NASDAQ: ALZN

Our pipeline consists of two
novel therapeutic drug candidates:

· AL001 - A patented ionic cocrystal technology delivering a therapeutic combination of lithium, salicylate
and proline through three royalty-bearing exclusive worldwide licenses from the University of South Florida Research Foundation, Inc.,
as licensor (the “Licensor”); and

· ALZN002 - A patented method using a mutant peptide sensitized cell as a cell-based therapeutic vaccine
that seeks to restore the ability of a patient’s immunological system to combat Alzheimer’s through a royalty-bearing exclusive
worldwide license from the Licensor.

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
in humans. Lithium was the first mood stabilizer approved by the U.S. Food and Drug Administration (“FDA”) and is still a
first-line treatment option (considered the “gold standard”) for BD and is prescribed off-label for MDD and PTSD. Moreover,
lithium has been marketed for more than 55 years and human toxicology regarding its use has been well characterized, potentially mitigating
the regulatory burden for safety data.

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.

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. 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.

- 2 -

Our Business Strategy

We intend to develop and commercialize
therapeutics that are better than existing treatments and have the potential to significantly improve the lives of individuals afflicted
by Alzheimer’s, BD, MDD and PTSD. To achieve these goals, we are pursuing the following key business strategies:

• 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 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
results:

· Bioequivalence Confirmed: AL001 delivered 101% of total lithium blood exposure and 97% of peak lithium
levels vs. standard lithium carbonate;

· Superior Brain Penetration: AL001 showed numerically higher lithium concentrations in all measured brain
regions, including whole brain; and

· 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; and

· 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. 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. Another element
of our business strategy is to explore, resources permitting, different formulations (liquid, immediate release and sprinkle capsules)
to deliver AL001 to accommodate the needs of patients afflicted with Alzheimer’s, BD, MDD and PTSD;

- 3 -

• Focus on translational and functional endpoints to efficiently develop product candidates. We believe
that AL001 is positioned for a Section 505(b)(2) regulatory pathway for new drug approvals. We also believe that AL001 and ALZN002 are
positioned for breakthrough therapy designations because of their positive effects on a pharmacodynamic biomarker (beta-amyloids) and
potential for a clinically meaningful effect on Alzheimer’s, making them eligible to receive assistance from the FDA throughout
the approval process that may shorten the development timelines. However, we have neither received breakthrough therapy designation nor
have we qualified for expedited development, and no assurance can be given that we will. Even if we qualify for breakthrough therapy designation
or expedited development, it may not actually lead to faster development or expedited regulatory review and approval or necessarily increase
the likelihood that we will ultimately receive FDA approval; and

• Optimize the value of AL001 and ALZN002 in major markets. We intend to commercialize AL001 and
ALZN002 by seeking FDA marketing approval for both product candidates and partnering with biopharmaceutical companies seeking to strategically
fortify pipelines and, in turn, receiving funding for the costly later-stage clinical development. We do not anticipate selling products
directly into the marketplace, though we may do so depending on market conditions. 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

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

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

- 4 -

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
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.

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:

· AL001 was shown to be safe and well-tolerated in healthy adult subjects;

· No deaths or serious adverse events were reported during the trial;

· The safety profiles of both AL001 and the marketed lithium carbonate capsule were benign;

· No clinically significant abnormal findings in electrocardiograms were noted during the trial;

· AL001 salicylate plasma concentrations were observed to be well tolerated and consistently within safe
limits; and

- 5 -

· Dose-adjusted relative bioavailability analyses of the rate and extent of lithium absorption in plasma
indicated that AL001, at a lithium carbonate equivalent dose of 150 mg, is bioequivalent to a marketed 300 mg lithium carbonate capsule
and the shapes of the lithium plasma concentration versus time curves are similar.

Phase IIA Study

On May 5, 2022, we initiated
a multiple-dose, steady-state, double-blind, ascending dose safety, tolerability, pharmacokinetic clinical trial (www.clinicaltrials.gov,
identifier: NCT05363293) of AL001 in patients with mild to moderate Alzheimer’s and healthy subjects with the following objectives:

· Primary: To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions
in Alzheimer’s patients and healthy subjects;

· Secondary: To characterize the MTD of AL001 in patients with mild to moderate Alzheimer’s
and healthy subjects; and

· Tertiary: 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:

o Facilitate recruitment into subsequent AL001 clinical trials; and

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

We completed the Phase IIA
clinical trial in March 2023, announced positive topline data in June 2023 and announced full data sets in October 2024. We successfully
identified an MTD for development of AL001 from a multiple-ascending dose study as assessed by an independent safety review committee.
This dose, providing lithium at a lithium carbonate equivalent dose of 240 mg 3-times daily (“TID”), is designed to be unlikely
to require lithium TDM. Also, the risk of this MTD is mitigated for the purpose of treating fragile populations, such as Alzheimer’s
patients.

Lithium is a commonly prescribed
drug for manic episodes in BD type 1 as well as maintenance therapy of BP in patients with a history of manic episodes. Lithium is also
prescribed off-label for MDD, BD and treatment of PTSD, among other disorders. Lithium was the first mood stabilizer approved by the FDA
and is still a first-line treatment option (considered the “gold standard”) but is underutilized, at least in part because
of the need for TDM. Lithium was the first drug that required TDM by regulatory authorities in product labelling because the effective
and safe range of therapeutic drug blood concentrations is narrow and well defined for treatment of BP when using lithium salts. Excursions
above this range can be toxic, and dosages below it can impair effectiveness.

Current and Future Phase II “Lithium
in Brain” Studies

In August 2024, we announced
a partnership with 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 November 2024, we announced
a full data set from a nonclinical study comparing brain and plasma lithium exposures between AL001 and lithium carbonate in Alzheimer’s
transgenic mice. This study was a precursor to the five clinical trials and showed that AL001 exhibited consistently higher lithium concentrations
in brain tissues, particularly at lower doses, compared to lithium carbonate.

