What changed in this filing

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Item 2. Management’s Discussion and Analysis

2021-12-14 compared with 2021-09-14 · 195 added, 214 removed, 156 unchanged (72% of the section changed)

Management’s Discussion

and Analysis of Financial Conditions and Results of Operations

Management’s Discussion and Analysis of

Financial Conditions and Results of Operations

Cautionary Note Regarding Forward-Looking Statements

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of operations, as well as any forward-looking statements, are subject to inherent risk and uncertainties, including, but not limited to,

the risk factors set forth in “Part I, Item 1A – Risk Factors” set forth in this Report and for the reasons described

elsewhere in this Report.

Among others, these include our estimates regarding expenses, future revenues, capital requirements and needs

for additional financing;

whether the United States Food and Drug Administration (“FDA”) approves our Investigational New

Drug Application (“IND”) after we submit a response to the FDA’s clinical hold, so that we can commence our planned

clinical trial involving locally advanced, inoperable, non-metastatic pancreatic cancer (“LAPC”);

the success and timing of

our preclinical studies and clinical trials;

the potential that results of preclinical studies and clinical trials may indicate that any

of our technologies and product candidates are unsafe or ineffective;

our dependence on third parties in the conduct of our preclinical

studies and clinical trials;

the difficulties and expenses associated with obtaining and maintaining regulatory approval of our product

the material adverse impact that the coronavirus pandemic may have on our business, including our planned clinical trial involving

LAPC, which could materially affect our operations as well as the business or operations of third parties with whom we conduct business;

and whether the FDA will approve our product candidates after our clinical trials are completed, assuming the FDA allows our clinical

trials to proceed after submission and review of our response to the FDA’s clinical hold.

All forward- looking statements and reasons

why results may differ included in this Report are made as of the date hereof, and we do not intend to update any forward-looking statements

except as required by law or applicable regulations.

Except where the context otherwise requires, in this Report, the “Company,”

“we,” “us” and “our” refer to PharmaCyte Biotech, Inc., a Nevada corporation, and, where appropriate,

its subsidiaries.

the risk factors set forth in “Part I, Item 1A – Risk Factors” set forth in our Annual Report on Form 10-K for the fiscal

year ended April 30, 2021, and for the reasons described elsewhere in this Report.

Among others, these include our estimates regarding

expenses, future revenues, capital requirements and needs for additional financing;

whether the United States Food and Drug Administration

(“FDA”) approves our Investigational New Drug Application (“IND”) after we submit a response to the FDA’s

clinical hold, so that we can commence our planned clinical trial involving locally advanced, inoperable pancreatic cancer (“LAPC”);

the success and timing of our preclinical studies and clinical trials;

the potential that results of preclinical studies and clinical

trials may indicate that any of our technologies and product candidates are unsafe or ineffective;

our dependence on third parties in

the conduct of our preclinical studies and clinical trials;

the difficulties and expenses associated with obtaining and maintaining regulatory

approval of our product candidates;

the material adverse impact that the coronavirus pandemic may have on our business, including our

planned clinical trial involving LAPC, which could materially affect our operations as well as the business or operations of third parties

with whom we conduct business;

and whether the FDA will approve our product candidates after our clinical trials are completed, assuming

the FDA allows our clinical trials to proceed after submission and review of our response to the FDA’s clinical hold.

looking statements and reasons why results may differ included in this Report are made as of the date hereof, and we do not intend to

update any forward-looking statements except as required by law or applicable regulations.

Except where the context otherwise requires,

in this Report, the “Company,” “we,” “us” and “our” refer to PharmaCyte Biotech, Inc.,

a Nevada corporation, and, where appropriate, its subsidiaries.

Overview of Business

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The Cell-in-a-Box ® technology is intended to be used as a platform upon which therapies for several types of cancer, including

locally advanced, inoperable, non-metastatic pancreatic cancer (“LAPC”) will be developed.

The current generation of our product

candidate is referred to as “CypCaps™”.

