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Item 1. Business

2026-07-22 compared with 2025-07-22 · 580 added, 489 removed, 810 unchanged (57% of the section changed)

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 and its subsidiary.

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 and its subsidiary.

Company Overview

are a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease (“Alzheimer’s”),

bipolar disorder (“BD”), major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”).

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

We are a clinical-stage biopharmaceutical

company focused on developing novel products for the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar

disorder (“BD”), major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”).

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

Far too many individuals,

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

Our primary target,

Alzheimer’s, is among the most-feared diseases (second only to cancer) among Americans, according to a 2023 Center for Disease Control

Alzheimer’s is also the seventh leading cause of death (in 2021 and 2022) in the United States (“U.S.”) according

to a 2025 report from the Alzheimer’s Association, a nonprofit that funds research.

Existing Alzheimer’s treatments only temporarily

relieve symptoms and while one treatment has been shown to slow the progression of the disease, none has been shown to halt the progression

of the disease, which currently affects roughly 7.2 million Americans;

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 19 billion hours of unpaid care per year, according

to data provided by the Alzheimer’s Association.

In 2025, the estimated healthcare costs for treating individuals with Alzheimer’s

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

target, Alzheimer’s, is among the most-feared diseases (second only to cancer) among Americans, according to a 2024 Center for Disease

Control and Prevention survey.

Alzheimer’s is also the fifth leading cause of death (in 2024) in the United States (the “U.S.”)

according to a 2026 report from the Alzheimer’s Association, a nonprofit that funds research.

Existing Alzheimer’s treatments

only temporarily relieve symptoms and while one treatment has been shown to slow the progression of the disease, none has been shown to

halt its progression , which currently affects roughly 7.4 million Americans;

that number is expected to grow to 13 million individuals

Alzheimer’s also impacts more than 13 million Americans who provide an estimated 19 billion hours of unpaid care per year,

according to data provided by the Alzheimer’s Association.

In 2026, the estimated healthcare costs for treating individuals with

Alzheimer’s in the U.S.

will be $409 billion, including $263 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, according to the Alzheimer’s Association.

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, according to the Alzheimer’s

Our pipeline consists of two

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worldwide license from the Licensor.

most advanced product candidate (lead product), which is licensed and in clinical development in humans, is AL001, an ionic cocrystal

of lithium for the treatment of Alzheimer’s, BD, MDD and PTSD.

Based on our preclinical data involving mice models, AL001 treatment

prevented cognitive deficits, depression and irritability and is superior in improving associative learning and memory and irritability

Our most advanced product

candidate (our lead product) is AL001, an ionic cocrystal of lithium designed to treat Alzheimer’s, BD, MDD and PTSD, is licensed

and in clinical development in humans.

Based on our preclinical data involving mice models, treatment using AL001 prevented cognitive

deficits, depression and irritability and demonstrated that AL001 is superior in improving associative learning and memory and irritability

compared with lithium carbonate treatments, supporting the potential of AL001 for the treatment of Alzheimer’s, BD, MDD and PTSD

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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.

The 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,”

which appeared 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,

widely adopted 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, particularly for treatments with neuroprotective properties.

is increasing evidence to suggest that depressive illness, particularly in the elderly, is associated with neuronal cell loss.

These findings

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

Forlenza, et al., entitled “Disease-Modifying Properties

of Long-Term Lithium Treatment for Amnestic Mild Cognitive Impairment:

Randomized Controlled Trial,” which appeared 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, widely adopted 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,

particularly for treatments with neuroprotective properties.

There is increasing evidence

to suggest that depressive illness, particularly in the elderly, is associated with neuronal cell loss.

These findings suggest that lithium

may exert some long-term beneficial effects in the treatment of affective disorders through underappreciated neuroprotective effects.

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

absence of other adequate treatments, we believe that research and commercialization of the potential efficacy of lithium in the long-term

treatment of neurodegenerative disorders is well worth pursuing.

Given the absence

of other adequate treatments, we believe that research and commercialization of the potential efficacy of lithium in the long-term treatment

of neurodegenerative disorders is well worth pursuing.

Our Business Strategy

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• Advance clinical development of AL001 for Alzheimer’s, BD, MDD and PTSD treatment .

We completed our Phase I clinical trial in March 2022 and initiated

a Phase IIA Multiple Ascending Dose (“MAD”) clinical trial in May 2022.

We completed the clinical portion of the Phase IIA

MAD clinical trial in March 2023, reported topline data in June 2023 and announced full data in October 2024.

We announced that we successfully

identified a maximum tolerated dose (“MTD”) for development of AL001, as assessed by an independent safety review committee.

This MTD, providing lithium at a lithium carbonate equivalent dose of 240 mg 3-times daily, is designed to be unlikely to require lithium

therapeutic drug monitoring (“TDM”).

Also, this MTD mitigates risk in treatments for fragile populations, such as Alzheimer’s

Additionally, we are investigating the potential of AL001 for patients suffering from BD, MDD and PTSD, and submitted several

Investigational New Drug (“IND”) applications to the FDA for these indications and received a “study may proceed”

letter from the FDA for each.

In August 2024, we announced a partnership with Massachusetts General Hospital (“MGH”) and Harvard

Medical School to conduct five Phase II imaging clinical trials.

The purpose of these trials is to assess the comparative increase in

lithium levels within the brain and its structures as opposed to a commonly marketed lithium salt among healthy subjects and patients

afflicted with Alzheimer’s, BD, MDD and PTSD.

In May 2025, we announced the initiation, enrollment and dosing of the first

patient for the healthy human patients.

We expect to present topline data from this study by the end of 2025.

The second trial, for treatment

of patients with BD, is expected to commence in the fourth quarter of 2025.

The trials for treatment of patients with MDD and PTSD are

expected to commend in the first quarter of 2026, followed by Alzheimer’s in the second quarter of 2026.

Upon completion of these

five clinical trials, we intend on initiating Phase III clinical trials for the respective indications.

If we obtain successful results

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

• Advance clinical development of

ALZN002 for Alzheimer’s treatment.

We submitted an IND application to the FDA in

September 2022, and received a “study may proceed” letter in October 2022.

April 2023, we announced the initiation of a Phase I/IIA clinical trial for ALZN002 to treat

mild to moderate dementia similar to Alzheimer’s.

The purpose of this trial is to assess

the safety, tolerability, and efficacy of multiple ascending doses of ALZN002 compared with

that of a placebo in 20-30 subjects with mild to moderate morbidity.

The primary goal of

this clinical trial is to determine an appropriate dose of ALZN002 for treatment of patients

with Alzheimer’s in a larger Phase IIB efficacy and safety clinical trial.

2024, we received notice from the company we engaged as our contract research organization

(“CRO”), Biorasi, LLC (“Biorasi”) that Biorasi was terminating our

contract with them.

our Phase I clinical trial in March 2022 and initiated a Phase IIA Multiple Ascending Dose (“MAD”) clinical trial in May 2022.

We completed the clinical portion of the Phase IIA MAD clinical trial in March 2023, reported topline data in June 2023 and announced

full data in October 2024.

We announced that we successfully identified a maximum tolerated dose (“MTD”) for AL001, as assessed

by an independent safety review committee.

