What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2023-12-15 compared with 2023-09-13 · 438 added, 327 removed, 191 unchanged (80% of the section changed)

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NOTE ABOUT FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking

statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934, as

amended (the “Exchange Act”).

This section should be read in conjunction with our unaudited condensed financial statements

and related notes included in Part I, Item 1 of this report.

The statements contained in this report that are not purely historical are

forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange

These statements relate to future events or our

future financial performance.

This Quarterly Report on Form 10-Q contains

forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”),

and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

This section should be read in conjunction

with our unaudited condensed financial statements and related notes included in Part I, Item 1 of this report.

The statements contained

in this report that are not purely historical are forward-looking statements within the meaning of Section 27A of the Securities Act and

Section 21E of the Exchange Act.

These statements relate to future events

or our future financial performance.

We have attempted to identify forward-looking statements by terminology including “anticipates,”

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of activity, performance or achievements.

In this Quarterly Report,

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

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

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

In this Quarterly Report, unless the context

requires otherwise, references to the “Company,” “Alzamend,” “we,” “our company” and “us”

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

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.

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

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.

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”).

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as well as fees paid to other entities that conduct certain research and development activities on behalf of our company.

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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· Fair Value of Common Stock.

the subsection titled “Common Stock Valuations” below.

See the subsection titled “Common Stock Valuations”

· Risk-Free Interest Rate.

risk-free interest rate is based on the U.S.

Treasury zero coupon issues in effect at the time of grant for periods corresponding with

the expected term of the option.

The risk-free interest rate is based on the U.S.

zero coupon issues in effect at the time of grant for periods corresponding with the expected term of the option.

· Expected Volatility.

we do not have a sufficient trading history for our common stock (“Common Stock”), the expected volatility was estimated based

on the average volatility for comparable publicly traded life sciences companies over a period equal to the expected term of the stock

option grants.

The comparable companies were chosen based on the similar size, stage in life cycle or area of specialty.

We will continue

to apply this process until a sufficient amount of historical information regarding the volatility of our own stock price becomes available.

Because we do not have a sufficient trading history for our common

stock (“Common Stock”), the expected volatility was estimated based on the average volatility for comparable publicly traded

life sciences companies over a period equal to the expected term of the stock option grants.

The comparable companies were chosen based

on the similar size, stage in life cycle or area of specialty.

We will continue to apply this process until a sufficient amount of historical

information regarding the volatility of our own stock price becomes available.

· Expected Term.

term represents the period that the stock-based awards are expected to be outstanding and is determined using the simplified method (based

on the mid-point between the vesting date and the end of the contractual term), as we do not have sufficient historical data to use any

other method to estimate expected term.

The expected term represents the period that the stock-based awards

are expected to be outstanding and is determined using the simplified method (based on the mid-point between the vesting date and the

end of the contractual term), as we do not have sufficient historical data to use any other method to estimate expected term.

· Expected Dividend Yield.

have never paid dividends on our Common Stock and have no plans to pay dividends on our Common Stock.

Therefore, we used an expected dividend

yield of zero.

We have never paid dividends on our Common Stock and have

no plans to pay dividends on our Common Stock.

Therefore, we used an expected dividend yield of zero.

Certain of such assumptions involve inherent

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These factors included, but were not limited to:

· our results of operations and financial position,

including our levels of available capital resources;

· our stage of development and material risks related

to our business;

· our results of operations and financial position, including our levels of available capital resources;

· our stage of development and material risks related to our business;

· progress of our research and development activities;

· our business conditions and projections;

· the valuation of publicly traded companies in

the life sciences and biotechnology sectors, as well as recently completed mergers and acquisitions of peer companies;

· the lack of marketability of our Common Stock

as a private company;

· the prices at which we sold shares of our Common

Stock to outside investors in arms-length transactions;

· the likelihood of achieving a liquidity event

for our security holders, such as an IPO or a sale of our company, given prevailing market conditions;

· the valuation of publicly traded companies in the life sciences and biotechnology sectors, as well as

recently completed mergers and acquisitions of peer companies;

· the lack of marketability of our Common Stock as a private company;

· the prices at which we sold shares of our Common Stock to outside investors in arms-length transactions;

· the likelihood of achieving a liquidity event for our security holders, such as an IPO or a sale of our

company, given prevailing market conditions;

· trends and developments in our industry;

· external market conditions affecting the life

sciences and biotechnology industry sectors.

