What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2024-12-11 compared with 2024-09-11 · 274 added, 96 removed, 466 unchanged (44% of the section changed)

27 unchanged sentences

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

We were incorporated on February

26, 2016, as Alzamend Neuro, Inc.

were incorporated on February 26, 2016, as Alzamend Neuro, Inc.

under the laws of the State of Delaware.

We were formed to acquire and commercialize patented intellectual

property and know-how to prevent, treat and potentially cure the crippling and deadly Alzheimer’s disease (“Alzheimer’s”).

With our two product candidates, we aim to bring treatment or cures not only for Alzheimer’s, but also bipolar disorder (“BD”),

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

Existing Alzheimer’s treatments

only temporarily relieve symptoms but do not, to our knowledge, slow or halt the underlying progression of the disease.

We have developed

a novel approach to combat Alzheimer’s through immunotherapy.

We were formed to acquire and

commercialize patented intellectual property and know-how to prevent, treat and potentially cure the crippling and deadly Alzheimer’s

disease (“Alzheimer’s”).

With our two product candidates, we aim to bring treatment or cures not only for Alzheimer’s,

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

Existing Alzheimer’s treatments only temporarily relieve symptoms but do not, to our knowledge, slow or halt the underlying progression

of the disease.

We have developed a novel approach to combat Alzheimer’s through immunotherapy.

Critical Accounting Policies and Estimates

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fees and lab supplies, as well as fees paid to other entities that conduct certain research and development activities on behalf of our

We have acquired and may continue to acquire the rights to develop

and commercialize new product candidates from third parties.

The upfront payments to acquire license, product or rights, as well as any

future milestone payments, are immediately recognized as research and development expense, provided that there is no alternative future

use of the rights in other research and development projects.

We have acquired and may continue

to acquire the rights to develop and commercialize new product candidates from third parties.

The upfront payments to acquire license,

product or rights, as well as any future milestone payments, are immediately recognized as research and development expense, provided

that there is no alternative future use of the rights in other research and development projects.

Stock-Based Compensation.

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We completed the Phase IIA clinical trial in March

2023 and announced positive topline data in June 2023.

2023 and announced positive topline data in June 2023, followed by the full data set in October 2024.

announced that we successfully identified a maximum tolerated dose (“MTD”) for development of AL001 from a multiple-ascending

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

on the results from our Phase IIA MAD study, we plan to initiate two safety and efficacy clinical trials in subjects with mild to moderate

dementia of the Alzheimer’s type.

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

and PTSD, and submitted investigational new drug (“IND”) applications to the FDA for these indications.

The IND for BD was

submitted in August 2023 and we received a “study may proceed” letter from the FDA in September 2023.

The IND for MDD was

submitted in October 2023 and we received a “study may proceed” letter from the FDA in November 2023.

The IND for PTSD was

submitted in November 2023 and we received a “study may proceed” from the FDA in December 2023.

intend to initiate clinical trials in 2025 at this MTD to determine relative increased lithium levels in the brain compared to a marketed

lithium salt for Alzheimer’s, BD, MDD and PTSD, based on published mouse studies that predict that lithium can be given at lower

doses for equivalent therapeutic benefit when treating with AL001.

For example, the goal is to replace a 300 mg TID lithium carbonate

dose for treatment of BD with a 240 mg TID AL001 lithium equivalent, which represents a daily decrease of 20% of lithium given to a patient.

In August 2024, we announced that we had partnered with Massachusetts General Hospital to serve as the CRO for these clinical trials.

Existing lithium drugs suffer

from chronic toxicity, poor physicochemical properties, and poor brain bioavailability.

Alzamend’s novel AL001 formulation, a lithium-salicylate/L-proline

engineered ionic cocrystal, is designed to overcome the toxicities associated with conventional lithium salts, promising a next-generation

lithium treatment with an enhanced safety profile and advantageous distribution to brain and brain structures.

on the results from our Phase IIA MAD study, we plan to initiate five clinical trials to determine relative increased lithium levels in

the brain compared to a marketed lithium salt for healthy subject and patients diagnosed with mild to moderate Alzheimer’s, BD,

MDD and PTSD, based on published mouse studies that predict that lithium can be given at lower doses for equivalent therapeutic benefit

when treating with AL001.