For these clinical trials,
we partnered with Tesla Dynamic Coils BV to create a head coil to enable whole-brain imaging of lithium with remarkable resolution, allowing
precise quantification within brain structures. The coil will be used to help identify the disease-specific target doses of AL001 that
improve the balance of safety and efficacy compared to lithium carbonate. The coil will also be used to scan the entire brain, helping
us clearly identify the different structures and important areas necessary for understanding how lithium works and moves within the brain.
We announced completion of the head coil in February 2025.

In May 2025, we announced
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
to a marketed lithium carbonate capsule in healthy adult subjects for the purpose of determining potential clinically safe and effective
AL001 dosing in future studies;

· To characterize AL001 lithium and salicylate steady-state plasma PK, and lithium relative to a marketed
lithium carbonate capsule;

· To characterize differences in brain and brain structure(s) PK behaviors such as absorption and persistence
between AL001 capsule and a marketed lithium carbonate capsule; and

· To characterize safety and tolerability of the tested formulations under the conditions of this study
(38% below the pre-determined MTD for AL001, at a half-dose of a usual lithium starting dose of lithium carbonate for treatment of BD,
equivalent to 150 mg lithium carbonate TID).

- 6 -

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
carbonate; (2) Superior Brain Penetration: AL001 showed numerically higher lithium concentrations in all measured brain regions, including
whole brain; 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; and

· 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

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
system, resulting in the clearance of brain amyloid. Preclinical studies conducted from April 2005 to July 2010 demonstrated that the
infusion of transgenic (or genetically modified) mice with ALZN002-pulsed DCs is associated with lower amyloid burden and improved neuro-behavioral
performance. This is likely to be mediated by an anti-inflammatory effect in addition to the immunogenicity of this therapy.

The development of ALZN002
is predicated on the theory that Alzheimer’s symptoms may be caused in large part by plaque deposits that can cluster in the brain
composed of protein fragments called beta-amyloids that build up between nerve cells. One hypothesis is that a special type of immune
cell, a natural beta-amyloid antibody, may play a role in preventing plaque build-up in people without Alzheimer’s. As people age,
their immune systems tend to degrade, and some people may be unable to produce natural beta-amyloid antibodies, the absence of which leads
to the plaque build-up causing Alzheimer’s.

ALZN002 is intended to elicit
an immune response to produce anti-amyloid antibodies, which can then neutralize circulated beta-amyloids and prevent additional plaque
build-up. The 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. 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.

- 7 -

Clinical Trials

Preclinical

On July 23, 2021, we announced
that Alzamend received positive toxicology results for ALZN002 in a good laboratory practices (“GLP”) toxicology study using
a transgenic mouse model of Alzheimer’s. The study was conducted by Charles River Laboratories. ALZN002 is a patented method using
a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient’s immunological
system to combat Alzheimer’s.

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.

Modified cell therapies, especially
DCs, may provide a safer and more patient-specific active immunization. Ex-vivo modification of DCs as a modality of treatment has been
previously used in oncological therapeutics. It has been shown to be relatively safe and capable of engaging the immune system to attack
the target tissues with success. Its use in Alzheimer’s therapeutics is relatively recent.

Phase I/II Study

We submitted a pre-IND meeting
request for ALZN002 and supporting briefing documents to the Center for Biological Evaluation and Research of the FDA on July 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.

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. 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 April 3, 2023, we announced
the initiation of a Phase I/IIA clinical trial for ALZN002 to treat mild to moderate dementia of the Alzheimer’s type. 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 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

On July 2, 2018, we entered
into two Standard Exclusive License Agreements with Sublicensing Terms for AL001 with the Licensor and its affiliate, the University of
South Florida (the “AL001 Licenses”), pursuant to which the Licensor granted us a royalty bearing exclusive worldwide licenses
limited to the field of Alzheimer’s, under U.S. Patent Nos. (i) 9,840,521, entitled “Organic Anion Lithium Ionic Cocrystal
Compounds and Compositions,” filed September 24, 2015 and granted December 12, 2017, and (ii) 9,603,869, entitled “Lithium
Co-Crystals for Treatment of Neuropsychiatric Disorders,” filed May 21, 2016 and granted March 28, 2017. On February 1, 2019, we
entered into the First Amendments to the AL001 Licenses, on March 30, 2021, we entered into the Second Amendments to the AL001 Licenses
and on June 8, 2023, we entered into the Third Amendments to the AL001 Licenses (collectively, the “AL001 License Agreements”).
The Third Amendments to the AL001 Licenses modified the timing of the payments for the license fees.

The AL001 License Agreements
require that we pay combined royalty payments of 4.5% on net sales of products developed from the licensed technology for AL001. We have
already paid an initial license fee of $200,000 for AL001. As an additional licensing fee for the 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
of the first commercial sale, $80,000 on the second anniversary of the first commercial sale and $100,000 on the third anniversary of
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.

- 8 -

On May 1, 2016, we entered
into a Standard Exclusive License Agreement with Sublicensing Terms for ALZN002 with the Licensor (the “ALZN002 License”),
pursuant to which the Licensor granted us a royalty bearing exclusive worldwide license limited to the field of Alzheimer’s Immunotherapy
and Diagnostics, under U.S. Patent No. 8,188,046, entitled “Amyloid Beta Peptides and Methods of Use”, filed April 7, 2009
and granted May 29, 2012. On August 18, 2017, we entered into the First Amendment to the ALZN002 License, on May 7, 2018, we entered into
the Second Amendment to the ALZN002 License, on January 31, 2019, we entered into the Third Amendment to the ALZN002 License, on January
24, 2020, we entered into the Fourth Amendment to the ALZN002 License, on March 30, 2021, we entered into the Fifth Amendment to the ALZN002
License, on April 17, 2023, we entered into the Sixth Amendment to the ALZN002 License and on December 11, 2023, we entered into the Seventh
Amendment to the ALZN002 License (collectively, the “ALZN002 License Agreement”). The Seventh Amendment to the ALZN002 License
modified the timing of the payments for the license fees.

