation in the United States

the United States, the FDA regulates pharmaceuticals under the Federal Food, Drug, and Cosmetic Act and related regulations.

In the United States,

the FDA regulates pharmaceuticals under the Federal Food, Drug, and Cosmetic Act and related regulations promulgated thereunder.

Pharmaceuticals

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FDA and comparable regulatory agencies in state and local jurisdictions impose substantial requirements upon the clinical development,

manufacture and marketing of pharmaceutical products.

manufacturing and marketing of pharmaceutical products.

These agencies and other federal, state and local entities regulate research and

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approval, advertising and promotion of our products.

FDA’s policies may change, and additional government regulations may be enacted that could prevent or delay regulatory approval

of new disease indications or label changes.

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• pre-approval inspection of manufacturing facilities and clinical trial sites;

FDA approval of an NDA or Biologics License Application (“BLA”), which must occur before a

drug or biologic product can be marketed or sold.

• FDA approval of an NDA or BLA, which must occur before a drug or biologic product can be marketed or sold.

will need to successfully complete sufficient clinical trials in order to be in a position to submit a BLA or NDA to the FDA.

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limited drug exposure and efficacy signals, and Phase IIB studies, which are larger studies testing both safety and efficacy more rigorously.

• Phase III .

This phase involves trials undertaken to further evaluate dosage, clinical efficacy

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the overall risk/benefit ratio of the product and provide an adequate basis for product labeling.

of these trials must be conducted in accordance with Good Clinical Practice (“GCP”), requirements in order for the data to

be considered reliable for regulatory purposes.

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order to obtain approval to market a pharmaceutical in the United States, a marketing application must be submitted to the FDA that provides

data establishing to the FDA’s satisfaction the safety and effectiveness of the investigational drug for the proposed indication.

Each NDA or BLA submission requires a substantial user fee payment unless a waiver or exemption applies (such as with the Orphan Drug

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includes all relevant data available from pertinent non-clinical studies and clinical trials, including negative or ambiguous results

as well as positive findings, together with detailed information relating to the product’s chemistry, manufacturing, controls and

proposed labeling, among other things.

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The FDA has 60 days from its receipt of an

NDA or BLA to determine whether the application will be accepted for filing based on the agency’s threshold determination that the

application is sufficiently complete to permit substantive review.

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the NDA or BLA to determine, among other things, whether the proposed product is safe and effective for its intended use, and whether

the product is being manufactured in accordance with current Good Manufacturing Practices, or cGMP, to assure and preserve the product’s

identity, strength, quality and purity.

The FDA may refer applications for novel drug products or drug products that present difficult

questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation

and a recommendation as to whether the application should be approved and, if so, under what conditions.

The FDA is not bound by the recommendations

of an advisory committee, but it typically considers such recommendations carefully when making decisions.

on pivotal Phase III trial results submitted in an NDA or BLA, upon the request of an applicant, the FDA may grant a “Priority Review”

the product is being manufactured in accordance with current GMP, or cGMP, to assure and preserve the product’s identity, strength,

quality and purity.

The FDA may refer applications for novel drug products or drug products that present difficult questions of safety

or efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation

as to whether the application should be approved and, if so, under what conditions.

The FDA is not bound by the recommendations of an

advisory committee, but it typically considers such recommendations carefully when making decisions.

on pivotal Phase III trial results submitted in an NDA or BLA, upon the request of an applicant, the FDA may grant a “Priority Review”

designation to a product, which sets the target date for FDA action on the application at six to eight months, rather than the standard

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the quality of evidence necessary to support approval.

the FDA completes its initial review of an NDA or BLA, it will communicate to the sponsor that the drug will either be approved, or it

will issue a complete response letter to communicate that the NDA or BLA will not be approved in its current form and inform the sponsor

After the FDA completes

its initial review of an NDA or BLA, it will communicate to the sponsor that the application for the drug will either be approved, or

it will issue a complete response letter to communicate that the NDA or BLA will not be approved in its current form and inform the sponsor

of changes that must be made or additional clinical, nonclinical or manufacturing data that must be received before the application can

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with cGMP requirements and adequate to assure consistent production of the product within required specifications.