This MTD, providing lithium at a lithium carbonate equivalent dose of 240 mg 3-times daily,

is designed to be unlikely to require lithium therapeutic drug monitoring (“TDM”).

Also, this MTD mitigates risk in treatments

for fragile populations, such as Alzheimer’s patients.

Additionally, we are investigating the potential of AL001 for patients suffering

from BD, MDD and PTSD, and have submitted several Investigational New Drug (“IND”) applications to the FDA for these indications

and received a “study may proceed” letter from the FDA for each.

In August 2024, we announced a partnership with Massachusetts

General Hospital (“MGH”) and Harvard Medical School to conduct five Phase II imaging clinical trials.

The purpose of these

trials is to assess the comparative increase in lithium levels within the brain and its structures as opposed to a commonly marketed lithium

salt among healthy subjects and patients afflicted with Alzheimer’s, BD, MDD and PTSD.

In May 2025, we announced the initiation,

enrollment and dosing of the first patient of AL001 “Lithium in Brain” Study in healthy human subjects.

In November 2025,

we announced the completion of the clinical portion of this study and reported pharmacokinetics topline data in March 2026, with the following

· Bioequivalence Confirmed:

AL001 delivered 101% of total lithium blood exposure and 97% of peak lithium

standard lithium carbonate;

· Superior Brain Penetration:

AL001 showed numerically higher lithium concentrations in all measured brain

regions, including whole brain;

· Faster Brain Uptake:

AL001 reached peak brain concentration in 6.7 hours vs.

8.4 hours for standard lithium

In April 2026, we announced pharmacodynamic

topline data of the healthy human subjects with the following results:

· Potentially Distinct Brain Profile:

Across multiple brain regions, AL001 and lithium

carbonate appeared to trend in opposite directions in brain chemistry measures, suggesting that AL001 may interact with the brain in a

distinct manner and generate a lower neurochemical footprint than lithium carbonate;

· Expected Trends for Myo-Inositol Reduction:

Both AL001 and lithium carbonate showed a trend toward reducing

myo-inositol, potentially supporting the hypothesis that AL001 retains lithium's core mechanism of action;

· Potentially Preserved Glutamate Balance:

Lithium carbonate showed large effects across all brain

regions whereas AL001 showed minimal glutamate effect in most brain regions, which may suggest better long-term tolerability.

Full pharmacokinetics

and pharmacodynamic results are expected in August 2026.

In March 2026, we announced the initiation

of the Phase II Clinical Trial of AL001 “Lithium in Brain” Study in Patients with BD and expect to report topline data in

the fourth quarter of 2026.

The clinical trials for treatment of patients with MDD and PTSD are expected to commence in the fourth quarter

of 2026, followed by Alzheimer’s in the first quarter of 2027.

Upon completion of these five clinical trials, we intend to initiate

Phase III clinical trials for the respective indications.

If we obtain successful results from the Phase III clinical trials in humans,

we intend to seek approval to commercialize AL001 via a New Drug Application (“NDA”);

• Advance clinical development of ALZN002 for Alzheimer’s treatment.

We submitted an IND application

to the FDA in September 2022, and received a “study may proceed” letter in October 2022.

In April 2023, we announced the initiation

of a Phase I/IIA clinical trial for ALZN002 to treat mild to moderate dementia similar to Alzheimer’s.

The purpose of this trial

is to assess the safety, tolerability, and efficacy of multiple ascending doses of ALZN002 compared with that of a placebo in 20-30 subjects

with mild to moderate morbidity.

The primary goal of this clinical trial is to determine an appropriate dose of ALZN002 for treatment

of patients with Alzheimer’s in a larger Phase IIB efficacy and safety clinical trial.

In February 2024, we received notice from

Biorasi, LLC (“Biorasi”), the company formerly engaged as our contract research organization (“CRO”), terminating

our contract with Biorasi.

We are currently pursuing the engagement of a replacement CRO.

achieve successful Phase III clinical trials in humans, we intend to seek approval to commercialize

ALZN002 through a Biologics License Application (“BLA”);

Due to the scientific and operational complexities

of the ALZN002 trial, along with the limited number of CROs with the expertise and capacity to complete the trial, we have experienced

a delay in engaging a new CRO.

We do not expect to restart this trial until the first quarter of 2027.

If we achieve successful Phase

III clinical trials in humans, we intend to seek approval to commercialize ALZN002 through a Biologics License Application (“BLA”);

• Expand our pipeline of pharmaceuticals to include additional delivery methods.

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

Our focus is expected to concentrate on entering into

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

sale of our products in the marketplace.

Our focus is to concentrate on entering into strategic

transactions with established distributors and producers, which will provide distribution and marketing capabilities for the sale of our

products in the marketplace.

Our Development Pipeline

following chart provides an overview of the current development stages of our product candidates.

product candidates will require extensive clinical evaluation, regulatory review and approval, significant marketing efforts and substantial

investment before either of them 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 our product candidates, our long-term business objectives will not materialize, and

we will be unable to generate the revenue we have forecast in the foreseeable future, if at all.

We do not anticipate that we will generate

our maximum revenue for several years, or that we will achieve profitability for any of our therapeutic drug candidates until at least

a few years after generating material revenue, if at all.

If we are unable to generate revenue or raise substantial additional capital,

we will not be able to pursue any expansion of our business or acquire additional intellectual property, we will never become profitable,

and we will be unable to continue our operations at the currently planned pace, if at all.

The following chart provides

an overview of the current development stages of our product candidates.

Our product candidates will

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

either of them 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 our product candidates, our long-term business objectives may not materialize, and we may be unable to

generate the revenue we have forecast in the foreseeable future, if at all.

We do not anticipate that we will generate our maximum revenue

for several years, or that we will achieve profitability for any of our therapeutic drug candidates until at least a few years after generating

material revenue, if at all.

If we are unable to generate revenue or raise substantial additional capital, we may not be able to pursue

any expansion of our business or acquire additional intellectual property, we may never become profitable, and we may be unable to continue

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

AL001 Drug Candidate

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

of Alzheimer’s, BD, MDD and PTSD.

Our lead product candidate

that we have licensed and begun clinical development of in humans is AL001, an ionic cocrystal of lithium for the treatment of Alzheimer’s,

BD, MDD and PTSD.

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 BD.

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 BD, it is still used clinically despite its narrow therapeutic index.

This has led researchers to begin

to look for other treatment methods than lithium but that may evince 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 tests 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,

which only address a single therapeutic target, lithium appears to be neuroprotective through several modes of action.

For example, recent

studies have indicated that it exerts neuroprotective effects, in part, by increasing a brain-derived neurotrophic factor leading to restoration

of learning and memory.

Another neuroprotective mechanism of lithium indicated by recent studies is the attenuation of the production

of inflammatory cytokines like IL-6 and nitric oxide in activated microglia.

Results from recent clinical studies suggest that lithium

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

the novel ionic cocrystal of lithium, 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 available 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, BD, MDD

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

wide range of clinical applications beyond neurodegenerative disorders other than Alzheimer’s, but also amyotrophic lateral sclerosis

(known as ALS and popularly referred to as Lou Gehrig’s disease), Huntington’s disease, multiple sclerosis, Parkinson’s

disease and traumatic brain injury, to more psychiatric conditions such as BD, 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 for AL001 should avoid acutely toxic peak concentrations in blood, as well as in the brain, and should maintain such relatively

minor 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.