Following the closing of our IPO, our Board determined

the fair market value of our Common Stock based on the closing price of our Common Stock as reported on the date of grant.

· external market conditions affecting the life sciences and biotechnology industry sectors.

Following the closing of our IPO, our Board

determined the fair market value of our Common Stock based on the closing price of our Common Stock as reported on the date of grant.

Plan of Operations

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.

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;

· Advance clinical development of ALZN002 for Alzheimer’s

· Expand our pipeline of pharmaceuticals to include

additional indications for AL001 and delivery methods;

· Focus on translational and functional endpoints

to efficiently develop product candidates;

· Optimize the value of AL001 and ALZN002 in major

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”);

· 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 (lead product) licensed and in clinical development in humans is AL001, an ionic cocrystal of lithium for the treatment of Alzheimer’s,

· Advance clinical development of AL001 for Alzheimer’s, BD, MDD and PTSD treatment;

· Advance clinical development of ALZN002 for Alzheimer’s treatment;

· Expand our pipeline of pharmaceuticals to include additional indications for AL001 and delivery methods;

· Focus on translational and functional endpoints to efficiently develop product candidates;

· Optimize the value of AL001 and ALZN002 in major markets.

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”);

· 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 (lead

product) licensed and in clinical development in humans is AL001, an ionic cocrystal of lithium for the treatment of Alzheimer’s,

BD, MDD and PTSD.

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for safety data.

On May 5, 2022, we initiated a multiple-dose,

steady-state, double-blind, ascending dose safety, tolerability, pharmacokinetic clinical trial of AL001 in patients with mild to moderate

Alzheimer’s and healthy subjects.

We completed the Phase IIA clinical trial patient dosing in March 2023 and announced positive

topline data in June 2023.

We announced that we

successfully identified a maximum tolerated dose (“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 therapeutic drug monitoring (“TDM”).

Also, this MTD

is risk 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 BD in patients with a history of manic episodes.

Lithium is also prescribed off-label

for MDD, BD and treatment of PTSD, among other disorders.

On May 5, 2022,

we initiated a multiple-dose, steady-state, double-blind, ascending dose safety, tolerability, pharmacokinetic clinical trial of AL001

in patients with mild to moderate Alzheimer’s and healthy subjects.

We completed the Phase IIA clinical trial patient dosing in

March 2023 and announced positive topline data in June 2023.

We announced that we successfully identified

a maximum tolerated dose (“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 therapeutic drug monitoring (“TDM”).

Also, this MTD is risk 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 BD 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 U.S.

Food and Drug Administration

(“FDA”) and is still a first-line treatment option (considered the “gold standard”) but is underutilized perhaps

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 BD when using lithium salts.

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

Based 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 intend to investigate the potential of AL001 for patients suffering from BD, MDD and PTSD

by submitting Investigational New Drug (“IND”) applications to the FDA for these indications.

The IND for BD was filed in

August 2023 and the INDs for MDD and PTSD are expected to be filed by the end of 2023.

After FDA permission to proceed on the INDs, we

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

salt for 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.

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

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

of ALZN002 on September 30, 2021.

Drug Administration (“FDA”) and is still a first-line treatment option (considered the “gold standard”) but is

underutilized perhaps 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 BD when using

lithium salts.

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

Based 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

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 filed in August 2023 and we received a

“study may proceed” letter from the FDA in September 2023.

The IND for MDD was filed in October 2023 and we received a “study

may proceed” letter from the FDA in November 2023.

The IND for PTSD was filed in November 2023.

After FDA permission to proceed

on the INDs, we intend to initiate clinical trials at the MTD to determine relative increased lithium levels in the brain compared to

a marketed lithium salt for 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.

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.

a written response relating to the pre-IND from the FDA providing a path for Alzamend’s planned clinical development of ALZN002

on September 30, 2021.