Additionally, before

approving an NDA or BLA, the FDA may inspect one or more clinical sites and manufacturing sites to assure compliance with GCP and GMP.

If the FDA determines that any of the application, manufacturing process or manufacturing facilities is not acceptable, it typically will

outline the deficiencies and often will request additional testing or information.

This may significantly delay further review of the

If the FDA finds that a clinical site did not conduct the clinical trial in accordance with GCP, the FDA may determine that

the data generated by the clinical site should be excluded from the primary efficacy analyses provided in the NDA or BLA.

Additionally,

before approving an NDA or BLA, the FDA may inspect one or more clinical sites to assure compliance with GCP.

If the FDA determines that

any of the application, manufacturing process or manufacturing facilities is not acceptable, it typically will outline the deficiencies

and often will request additional testing or information.

This may significantly delay further review of the application.

If the FDA finds

that a clinical site did not conduct the clinical trial in accordance with GCP, the FDA may determine that the data generated by the clinical

site should be excluded from the primary efficacy analyses provided in the NDA or BLA.

Additionally, notwithstanding the submission of

the FDA may identify deficiencies in the manufacturing process and require changes prior to approval.

Notwithstanding the submission of

any requested additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for

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prospects for AL001 or AL002.

FDA also has authority to require a Risk Evaluation and Mitigation Strategy (“REMS”), from manufacturers to ensure that the

benefits of a drug or biological product outweigh its risks.

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Based on statutory standards, elements of a REMS may include

“dear doctor letters,”

a medication guide, more elaborate targeted educational programs, and in some cases restrictions on

“dear doctor letters,” a medication guide, more elaborate targeted educational programs, and in some cases restrictions on

distribution.

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The 505(b)(2) application

process requires, among other things, the submission of data from studies demonstrating the product’s safety and efficacy for the

new indication.

Hatch-Waxman Amendments permit companies to rely upon not only certain published nonclinical or clinical studies conducted for an approved

product, but also the FDA’s conclusions from a prior review of the studies.

Additionally, the FDA may require companies to perform

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such as information about the development, process, stability, qualification and validation.

a company chooses to rely on the FDA’s conclusions regarding studies conducted for an already approved product, the company is required

to provide a certification statement for any patents listed for the approved product in the FDA’s Orange Book publication.

a company chooses to rely on the FDA’s conclusions regarding studies conducted for an already approved product, the company is required

to provide a certification statement for any patents listed for the approved product in the FDA’s Orange Book publication.

Specifically,

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to five years.

The permissible patent term extension is calculated as half of the drug’s testing phase, that is, the time between

IND submission and NDA or BLA submission, and all of the review phase, or the time between either NDA or BLA submission and approval up

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The total patent term after the extension may not exceed 14 years.

patents that might expire during the application phase, the patent owner may request an interim patent extension.

An interim patent extension

increases the patent term by one year and may be renewed up to four times.

For each interim patent extension granted, the post-approval

patent extension is reduced by one year.

The director of the United States Patent and Trademark Office, or PTO, must determine that approval

of the drug covered by the patent for which a patent extension is being sought is likely.

Interim patent extensions are not available

for a drug for which an NDA or BLA has not been submitted.

For patents that

might expire during the application phase, the patent owner may request an interim patent extension.

An interim patent extension increases

the patent term by one year and may be renewed up to four times.

For each interim patent extension granted, the post-approval patent extension

is reduced by one year.

The director of the U.S.

Patent and Trademark Office, or USPTO, must determine that approval of the drug covered

by the patent for which a patent extension is being sought is likely.

Interim patent extensions are not available for a drug for which

an NDA or BLA has not been submitted.

Environmental

generally requires an environmental assessment, which discusses a company’s proposed action, possible

alternatives to the action, and whether the further analysis of an environmental impact statement is necessary.

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have been significant ongoing judicial, administrative, executive and legislative efforts to modify, amend or eliminate the ACA.