The ALZN002 License Agreement
requires us to pay royalty payments of 4% on net sales of products developed from the licensed technology for ALZN002. We have already
paid an initial license fee of $200,000 for ALZN002. As an additional licensing fee for the license of ALZN002, the Licensor received
24,012 shares of our common stock. Minimum royalties for ALZN002 are $20,000 on the first anniversary of the first commercial sale, $40,000
on the second anniversary of the first commercial sale and $50,000 on the third anniversary of the first commercial sale and every year
thereafter, for the life of the ALZN002 License Agreement.

On November 19, 2019, we entered
into two Standard Exclusive License Agreements with Sublicensing Terms for two additional indications of AL001 with the Licensor (the
“November AL001 License”), pursuant to which the Licensor granted us a royalty bearing exclusive worldwide license limited
to the fields of (i) neurodegenerative diseases excluding Alzheimer’s and (ii) psychiatric diseases and disorders. On March 30,
2021, we entered into the First Amendments to the November AL001 License and on April 17, 2023, we entered into the Second Amendments
to the November AL001 License (collectively, the “November AL001 License Agreements”). The Second Amendments to the November
AL001 License modified the timing of the payments for the license fees.

The November AL001 License
Agreements require us to pay royalty payments of 3% on net sales of products developed from the licensed technology for AL001 in those
fields. We paid an initial license fee of $20,000 for the additional indications. Minimum royalties for November AL001 License Agreements
are $40,000 on the first anniversary of the first commercial sale, $80,000 on the second anniversary of the first commercial sale and
$100,000 on the third anniversary of the first commercial sale and every year thereafter, for the life of the November AL001 License Agreements.

These license agreements have
an indefinite term that continue until the later of the date that no licensed patent under the applicable agreement remains a pending
application or enforceable patent, the end date of any period of market exclusivity granted by a governmental regulatory body, or the
date on which the licensee’s obligations to pay royalties expire under the applicable license agreement. Under our various license
agreements, if we fail to meet a milestone by its specified date, Licensor may terminate the license agreement. The Licensor was also
granted a preemptive right to acquire such shares or other equity securities that may be issued from time to time by us while the Licensor
remains the owner of any equity securities of our company.

Additionally, we are required
to pay milestone payments on the due dates to the Licensor for the license of the AL001 technologies and for the ALZN002 technology, as
follows:

Original AL001 Licenses:

Payment
Due Date

$
50,000*
Pre-IND Meeting - Completed September 2019

$
65,000*
IND application filing - Completed June 2021

$
190,000*
Upon first dosing of patient in a clinical trial - Completed December 2021

$
500,000*
Upon completion of first clinical trial - Completed March 2022

$
1,250,000
Upon first patient treated in a Phase III clinical trial

$
10,000,000
Upon FDA NDA approval

* Milestone met and completed

- 9 -

ALZN002 License:

Payment
Due Date

$
50,000*
Upon IND application - Completed January 2022

$
50,000
Upon first dosing of patient in first Phase I clinical trial

$
500,000
Upon completion of first Phase IIB clinical trial

$
1,000,000
Upon first patient treated in a Phase III clinical trial

$
10,000,000
Upon first commercial sale

* Milestone met and completed

Additional AL001 Licenses:

Payment
Due Date

$
2,000,000
Upon first patient treated in a Phase III clinical trial

$
16,000,000
First commercial sale

Market Opportunity

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.

Industry Overview

Alzheimer’s

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 7.4 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. These death certificates only list the most immediate cause. The fastest growing
age group in the U.S. is the “over 85” group within which one in three individuals has Alzheimer’s.

It is estimated that the cost
of caring for people with Alzheimer’s and other dementias will increase from an estimated $409 billion in 2026 to a projected $1
trillion per year by 2050, with Medicare and Medicaid covering approximately 70% of such costs. Over 13 million Americans provide unpaid
care for people with Alzheimer’s or other dementias. 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.

- 10 -

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 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 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

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

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 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
their lives; rates appear to be similar in men and women. Symptoms most commonly begin to appear 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 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

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; 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 could present a risk of harm to themselves
or others; and involuntary treatment may sometimes be necessary if the affected person refuses treatment.

Major Depressive Disorder

MDD, also known simply as
depression, is a mental disorder characterized by at least two weeks of pervasive low mood, low self-esteem, and loss of interest or pleasure
in normally enjoyable activities. Those affected may also occasionally have delusions or hallucinations. Introduced by a group of U.S.
clinicians in the mid-1970s, the term was adopted by the American Psychiatric Association for this symptom cluster under mood disorders
in the 1980 version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-III), and has become widely used since.

- 11 -

The diagnosis of MDD is based
on the person's reported experiences and a mental status examination. There is no laboratory test for the disorder, but testing may be
done to rule out physical conditions that can cause similar symptoms. The most common time of onset is in a person’s 20s, with women
affected about twice as often as men. 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. It can
negatively affect a person's personal life, work life, and education, as well as sleeping, eating habits, and general health. According
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

Those with MDD are typically
treated with psychotherapy and antidepressant medication. Medication appears to be effective, but the effect may predominantly be significant
in the most severely depressed. Hospitalization (which may be involuntary) may be necessary in cases with associated self-neglect or a
significant risk of harm to self or others. ECT may be considered if other measures are not effective.

Although lithium does not
have an FDA approved indication for augmentation of an antidepressant in MDD, it has been prescribed off-label for this purpose for decades.
While a wide variety of medications have been used historically in this capacity, lithium is one of the few agents that has demonstrated
efficacy in multiple randomized controlled trials. Although the ideal role for lithium augmentation has yet to be established, there is
evidence to support the clinical practice of adding lithium to conventional antidepressants in pursuit of MDD remission. Lithium augmentation
has been cited as a main strategy for depressed patients not responding to an antidepressant, lithium prophylaxis for recurrent unipolar
depression as an alternative to prophylaxis with an antidepressant, and for lithium’s anti-suicidal properties, where appropriate.

Post-Traumatic Stress Disorder

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.