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

application 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 that are 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 being to foster tolerance to treatment for safety purposes while stimulating the immune

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

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

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

This could provide a safer approach 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 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, which Alzamend expects to initiate within

three months of receiving data from the initial trial.

The continuation of our current plan of

operations with respect to conducting the series of human clinical trials for each of our therapeutics requires us to raise additional

capital to fund our operations.

Because our working capital requirements

depend upon numerous factors, including the progress of our preclinical and clinical testing, timing and cost of obtaining regulatory

approvals, changes in levels of resources that we devote to the development of manufacturing and marketing capabilities, competitive and

technological advances, status of competitors, and our ability to establish collaborative arrangements with other organizations, we will

require additional financing to fund future operations.

On September 26,

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

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

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

of autologous DCs that are 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 being 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 could provide a safer approach 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 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, which Alzamend expects

to initiate within three months of receiving data from the initial trial.

The continuation of our current plan of operations

with respect to completing our IND applications and conducting the series of human clinical trials for each of our therapeutics requires

us to raise additional capital to fund our operations.

Because our working capital requirements depend

upon numerous factors, including the progress of our preclinical and clinical testing, timing and cost of obtaining regulatory approvals,

changes in levels of resources that we devote to the development of manufacturing and marketing capabilities, competitive and technological

advances, status of competitors, and our ability to establish collaborative arrangements with other organizations, we will require additional

financing to fund future operations.

2023, we received a notice from the staff of The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, for the previous 30 consecutive

business days, the minimum Market Value of Listed Securities (“MVLS”) for our Common Stock was below the $35 million minimum

MVLS requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(2) (the “MVLS Rule”).

In accordance with Nasdaq Listing Rule 5810(c)(3)(C), we have 180 calendar days, or until March 25, 2024, to regain compliance with the

To regain compliance with the MVLS Rule, the MVLS for our Common Stock must close at $35 million or more for a minimum of 10

consecutive business days at any time during this 180-day period.

If we regain compliance with the MVLS Rule, Nasdaq will provide us with

written confirmation and will close the matter.

If we do not regain compliance with the rule by March 25, 2024, Nasdaq will provide notice

that our Common Stock will be delisted from the Nasdaq Capital Market.

In the event of such notification, the Nasdaq rules permit us an

opportunity to appeal Nasdaq’s determination.

Results of Operations

Results of Operations for the Three Months Ended July 31,

2023 and 2022

The following table summarizes the results of

our operations for the three months ended July 31, 2023 and 2022.

For the Three Months Ended July 31,

Results of Operations for the Three Months Ended October 31, 2023 and 2022

The following table summarizes the results

of our operations for the three months ended October 31, 2023 and 2022.

For the Three Months Ended October 31,

OPERATING EXPENSES

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* Not meaningful

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 three months ended July 31, 2023 and 2022, and we do not anticipate that we will generate revenue for the foreseeable future.

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 three months ended October 31, 2023 and 2022, 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,

2023 and 2022 were $2.4 million and $1.4 million, respectively.

As reflected in the table below, research and development expenses primarily

consisted of professional fees, clinical trial fees and licenses and fees.

For the Three Months Ended July 31,

Research and development expenses

for the three months ended October 31, 2023 and 2022 were $2.0 million and $1.5 million, respectively.

As reflected in the table below,

research and development expenses primarily consisted of professional fees, clinical trial fees and licenses and fees.

For the Three Months Ended October 31,

Professional fees

1 unchanged sentence

Licenses and fees

Stock-based compensation

Other research and development expenses

2 unchanged sentences

Professional Fees

During the three months ended July 31, 2023 and

2022, we reported professional fees of $1.1 million and $1.2 million, respectively, which were principally 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 Phase IIA clinical trial monitoring AL001 partially offset by increased professional fees related to IND preparation

for the additional indications for AL001.

During the three months ended October 31,

2023 and 2022, we incurred professional fees of $1.0 million and $900,000, respectively, which were principally comprised of professional

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

The increase relates to higher professional

fees incurred related to IND preparation for the additional indications for AL001.