For example, the goal is to replace the amount of lithium needed for maintenance treatment of BD with a clinically

relevant, lower AL001 lithium carbonate equivalent lithium dose.

Such lithium dose mitigation could redefine the landscape of neuropsychiatric,

neurodegenerative, and neurological treatment practices.

In August 2024, we announced that we had partnered with Massachusetts General

Hospital to serve as the CRO for these clinical trials.

November 19, 2024, we announced final full data set from a nonclinical study comparing brain and plasma lithium exposures between AL001

and lithium carbonate in Alzheimer’s transgenic mice.

The study was conducted at the University of South Florida and the bioanalytical

procedures for determination of lithium concentration in the brain and plasma samples were conducted under good laboratory practice standards

by Sannova Analytical LLC.

The study involved administering AL001, a good manufacturing practices-quality active pharmaceutical ingredient

(“API”) to 5XFAD mice, a recognized model for Alzheimer’s research, to compare its effects against lithium carbonate,

an FDA approved and marketed API.

Mice received either high or low doses scaled to humans of both AL001 and lithium carbonate over a 14-day

period to observe pharmacokinetic steady-state drug conditions.

On the 15th day, the mice were analyzed to assess how the treatments affected

lithium concentrations in different brain regions and in their plasma.

Based on the study, both treatments

had no negative impact on the mice's body weight or clinical signs during the treatment period.

AL001 showed lower plasma lithium levels

than lithium carbonate, reducing the risk of adverse systemic effects, suggesting an expansion for safety of lithium’s therapeutic

Further, AL001 showed consistently higher lithium concentrations in brain tissues, particularly at lower doses, compared to lithium

Finally, the study found that different brain regions absorb and retain lithium differently.

This means treatments can potentially

be tailored to target specific brain areas, allowing for more precise treatment of various brain-related conditions when applied in human

results highlight the potential clinical advantages of AL001 for conditions like Alzheimer’s, BD, MDD and PTSD at low doses.

reducing the systemic burden, AL001 could lessen the risk of side effects such as thyroid and kidney complications often associated with

extant lithium therapies.

This positions AL001 as a promising candidate for safer long-term treatment options, without the need for TDM.

This innovation is specifically designed to address the needs of fragile populations, such as elderly and Alzheimer’s patients,

by offering a potentially more efficient and safer alternative to existing treatments.

The dosing level identified

as optimal in this robust nonclinical study will serve as the foundation for advancing the evaluation of AL001 in the comprehensive ‘Lithium

in Brain’ Phase II clinical trials.

These trials, conducted in collaboration with Massachusetts General Hospital, will encompass

a diverse cohort of both healthy subjects and patients diagnosed with mild to moderate Alzheimer’s disease, BD, MDD and PTSD.

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

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Results of Operations

Results of Operations for the Three Months Ended July 31,

Results of Operations for the Three Months Ended October 31,

2024 and 2023

The following table summarizes

the results of our operations for the three months ended July 31, 2024 and 2023:

For the Three Months Ended July 31,

the results of our operations for the three months ended October 31, 2024 and 2023:

For the Three Months Ended October 31,

OPERATING EXPENSES

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Total other expense, net

Dividends on preferred shares

NET LOSS AVAILABLE TO COMMON SHARES

$ (1,415,214 )

$ (2,906,033 )

Basic and diluted net loss per common share

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We did not generate any revenues

during the three months ended July 31, 2024 and 2023, and we do not anticipate that we will generate revenue for the foreseeable future.

during the three months ended October 31, 2024 and 2023, and we do not anticipate that we will generate revenue for the foreseeable future.

Research and Development Expenses

Research and development expenses

for the three months ended July 31, 2024 and 2023 were $207,000 and $2.4 million, respectively.

for the three months ended October 31, 2024 and 2023 were $311,000 and $2.1 million, respectively.