Most people who experience
traumatic events do not develop PTSD. People who experience interpersonal violence such as rape, other sexual assaults, being kidnapped,
stalking, physical abuse by an intimate partner, and incest or other forms of childhood sexual abuse are more likely to develop PTSD than
those who experience non-assault-based trauma, such as accidents and natural disasters. Those who experience prolonged trauma, such as
slavery, concentration camps, or chronic domestic abuse, may develop complex post-traumatic stress disorder (“C-PTSD”). C-PTSD
is similar to PTSD but has a distinct effect on a person's emotional regulation and core identity.

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. 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
included psychological problems related to traumatic events such as wartime combat, it limited symptoms to six months. This diagnosis
was removed from the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders (DSM-II) in 1968, representing
a regression in accurate PTSD characterization. The long-term psychological disabilities experienced by trauma survivors, including combat
veterans, sexual assault victims and Holocaust survivors, led to the introduction of PTSD in the American Psychiatric Association Diagnostic
and Statistical Manual of Mental Disorders (DSM-III) in 1980 when, for the first time, the definition of PTSD highlighted the critical
connection between traumatic events and long-term psychological symptoms.

Post-Traumatic Stress Disorder Therapeutic
Landscape

Prevention may be possible
when counselling is targeted at those with early symptoms but is not effective when provided to all trauma-exposed individuals, whether
or not symptoms are present. The main treatments for people with PTSD are counselling (psychotherapy) and medication. Antidepressants
of the selective serotonin reuptake inhibitors (“SSRI”) or serotonin-norepinephrine reuptake inhibitors (“SNRI”)
type are the first-line medications used for PTSD and are moderately beneficial for about half of people. Benefits from medication are
less effective than those seen with counselling. 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
(Paxil) are FDA-approved medications for PTSD. Reviews by a group of doctors of pharmacological monotherapy in 2015 and 2021 found that
paroxetine, fluoxetine, sertraline and venlafaxine could be effective for PTSD, but the magnitude of the effect was low and the clinical
relevance was unclear. These reviews excluded lithium treatments. Medications, other than some SSRIs or SNRIs, do not have enough evidence
to support their use and, in the case of benzodiazepines, may worsen outcomes.

- 12 -

Case reports suggest that
lithium treatment may be useful for irritability/anger outbursts in PTSD patients. For example, one study by Kitchner and Greenstein provided
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
mood swings beyond the normal range but milder than those associated with BD reportedly suggested the presence of a subthreshold mood
disorder in these PTSD patients. It has also been proposed that treatment of trauma with lithium to forestall the development of PTSD
may be provided by pharmacological induction of a mild transient amnesia.

Manufacturing

Currently, we do not have
in-house manufacturing capabilities. We have outsourced and expect to continue to outsource the manufacturing of our products to third
party contractors with special capabilities to manufacture chemical drugs and biologic drug candidates for submission and clinical testing
under FDA guidelines and, for AL001 and ALZN002, have received Good Manufacturing Practices, or GMP, material manufactured for clinical
trial. There are several sources of manufacturing available once a therapy or treatment can achieve Phase II study as identified in a
publication by Pharma.org released in 2013 (http://www.phrma.org/sites/default/files/Alzheimer’s%202013.pdf).

Distribution and Marketing

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

Clinical trials, the pharmaceutical
approval process, and the marketing of pharmaceutical products are intensively regulated in the United States and in all major foreign
countries.

Human Health Product Regulation in the United
States

In the United States, the
FDA regulates pharmaceuticals under the Federal Food, Drug, and Cosmetic Act and related regulations promulgated thereunder. Pharmaceuticals
are also subject to other federal, state, and local statutes and regulations. Failure to comply with applicable U.S. regulatory requirements
at any time during the product development process, approval process or after approval may subject an applicant to administrative or judicial
sanctions. 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
products. 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 healthcare pharmaceuticals may be marketed in the U.S. generally involves the following:

• nonclinical laboratory and, at times, animal testing;

• adequate and well-controlled human clinical trials to establish the safety and efficacy of the proposed
drug for its intended use or uses;

- 13 -

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

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

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
approval for human health products, human clinical trials are typically conducted in phases that may overlap.

• Phase I. The drug is initially introduced into healthy human subjects and tested for safety, dosage
tolerance, absorption, metabolism, distribution and excretion. In the case of some products for severe or life-threatening diseases, especially
when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted
in patients.

• Phase II. This phase involves trials in a limited subject population to identify possible adverse
effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage
tolerance and optimal dosage. Phase II studies may be sub-categorized into Phase IIA studies, which are smaller, pilot studies to evaluate
limited drug exposure and efficacy signals, and Phase IIB studies, which are larger studies testing both safety and efficacy more rigorously.

• Phase III. This phase involves trials undertaken to further evaluate dosage, clinical efficacy
and safety in an expanded subject population, often at geographically dispersed clinical trial sites. These trials are intended to establish
the overall risk/benefit ratio of the product and provide an adequate basis for product labeling.

All of these trials must be
conducted in accordance with Good Clinical Practice (“GCP”) requirements in order for the data to be considered reliable for
regulatory purposes.

New Drug and Biologics License Applications

In order to obtain approval
to market a pharmaceutical in the United States, a marketing application must be submitted to the FDA that provides data establishing
to the FDA’s satisfaction the safety and effectiveness of the investigational drug for the proposed indication. Each NDA or BLA
submission requires a substantial user fee payment unless a waiver or exemption applies (such as with the Orphan Drug Designation discussed
below). For fiscal year 2026, the FDA set the application fee at $4,682,003 for new drug applications that require clinical data. The
manufacturer and/or sponsor of certain drugs approved under an NDA or BLA is also subject to annual prescription drug program fees, currently
set at $442,213 per product for fiscal year 2026. These fees are typically increased annually. The NDA or BLA includes all relevant data
available from pertinent non-clinical studies and clinical trials, including negative or ambiguous results as well as positive findings,
together with detailed information relating to the product’s chemistry, manufacturing, controls and proposed labeling, among other
things. Data can come from company-sponsored clinical trials intended to test the safety and effectiveness of the use of a product, or
from a number of alternative sources, including studies initiated by investigators.