On September 1, 2020, we submitted an Investigational New Drug Application (“IND”)

Food and Drug Administration (“FDA”) for a planned Phase 2b clinical trial in LAPC.

On October 1, 2020, the Company

received notice from the FDA that it had placed the IND on clinical hold.

On October 30, 2020, the FDA sent a letter to us setting forth

the reasons for the clinical hold and specific guidance on what we must do to have the clinical hold lifted.

To lift the clinical hold,

the FDA has informed us that we need to conduct several additional preclinical studies and assays.

The FDA also requested additional information

regarding several topics, including DNA sequencing data, manufacturing information and product release specifications.

We are in the process

of conducting these studies and assays and gathering additional information to submit to the FDA.

LAPC will be developed.

The current generation of our product candidate is referred to as “CypCaps™”.

On September 1,

2020, we submitted an IND”) to the FDA for a planned Phase 2b clinical trial in LAPC.

On October 1, 2020, the Company received notice

from the FDA that it had placed the IND on clinical hold.

On October 30, 2020, the FDA sent a letter to us setting forth the reasons for

the clinical hold and specific guidance on what we must do to have the clinical hold lifted.

To lift the clinical hold, the FDA has informed

us that we need to conduct several additional preclinical studies and assays.

The FDA also requested additional information regarding

several topics, including DNA sequencing data, manufacturing information and product release specifications.

We are in the process of

conducting these studies and assays and gathering additional information to submit to the FDA.

See “Our Investigational New Drug

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The capsules are largely composed of cellulose (cotton) and are bio inert.

We are developing therapies for pancreatic and

other solid cancerous tumors by using genetically engineered live human cells that we believe are capable of converting a cancer prodrug

into its cancer-killing form.

We encapsulate those cells using the Cell-in-a-Box ® technology and place those capsules in

the body as close as possible to the tumor.

In this way, we believe that when a cancer prodrug is administered to a patient with a particular

type of cancer that may be affected by the prodrug, the killing of the patient’s cancerous tumor may be optimized.

We are developing therapies for pancreatic

and other solid cancerous tumors by using genetically engineered live human cells that we believe are capable of converting a cancer

prodrug into its cancer-killing form.

We encapsulate those cells using the Cell-in-a-Box ® technology and place those capsules

in the body as close as possible to the tumor.

In this way, we believe that when a cancer prodrug is administered to a patient with a

particular type of cancer that may be affected by the prodrug, the killing of the patient’s cancerous tumor may be optimized.

In addition, we have been exploring ways to delay

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of the abdomen, severe breathing difficulties and extreme pain.

On November 30, 2021, we announced the commencement of a pre-clinical

study to determine if the treatment we use for LAPC can also delay the rate of production and accumulation of malignant ascites.

We have also been developing a potential therapy

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the Clinical Hold

On September 1, 2020, we submitted an IND to the

FDA for a planned Phase 2b clinical trial in LAPC.

On September 1, 2020, we submitted an IND to the FDA for a planned

Phase 2b clinical trial in LAPC.

Shortly thereafter, we received Information Requests from the FDA related to the IND.

We timely responded to all Information Requests.

On October 1, 2020, we received notice that the

FDA had placed our IND on clinical hold.

On October 30, 2020, the FDA sent a letter to

us setting forth the reasons for the clinical hold and providing specific guidance on what we must do to have the clinical hold lifted.

We timely responded

to all Information Requests.

On October 1, 2020, we received notice that the FDA had placed our

IND on clinical hold.

On October 30, 2020, the FDA sent a letter to us setting forth the

reasons for the clinical hold and providing specific guidance on what we must do to have the clinical hold lifted.