As reflected in the table below, research

and development expenses primarily consisted of professional fees and clinical trial fees:

For the Three Months Ended July 31,

For the Three Months Ended October 31,

Professional fees

Clinical trial fees

Stock-based compensation expense

Other research and development expenses

1 unchanged sentence

$ (1,685,695 )

* Not meaningful

Professional Fees

During the three months ended

July 31, 2024 and 2023, we incurred professional fees of $184,000 and $1.1 million, respectively, which were primarily comprised of professional

fees attributed to various types of scientific services, including FDA consulting services.

The decrease relates to lower professional

fees incurred related to minimal clinical trial activities.

October 31, 2024 and 2023, we incurred professional fees of $181,000 and $1.0 million, respectively, which were primarily comprised of

professional fees attributed to various types of scientific services, including FDA consulting services.

The decrease relates to lower

professional fees incurred related to minimal clinical trial activities.

Clinical Trial Fees

During the three months ended

July 31, 2024 and 2023, we incurred clinical trial fees of nil and $1.2 million, respectively.

We had no clinical trial activity for the

three months ended July 31, 2024.

Clinical trial fees for the three months ended July 31, 2023 were for our Phase IIA clinical trial for

AL001 and our Phase I/IIA clinical trial for ALZN002.

October 31, 2024 and 2023, we incurred clinical trial fees of $124,000 and $795,000, respectively.

Clinical trial fees for the three months

ended October 31, 2024 were for our initial set-up for our Phase IIA brain imaging study with Massachusetts General.

Clinical trial fees

for the three months ended October 31, 2023 were for our Phase IIA clinical trial for AL001 and our Phase I/IIA clinical trial for ALZN002.

Stock-Based Compensation Expense

During the three months ended

October 31, 2024 and 2023, we incurred research and development stock-based compensation expense of nil and $143,000, respectively, related

to stock option grants and restricted stock grants to executives, employees and consultants.

The decrease in stock-based compensation

expense for the three months ended October 31, 2024 was a result of fewer stock options vesting during the period compared to the prior

Other Research and Development Expenses

During the three months ended

July 31, 2024 and 2023, we incurred other fees of $22,000 and $51,000, respectively, which were primarily comprised of scientific materials

October 31, 2024 and 2023, we incurred other fees of $6,000 and $14,000, respectively, which were primarily comprised of scientific materials

required for our clinical trials.

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General and administrative

expenses for the three months ended July 31, 2024 and 2023 were $756,000 and $1.2 million, respectively.

As reflected in the table below,

general and administrative expenses primarily consisted of the following expense categories:

expenses for the three months ended October 31, 2024 and 2023 were $1.0 million and $0.9 million, respectively.

As reflected in the table

below, general and administrative expenses primarily consisted of the following expense categories:

salaries and benefits;

professional fees;

stock-based compensation expense;

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as well as board of director fees.

For the three months ended July 31, 2024

and 2023, the remaining general and administrative expenses of $62,000 and $83,000, respectively, primarily consisted of payments for

filing fees, transfer agent fees, travel and entertainment and other office expenses, none of which was significant individually.

For the Three Months Ended July 31,

Salaries and benefits

For the three months ended October

31, 2024 and 2023, the remaining general and administrative expenses of $83,000 and $93,000, respectively, primarily consisted of payments

for filing fees, transfer agent fees, travel and entertainment and other office expenses, none of which was significant individually.

For the Three Months Ended October 31,

Salary and benefits

Professional fees

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Total general and administrative expenses

* Not meaningful

Salaries and Benefits

During the three months ended

July 31, 2024 and 2023, we incurred $228,000 and $153,000, respectively, in employee-related expenses.

The decrease in salaries and benefits

was due to a reversal of bonus accrual.

As of July 31, 2024, we had four full-time and three part-time employees.

October 31, 2024 and 2023, we incurred $326,000 and $226,000, respectively, in employee-related expenses.

The increase in salaries and

benefits was due to a bonus paid to our chief executive officer.

As of October 31, 2024, we had four full-time and three part-time employees.

Professional Fees

During the three months ended

July 31, 2024 and 2023, we incurred professional fees of $222,000 and $151,000, respectively.