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 BD.

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.

The administration of existing lithium drugs, such as lithium chloride and lithium carbonate,

may cause patients to suffer from chronic toxicity, poor physicochemical properties, and poor brain bioavailability.

Because lithium is

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

led researchers to begin to look for other treatment methods than lithium but that may evince similar bioactivities.

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 tests 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.

Recent evidence suggests that

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

Unlike traditional medications, which only address

a single therapeutic target, lithium appears to be neuroprotective through several modes of action.

For example, recent studies have indicated

that it exerts neuroprotective effects, in part, by increasing a brain-derived neurotrophic factor leading to restoration of learning

Another neuroprotective mechanism of lithium indicated by recent studies is the attenuation of the production of inflammatory

cytokines like IL-6 and nitric oxide in activated microglia.

Results from recent clinical studies suggest that lithium treatment may reduce

the progression of dementia while preserving cognitive function and reducing biomarkers associated with Alzheimer’s.

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 available 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, BD, MDD and PTSD.

We believe that our ability

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

beyond neurodegenerative disorders other than Alzheimer’s, but also amyotrophic lateral sclerosis (known as ALS and popularly referred

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

to more psychiatric conditions such as BD, 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 for AL001 should avoid acutely

toxic peak concentrations in blood, as well as in the brain, and should maintain such relatively minor 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.

Clinical Trials

Phase I Study

On September 13, 2021, we initiated a randomized, balanced, Phase I,

single-dose, open-label, two-treatment, two-period, two- sequence, crossover, relative bioavailability clinical trial 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 clinical trial 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 clinical trial.

This was a first-in-human clinical trial of the AL001 formulation and 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

clinical trials.

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 BD.

Lithium carbonate 300 mg (Reference product)

was given as a single dose in this clinical trial;

this is often used as a starting dose for treatment of BD 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 rate and

extent of lithium absorption of AL001.

The Phase I study was completed in March 2022 with the following results:

On September 13, 2021, we

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

clinical trial 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 clinical trial 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 clinical trial.

This was a first-in-human clinical trial of the AL001 formulation

and 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 clinical trials.

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

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

this is often used as a starting

dose for treatment of BD 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 rate and extent of lithium absorption of AL001.

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;

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To establish the qualitative and quantitative evaluations of patients with Alzheimer’s

and healthy subjects leading to our ability to ascertain desirable characteristics for future

Phase II and III clinical studies in order to:

and healthy subjects, leading to our ability to ascertain desirable characteristics for future Phase II and III clinical studies in order

o Facilitate recruitment into subsequent AL001 clinical trials;

17 unchanged sentences

above this range can be toxic, and dosages below it can impair effectiveness.

Current and Future Phase II Studies

Current and Future Phase II “Lithium

in Brain” Studies

In August 2024, we announced

17 unchanged sentences

In May 2025, we announced

the initiation, enrollment and dosing of the first patient for the healthy human patients.

This clinical trial has the following objectives:

the initiation, enrollment and dosing of the first of the healthy human patients.

This clinical trial had the following objectives:

· To assess lithium brain/plasma pharmacokinetics (“PK”) of the AL001 oral capsule relative

8 unchanged sentences

equivalent to 150 mg lithium carbonate TID).

We expect to present topline

data from this study by the end of 2025.

Following completion of this clinical trial, we intend to initiate four more identical clinical

trials, with the first of these trials, for treatment of patients with BD, expected to commence in the third quarter of 2025.

We anticipate

launching the clinical trial for patients with bipolar disorder (BD) in the fourth quarter of 2025, followed by clinical trials for major

depressive disorder (MDD) and post-traumatic stress disorder (PTSD) patients in the first quarter of 2026.

Subsequently, the clinical

trial for Alzheimer’s patients is expected to commence in the second quarter of 2026.

These projected timelines reflect our commitment

to advancing our clinical development programs across multiple neuropsychiatric and neurodegenerative indications.

In November 2025, we announced

the completion of the clinical portion of this study and reported pharmacokinetics topline data in March 2026, with the following results:

(1) Bioequivalence Confirmed:

AL001 delivered 101% of total lithium blood exposure and 97% of peak lithium levels vs.

standard lithium

(2) Superior Brain Penetration:

AL001 showed numerically higher lithium concentrations in all measured brain regions, including

and (3) Faster Brain Uptake:

AL001 reached peak brain concentration in 6.7 hours vs.

8.4 hours for standard lithium carbonate.

In April 2026, we announced pharmacodynamic topline data of the healthy human subjects with the following results:

· Potentially Distinct Brain Profile:

Across multiple brain regions, AL001 and lithium

carbonate appeared to trend in opposite directions in brain chemistry measures, suggesting that AL001 may interact with the brain in a

distinct manner and generate a lower neurochemical footprint than lithium carbonate;

· Expected Trends for Myo-Inositol Reduction:

Both AL001 and lithium carbonate showed a trend toward reducing

myo-inositol, potentially supporting the hypothesis that AL001 retains lithium's core mechanism of action;

· Potentially Preserved Glutamate Balance:

Lithium carbonate showed large effects across all brain

regions whereas AL001 showed minimal glutamate effect in most brain regions, which may suggest better long-term tolerability.

Full pharmacokinetics and

pharmacodynamic results are expected in August 2026.

In March 2026, we announced

the initiation of the Phase II Clinical Trial of AL001 “Lithium in Brain” Study in Patients with BD and expect to report topline

data in the fourth quarter of 2026.

The clinical trials for treatment of patients with MDD and PTSD are expected to commence in the fourth

quarter of 2026, followed by Alzheimer’s in the first quarter of 2027.

These projected timelines reflect our commitment to advancing

our clinical development programs across multiple neuropsychiatric and neurodegenerative indications.

ALZN002 Drug Candidate

The other product candidate

that we have obtained a license to clinically develop in humans is ALZN002, 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.

ALZN002 is our other product

candidate that we have obtained a license to clinically develop in humans is ALZN002, 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

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to the plaque build-up causing Alzheimer’s.

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 ALZN002 was selected specifically for its high human leukocyte antigens binding

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

is an autologous modified DC treatment.

More precisely, it is a patient-specific therapy where the patient undergoes leukapheresis, a

nonsurgical treatment used to reduce the quantity of white blood cells in the bloodstream, to isolate peripheral blood monocytes that

are subsequently matured into DCs using cytokine therapy (IL4+ GM-CSF) cocktail.

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

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.

immunization may offer additional or more lasting effects on the clearance of amyloid and a safer approach due to its reliance on autologous

immune mechanisms.

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.

The Phase IIA study with AN-1792 was terminated by the FDA due to severe

meningoencephalitis in approximately 6% of vaccinated subjects.

We believe that this may have been caused by using a QS-21 adjuvant in

the vaccine formulation, which we will not use

ALZN002 is intended to elicit

an immune response to produce anti-amyloid antibodies, which can then neutralize circulated beta-amyloids and prevent additional plaque

The mutant antigen within ALZN002 was selected specifically for its high human leukocyte antigens binding affinity, thereby

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

ALZN002 is an autologous modified

DC treatment.