In order to address the clinical hold, the FDA has requested that we:

Provide additional sequencing data and genetic stability studies;

Conduct a stability study on the final formulated drug product as well as the cells from our Master Cell Bank;

Conduct a stability study on the final formulated drug product candidate as well as the cells from our Master Cell Bank;

Evaluate the compatibility of the delivery devices (the prefilled syringe and the microcatheter used to implant the CypCaps ™ ) with our drug product candidate;

Provide additional detailed description of the manufacturing process;

Provide additional detailed description of the manufacturing process of our drug product candidate;

Provide additional product release specifications for our encapsulated cells;

Demonstrate comparability between the 1 st and 2 nd generation products and ensure adequate and consistent product performance and safety between the two generations of product;

Conduct a biocompatibility assessment using the final finished capsules after the entire drug product manufacturing process (but without cells);

Address insufficiencies in Chemistry, Manufacturing and Controls information in the cross-referenced Drug Master File;

Conduct an additional nonclinical study in a large animal (such as a pig) to assess the safety, activity and distribution of the drug product candidate;

Revise the Investigators Brochure to include any additional preclinical studies conducted in response to the clinical hold and remove any statements not supported by the data.

The FDA also requested that we address the following

issues as an amendment to the IND:

Demonstrate comparability between the 1 st and 2 nd generation of our drug product candidate and ensure adequate and consistent product performance and safety between the two generations of our drug product candidate;

Conduct a biocompatibility assessment using the final finished capsules after the entire drug product candidate manufacturing process (but without cells);

Address insufficiencies in Chemistry, Manufacturing and Controls information in the cross-referenced Drug Master File Prepared by Austrianova Singapore Pte.

(“Austrianova”);

Conduct an additional nonclinical study in a large animal (such as a pig) to assess the safety, activity, and distribution of our drug product candidate;

Revise our Investigators Brochure to include any additional preclinical studies conducted in response to the clinical hold and remove any statements not supported by the data.

The FDA also requested that we address the following issues as an amendment

Provide a Certificate of Analysis for pc3/2B1 plasmid that includes tests for assessing purity, safety, and potency;

Perform qualification studies for the drug substance filling step to ensure that the product remains sterile and stable during the filling process;

Submit an updated batch analysis for the drug product for the specific lot that will be used for manufacturing all future drug product;

Perform qualification studies for the drug product candidate filling step to ensure that the drug product candidate remains sterile and stable during the filling process;

Submit an updated batch analysis for the drug product candidate for the specific lot that will be used for manufacturing all future drug product candidate;

Provide additional details for the methodology for the Resorufin (CYP2B1) potency and the PrestoBlue cell metabolic assays;

Provide a few examples of common microcatheters that fit the specifications in our Angiography Procedure Manual;

Clarify the language in the Pharmacy Manual regarding proper use of the syringe fill with the drug product;

Clarify the language in the Pharmacy Manual regarding proper use of the syringe fill with the drug product candidate;

Provide a discussion with data for trial of the potential for cellular and humoral immune reactivity against the heterologous rat CYP2B1 protein and potential for induction of autoimmune-mediated toxicities in our study population in the LAPC.

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of addressing the studies and acquiring the information requested by the FDA.

The following provides a summary of the activities

in which we are engaged to have the clinical hold lifted:

The following provides a summary

of the activities in which we are engaged to have the clinical hold lifted:

We have completed a 3, 6, 9, 12 and 18-month product stability study of our clinical trial product (CypCaps™), including container closure integrity testing for certain timepoints;

the next time point in this ongoing study will be at 24 months of product stability.

We have designed and commenced various additional studies required by the FDA.

We are involved in various additional studies required by the FDA.

These include (i) a stability study on the cells from our Master Cell Bank (“MCB”) used to make the CypCaps™, which are already at the 3-year stability timepoint;

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and (iii) collated existing information on the reproducibility and quality of the filling of the MCB cells into vials ready for CypCaps™ manufacturing.

We have designed and commenced biocompatibility studies such as (i) a Subchronic and Chronic Toxicity study;

(ii) a Skin Sensitization study;

We are also involved in a (i) Subchronic and Chronic Toxicity study (ii) a Skin Sensitization study;

(iii) an Acute Systematic Toxicity study;

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(vii) a Hemolysis test;

(viii) an In Vitro Cytotoxicity test;

and (ix) an In Vivo Micronucleus assay.