Clinical Trial Fees

During the three months ended July 31, 2023 and

2022, we incurred clinical trial fees of $1.2 million and $24,000, respectively.

Clinical trial fees for the three months ended July 31,

2023, consisted of $926,000 for our Phase IIA clinical trial for AL001 and $319,000 for our Phase IIA clinical trial for ALZN002.

trial fees for the three months ended July 31, 2022 were for our Phase I clinical trial for AL001.

During the three months ended October 31,

2023 and 2022, we incurred clinical trial fees of $795,000 and $552,000, respectively.

Clinical trial fees for the three months ended

October 31, 2023, consisted of $455,000 for our Phase IIA clinical trial for AL001 and $340,000 for our Phase IIA clinical trial for ALZN002.

Clinical trial fees for the three months ended October 31, 2022 were for our Phase I clinical trial for AL001.

Licenses and Fees

There are certain initial license fees and milestone

payments required to be paid to the University of South Florida and the Licensor, for the licenses of the technologies, pursuant to the

terms of the License Agreement with Sublicensing Terms.

There are certain initial license fees and

milestone payments required to be paid to the University of South Florida and the Licensor, for the licenses of the technologies, pursuant

to the terms of the License Agreement with Sublicensing Terms.

Stock-Based Compensation Expense

During the three months ended

October 31, 2023, we incurred research and development stock-based compensation of $143,000, related to stock option grants to consultants.

The increase in research and development stock compensation expense for the three months ended October 31, 2023 was a result of the vesting

of performance stock options grants.

Other Research and Development Expenses

During the three months ended July 31, 2023 and

2022, we incurred other fees of $51,000 and $156,000, respectively, which were principally comprised of scientific materials required

During the three months ended October 31,

2023 and 2022, we incurred other fees of $14,000 and $15,000, respectively, which were principally comprised of scientific materials required

for our clinical trials.

General and Administrative Expenses

General and administrative expenses for the three

months ended July 31, 2023 and 2022 were $1.2 million and $1.7 million, respectively.

As reflected in the table below, general and administrative

expenses primarily consisted of the following expense categories:

General and administrative expenses for the three months ended October

31, 2023 and 2022 were $905,000 and $1.6 million, respectively.

As reflected in the table below, general and administrative expenses primarily

consisted of the following expense categories:

stock-based compensation expense;

1 unchanged sentence

professional fees;

as salaries and benefits.

For the three months ended October 31, 2023 and 2022, the remaining general and administrative expenses of $131,000

and $129,000, respectively, primarily consisted of payments for filing fees, transfer agent fees, travel and entertainment, board of director

fees and other office expenses, none of which is significant individually.

For the Three Months Ended October 31,

Stock-based compensation expense

Professional fees

Salary and benefits

Marketing fees

Other general and administrative expenses

Total general and administrative expenses

Stock-Based Compensation Expense

During the three months ended

October 31, 2023 and 2022, we incurred general and administrative stock-based compensation expense of $175,733 and $716,000, respectively,

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

The decrease in stock-based compensation

for the three months ended October 31, 2023 was a result of fewer stock options vesting during the period compared to the prior year.

Professional Fees

During the three months ended October 31,

2023 and 2022, we incurred professional fees of $284,000 and $133,000, respectively, which were principally comprised of the following

Three Months Ended October 31, 2023

· During the three months ended October 31, 2023, we incurred $92,000 in audit fees, $89,000 in investor

relations, $67,000 in legal fees, $13,000 in tax preparation fees, $12,000 in related party consulting and $11,000 in Sarbanes-Oxley compliance

Three Months Ended October 31, 2022

· During the three months ended October 31, 2022, we recorded an expense of $70,000 in connection with the

five-year consulting agreement with Spartan Capital;

· During the three months ended October 31, 2022, we incurred $20,000 in audit fees, $13,000 in related

party consulting, $11,000 in Sarbanes-Oxley compliance fees, $7,000 in tax preparation fees and $12,000 in other professional fees.

Insurance Expense

During the three months ended October 31,

2023 and 2022, we incurred insurance expense of $89,000 and $130,000, respectively, which was primarily directors’ and officers’

Salaries and Benefits

During the three months ended October 31,

2023 and 2022, we incurred $226,000 and $219,000, respectively, in employee-related expenses.