The FDA will initially review
the NDA or BLA for completeness before it accepts it for filing. The FDA has 60 days from its receipt of an NDA or BLA to determine whether
the application will be accepted for filing based on the agency’s threshold determination that the application is sufficiently complete
to permit substantive review. After the NDA or BLA submission is accepted for filing, the FDA reviews the NDA or BLA to determine, among
other things, whether the proposed product is safe and effective for its intended use, and whether the product is being manufactured in
accordance with current GMP, or cGMP, to assure and preserve the product’s identity, strength, quality and purity. The FDA may refer
applications for novel drug products or drug products that present difficult questions of safety or efficacy to an advisory committee,
typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application
should be approved and, if so, under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it typically
considers such recommendations carefully when making decisions.

Based on pivotal clinical
trial results submitted in an NDA or BLA, upon the request of an applicant, the FDA may grant a “Priority Review” designation
to a product, which sets the target date for FDA action on the application at six to eight months, rather than the standard ten to 12
months. The FDA can extend these reviews by three months. Priority Review is given where preliminary estimates indicate that a product,
if approved, has the potential to provide a significant improvement compared to marketed products or offers a therapy where no satisfactory
alternative therapy exists. Priority Review designation does not change the scientific/medical standard for approval or the quality of
evidence necessary to support approval.

After the FDA completes its
initial review of an NDA or BLA, it will communicate to the sponsor that the application for the drug will either be approved, or it will
issue a complete response letter to communicate that the NDA or BLA will not be approved in its current form and inform the sponsor of
changes that must be made or additional clinical, nonclinical or manufacturing data that must be received before the application can be
approved, with no implication regarding the ultimate approvability of the application.

- 14 -

Before approving an NDA or
BLA, the FDA will inspect the facilities at which the product is manufactured, even if such facilities are located overseas. The FDA will
not approve the product unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements
and are adequate to ensure consistent production of the product within required specifications.

Additionally, before approving
an NDA or BLA, the FDA may inspect one or more clinical sites and manufacturing sites to ensure compliance with GCP and GMP. If the FDA
determines that any of the application, manufacturing process or manufacturing facilities is not acceptable, it typically will outline
the deficiencies and often will request additional testing or information. This may significantly delay further review of the application.
If the FDA finds that a clinical site did not conduct the clinical trial in accordance with GCP, the FDA may determine that the data generated
by the clinical site should be excluded from the primary efficacy analyses provided in the NDA or BLA. Additionally, the FDA may identify
deficiencies in the manufacturing process and require changes prior to approval. Notwithstanding the submission of any requested additional
information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.

The testing and approval process
for a drug requires substantial time, effort and financial resources, and this process may take several years to complete. Data obtained
from clinical activities are not always conclusive and may be susceptible to varying interpretations, which could delay, limit or prevent
regulatory approval. The FDA may not grant approval on a timely basis, or at all. We may encounter difficulties or unanticipated costs
in our efforts to secure necessary governmental approvals, which could delay or preclude us from marketing our products.

The FDA may require, or companies
may in their own discretion pursue, additional clinical trials after a product is approved. These so-called Phase IV studies may be made
a condition that must be satisfied for continuing drug approval. The results of Phase IV studies can confirm the effectiveness of a product
candidate and can provide important safety information. In addition, the FDA has express statutory authority to require sponsors to conduct
post-market studies to specifically address safety issues identified by the agency. Any approvals that we may ultimately receive could
be withdrawn if required post-marketing trials or analyses do not meet the FDA requirements, which would materially harm the commercial
prospects for AL001 or ALZN002.

The FDA also has authority
to require a Risk Evaluation and Mitigation Strategy (“REMS”), from manufacturers to ensure that the benefits of a drug or
biological product outweigh its risks. A sponsor may also voluntarily propose a REMS as part of the NDA or BLA submission. The need for
a REMS is determined as part of the review of the NDA or BLA. Based on statutory standards, elements of a REMS may include “dear
doctor letters,” a medication guide, more elaborate targeted educational programs, and in some cases restrictions on distribution.
These elements are negotiated as part of the NDA or BLA approval, and in some cases if consensus is not obtained until after the Prescription
Drug User Fee Act review cycle, the approval date may be delayed. Once adopted, a REMS is subject to periodic assessment and modification.

Even if AL001 or ALZN002 receives
regulatory approval, the approval may be limited to specific disease states, patient populations and dosages, or might contain significant
limitations on use in the form of warnings, precautions or contraindications, or in the form of onerous risk management plans, restrictions
on distribution, or post-marketing study requirements. Further, even after regulatory approval is obtained, later discovery of previously
unknown problems with a product may result in restrictions on the product or even complete withdrawal of the product from the market.
Any delay in obtaining, or failure to obtain, regulatory approval for AL001 or ALZN002, or obtaining approval only for significantly limited
use, would harm our business. In addition, we cannot predict what adverse governmental regulations may arise from future U.S. or foreign
governmental action.

Breakthrough Therapy Designation

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). For purposes
of breakthrough therapy designation, a clinically significant endpoint generally refers to an endpoint that measures an effect on irreversible
morbidity or mortality (“IMM”), or on symptoms that represent serious consequences of the disease. A clinically significant
endpoint can also refer to findings that suggest an effect on IMM or serious symptoms, including:

• an effect on an established surrogate endpoint;

• an effect on a surrogate endpoint or intermediate clinical endpoint considered reasonably likely to predict
a clinical benefit (i.e., the accelerated approval standard);

• an effect on a pharmacodynamic biomarker (which is a measurable indicator of the disease state) that does
not meet criteria for an acceptable surrogate endpoint, but strongly suggests the potential for a clinically meaningful effect on the
underlying disease; and

• a significantly improved safety profile compared to available therapy (e.g., less dose-limiting toxicity
for an oncology agent), with evidence of similar efficacy.