District Court Judge ruled that the ACA is unconstitutional in its entirety because the “individual mandate”

was repealed by Congress.

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a process that requires the submission of a clinical trial application prior to the commencement of human clinical trials.

for example, a Clinical Trial Application (“CTA”) must be submitted to the competent national health authority and to independent

ethics committees in each country in which a company intends to conduct clinical trials.

Once the CTA is approved in accordance with a

country’s requirements, clinical trial development may proceed in that country.

requirements and process governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country,

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recognition procedure, (iii) the decentralized procedure or (iv) the national authorization procedure.

European Medicines Agency (“EMA”) implemented the centralized procedure for the approval of human drugs to facilitate marketing

authorizations that are valid throughout the EU.

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centralized procedure is compulsory for human drugs that:

(i) are derived from biotechnology processes, such as genetic engineering, (ii)

(i) are derived from biotechnology processes, such as genetic engineering;

contain a new active substance indicated for the treatment of certain diseases, such as HIV/AIDS, cancer, diabetes, neurodegenerative

diseases, autoimmune and other immune dysfunctions and viral diseases, (iii) are officially designated orphan drugs, and (iv) constitute

diseases, autoimmune and other immune dysfunctions and viral diseases;

(iii) are officially designated orphan drugs;

and (iv) constitute

advanced-therapy medicines, such as gene-therapy, somatic cell-therapy or tissue-engineered medicines.

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the centralized procedure in the European Union, the maximum timeframe for the evaluation of a Marketing Authorization Application by

the EMA is 210 days, though the date count stops whenever the Committee for Medicinal Products for Human Use (“CHMP”) asks

the applicant for additional written or oral information, with adoption of the actual marketing authorization by the European Commission

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(i) the seriousness

of the disease to be treated, (ii) the absence of an appropriate alternative therapeutic approach, and (iii) anticipation of exceptional

of the disease to be treated;

(ii) the absence of an appropriate alternative therapeutic approach;

and (iii) anticipation of exceptional

high therapeutic benefit.

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and the opinion issued thereafter.

We plan to submit an application for marketing authorizations in the United States for AL001 and AL002

in the second half of 2022.

Mutual Recognition Procedure (“MRP”) for the approval of human drugs is an alternative approach to facilitate individual national

marketing authorizations within the European Union.

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Marketing and Promotion.

Once an NDA or BLA is approved, a product will be subject to certain post-approval requirements.

instance, the FDA closely regulates the post-approval marketing and promotion of pharmaceuticals, including standards and regulations

for direct-to-consumer advertising, off-label promotion, industry-sponsored scientific and educational activities and promotional activities

on the internet and elsewhere.

Once an NDA or BLA is approved, or just before approval, a product will be subject to certain marketing

and promotional requirements.

For instance, the FDA closely regulates the post-approval marketing and promotion of pharmaceuticals, including

standards and regulations for direct-to-consumer advertising, off-label promotion, industry-sponsored scientific and educational activities

and promotional activities on the internet and elsewhere.

doctors are free to prescribe any pharmaceutical approved by the FDA for any use, a company can only make claims relating to the safety

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and False Claims Laws.

In the United States, we are subject to complex laws and regulations pertaining to health care “fraud

and abuse,”

including, but not limited to, the federal Anti- Kickback Statute, the federal False Claims Act, state false claims

acts and anti-kickback statutes, and other state and federal laws and regulations.

The Anti-Kickback Statute makes it illegal for any

person, including a prescription drug manufacturer (or a party acting on its behalf) to knowingly and willfully solicit, receive, offer,

or pay any remuneration that is intended to induce the referral of business, including the purchase, order, or prescription of a particular

pharmaceutical, for which payment may be made under a federal health care program, such as Medicare or Medicaid.

In the United States, we are subject to complex laws and regulations pertaining to health care “fraud

and abuse,” including, but not limited to, the federal Anti-Kickback Statute, the federal False Claims Act, state false claims acts

and anti-kickback statutes, and other state and federal laws and regulations.