During the three months ended July 31, 2024,

we incurred $85,000 in investor relations fees, $74,000 in legal fees, $56,000 in audit fees, and $7,000 in tax preparation fees.

the three months ended July 31, 2023, we incurred $78,000 in audit fees, $29,000 in investor relations fees, $16,000 in tax preparation

fees, $13,000 in related party consulting, $6,000 in Sarbanes-Oxley compliance fees and $9,000 in other professional fees.

in professional fees was due mainly to investor relations related to our reverse split and legal fees, partially offset by lower related

party consulting, audit fees and tax preparation fees.

October 31, 2024 and 2023, we incurred professional fees of $149,000 and $284,000, respectively.

During the three months ended October

31, 2024, we incurred $96,000 in audit fees, $35,000 in legal fees, $14,000 in tax preparation fees, and $2,000 in consulting fees.

the three months ended October 31, 2023, we incurred $92,000 in audit fees, $89,000 in investor relations fees, 67,000 in legal fees,

$13,000 in tax preparation fees, $12,000 in related party consulting, and $11,000 in Sarbanes-Oxley compliance fees.

The decrease in professional

fees was due mainly to lower investor relations and legal fees.

Insurance Expense

During the three months ended

July 31, 2024 and 2023, we incurred insurance expense of $78,000 and $118,000, respectively, which was primarily directors’ and

October 31, 2024 and 2023, we incurred insurance expense of $60,000 and $89,000, respectively, which was primarily directors’ and

officers’ insurance.

1 unchanged sentence

During the three months ended

July 31, 2024 and 2023, we incurred general and administrative stock-based compensation expense of $81,000 and $369,000, respectively,

October 31, 2024 and 2023, we incurred general and administrative stock-based compensation expense of $81,000 and $176,000, respectively,

related to stock option grants and restricted stock grants to executives, employees and consultants.

The decrease in stock-based compensation

expense for the three months ended July 31, 2024 was a result of fewer stock options vesting during the period compared to the prior year

expense for the three months ended October 31, 2024, was a result of fewer stock options vesting during the period compared to the prior

Marketing Fees

During the three months ended

July 31, 2024 and 2023, we incurred marketing fees of $40,000 and $247,000, respectively.

The decrease was due to the completion of the

marketing and branding agreement with Ault Alliance, Inc.

During the three months ended October 31, 2024

and 2023, we incurred marketing fees of $304,000 and nil, respectively.

The increase was due to a marketing program launched to promote

our company and our stock during the three months ended October 31, 2024.

Results of Operations for the Six Months Ended October 31,

2024 and 2023

The following table summarizes

the results of our operations for the six months ended October 31, 2024 and 2023:

For the Six Months Ended October 31,

OPERATING EXPENSES

Research and development

$ (3,845,261 )

General and administrative

Total operating expenses

Loss from operations

OTHER EXPENSE, NET

Interest expense

Total other expense, net

Dividends on preferred shares

NET LOSS AVAILABLE TO COMMON SHARES

$ (2,389,625 )

$ (6,433,799 )

Basic and diluted net loss per common share

Basic and diluted weighted average common shares outstanding

* Not meaningful

currently have only two product candidates, AL001 and ALZN002.

These products are in the clinical stage of development and will require

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

before either or both of them, and any respective successors, will provide us with any revenue.

We did not generate any revenues

during the six months ended October 31, 2024 and 2023, and we do not anticipate that we will generate revenue for the foreseeable future.

Research and Development Expenses

Research and development expenses

for the six months ended October 31, 2024 and 2023 were $518,000 and $4.4 million, respectively.

As reflected in the table below, research

and development expenses primarily consisted of professional fees and clinical trial fees:

For the Six Months Ended October 31,

Professional fees

$ (1,749,404 )

Clinical trials

Stock-based compensation expense

Other research and development expenses

Total research and development expenses

$ (3,845,261 )

* Not meaningful

Professional Fees

During the six months ended

October 31, 2024 and 2023, we incurred professional fees of $365,000 and $2.1 million, respectively, which were primarily comprised of

professional fees attributed to various types of scientific services, including FDA consulting services.

The decrease relates to lower

professional fees incurred related to minimal clinical trial activities.

Clinical Trial Fees

During the six months ended

October 31, 2024 and 2023, we incurred clinical trial fees of $124,000 and $2.0 million, respectively.