- 15 -

A drug that receives a breakthrough
therapy designation is eligible for fast-track designation features, intensive guidance on an efficient drug development program and FDA
organizational commitment involving senior managers. However, we have not yet applied for breakthrough therapy designation nor have we
received any official designation for expedited development. Our product candidates may not qualify for breakthrough therapy designation;
further, even if one or both do qualify for breakthrough therapy designation, it may not actually lead to faster development or expedited
regulatory review and approval or necessarily increase the likelihood that it will receive FDA approval.

Based on our preclinical data,
AL001 has a positive effect on the pharmacodynamic biomarkers of Alzheimer’s. We intend to validate this clinically and, if confirmed,
we believe that AL001 is a candidate for breakthrough therapy designation because of its positive effect on a pharmacodynamic biomarker
(beta-amyloids) and potential for a clinically meaningful effect on Alzheimer’s. We also believe that ALZN002 is positioned for
a breakthrough therapy designation because of its positive effect on a pharmacodynamic biomarker (beta-amyloids) and potential for a clinically
meaningful effect on Alzheimer’s.

Section 505(b)(2) New Drug Applications

Companies may also consider
seeking FDA approval through the Section 505(b)(2) NDA process if their product candidates are similar to previously approved drugs but
differ in dosage form, strength, route of administration, formulation or indication. Section 505(b)(2) of the Food, Drug, and Cosmetic
Act was enacted as part of the Drug Price Competition and Patent Term Restoration Act of 1984 and is also known as the Hatch-Waxman Amendments.
The purpose of Section 505(b)(2) is to allow companies to avoid duplicative testing by allowing applicants to utilize data from previous
clinical and non-clinical studies in the current NDA submission, when pertinent. The 505(b)(2) application process requires, among other
things, the submission of data from studies demonstrating the product’s safety and efficacy for the new indication.

We believe that AL001 is positioned
for an expedited Section 505(b)(2) regulatory pathway for a new drug. AL001’s active pharmaceutical ingredients (lithium, proline
and salicylate) are well documented and approved by the FDA. The provisions of 505(b)(2) were created, in part, to help avoid unnecessary
duplication of studies already performed on a previously approved (“reference” or “listed”) drug. This section
gives the FDA express permission to rely on data not developed by the NDA applicant. This process can result in a much less expensive
and much faster route to approval, compared with a traditional development path such as 505(b)(1), while creating new, differentiated
products with tremendous commercial value.

The Hatch-Waxman Amendments
permit companies to rely upon not only certain published nonclinical or clinical studies conducted for an approved product, but also the
FDA’s conclusions from a prior review of the studies. Additionally, the FDA may require companies to perform further studies to
support changes from the approved product. After completion of the review, the FDA may approve the new product for all or some of the
labeled indications for which the reference product has been approved, as well as for any new indication supported by the NDA. While references
to nonclinical and clinical data not created by the applicant or for which the applicant does not have a right of reference are allowed,
the applicant must still submit data related to the manufacturing and quality of the product candidate, such as information about the
development, process, stability, qualification and validation.

If a company chooses to rely
on the FDA’s conclusions regarding studies conducted for an already approved product, the company is required to provide a certification
statement for any patents listed for the approved product in the FDA’s Orange Book publication. Specifically, the applicant must
certify that: (i) the required patent information has not been filed; (ii) the listed patent has expired; (iii) the listed patent has
not expired but will expire on a particular date and approval is sought after patent expiration; or (iv) the listed patent is invalid
or will not be infringed by the new product. The FDA will also not approve a Section 505(b)(2) until any non-patent exclusivity period
for the reference product has expired, such as the exclusivity granted for obtaining approval of a new chemical entity.

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

Sponsors of clinical trials
of certain FDA-regulated products, including prescription drugs, are required to register and disclose certain clinical trial information
on a public website maintained by the NIH. Information related to the product, patient population, phase of investigation, study sites
and investigator, and other aspects of the clinical trial is made public as part of the registration. Sponsors are also obligated to disclose
the results of these trials after completion. Disclosure of the results of these trials can be delayed until the product or new indication
being studied has been approved. Competitors may use this publicly available information to gain knowledge regarding the design and progress
of our development programs.

The Drug Price Competition and Patent Term
Restoration Act

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
products.

- 16 -

Patent Term Extension.
After receipt of an NDA or BLA approval, owners of relevant drug patents may apply for a patent extension of up to five years. The permissible
patent term extension is calculated as half of the drug’s testing phase, that is, the time between IND submission and NDA or BLA
submission, and all of the review phase, or the time between either NDA or BLA submission and approval up to a maximum of five years.
The time can be shortened if FDA determines that the applicant did not pursue approval with due diligence. The total patent term after
the extension may not exceed 14 years.

For patents that might expire
during the application phase, the patent owner may request an interim patent extension. An interim patent extension increases the patent
term by one year and may be renewed up to four times. For each interim patent extension granted, the post-approval patent extension is
reduced by one year. The director of the U.S. Patent and Trademark Office, or USPTO, must determine that approval of the drug covered
by the patent for which a patent extension is being sought is likely. Interim patent extensions are not available for a drug for which
an NDA or BLA has not been submitted.

Environmental Regulations.
The U.S. 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

Following the approval of
an NDA or BLA, the FDA continues to require adverse event reporting and submission of periodic reports. The FDA also may require post-marketing
testing, known as Phase IV testing, REMS, and surveillance to monitor the effects of an approved product, or the FDA may place conditions
on an approval that could restrict the distribution or use of the product. In addition, quality control, drug manufacture, packaging,
and labeling procedures must continue to conform to cGMP after approval. Drug manufacturers and certain of their subcontractors are required
to register their establishments with FDA and certain state agencies. Registration with the FDA subjects entities to periodic unannounced
inspections by the FDA, during which the agency inspects manufacturing facilities to assess compliance with cGMP. Accordingly, manufacturers
must continue to expend time, money and effort in the areas of production and quality control to maintain compliance with cGMP. Regulatory
authorities may withdraw product approvals or request product recalls if a manufacturer fails to comply with regulatory standards, if
it encounters problems following initial marketing or if previously unrecognized problems are subsequently discovered.