The Anti-Kickback Statute makes it illegal for any person,

including a prescription drug manufacturer (or a party acting on its behalf) to knowingly and willfully solicit, receive, offer, or pay

any remuneration that is intended to induce the referral of business, including the purchase, order, or prescription of a particular pharmaceutical,

for which payment may be made under a federal health care program, such as Medicare or Medicaid.

federal False Claims Act prohibits anyone from knowingly presenting, or causing to be presented, for payment to federal programs (including

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of patent, the scope of its coverage and the availability of legal remedies in the country.

A summary of the licensed patents is as follows:

summary of the licensed patents is as follows:

Title of Patent

Lithium Cocrystals and an Additional Neuropsychiatric Agent for

Treatment of Neuropsychiatric Disorders

Method of Use

Organic Anion Lithium Ionic Cocrystal Compounds and Compositions

Composition of Matter

Amyloid Beta Peptides and Methods of Use

Composition of Matter

trade secret protection is an essential element of our business and we take security measures to protect our proprietary information and

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If we are forced to defend ourselves against such claims, whether they are with or without merit and whether

they are resolved in favor of, or against, our licensors or ourselves, we may face costly litigation and the diversion of our management’s

attention and resources.

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These agreements, if necessary, may be unavailable on terms acceptable to us, or at all.

currently have four trademarks registered with the PTO that include our corporate name, Alzamend Neuro, two for our corporate slogan and

one for our trade name.

We currently have

four trademarks registered with the USPTO that include our corporate name, Alzamend Neuro, two for our corporate slogan and one for our

Our Competition

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competition will be determined in part by the potential indications for which our products are developed and ultimately approved by regulatory

It is likely that the timing of market introductions of some of our potential products or our competitors’

It is likely that the timing of market introductions of some of our potential products or our competitors’ products

will be an important competitive factor.

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Capital Resources

of July 15, 2021, we had two full-time employees (Stephan Jackman, our Chief Executive Officer, and Lien T.

of April 30, 2022, we have four full-time employees (Stephan Jackman, our Chief Executive Officer, Lien T.

Escalona, our Chief Financial

Officer) and four part-time employees.

Officer, Bradford Sullivan, our Director of Investor Relations, and Kraingsak Roajphlastien, our Senior Operations Manager) and four part-time

We also utilize independent consultants to assist us in our medical research and development projects.

Nisser, our Executive Vice President and General Counsel, Kenneth S.

Cragun, our Senior Vice President of Finance, and David Katzoff,

our Chief Operating Officer, work for us on a part-time basis.

Nisser and Katzoff spend no less than an average of 8 hours per

week on our company’s business and Mr.

Cragun spends no less than an average of 10 hours per week on our company’s business.

In addition, Milton C.

(Todd) Ault III, our Founder and Chairman Emeritus, serves as a consultant.

Cragun, our Senior Vice President of Finance, David Katzoff,

our Chief Operating Officer and James M.

Turner, our Deputy General Counsel, work for us on a part-time basis.

human capital resources objectives include, as applicable, identifying, recruiting, retaining, incentivizing and integrating our existing

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scientific advisory board of leading researchers in the neurodegenerative and neuropathology fields presently consists of Dr.

Wisniewski and Dr.

Wisniewski, Dr.

Eric McDade and Dr.

Terri Hunter.

Wisniewski, MD is a board-certified neurologist and neuropathologist and is the Director of the NYU Pearl I.

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He operates an active research laboratory focusing on neurodegenerative disorders with a particular focus

on the mechanisms that drive amyloid deposition in Alzheimer’s and prion diseases.

This work has led to more than 300 peer-reviewed

publications, 28 issued patents, and continuous funding from the NIH for over 30 years.

Wisniewski’s career has been dedicated

to researching and developing treatments for numerous conditions including Alzheimer’s, mild cognitive impairment, Lewy body dementia,

Wisniewski’s career has been dedicated

to researching and developing treatments for numerous conditions including Alzheimer’s, mild cognitive impairment, Lewy body dementia,

frontotemporal dementia, prion disease, Jakob-Creutzfeldt disease, multiple system atrophy and memory loss.