More precisely, it is a patient-specific therapy where the patient undergoes leukapheresis, a nonsurgical treatment used

to reduce the quantity of white blood cells in the bloodstream, to isolate peripheral blood monocytes that are subsequently matured into

DCs using cytokine therapy (IL4+ GM-CSF) cocktail.

The DCs are incubated with a modified amyloid beta (Aβ) peptide to sensitize them,

and then administered to the same patient.

Significant evidence has accumulated

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

Most current immune-based active

investigations are focused on passive immunization by pre-prepared Aβ antibody administration.

Active immunization may offer additional

or more lasting effects on the clearance of amyloid and a safer approach due to its reliance on autologous immune mechanisms.

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.

The Phase IIA study with AN-1792 was terminated by the FDA due to severe meningoencephalitis in approximately

6% of vaccinated subjects.

We believe that this may have been caused by using a QS-21 adjuvant in the vaccine formulation, which we will

Clinical Trials

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system to combat Alzheimer’s.

five-dose GLP study with ALZN002-sensitized cells was completed using a transgenic mouse model of Alzheimer’s to investigate the

tolerability of ALZN002.

A five-dose GLP study with

ALZN002-sensitized cells was completed using a transgenic mouse model of Alzheimer’s to investigate the tolerability of ALZN002.

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

The mice were evaluated for potential toxicity

and reversibility of any findings at 75 and 90 days after the final dosing.

Histopathology

results demonstrate that there was no indication of T-cell infiltration or meningoencephalitis, which suggests that ALZN002 therapy is

safe and tolerable as there were no adverse findings over a 90-day period or 90 days after the last dose.

There were no treatment-related

mortalities or reports of adverse effects on clinical observations, body weight parameters, organ weight parameters, clinical pathology

parameters, gross pathology observations, or histopathologic observations during the main study or the recovery phase.

The mice were evaluated for potential toxicity and reversibility of

any findings at 75 and 90 days after the final dosing.

Histopathology results demonstrate

that there was no indication of T-cell infiltration or meningoencephalitis, which suggests that ALZN002 therapy is safe and tolerable

as there were no adverse findings over a 90-day period or 90 days after the last dose.

There were no treatment-related mortalities or

reports of adverse effects on clinical observations, body weight parameters, organ weight parameters, clinical pathology parameters, gross

pathology observations, or histopathologic observations during the main study or the recovery phase.

Modified cell therapies, especially

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request for ALZN002 and supporting briefing documents to the Center for Biological Evaluation and Research of the FDA on July 30, 2021.

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

of ALZN002 on September 30, 2021.

On September 30, 2021, we received a written response relating to the pre-IND from the FDA providing a path for Alzamend’s planned

clinical development of ALZN002.

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

September 28, 2022, we submitted an IND to the FDA for ALZN002 and received a “study may proceed” letter on October 31, 2022.

The product candidate is an immunotherapy vaccine designed to treat mild to moderate dementia of the Alzheimer’s type.

a proprietary “active” immunotherapy product, which means it is produced by each patient’s immune system.

of autologous DCs consisting of activated white blood cells taken from each individual patient so that they can be engineered outside

of the body to attack Alzheimer’s-related amyloid-beta proteins.

These DCs are pulsed with a novel amyloid-beta peptide (E22W) designed

to bolster the ability of the patient’s immune system to combat Alzheimer’s;

the goal is to foster tolerance to treatment

for safety purposes while stimulating the immune system to reduce the brain’s beta-amyloid protein burden, resulting in reduced

Alzheimer’s signs and symptoms.

Compared to passive immunization treatment approaches that use foreign blood products (such as monoclonal

antibodies), active immunization with ALZN002 is anticipated to offer a more robust and long-lasting effect on the clearance of amyloid.

This approach could prove safer due to its reliance on autologous immune components, using each individual patient’s own white blood

cells rather than foreign cells and/or blood products.

On September 28, 2022, we

submitted an IND to the FDA for ALZN002 and received a “study may proceed” letter on October 31, 2022.

The product candidate

is an immunotherapy vaccine designed to treat mild to moderate dementia of the Alzheimer’s type.

ALZN002 is a proprietary “active”

immunotherapy product, which means it is produced by each patient’s immune system.

It consists of autologous DCs consisting of activated

white blood cells taken from each individual patient so that they can be engineered outside of the body to attack Alzheimer’s-related

amyloid-beta proteins.

These DCs are pulsed with a novel amyloid-beta peptide (E22W) designed to bolster the ability of the patient’s

immune system to combat Alzheimer’s;

the goal is to foster tolerance to treatment for safety purposes while stimulating the immune

system to reduce the brain’s beta-amyloid protein burden, resulting in reduced Alzheimer’s signs and symptoms.

passive immunization treatment approaches that use foreign blood products (such as monoclonal antibodies), active immunization with ALZN002

is anticipated to offer a more robust and long-lasting effect on the clearance of amyloid.

This approach could prove safer due to its

reliance on autologous immune components, using each individual patient’s own white blood cells rather than foreign cells and/or

blood products.

On April 3, 2023, we announced

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In February 2024, we received

notice from Biorasi, our CRO, that Biorasi was terminating our contract with it.

We are currently pursuing the engagement of a replacement

Due to the scientific and operational complexities of the ALZN002 trial, along with the limited number of CROs with the expertise

and capacity to complete the trial, we have experienced a delay in engaging a new CRO.

We do not expect to resume this trial until mid-2026.

notice from Biorasi terminating our contract with Biorasi.

We are currently pursuing the engagement of a replacement CRO.

Due to the scientific

and operational complexities of the ALZN002 trial, along with the limited number of CROs with the expertise and capacity to complete the

trial, we have experienced a delay in engaging a new CRO.

We do not expect to restart this trial until first quarter of 2027.

Intellectual Property and Licensing Agreements

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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 14,853 shares of our common stock.

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

the Licensor received 14,853 shares of our common stock.

Minimum royalties for AL001 License Agreements are $40,000 on the first anniversary

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the first commercial sale and every year thereafter, for the life of the AL001 License Agreements.

On April 25, 2025, we entered

into a Fourth Amendment of the AL001 Licenses (collectively, the “AL001 License Agreements”).

This amendment deleted the timing

of milestone events.

On May 1, 2016, we entered

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Market Opportunity

to the National Institute of Health (“NIH”), there are more than 48.2 million Americans afflicted with Alzheimer’s,

BD, MDD or PTSD.

The rise in the prevalence of these disorders and the associated risks arising therefrom, such as high stress, substance

abuse, and advancements in a combination of drugs are primarily propelling market growth.

Advancements in technology allowing more accurate

diagnosis/detection of Alzheimer’s, BD, MDD, and PTSD are also positively influencing market growth.

Other factors, such as increasing

research and development activities (via clinical trials) and investments by the government to improve the healthcare industry, are expected

to further drive market growth.

According to the National

Institutes of Health (“NIH”), there are more than 48.4 million Americans afflicted with Alzheimer’s, BD, MDD or PTSD.

The rise in the prevalence of these disorders and the associated risks arising therefrom, such as high stress, substance abuse, and advancements

in a combination of drugs are primarily propelling market growth.

Advancements in technology allowing more accurate diagnosis/detection

of Alzheimer’s, BD, MDD, and PTSD are also positively influencing market growth.