Patient Protection and Affordable Care Act

In March 2010, the Patient
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 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. The ACA
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
Union

In addition to domestic regulations,
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.

Whether or not we obtain FDA
approval for a product, we must obtain the requisite approvals from regulatory authorities in non-U.S. countries prior to the commencement
of clinical trials or marketing of the product in those countries. Certain countries outside of the U.S. have a process that requires
the submission of a clinical trial application prior to the commencement of human clinical trials. In Europe, for example, a Clinical
Trial Application (“CTA”) must be submitted to the competent national health authority and to independent ethics committees
in each country in which a company intends to conduct clinical trials. Once the CTA is approved in accordance with a country’s requirements,
clinical trial development may proceed in that country.

The requirements and process
governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country, even though there
is already some degree of legal harmonization in the EU Member States resulting from the national implementation of underlying EU legislation.
In all cases, the clinical trials are conducted in accordance with GCP and other applicable regulatory requirements.

To obtain regulatory approval
of an investigational drug under European Union regulatory systems, we will be required to submit a marketing authorization application.
This application is similar to the BLA in the United States, with the exception of, among other things, country-specific document requirements.
Drugs can be authorized in the European Union by using (i) the centralized authorization procedure, (ii) the mutual recognition procedure,
(iii) the decentralized procedure or (iv) the national authorization procedure.

- 17 -

The European Medicines Agency
(“EMA”) implemented the centralized procedure for the approval of human drugs to facilitate marketing authorizations that
are valid throughout the EU. This procedure results in a single marketing authorization granted by the European Commission that is valid
across the EU, as well as in Iceland, Liechtenstein and Norway, at times referred to as the European Economic Area. The centralized procedure
is compulsory for human drugs that: (i) are derived from biotechnology processes, such as genetic engineering; (ii) contain a new active
substance indicated for the treatment of certain diseases, such as HIV/AIDS, cancer, diabetes, neurodegenerative diseases, autoimmune
and other immune dysfunctions and viral diseases; (iii) are officially designated orphan drugs; and (iv) constitute advanced-therapy medicines,
such as gene-therapy, somatic cell-therapy or tissue-engineered medicines. The centralized procedure may at the request of the applicant
also be used for human drugs that do not fall within the above mentioned categories if the human drug (a) contains a new active substance
which, on the date of entry into force of Regulation (EC) No. 726/2004, was not authorized in the European Economic Area; or (b) the applicant
shows that the medicinal product constitutes a significant therapeutic, scientific or technical innovation or that the granting of authorization
in the centralized procedure is in the interests of patients at European Economic Area level.

Under the centralized procedure
in the European Union, the maximum timeframe for the evaluation of a Marketing Authorization Application by the EMA is 210 days, though
the date count stops whenever the Committee for Medicinal Products for Human Use (“CHMP”) asks the applicant for additional
written or oral information, with adoption of the actual marketing authorization by the European Commission thereafter. Accelerated evaluation
might be granted by the CHMP in exceptional cases, as when a medicinal product is expected to be of a major public health interest from
the point of view of therapeutic innovation, defined by three cumulative criteria: (i) the seriousness of the disease to be treated; (ii)
the absence of an appropriate alternative therapeutic approach; and (iii) anticipation of exceptional high therapeutic benefit. In this
circumstance, EMA ensures that the evaluation for the opinion of the CHMP is completed within 150 days and the opinion issued thereafter.

The Mutual Recognition Procedure
(“MRP”) for the approval of human drugs is an alternative approach to facilitate individual national marketing authorizations
within the European Union. Essentially, the MRP may be applied for all human drugs for which the centralized procedure is not obligatory.
The MRP is applicable to the majority of conventional medicinal products and is based on the principle of recognition of an already existing
national marketing authorization by one or more 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
of mutual recognition by EU Member States of their respective national marketing authorizations. Based on a marketing authorization in
the reference EU Member State, the applicant may apply for marketing authorizations in other EU Member States. In such case, the reference
EU Member State will update its existing assessment report about the drug in 90 days. After the assessment is completed, copies of the
report are sent to all EU Member States, together with the approved summary of product characteristics, labeling and package leaflet.
The concerned EU Member States then have 90 days to recognize the decision of the referenced EU Member State and the summary of product
characteristics, labeling and package leaflet. National marketing authorizations will be granted within 30 days after acknowledgement
of the agreement.

If any EU Member State refuses
to recognize the marketing authorization by the reference EU Member State on the grounds of potential serious risk to public health, the
issue will be referred to a coordination group. Within 60 days, EU Member States will, within the coordination group, make all efforts
to reach a consensus. If this fails, the procedure is submitted to an EMA scientific committee for arbitration. The opinion of this EMA
Committee is then forwarded to the Commission, for the start of the decision-making process. As in the centralized procedure, this process
entails consulting various European Commission Directorates General and the Standing Committee on Human Medicinal Products.

Human Health Product Regulation in the Rest
of World

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

Labeling, Marketing
and Promotion. Once an NDA or BLA is approved, or just before approval, a product will be subject to certain marketing and promotional
requirements. For instance, the FDA closely regulates the post-approval marketing and promotion of pharmaceuticals, including standards
and regulations for direct-to-consumer advertising, off-label promotion, industry-sponsored scientific and educational activities and
promotional activities on the internet and elsewhere.

- 18 -

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
NDAs.

In addition, any claims we
make for our products in advertising or promotion must be appropriately balanced with important safety information and otherwise be adequately
substantiated. Failure to comply with these requirements can result in adverse publicity, warning letters, corrective advertising, injunctions
and potential civil and criminal penalties. Government regulators recently have increased their scrutiny of the promotion and marketing
of pharmaceuticals.

Anti-Kickback and False
Claims Laws. 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
statutes, and other state and federal laws and regulations. The Anti-Kickback Statute makes it illegal for any person, including a prescription
drug manufacturer (or a party acting on its behalf) to knowingly and willfully solicit, receive, offer, or pay any remuneration that is
intended to induce the referral of business, including the purchase, order, or prescription of a particular pharmaceutical, for which
payment may be made under a federal healthcare program, such as Medicare or Medicaid.