As of October 31, 2023, we had four full-time

and three part-time employees.

Marketing Fees

During the three months ended October 31,

2022, we incurred marketing fees of $247,000, which was primarily expenses related to the marketing and brand development agreement with

Ault Alliance, Inc.

(“AAI”), a related party.

Results of Operations for the Six Months Ended October 31, 2023 and 2022

The following table summarizes the results

of our operations for the six months ended October 31, 2023 and 2022.

For the Six Months Ended October 31,

OPERATING EXPENSES

Research and development

General and administrative

Total operating expenses

Loss from operations

OTHER EXPENSE, NET

Interest expense

Total other expense, net

$ (6,433,799 )

$ (6,147,065 )

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, 2023 and 2022, 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, 2023 and 2022 were $4.4 million and $2.9 million, respectively.

As reflected in the table below,

research and development expenses primarily consisted of professional fees, clinical trial fees and licenses and fees.

For the Six Months Ended October 31,

Professional fees

Clinical trials

Licenses and fees

Stock-based compensation

Other research and development expenses

Total research and development expenses

* Not meaningful

Professional Fees

During each of the six months ended October

31, 2023 and 2022, we incurred professional fees of $2.1 million, which were principally comprised of professional fees attributed to

various types of scientific services, including FDA consulting services.

Clinical Trial Fees

During the six months ended October 31,

2023 and 2022, we incurred clinical trial fees of $2.0 million and $575,000, respectively.

Clinical trial fees for the six months ended

October 31, 2023 consisted of $1.4 million for our Phase IIA clinical trial for AL001 and $650,000 for our Phase IIA clinical trial for

Clinical trial fees for the six months ended October 31, 2022 were for our Phase I clinical trial for AL001.

Licenses and Fees

There are certain initial license fees and

milestone payments required to be paid to the University of South Florida and the Licensor, for the licenses of the technologies, pursuant

to the terms of the License Agreement with Sublicensing Terms.

Stock-Based Compensation Expense

During the six months ended

October 31, 2023, we incurred research and development stock-based compensation of $143,000, related to stock option grants to consultants.

The increase in research and development stock compensation expense for the six months ended October 31, 2023 was a result of the vesting

of performance stock options grants

Other Research and Development Expenses

During the six months ended October 31,

2023 and 2022, we incurred other fees of $66,000 and $170,000, respectively, which were principally comprised of scientific materials

required for our clinical trials.

General and Administrative Expenses

General and administrative

expenses for the six months ended October 31, 2023 and 2022 were $2.1 million and $3.2 million, respectively.

As reflected in the table

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

stock-based compensation expense;

marketing fees;

professional fees;

as well as salaries and benefits.

For the three months ended July 31, 2023 and 2022, the remaining general and administrative

expenses of $121,000 and $128,000, respectively, primarily consisted of payments for filing fees, transfer agent fees, travel and entertainment,

board of director fees and other office expenses, none of which is significant individually.

For the Three Months Ended July 31,

For the six months ended October 31, 2023 and 2022, the

remaining general and administrative expenses of $252,000 and $257,000, respectively, primarily consisted of payments for filing fees,

transfer agent fees, travel and entertainment, board of director fees and other office expenses, none of which is significant individually.

For the Six Months Ended October 31,

Stock-based compensation expense

$ (1,037,865 )

Professional fees

Salary and benefits

Travel and entertainment

Marketing fees

Board of director fees

Other general and administrative expenses

Total general and administrative expenses

$ (1,168,273 )

Stock-Based Compensation Expense

During the three months ended July 31, 2023 and

2022, we incurred general and administrative stock-based compensation expense of $369,000 and $867,000, respectively, related to stock

option grants to executives, employees and consultants.

All option grants are granted at the per share fair value on the grant date.

of options differs based on the terms of each option.

We valued the options at their date of grant utilizing the Black-Scholes option

pricing model.

We valued the shares issued for services at their intrinsic value on the date of issuance.

Stock-based compensation is

a non-cash expense because we settle these obligations by issuing shares of our common stock from authorized shares instead of settling

such obligations with cash payments.