Other factors, such as increasing research and

development activities (via clinical trials) and investments by the government to improve the healthcare industry, are expected to further

drive market growth.

Additionally, increased awareness about Alzheimer’s, BD, MDD and PTSD via the various disease/disorder-specific

non-profit organizations is accelerating market growth.

The potential marketplace for a commercialized therapy or treatment would be tremendously

significant with large financial support available from numerous national and international pharmaceutical companies and various governments

and worldwide agencies.

We were founded with a mission to further develop AL001 and ALZN002, by funding them through human clinical trials

administered by the FDA and ultimately, if successful, making them available to the public.

The potential marketplace for a commercialized therapy or treatment would be

tremendously significant with large financial support available from numerous national and international pharmaceutical companies and

various governments and worldwide agencies.

We were founded with a mission to further develop AL001 and ALZN002, by funding them through

human clinical trials administered by the FDA and ultimately, if successful, making them available to the public.

Industry Overview

Alzheimer’s is the seventh 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.

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

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

diseases has also increased.

Currently, Alzheimer’s

is the fifth 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.

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 U.S.

alone, one of nine persons older than 65 has

Alzheimer’s, with roughly 7.2 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 account for deaths from complications

alone, one of nine persons older than 65 has Alzheimer’s,

with roughly 7.4 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 account for deaths from complications

or from related diseases like pneumonia or heart attack.

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care for people with Alzheimer’s or other dementias.

The Alzheimer’s Association estimated that, in 2024, caregivers to individuals

with Alzheimer’s provided 19 billion hours of care valued at $413 billion.

The Alzheimer’s Association estimates that, in 2026, caregivers to individuals

with Alzheimer’s provided 19 billion hours of care, valued in total at approximately $446 billion.

Alzheimer’s Therapeutic Landscape

There 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.

In June 2021, the FDA approved

Biogen’s Alzheimer’s drug aducanumab, also known as Aduhelm, making it the first medication cleared by U.S.

regulators to

reduce amyloid plaques in people living with Alzheimer’s and the first new medication for the disease in nearly two decades.

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

cause of death in the U.S.

In July 2023, an anti-beta amyloid antibody known as Lecanemab-irmb (“Leqembi”), received full

approval by FDA for treatment of Alzheimer’s.

In July 2024, the FDA approved Eli Lilly’s Alzheimer’s drug donanemab,

also known as Kisunla, which targets amyloid in the brain.

Given the current weight of evidence, amyloid is now established as a cause

of Alzheimer’s.

There 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.

In June 2021, the FDA approved Biogen’s Alzheimer’s drug aducanumab,

also known as Aduhelm, making it the first new medication for the disease in nearly two decades and the first medication cleared by U.S.

regulators to reduce amyloid plaques in people living with Alzheimer’s.

There had previously been no drugs cleared by the FDA that

could slow the mental decline caused by Alzheimer’s.

In July 2023, an anti-beta amyloid antibody known as Lecanemab-irmb (“Leqembi”)

received full approval by the FDA for the treatment of Alzheimer’s.

In July 2024, the FDA approved Eli Lilly’s Alzheimer’s

drug donanemab, also known as Kisunla, which targets amyloid in the brain.

Given the current weight of evidence, amyloid is now established

as a cause of Alzheimer’s.

In April 2026, the FDA approved Axsome Therapeutics’ Auvelity for treatment of agitation associated

with Alzheimer’s dementia.

Both Leqembi and Kisunla are

humanized monoclonal antibodies that bind with high affinity to soluble amyloid-beta oligomers, which reportedly are toxic to neurons.

Both Leqembi and Kisunla reduced biomarkers of amyloid in early Alzheimer’s and resulted in moderately less decline in measures

of cognition and function compared to placebo at 18 months.

Since Leqembi and Kisunla only provide passive immunity, antibody infusions

are needed every 2 or 4 weeks, respectively.

Both Leqembi and Kisunla support and validate the amyloid theory, but in routine medical

practice there will be a large burden on the health care system due to the need for bi-weekly or monthly infusions.

Both Leqembi and Kisunla have been demonstrated to reduce biomarkers of amyloid in early Alzheimer’s and result in moderately less

decline in measures of cognition and function as compared to a placebo at 18 months.

Since each of Leqembi and Kisunla provides only passive

immunity, antibody infusions are needed every 2 and 4 weeks, respectively.

Both Leqembi and Kisunla support and validate the amyloid theory,

but in routine medical practice there will be a large burden on the healthcare system due to the need for bi-weekly or monthly infusions.

Bipolar Disorder

previously known as manic depression, is a mood disorder characterized by periods of depression and periods of abnormally elevated happiness

that each lasts from days to weeks.

If the elevated mood is severe or associated with psychosis, it is called mania;

if it is less severe,

it is called hypomania.

During mania, an individual behaves or feels abnormally energetic, happy, or irritable, and they often make impulsive

BD, previously known as manic

depression, is a mood disorder characterized by periods of depression or abnormally elevated happiness, each lasting from days to weeks.

If the elevation in mood is severe or associated with psychosis, the disorder is diagnosed as mania;

if it is less severe, the diagnosis

is called hypomania.

During mania, an individual behaves or feels abnormally energetic, happy, or irritable, and often makes impulsive

decisions with little regard for the consequences.

There is usually also a reduced need for sleep during manic phases.

There usually will also be a reduced need for sleep during manic phases.

During periods

of depression, the individual may experience crying and have a negative outlook on life and poor eye contact with others.

self-abuse and even suicide is high;

over a period of 20 years, 6% of those with BD died by suicide, while 30–40% engaged in self-harm.

of depression, the individual may experience crying episodes, have a negative outlook on life and maintain poor eye contact with others.

The risk of self-abuse and even suicide is high;

over a period of 20 years, 6% of those with BD died by suicide, while 30–40% engaged

in self-harm.

Other mental health issues, such as anxiety disorders and substance use disorders, are commonly associated with BD.

the causes of BD are not clearly understood, both genetic and environmental factors are thought to play a role.

Many genes, each with

small effects, may contribute to the development of the disorder.

Genetic factors account for about 70–90% of the risk of developing

Environmental risk factors include a history of childhood abuse and long-term stress.

The condition is classified as bipolar I disorder

if there has been at least one manic episode, with or without depressive episodes, and as bipolar II disorder if there has been at least

one hypomanic episode (but no full manic episodes) and one major depressive episode.

If these symptoms are due to drugs or medical problems,

While the causes of BD are

not clearly understood, both genetic and environmental factors are thought to play a role.

Many genes, each with small effects, may contribute

to the development of the disorder.

Genetic factors account for about 70–90% of the risk of developing BD.

Environmental risk factors

include a history of childhood abuse and long-term stress.

The condition is classified as bipolar I disorder when a patient has experienced

at least one manic episode, with or without depressive episodes, or as bipolar II disorder when at least one hypomanic episode (but no

full manic episodes) and one major depressive episode have occurred.

If these symptoms manifest due to drugs or unrelated medical problems,

they are not diagnosed as BD.

Other conditions that have overlapping symptoms with BD include attention deficit hyperactivity disorder,

personality disorders, schizophrenia, and substance use disorder as well as many other medical conditions.

Medical testing is not required

for a diagnosis, though blood tests or medical imaging can rule out other problems.

occurs in approximately 1% of the global population.