Clinical trial fees for the six

months ended October 31, 2024 were for our initial set-up for our Phase IIA brain imaging study with Massachusetts General.

Clinical trial

fees for the six months ended October 31, 2023 were for our Phase IIA clinical trial for AL001 and our Phase I/IIA clinical trial for

Stock-Based Compensation Expense

During the six months ended

October 31, 2024 and 2023, we incurred research and development stock-based compensation expense of nil and $143,000, respectively, related

to stock option grants and restricted stock grants to executives, employees and consultants.

The decrease in stock-based compensation

expense for the six months ended October 31, 2024 was a result of fewer stock options vesting during the period compared to the prior

Other Research and Development Expenses

During the six months ended

October 31, 2024 and 2023, we incurred other fees of $28,000 and $66,000, respectively, which were primarily comprised of scientific materials

required for our clinical trials.

General and Administrative Expenses

General and administrative

expenses for the six months ended October 31, 2024 and 2023 were $1.8 million and $2.1 million, respectively.

As reflected in the table

below, general and administrative expenses primarily consisted of the following expense categories:

salaries and benefits;

stock-based compensation expense;

marketing fees;

as well as board of director fees.

For the six months ended October

31, 2024 and 2023, the remaining general and administrative expenses of $145,000 and $177,000, respectively, primarily consisted of payments

for filing fees, transfer agent fees, travel and entertainment and other office expenses, none of which was significant individually.

For the Six Months Ended October 31,

Salaries and benefits

Professional fees

Stock-based compensation expense

Marketing fees

Board of director fees

Other general and administrative expenses

Total general and administrative expenses

Salaries and Benefits

During the six months ended

October 31, 2024 and 2023, we incurred $554,000 and $379,000, respectively, in employee-related expenses.

The increase in salaries and

benefits was due to a bonus paid to our chief executive officer.

As of October 31, 2024, we had four full-time and three part-time employees.

Professional Fees

During the six months ended

October 31, 2024 and 2023, we incurred professional fees of $371,000 and $435,000, respectively.

During the six months ended October 31,

2024, we incurred $151,000 in audit fees, $109,000 in legal fees, $86,000 in investor relations fees, $22,000 in tax preparation fees,

and $2,000 in consulting fees.

During the six months ended October 31, 2023, we incurred $170,000 in audit fees, $118,000 in investor

relations fees, $69,000 in legal fees, $29,000 in tax preparation fees, $24,000 in related party consulting, and $17,000 in Sarbanes-Oxley

compliance fees.

The decrease in professional fees was due mainly to lower audit, investor relations, related party consulting and Sarbanes-Oxley

compliance fees partially offset by higher legal fees.

Insurance Expense

During the six months ended

October 31, 2024 and 2023, we incurred insurance expense of $139,000 and $207,000, respectively, which was primarily directors’

and officers’ insurance.

Stock-Based Compensation Expense

During the six months ended

October 31, 2024 and 2023, we incurred general and administrative stock-based compensation expense of $163,000 and $545,000, respectively,

related to stock option grants and restricted stock grants to executives, employees and consultants.

The decrease in stock-based compensation

expense for the six months ended October 31, 2024, was a result of fewer stock options vesting during the period compared to the prior

Marketing Fees

During the six months ended

October 31, 2024 and 2023, we incurred marketing fees of $344,000 and $207,000, respectively.

The increase was due to a marketing program

launched to promote our company and our stock during the six months ended October 31, 2024.

Liquidity and Capital Resources

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as a going concern.

As of July 31, 2024, we had cash of $1.2 million, a working capital deficiency of $1.5 million, an accumulated deficit

of $55.0 million and stockholders’ deficit of $1.2 million.

We have incurred recurring losses and reported losses for the three

ended July 31, 2024 totaling $974,000.

In the past, we have financed our operations principally through sales of equity securities and

debt instruments.

As of October 31, 2024, we had cash of $4.1 million, working capital of $3.5 million, an accumulated deficit of $56.4

million and stockholders’ equity of $3.8 million.

For the three and six months ended October 31, 2024, we had net losses of $1.4

million and $2.4 million, respectively.