During the six months ended

October 31, 2023 and 2022, we incurred general and administrative stock-based compensation expense of $545,000 and $1.6 million, respectively,

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

The decrease in stock-based compensation

for the six months ended October 31, 2023 was a result of fewer stock options vesting during the period compared to the prior year.

Professional Fees

During the three months ended July 31,

2023 and 2022, we reported professional fees of $151,000 and $243,000, respectively, which were principally comprised of the following

Three Months Ended July 31, 2023

· During the three months ended July 31, 2023,

we incurred $78,000 in audit fees, $16,000 in tax preparation fees, $13,000 in related party consulting, $6,000 in Sarbanes-Oxley compliance

fees and $3,000 in miscellaneous fees.

Three Months Ended July 31, 2022

· During the three months ended July 31, 2022,

we recorded an expense of $70,000 in connection with the five-year consulting agreement with Spartan Capital.

· During the three months ended July 31, 2022,

we incurred $80,000 in audit fees, $23,000 in Sarbanes-Oxley compliance fees, $24,000 in tax preparation fees and $13,000 in related party

During the six months ended October 31,

2023 and 2022, we incurred professional fees of $435,000 and $376,000, respectively, which were principally comprised of the following

Six Months Ended October 31, 2023

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

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

fees and $8,000 in other professional fees.

Six Months Ended October 31, 2022

· During the six months ended October 31, 2022, we recorded an expense of $140,000 in connection with the

five-year consulting agreement with Spartan Capital;

· During the six months ended October 31, 2022, we incurred $100,000 in audit fees, $41,000 in Sarbanes-Oxley

compliance fees, $25,000 in related party consulting, $25,000 in tax preparation fees and $43,000 in other professional fees.

Insurance Expense

During the three months ended July 31, 2023 and

2022, we incurred insurance expense of $118,000 and $196,000, respectively, which was primarily directors’ and officers’ insurance.

During the six months ended October 31,

2023 and 2022, we incurred insurance expense of $207,000 and $326,000, respectively, which was primarily directors’ and officers’

Salaries and Benefits

During the three months ended July 31, 2023 and

2022, we incurred $153,000 and $224,000, respectively, in employee-related expenses.

As of July 31, 2023, we had four full-time and three

part-time employees.

During the six months ended October 31,

2023 and 2022, we incurred $379,000 and $443,000, respectively, in employee-related expenses.

As of October 31, 2023, we had four full-time

and three part-time employees.

Marketing Fees

During the three months ended July 31,

During the six months ended October 31,

2023 and 2022, we incurred marketing fees of $247,000 and $248,000, respectively, which was primarily expenses related to the marketing

and brand development agreement with Ault Alliance, Inc., a related party.

and brand development agreement with AAI, a related party.

Liquidity and Capital Resources

The accompanying financial statements have been

prepared assuming that we will continue as a going concern.

We have incurred recurring net losses and operations have not provided sufficient

The accompanying condensed financial statements have been prepared

assuming that we will continue as a going concern.

We have incurred recurring net losses and operations have not provided sufficient cash

We believe that we will continue to incur operating and net losses each quarter until at least the time we are able to generate

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We believe our current cash on hand is insufficient to fund our planned

operations through one year after the date the financial statements are issued.

These factors create substantial doubt about our ability

to continue as a going concern for at least one year after the date that our financial statements are issued.

Our inability to continue as a going

concern could have a negative impact on our company, including our ability to obtain needed financing.

We intend to finance our future development activities and our working capital needs largely through the sale of equity securities with

some additional funding from other sources, including debt financing, until such time as funds provided by operations are sufficient to

fund working capital requirements.

Our financial statements do not include any adjustments relating to the recoverability and classification

of recorded assets, or the amounts and classifications of liabilities that might be necessary should we be unable to continue as a going

As of July 31, 2023, we had cash of $1.7 million, an accumulated deficit of $47.6 million and stockholders’ deficit of

We have incurred recurring losses and reported losses for the three months ended July 31, 2023 totaling $3.5 million.

past, we have financed our operations principally through sales of equity securities and debt instruments.

operations through one year after the date the condensed financial statements are issued.