According to the NIH, roughly seven million Americans are estimated to be affected

at some point in their lives;

Other medical conditions that may have overlapping symptoms with BD include attention deficit hyperactivity

disorder, personality disorders, schizophrenia, and substance use disorder.

Medical testing is not required to diagnose BD, although blood

tests and medical imaging can assist in ruling out other possible medical conditions.

BD occurs in approximately

1% of the global population.

According to the NIH, roughly seven million Americans are estimated to be affected by BD at some point in

rates appear to be similar in men and women.

Symptoms most commonly begin between the ages of 20 and 25

an earlier onset in life is associated with a worse prognosis.

Interest in functioning in the assessment of patients with BD

is growing, with an emphasis on specific domains such as work, education, social life, family and cognition.

Around one-quarter to one-third

of people with BD have financial, social or work-related problems due to the illness.

BD is among the top 20 causes of disability worldwide

and leads to substantial costs for society.

Due to lifestyle choices and the side effects of medications, the risk of death from natural

causes such as coronary heart disease in people with BD is twice that of the general population.

Symptoms most commonly begin to appear between the ages of 20 and 25;

onset in life is associated with a worse prognosis.

Interest in functioning in the assessment of patients with BD is growing, with an

emphasis on specific domains such as work, education, social life, family and cognition.

Around one-quarter to one-third of people with

BD have financial, social or work-related problems due to the illness.

BD is among the top 20 causes of disability worldwide and has led

to substantial costs for society.

Due to lifestyle choices and the side effects of medications, the risk of death from natural causes

(such as coronary heart disease) in people with BD is reportedly twice that of the general population.

Bipolar Disorder Therapeutic Landscape

stabilizers, including lithium and certain anticonvulsants, such as valproate and carbamazepine, as well as atypical antipsychotics, such

as aripiprazole, are the mainstay of long-term pharmacologic relapse prevention.

Antipsychotics are additionally given during acute manic

episodes as well as in cases where mood stabilizers are poorly tolerated or ineffective.

In patients where compliance is of concern, long-acting

injectable formulations are available.

Mood stabilizers, including

lithium and certain anticonvulsants, such as valproate and carbamazepine, as well as atypical antipsychotics, such as aripiprazole, are

the mainstay of long-term pharmacologic relapse prevention.

Antipsychotics are additionally given during acute manic episodes as well

as in cases where mood stabilizers are poorly tolerated or ineffective.

In patients where compliance is of concern, long-acting injectable

formulations are available.

There is some evidence that psychotherapy improves the course of BD.

The use of antidepressants

in depressive episodes is controversial;

The use of antidepressants in depressive

episodes is controversial;

they can be effective but have been implicated in triggering manic episodes.

The treatment of

depressive episodes, therefore, is often difficult.

Electroconvulsive therapy (“ECT”) is effective in acute manic and depressive

episodes, especially with psychosis or catatonia.

Admission to a psychiatric hospital may be required if a person is a risk to themselves

involuntary treatment is sometimes necessary if the affected person refuses treatment.

The treatment of depressive episodes,

therefore, is often difficult.

Electroconvulsive therapy (“ECT”) is effective in acute manic and depressive episodes, especially

with psychosis or catatonia.

Admission to a psychiatric hospital may be required if a person could present a risk of harm to themselves

and involuntary treatment may sometimes be necessary if the affected person refuses treatment.

Major Depressive Disorder

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affected about twice as often as men.

The course of the disorder varies widely, from one-episode lasting months to a lifelong disorder

with recurrent major depressive episodes.

is believed to be caused by a combination of genetic, environmental, and psychological factors, with about 40% of the risk being genetic.

Risk factors include a family history of the condition, major life changes, certain medications, chronic health problems, and substance

use disorders.

It can negatively affect a person's personal life, work life, or education as well as sleeping, eating habits, and general

According to the NIH, MDD affected approximately 21 million adults (8.4% of all U.S.

adults) in 2020.

The prevalence of adults

with a major depressive episode was higher among adult women (10.5%) than men (6.2%).

The prevalence of adults with a major depressive

episode was highest among individuals aged 18-25 (17.0%).

MDD causes the second-most years lived with disability, after lower back pain.

The course of the disorder can vary widely amongst affected patients, with reported experiences

ranging from a single episode that lasts months to a life-long disorder with recurrent major depressive episodes.

MDD is believed to be caused

by a combination of genetic, environmental, and psychological factors, with about 40% of the risk being genetic.

Risk factors include

a family history of the condition, major life changes, certain medications, chronic health problems, and substance use disorders.

negatively affect a person's personal life, work life, and education, as well as sleeping, eating habits, and general health.

to the NIH, MDD affected approximately 21 million adults (8.4% of all U.S.

adults) in 2020, and the prevalence of adults with a major

depressive episode was higher among adult women (10.5%) than men (6.2%) and highest among individuals aged 18-25 (17.0%).

MDD causes the

second-most years lived with disability, after lower back pain.

Major Depressive Therapeutic Landscape

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Post-Traumatic Stress Disorder

is a mental and behavioral disorder that can develop because of exposure to a traumatic event, such as sexual assault, warfare, traffic

collisions, child abuse, domestic violence, or other threats to a person’s life.

Symptoms may include disturbing thoughts, feelings

or dreams related to the causal event, mental or physical distress to trauma-related cues, attempts to avoid trauma-related cues, alterations

in the way a person thinks and feels, and an increase in the fight-or-flight response.

These symptoms may remain for more than a month

after the event.

PTSD is a mental and behavioral

disorder that can develop because of exposure to a traumatic event, such as sexual assault, warfare, traffic collisions, child abuse,

domestic violence, or other threats to a person’s life.

Symptoms may include disturbing thoughts, feelings or dreams related to

the causal event, mental or physical distress to trauma-related cues, attempts to avoid trauma-related cues, alterations in the way a

person thinks and feels, and an increase in the fight-or-flight response.

These symptoms may remain for more than a month after the event.

A person with PTSD is at a higher risk of suicide and intentional self-harm.

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is similar to PTSD but has a distinct effect on a person's emotional regulation and core identity.

to the NIH, about 3.5%, or roughly nine million, adults in the U.S.

have PTSD in a given year, and 9% of people develop it at some point

in their life.

According to the NIH, about

3.5%, or roughly nine million, adults in the U.S.

have PTSD in a given year, and 9% of people develop it at some point in their life.

In much of the rest of the world, rates for a given year are between 0.5% and 1% of the population.

Higher rates may occur

in regions of armed conflict.

Higher rates may occur in regions

of armed conflict.

It is more common in women than men.

PTSD was first mentioned in the American Psychiatric Association Diagnostic

and Statistical Manual of Mental Disorders (DSM-I) in the 1950s under the term “gross stress reaction.” Although this diagnosis

PTSD was first mentioned in the American Psychiatric Association Diagnostic and

Statistical Manual of Mental Disorders (DSM-I) in the 1950s under the term “gross stress reaction.” Although this diagnosis

included psychological problems related to traumatic events such as wartime combat, it limited symptoms to six months.

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less effective than those seen with counselling.

It is not known whether using medications and counselling together have greater benefits

than either method separately.

It is not currently known whether using medications and counselling together will result

in more favorable preventative outcomes for PTSD patients than either method separately.