The federal False Claims Act
prohibits anyone from knowingly presenting, or causing to be presented, for payment to federal programs (including Medicare and Medicaid)
claims for items or services, including pharmaceuticals, that are false or fraudulent, claims for items or services not provided as claimed,
or claims for medically unnecessary items or services.

Many states have similar anti-kickback
or false claims statutes that can be even broader than their federal counterparts. There is also an increasing number of state laws that
require manufacturers to make reports to states on pricing and marketing information. Many of these laws contain ambiguities as to what
is required to comply with the laws. In addition, a federal law known as the Physician Payments Sunshine Act requires pharmaceutical manufacturers
to track and report to the federal government certain payments and other transfers of value made to physicians and teaching hospitals
and to disclose any physician ownership in the previous calendar year. The data is published annually in a publicly searchable database.
These laws may affect our sales, marketing, and other promotional activities by imposing administrative and compliance burdens on us.
In addition, given the lack of clarity with respect to these laws and their implementation, our reporting actions could be subject to
the penalty provisions of the pertinent state, and soon federal, authorities.

Other Healthcare Laws
and Compliance Requirements. In the United States, our activities are potentially subject to regulation by various federal, state
and local authorities in addition to the FDA, including the Centers for Medicare and Medicaid Services (formerly the Health Care Financing
Administration), other divisions of the U.S. Department of Health and Human Services (e.g., its Office of Inspector General), the U.S.
Department of Justice and individual U.S. Attorney offices within the Department of Justice, and state and local governments. For example,
sales, marketing and scientific/educational grant programs must comply with the anti-fraud and abuse provisions of the Social Security
Act, the False Claims Act, the privacy provisions of the Health Insurance Portability and Accountability Act, and similar state laws,
each as amended. Pricing and rebate programs must comply with the Medicaid rebate requirements of the Omnibus Budget Reconciliation Act
of 1990 and the Veterans Health Care Act of 1992, or VHCA, each as amended, among others. If products are made available to authorized
users of the Federal Supply Schedule of the General Services Administration, additional laws and requirements will apply. Under the VHCA,
drug companies are required to offer certain drugs at a reduced price to a number of federal agencies including U.S. Department of Veteran
Affairs and U.S. Department of Defense, the Public Health Service and certain private Public Health Service designated entities in order
to participate in other federal funding programs including Medicare and Medicaid. Legislative changes also require that discounted prices
be offered for certain U.S. Department of Defense purchases for its TRICARE program via a rebate system. Participation under the VHCA
requires submission of pricing data and calculation of discounts and rebates pursuant to complex statutory formulas, as well as the entry
into government procurement contracts governed by the Federal Acquisition Regulations.

In order to distribute products
commercially, we must comply with state laws that require the registration of manufacturers and wholesale distributors of pharmaceutical
products in a state, including, in certain states, manufacturers and distributors that ship products into the state even if such manufacturers
or distributors have no place of business within the state. Some states also impose requirements on manufacturers and distributors to
establish the pedigree of product in the chain of distribution, including some states that require manufacturers and others to adopt new
technology capable of tracking and tracing product as they move through the distribution chain. Several states have enacted legislation
requiring pharmaceutical companies to establish marketing compliance programs, file periodic reports with the state, make periodic public
disclosures on sales, marketing, pricing, clinical trials and other activities or register their sales representatives. Other legislation
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.

- 19 -

Our Intellectual Property

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
periods according to the date of patent filing or grant and the legal term of patents in the various countries where patent protection
is obtained. The actual protection afforded by a patent, which can vary from country to country, depending on the type of patent, the
scope of its coverage and the availability of legal remedies in the country.

A summary of the licensed
patents is as follows:

While trade secret protection
is an essential element of our business and we take security measures to protect our proprietary information and trade secrets, there
can be no assurance that our unpatented proprietary technology will afford us significant commercial protection. We seek to protect our
trade secrets by entering into confidentiality agreements with third parties, employees and consultants. However, it is possible that
these agreements may be breached or invalidated, and if so, there may not be an adequate corrective remedy available. Accordingly, we
cannot ensure that our employees, consultants or any third parties will not breach the confidentiality provisions in our contracts, infringe
or misappropriate our trade secrets and other proprietary rights or that measures we take to protect our proprietary rights will be adequate.

In the future, third parties
may file claims asserting that our technologies or products infringe on their intellectual property. We cannot predict whether third parties
will assert such claims against us or against the licensors of technology licensed to us, or whether those claims will harm our business.
If we are forced to defend ourselves against such claims, whether they are with or without merit and whether they are resolved in favor
of, or against, our licensors or ourselves, we may face costly litigation and the diversion of our management’s attention and resources.
As a result of such disputes, we may have to develop costly non-infringing technology or enter into licensing agreements. These agreements,
if necessary, may be unavailable on terms acceptable to us, or at all.

We currently have four trademarks
registered with the USPTO that include our corporate name, Alzamend Neuro, two for our corporate slogan and one for our trade name.

Competition

Our industry is highly competitive
and subject to rapid and significant technological change. While we have some, albeit limited, development experience and scientific knowledge,
we will face competition from both large and small pharmaceutical and biotechnology companies, including specialty pharmaceutical companies
and generic drug companies, as well as academic institutions, government agencies and research institutions, among others.

Our competition will be determined
in part by the potential indications for which our products are developed and ultimately approved by regulatory authorities. It is likely
that the timing of market introductions of some of our potential products or our competitors’ products will be an important competitive
factor. Accordingly, the speed with which we can develop our products, conduct preclinical studies and clinical trials to obtain approval
and manufacture or obtain supplies of commercial quantities of any approved products should also be important competitive factors. We
expect that competition among products approved for sale will be based on additional factors such as product efficacy, safety, reliability,
availability, price and patent position.

- 20 -

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.

- 21 -