These factors create substantial doubt about

our ability to continue as a going concern for at least one year after the date that our condensed financial statements are issued.

Our inability to continue as a going concern could have

a negative impact on our company, including our ability to obtain needed financing.

We intend to finance our

future development activities and our working capital needs largely through the sale of equity securities with some additional funding

from other sources, including debt financing, until such time as funds provided by operations are sufficient to fund working capital requirements.

Our condensed financial statements do not include any adjustments relating to the recoverability and classification of recorded assets,

or the amounts and classifications of liabilities that might be necessary should we be unable to continue as a going concern.

As of October

31, 2023, we had cash of $200,000, an accumulated deficit of $50.5 million and stockholders’ deficit of $2.7 million.

We have incurred

recurring losses and reported losses for the three and six months ended October 31, 2023 totaling $2.9 million and $6.4 million, respectively.

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

We will need to obtain substantial additional

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Our future capital requirements will depend on many factors, including:

· successful enrollment in and completion of clinical

· our ability to establish agreements with third-party

manufacturers for clinical supply for our clinical trials and, if our product candidates are approved, commercial manufacturing;

· our ability to maintain our current research

and development programs and establish new research and development programs;

· addition and retention of key research and development

· our efforts to enhance operational, financial,

and information management systems, and hire additional personnel, including personnel to support development of our product candidates;

· negotiating favorable terms in any collaboration,

licensing, or other arrangements into which we may enter and performing our obligations in such collaborations;

· the timing and amount of milestone and other

payments we may receive under our collaboration arrangements;

· our eventual commercialization plans for our

product candidates;

· the costs involved in prosecuting, defending,

and enforcing patent claims and other intellectual property claims;

· successful enrollment in and completion of clinical trials;

· our ability to establish agreements with third-party manufacturers for clinical supply for our clinical

trials and, if our product candidates are approved, commercial manufacturing;

· our ability to maintain our current research and development programs and establish new research and development

· addition and retention of key research and development personnel;

· our efforts to enhance operational, financial, and information management systems, and hire additional

personnel, including personnel to support development of our product candidates;

· negotiating favorable terms in any collaboration, licensing, or other arrangements into which we may enter

and performing our obligations in such collaborations;

· the timing and amount of milestone and other payments we may receive under our collaboration arrangements;

· our eventual commercialization plans for our product candidates;

· the costs involved in prosecuting, defending, and enforcing patent claims and other intellectual property

· the costs and timing of regulatory approvals.

A change in the outcome of any of these or other

variables with respect to the development of any of our product candidates could significantly change the costs and timing associated

A change in the outcome of any of these

or other variables with respect to the development of any of our product candidates could significantly change the costs and timing associated

with the development of that product candidate.

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funds to meet operational needs and capital requirements associated with such operating plans.

On September 8, 2023, we

entered into a Sales Agreement with Ascendiant Capital Markets, LLC, as sales agent to sell Shares from time to time, through an ATM Offering

as defined in Rule 415 under the Securities Act.

On September 8, 2023, we filed a prospectus supplement with the SEC relating to the offer

and sale of up to approximately $9.8 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.

The following table summarizes our cash flows for the three months

ended July 31, 2023 and 2022:

For the Three Months Ended July 31,

Net cash used in:

On September 8, 2023, we entered into an

At-the-Market Issuance Sales Agreement with Ascendiant Capital Markets, LLC, as sales agent to sell shares of our Common stock, having

an aggregate offering price of up to approximately $9.8 million (the “Shares”) from time to time, through an “at the

market offering” (the “ATM Offering”) as defined in Rule 415 under the Securities Act.

On September 8, 2023, we filed

a prospectus supplement with the SEC relating to the offer and sale of up to approximately $9.8 million in shares of Common Stock in the

ATM Offering.

During the six months ended October 31, 2023, we sold an aggregate

of 6,149 shares of Common Stock pursuant to the ATM Offering for gross proceeds of $19,000.

the period between November 1, 2023 through December 14, 2023, we sold an aggregate of 651,046 shares of Common Stock pursuant to

the ATM Offering for gross proceeds of $849,000.