Sertraline (Zoloft) and Paroxetine

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For example, one study by Kitchner and Greenstein provided

case histories of four males (aged approximately 31–42 years) who suffered from PTSD resulting from their experiences in the Vietnam

Results from treatment with low doses (300–600 mg/day) of lithium carbonate were reported to indicate that treatment was effective

in reducing inappropriate anger, irritability, anxiety, and insomnia.

case histories of four males (with ages ranging between approximately 31–42 years) who suffered from PTSD resulting from their experiences

in the Vietnam War.

Results from treatment with low doses (300–600 mg/day) of lithium carbonate were reported to indicate that treatment

was effective in reducing inappropriate anger, irritability, anxiety and insomnia.

The clinical observation of

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Distribution and Marketing

intend to develop AL001 and ALZN002 through successive de-risking milestones towards regulatory approval and seek marketing approval of

AL001 and ALZN002 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.

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

Our focus is to strategically

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

We intend to develop AL001

and ALZN002 through successive de-risking milestones towards regulatory approval and seek marketing approval of AL001 and ALZN002 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

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

Government Regulation

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at any time during the product development process, approval process or after approval may subject an applicant to administrative or judicial

These sanctions could include the imposition by the FDA of an Institutional Review Board, or IRB, a clinical hold on trials,

a refusal to approve pending applications, withdrawal of an approval, warning letters, product recalls, product seizures, total or partial

suspension of production or distribution, injunctions, fines, civil penalties or referrals to the Department of Justice for criminal prosecution.

Any agency or judicial enforcement action could have a material adverse effect on us.

These sanctions could include the imposition by the FDA of an Institutional Review Board (an “IRB”), a clinical

hold on trials, a refusal to approve pending applications, withdrawal of an approval, warning letters, product recalls, product seizures,

total or partial suspension of production or distribution, injunctions, fines, civil penalties or referrals to the Department of Justice

for criminal prosecution.

Any such agency or judicial enforcement action, if imposed on us, could have a material adverse effect on us.

The FDA and regulatory agencies

in state and local jurisdictions impose substantial requirements upon the clinical development, manufacturing and marketing of pharmaceutical

These agencies and other federal, state and local entities regulate research and development activities and the testing, manufacture,

quality control, safety, effectiveness, labeling, storage, distribution, record keeping, approval, advertising and promotion of our products.

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

of new disease indications or label changes.

We cannot predict the likelihood, nature or extent of adverse governmental regulation that

might arise from future legislative or administrative action, either in the United States or elsewhere.

These agencies and other relevant federal, state and local entities regulate research and development activities and the testing,

manufacturing, quality control, safety, effectiveness, labeling, storage, distribution, record keeping, approval, advertising and promotion

of our product candidates.

The FDA’s policies may

change, and additional government regulations may be promulgated, in a manner that could prevent or delay regulatory approval of new disease

indications or label changes.

We cannot predict the likelihood, nature or extent of adverse governmental regulation that might arise from

future legislative or administrative action, either in the United States or elsewhere.

Marketing Approval

The process required by the

FDA before human health care pharmaceuticals may be marketed in the U.S.

FDA before human healthcare pharmaceuticals may be marketed in the U.S.

generally involves the following:

• nonclinical laboratory and, at times, animal tests;

• nonclinical laboratory and, at times, animal testing;

• adequate and well-controlled human clinical trials to establish the safety and efficacy of the proposed

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

• FDA review and 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.

reach agreement with the FDA on the proposed protocols for our future clinical trials in the U.S.

A separate submission to the FDA must

be made for each successive clinical trial to be conducted during product development.

Further, an independent Institutional Review Board

(an “IRB”) for each site proposing to conduct the clinical trial must review and approve the plan for any clinical trial before

it commences at that site, and an informed consent must also be obtained from each study subject.

Regulatory authorities, a data safety

monitoring board or the sponsor may all suspend or terminate a clinical trial at any time on numerous grounds.

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

We will need to successfully

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

We must reach agreement with the FDA

on the proposed protocols for our future clinical trials in the U.S.

A separate submission to the FDA must be made for each successive

clinical trial to be conducted during product development.

Further, an independent IRB for each site proposing to conduct the clinical

trial must review and approve the plan for any clinical trial before it commences at that site, and an informed consent must also be obtained

from each study subject.

Regulatory authorities, a data safety monitoring board or the sponsor may all suspend or terminate a clinical

trial at any time on numerous grounds.

For purposes of BLA or NDA

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Breakthrough Therapy Designation

product can be designated as a breakthrough therapy if it is intended to treat a serious condition (which includes 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:

A product can be designated

as a breakthrough therapy if it is intended to treat a serious condition (which includes Alzheimer’s) and preliminary clinical evidence

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

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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for the reference product has expired, such as the exclusivity granted for obtaining approval of a new chemical entity.

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

However, AL001 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.

If we qualify for the Section

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

However, AL001 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.

Disclosure of Clinical Trial Information

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Restoration Act

Drug Price Competition and Patent Term Restoration Act, also known as the Hatch-Waxman Amendments, requires pharmaceutical companies to

divulge certain information regarding their products, which has the effect of making it easier for other companies to manufacture generic

drugs to compete with those products.

The Drug Price Competition

and Patent Term Restoration Act, also known as the Hatch-Waxman Amendments, requires pharmaceutical companies to divulge certain information

regarding their products, which has the effect of making it easier for other companies to manufacture generic drugs to compete with those

Patent Term Extension.

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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.

Certain exemptions are

available from the requirement to perform an environmental assessment and an environmental impact statement.

Once an exemption is claimed,

a company must state to the FDA that no extraordinary circumstances exist that may significantly affect the environment.

an exemption, under the category for biologic products, from the requirement to provide an environmental assessment and an environmental

impact statement for AL001 or ALZN002 and further state to the FDA that, to our knowledge, no extraordinary circumstance exists that would

significantly affect the environment.

Environmental Regulations.

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.

Certain exemptions are available from the

requirement to perform an environmental assessment and an environmental impact statement.

Once an exemption is claimed, a company must

state to the FDA that no extraordinary circumstances exist that may significantly affect the environment.

We may claim an exemption, under

the category for biologic products, from the requirement to provide an environmental assessment and an environmental impact statement

for AL001 or ALZN002 and further state to the FDA that, to our knowledge, no extraordinary circumstance exists that would significantly

affect the environment.

FDA Post-Approval Requirements

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Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, or the ACA, which includes

measures that have significantly changed the way health care is financed by both governmental and private insurers, became law in the

The ACA is a sweeping measure intended to expand health care coverage within the U.S., primarily through the imposition of health

insurance mandates on employers and individuals and expansion of the Medicaid program.

The ACA has significantly impacted the pharmaceutical

The ACA requires discounts under the Medicare drug benefit program and increased rebates on drugs covered by Medicaid.

the ACA imposes an annual fee, which increases annually, on sales by branded pharmaceutical manufacturers.

At this time, the financial

impact of these discounts, increased rebates and fees and the other provisions of the ACA on our business are unclear.

However, the fees,

discounts and other provisions of this law are expected to have a significant negative effect on the profitability of pharmaceuticals.

measures that have significantly changed the way healthcare is financed by both governmental and private insurers, became law in the U.S.