For the six months ended October 31, 2024, cash used in operating activities was $4.5 million.

Historically, we have financed our operations principally through issuances of equity and debt instruments.

We will need to obtain substantial

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The purchase price was paid

On September 11, 2024, we sold 100 shares of Series A Convertible Preferred Stock and warrant to purchase 80,000 shares of common

stock with an exercise price of $12.50, for a total purchase price of $1.0 million.

The purchase price was paid in cash.

to the Orchid SPA, Orchid has agreed to purchase the remaining 1,700 Preferred Shares based on our achievement of the milestones set forth

11 unchanged sentences

We also agreed to pay Orchid a fee of $100,000 upon the first closing, which occurred on May 10, 2024,

the Fourth Tranche and the third, eighth and thirteenth closings constituting parts of the Final Tranche.

$100,000 upon the third closing, which occurred on August 21, 2024, and the fourth, eighth and thirteenth closings constituting parts

of the Final Tranche.

Registration Statement registering for resale the shares of common stock issuable upon conversion of the Series A Convertible Preferred

35 unchanged sentences

issuable upon exercise of the warrants.

At-the-Market Offering

On October 3, 2024, we entered

into an At-the-Market Issuance Sales Agreement with Ascendiant Capital Markets, LLC (the “ATM Offering”), as sales agent to

sell shares of our common stock, having an aggregate offering price of up to approximately $6.5 million from time to time, through the

ATM Offering.

On October 3, 2024, we filed a prospectus supplement with the SEC relating to the offer and sale of up to approximately

$6.5 million in shares of common stock in the ATM Offering.

The offer and sale of the

shares will be made pursuant to our effective “shelf” registration statement on Form S-3 and an accompanying base prospectus

contained therein (Registration Statement No.

333-273610) filed with the SEC on August 2, 2023 and declared effective by the SEC

on August 10, 2023.

During the six months ended

October 31, 2024, we sold an aggregate of 755,888 shares of common stock pursuant to the ATM Offering for gross and net proceeds of $1.2

From November 1, 2024 to December 10, 2024, we sold an aggregate of 201,543 shares of common stock pursuant to the ATM Offering

for gross and net proceeds of $280,000.

The following table summarizes

our cash flows for the three months ended July 31, 2024 and 2023:

For the Three Months Ended July 31,

our cash flows for the six months ended October 31, 2024 and 2023:

For the Six Months Ended October 31,

Net cash provided by (used in):

7 unchanged sentences

Operating Activities

During the three months ended

July 31, 2024, net cash used in operating activities was $1.1 million.

This consisted primarily of a net loss of $974,000 and a decrease

in our net operating assets and liabilities of $185,000, partially offset by non-cash charges of $103,000.

The non-cash charges primarily

consisted of stock-based compensation expense.

The decrease in our net operating assets and liabilities was due to a decrease in accounts

payable and accrued liabilities and an increase in prepaid expenses and other current assets.

During the six months ended

October 31, 2024, net cash used in operating activities was $4.5 million.

This consisted primarily of a net loss of $2.4 million and a

decrease in our net operating assets and liabilities of $2.3 million, partially offset by non-cash charges of $197,000.

The non-cash charges

primarily consisted of stock-based compensation expense.

The decrease in our net operating assets and liabilities was due to a decrease

in accounts payable and accrued liabilities and an increase in prepaid expenses and other current assets.

Investing Activities

During the three months ended

July 31, 2024, net cash used in investing activities was $90,000 from the purchase of equipment.

During the six months ended

October 31, 2024, net cash used in investing activities was $90,000 from the purchase of equipment.

We purchased equipment, which measures

1 unchanged sentence

Financing Activities

During the three months ended

July 31, 2024, net cash provided by financing activities was $2.0 million from the sale of Series A Convertible Preferred Stock.

During the six months ended

October 31, 2024, net cash provided by financing activities was $8.3 million.

This consisted of $7.1 million from the sale of Series A

Convertible Preferred Stock and $1.2 million from the sale of common stock from our ATM Offering.

Contractual Obligations

95 unchanged sentences

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

What changed 10-Q

Item 2. Management’s Discussion and Analysis