The following table summarizes our cash

flows for the six months ended October 31, 2023 and 2022:

For the Six Months Ended October 31,

Net cash provided by (used in):

Operating activities

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Investing activities

Net decrease in cash

Financing activities

Net decrease in cash and cash equivalents

$ (4,940,780 )

1 unchanged sentence

Operating Activities

During the three months ended July 31, 2023, net

cash used in operating activities was $3.3 million.

This consisted primarily of a net loss of $3.5 million and a decrease in our net operating

assets and liabilities of $152,000, partially offset by non-cash charges of $382,000.

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,

an increase in prepaid expenses and other current assets and a decrease in prepaid expenses - related party.

During the six months ended

October 31, 2023, net cash used in operating activities was $4.8 million.

This consisted primarily of a net loss of $6.4 million partially

offset by an increase in our net operating assets and liabilities of $909,000 and non-cash charges of $714,000.

The non-cash charges primarily

consisted of stock-based compensation expense.

The increase in our net operating assets and liabilities was due to an increase in accounts

payable and accrued liabilities, an increase in prepaid expenses and other current assets and a decrease in prepaid expenses - related

Investing Activities

During the three months ended July 31, 2023, net

cash used in investing activities was $147,000 from the purchase of machinery and equipment.

We purchased equipment, which draws blood

from patients and separates the monocytes from their blood, to be used in the ALZN002 clinical trials.

During the six months ended October 31,

2023, net cash used in investing activities was $147,000 from the purchase of machinery and equipment.

We purchased equipment, which draws

blood from patients and separates the monocytes from their blood, to be used in the ALZN002 clinical trial.

Financing Activities

There were no financing activities for the three months ended July

31, 2023 or 2022.

During the six months ended October 31,

2023, net cash provided by financing activities was $18,000 from proceeds from the ATM Offering.

Contractual Obligations

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 United States Patent Nos.

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

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

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

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”).

Amendments to the AL001 Licenses modified the timing of the payments license fees.

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 United States Patent Nos.

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

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

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

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

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148,528 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 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 United States 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

and on April 17, 2023, we entered into the Sixth Amendment to the ALZN002 License (collectively, the “ALZN002 License Agreement”).

The Sixth Amendments to the ALZN002 License modified the timing of the payments license fees.

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 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 United States

8,188,046, entitled “Amyloid Beta Peptides and Methods of Use”, filed April 7, 2009 and granted May 29, 2012.

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

2 unchanged sentences

license fee of $200,000 for ALZN002.

As an additional licensing fee for the license of ALZN002, the Licensor received 3,601,809 shares

of our common stock.

As an additional licensing fee for the license of ALZN002, the Licensor received 240,120 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

1 unchanged sentence

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 licenses 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 license fees.

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 licenses limited

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

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

4 unchanged sentences

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 no licensed patent under the applicable agreement remains a pending application or enforceable

These license agreements have an indefinite

term that continue until the later of the date no licensed patent under the applicable agreement remains a pending application or enforceable

patent, the end date of any period of market exclusivity granted by a governmental regulatory body, or the date on which the licensee’s

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Upon completion of first clinical trial

24 months from completion of the first Phase II clinical trial

Upon first patient treated in a Phase III clinical trial

3 unchanged sentences

ALZN002 License:

Completed January 2022

Upon IND application filing

September 2023

Upon first dosing of patient in Phase I clinical trial

24 months from completion of first Phase I clinical trial

Upon completion of first Phase II clinical trial

12 months from completion of first Phase II clinical trial

Upon IND application - completed January 2022

Upon first dosing of patient in first Phase I clinical trial

Upon completion of first Phase IIb clinical trial

Upon first patient treated in a Phase III clinical trial

7 years from the effective date of the agreement

Upon FDA Biologics License Application approval

Upon fist commercial sale

* Milestone met and completed

Additional AL001 Licenses:

36 months from completion of first Phase II clinical trial

Upon first patient treated in a Phase III clinical trial

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QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Because we are a smaller

reporting company, this section is not applicable.

Because we are a smaller reporting company,

this section is not applicable.

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