The ACA is a sweeping measure intended to expand healthcare coverage within the U.S., primarily through the imposition of health insurance

mandates on employers and individuals and expansion of Medicaid.

The ACA has significantly impacted the pharmaceutical industry.

requires discounts under the Medicare drug benefit program and increased rebates on drugs covered by Medicaid.

In addition, the ACA imposes

an annual fee, which increases annually, on sales by branded pharmaceutical manufacturers.

At this time, the financial impact of these

discounts, increased rebates and fees and the other provisions of the ACA on our business are unclear.

However, the fees, discounts and

other provisions of this law are expected to have a significant negative effect on the profitability of pharmaceuticals.

Human Health Product Regulation in the European

In addition to domestic regulations,

we may eventually be subject, either directly or through our distribution partners, to a variety of regulations in other jurisdictions

we may eventually become subject, either directly or through our distribution partners, to a variety of regulations in other jurisdictions

governing, among other things, clinical trials and any commercial sales and distribution of our products, if approved.

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national marketing authorization by one or more EU Member States.

principal characteristic of the MRP is that the procedure builds on an already existing marketing authorization in an EU Member State

that is used as reference in order to obtain marketing authorizations in other Member States.

In the MRP, a marketing authorization for

a drug already exists in one or more EU Member States and subsequently marketing authorization applications are made in other EU Member

States by referring to the initial marketing authorization.

The EU Member State in which the marketing authorization was first granted

will then act as the referenced EU Member State.

The EU Member States where the marketing authorization is subsequently applied for act

as concerned EU Member States.

The principal characteristic

of the MRP is that the procedure builds on an already existing marketing authorization in an EU Member State that is used as reference

in order to obtain marketing authorizations in other Member States.

In the MRP, a marketing authorization for a drug already exists in

one or more EU Member States and subsequently marketing authorization applications are made in other EU Member States by referring to

the initial marketing authorization.

The EU Member State in which the marketing authorization was first granted will then act as the referenced

EU Member State.

The EU Member States where the marketing authorization is subsequently applied for act as concerned EU Member States.

The MRP is based on the principle

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Human Health Product Regulation in the Rest

countries outside of the EU, such as the United Kingdom, Canada, countries in Eastern Europe or Asia, the requirements governing the conduct

of clinical trials, product licensing, pricing and reimbursement vary from country to country.

In all cases, the clinical trials are conducted

in accordance with GCP and the other applicable regulatory requirements.

If we fail to comply with applicable foreign regulatory requirements,

we may be subject to, among other things, fines, suspension of clinical trials, suspension or withdrawal of regulatory approvals, product

recalls, seizure of products, operating restrictions and criminal prosecution.

For countries outside of the

EU, such as the United Kingdom, Canada, countries in Eastern Europe or Asia, the requirements governing the conduct of clinical trials,

product licensing, pricing and reimbursement vary from country to country.

In all cases, the clinical trials are conducted in accordance

with GCP and the other applicable regulatory requirements.

If we fail to comply with applicable foreign regulatory requirements, we may

be subject to, among other things, fines, suspension of clinical trials, suspension or withdrawal of regulatory approvals, product recalls,

seizure of products, operating restrictions and criminal prosecution.

Other Regulatory Considerations

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promotional activities on the internet and elsewhere.

appropriate medical professionals are free to prescribe any pharmaceutical approved by the FDA for any use, a company can only make claims

relating to the safety and efficacy of a pharmaceutical that are consistent with the FDA approval, and is only allowed to actively market

a pharmaceutical for the particular indication approved by the FDA.

Changes to some of the conditions established in an approved application,

including changes in indications, labeling, or manufacturing processes or facilities, require submission and FDA approval of a new NDA

or BLA or NDA/BLA supplement before the change can be implemented.

A BLA supplement for a new indication typically requires clinical data

similar to that in the original application, and the FDA uses the same procedures and actions in reviewing supplements as it does in reviewing

While appropriate medical

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

safety and efficacy of a pharmaceutical that are consistent with the FDA approval, and is only allowed to actively market a pharmaceutical

for the particular indication approved by the FDA.

Changes to some of the conditions established in an approved application, including

changes in indications, labeling, or manufacturing processes or facilities, require submission and FDA approval of a new NDA or BLA or

NDA/BLA supplement before the change can be implemented.

A BLA supplement for a new indication typically requires clinical data similar

to that in the original application, and the FDA uses the same procedures and actions in reviewing supplements as it does in reviewing

In addition, any claims we

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Anti-Kickback and False

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

In the United States, we are subject to complex laws and regulations pertaining to healthcare “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

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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.

payment may be made under a federal healthcare program, such as Medicare or Medicaid.

The federal False Claims Act

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the penalty provisions of the pertinent state, and soon federal, authorities.

Other Health Care Laws

Other Healthcare Laws

and Compliance Requirements.

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Other legislation

has been enacted in certain states prohibiting pharmacies and other health care entities from providing certain physician prescribing

data to pharmaceutical companies for use in sales and marketing and prohibiting certain other sales and marketing practices.

activities are potentially subject to federal and state consumer protection, unfair competition and other laws and regulations.

has been enacted in certain states prohibiting pharmacies and other healthcare entities from providing certain physician prescribing data

to pharmaceutical companies for use in sales and marketing and prohibiting certain other sales and marketing practices.

All of our activities

are potentially subject to federal and state consumer protection, unfair competition and other laws and regulations.

Our Intellectual Property

are able to protect our technology from unauthorized use by third parties only to the extent that it is covered by valid and enforceable

patents, is effectively maintained as a trade secret or is protected by confidentiality agreements.

Accordingly, patents or other proprietary

rights are an essential element of our business.

Currently, we do not own a patent, although we do possess a license for an immunotherapy

technology and three licenses for a lithium, salicylate and proline cocrystal technology from the Licensor.

We are able to protect our

technology from unauthorized use by third parties only to the extent that it is covered by valid and enforceable patents, is effectively

maintained as a trade secret or is protected by confidentiality agreements.

Accordingly, patents or other proprietary rights are an essential

element of our business.

Currently, we do not own a patent, although we do possess a license for an immunotherapy technology and three

licenses for a lithium, salicylate and proline cocrystal technology from the Licensor.

Patents extend for varying

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availability, price and patent position.

Employees and Human

Capital Resources

of April 30, 2025, we have four full-time employees and three part-time employees.

We also utilize independent consultants to assist us

in our medical research and development projects.

human capital resources objectives include identifying, recruiting, retaining, incentivizing and integrating our existing and new employees,

advisors and consultants.

The principal purposes of our equity and cash incentive plans are to attract, retain and reward personnel through

the granting of stock-based and cash-based compensation awards, in order to increase stockholder value and the success of our company

by motivating such individuals to perform to the best of their abilities and achieve our objectives.

Employees and Human Capital Resources

As of April 30, 2026, we had

four full-time employees and two part-time employees.

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

development projects.

Our human capital resources

objectives include identifying, recruiting, retaining, incentivizing and integrating our existing and new employees, advisors and consultants.

The principal purposes of our equity and cash incentive plans are to attract, retain and reward personnel through the granting of stock-based

and cash-based compensation awards, in order to increase stockholder value and the success of our company by motivating such individuals

to perform to the best of their abilities and achieve our objectives.

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