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numerous awards, honors and recognitions including being elected as a Distinguished Fellow in 2014, receiving the 2009 Prion Prize, the

Alzheimer’s Association Zenith Award in 2002 and being recognized every year by “Best Doctors in America”

Wisniewski has been an Associate Editor for the Journal of Alzheimer’s Disease and Chief Editor of Frontiers in Aging Neuroscience

Alzheimer’s Association Zenith Award in 2002 and being recognized every year by “Best Doctors in America” since 2008.

Wisniewski has been an Associate Editor for the Journal of Alzheimer’s Disease and Chief Editor of Frontiers in Aging Neuroscience

Wisniewski earned his M.D.

degree at King’s College London GKT School of Medical Education and completed his residencies

and chief residencies in neurology and neuropathology at NYU School of Medicine and New York-Presbyterian/Columbia University Medical

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and on developing a clinical research program that focuses on using brain imaging and cerebrospinal fluid markers to identify those at

risk for Alzheimer’s.

Currently, Dr.

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The goal of this work is to identify better

measures and target for interventions and prevention for Alzheimer’s and has led to more than 76 peer-reviewed publications and

continuous funding from the NIH for over ten years.

measures and target for interventions and prevention for Alzheimer’s and has led to more than 76 peer-reviewed publications and

continuous funding from the NIH for over 10 years.

Additionally, Dr.

McDade is the Associate Director of the Dominantly Inherited Alzheimer

Network Trials Unit (“DIAN-TU”).

The DIAN-TU is a global network of families at risk for dominantly inherited Alzheimer’s,

a genetic form of Alzheimer’s and is pioneering prevention trials for this young-onset form of Alzheimer’s.

Network Trials Unit (“DIAN-TU”).

The DIAN-TU is a global network of families at risk for dominantly inherited Alzheimer’s,

a genetic form of Alzheimer’s and is pioneering prevention trials for this young-onset form of Alzheimer’s.

McDade earned

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Neurologic Subspecialties.

Hunter, PhD is a Technology Transfer Specialist at the United States Department of Veterans Affairs (USDVA).

Hunter joined the

USDVA in September 2020 and is responsible for managing life science technologies from initial disclosure through licensing and the maintenance

of the license.

Prior to joining the USDVA, Dr.

Hunter worked as a senior licensing manager in the technology transfer Office, patents

& licensing at the University of South Florida for 9 years (2010 to 2020).

From 2003 to 2010, Dr.

Hunter worked as a Research Scientist

at Moffitt Cancer Center in Tampa, Florida.

At Moffitt Dr.

Hunter performed translational research focused on cancer vaccines and combination

therapies for cancer.

She has also served as a DNA analyst/expert witness for the Florida Department of Law Enforcement.

Her post-doctoral

training was conducted at St.

Jude Children’s Research Hospital in Memphis, Tennessee form 1998-2000.

She received a B.S.

from Palm Beach Atlantic University in 1994, a M.S.

in Medical Sciences from the University of South Florida, College of Medicine in 1997,

in Medical Sciences from the University of South Florida, College of Medicine (1998, Medical Microbiology and Immunology Program).

Hunter’s research interests included microbial genetics, DNA analysis, cell signaling, immunobiology of cancer, gene-modified

tumor cell vaccine research:

specifically pre-clinical and clinical research and combination biologic and pharmacologic treatments for

entered into consulting agreements with Drs.

Wisniewski and McDade on May 1, 2019.

The annual cash compensation under the consulting agreements

consists of $12,000 per scientific advisory board member and stock options to purchase 50,000 shares at $1.00 per share with a two-year

term, vesting over two years.

Wisniewski and McDade on May 1, 2019 and Dr.

Hunter on April 4, 2022.

The annual cash compensation

under the consulting agreements consists of $12,000 per scientific advisory board member.

Wisniewski and McDade were awarded stock

options to purchase 50,000 shares at $1.00 per share with a two-year term, vesting over two years.

Hunter was awarded stock options

to purchase 50,000 shares at $2.42 per share with a two-year term, vesting over two years.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business