Some of the data being generated by these studies will also be used to demonstrate comparability with the CypCaps ™ that were successfully used in the two earlier German clinical trials over twenty years ago for pancreatic cancer discussed below.

and (viii) an In Vitro Cytotoxicity test.

Some of the data being generated by these studies will also be used to demonstrate comparability with the CypCaps™ that were used in the two earlier German clinical trials over twenty years ago conducted by Bavarian Nordic.

To enable the biocompatibility studies to be performed, we had Austrianova manufacture and deliver an additional 400 syringes of empty capsules.

We designed and commenced studies designed to show that CypCaps ™ are not in any way adversely affected by the catheters used by interventional radiologists to deliver them, nor by the contract media used to visualize the blood vessels during implantation of the CypCaps ™ .

We designed and commenced studies to demonstrate how robust the CypCaps ™ are during delivery and use as well as to document that the syringes used to deliver the CypCaps ™ will allow delivery consistently, smoothly and safely.

With our support, Austrianova will provide additional detailed confidential information to the FDA on the manufacturing process, including information on the improvements made to the live cell encapsulated product since the last clinical trials with respect to reproducibility and safety of the CypCaps ™ .

We are in the process of updating our IND submission documents to include:

We have commenced studies to show that CypCaps™ are not in any way adversely affected by the catheters used by interventional radiologists to deliver them, nor by the contract media used to visualize the blood vessels during implantation of the CypCaps™.

We have commenced studies to demonstrate how robust the CypCaps™ are during delivery and use as well as to document that the syringes used to deliver the CypCaps™ will allow delivery consistently, smoothly, and safely.

With our support, Austrianova is providing additional detailed confidential information to the FDA on the manufacturing process, including information on the improvements made to the live cell encapsulated product since the last clinical trials with respect to reproducibility and safety of the CypCaps™.

We plan to update our IND submission documents to include:

(i) more pre-clinical data as discussed above, (ii) some additional parameters for release of the CypCaps™, (iii) a recommendation of the catheters and contrast medium to be used to deliver the CypCaps™;

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We have designed an abbreviated study in pigs to address biocompatibility and long-term implantation of the capsules.

This animal study will complement the positive data already available from the previous human clinical trials conducted by Bavarian Nordic showing the safety of CypCaps ™ implantation for up to two years in humans.

COVID-19 Potential Impact on the Financial

Condition and Results of Operations

The coronavirus SARS-Cov2 pandemic (“COVID-19”)

is causing significant, industry-wide delays in clinical trials.

Although we are not yet in a clinical trial, we have filed an IND with

the FDA to commence a clinical trial in LAPC.

While the IND has been placed on clinical hold by the FDA, we have assessed the impact of

COVID-19 on our operations.

As of the date of this Report, we believe the COVID-19 pandemic has had an impact upon our operations, primarily

relating to delays in tasks associated with the preparation of the Company’s responses to the FDA’s clinical hold, including

the requested preclinical studies and assays.

There may be further delays in generating responses to the requests from the FDA related

to the clinical hold.

Many of these delays are due to the impact of the COVID-19 pandemic in foreign countries where we are conducting

these preclinical studies and assays, including India, Europe, Singapore and Thailand.

There have also been supply chain interruptions

due to the COVID-19 pandemic.

Further, many clinical trials have been delayed

due to COVID-19.

There are numerous reasons for these delays.

For example, patients have shown a reluctance to enroll or continue in a

clinical trial due to fear of exposure to COVID-19 when they are in a hospital or doctor’s office.

There are local, regional and

state-wide orders and regulations restricting usual normal activity by people.

These discourage and interfere with patient visits to a

doctor’s office if the visit is not COVID-19 related.

Healthcare providers and health systems have shifted their resources away

from clinical trials toward the care of COVID-19 patients.

The FDA and other healthcare providers are making product candidates for the

treatment of COVID-19 a priority over product candidates unrelated to COVID-19.

As a result of COVID-19 and the mitigation efforts

to address it, we may experience additional disruptions that could adversely impact our business and clinical trial, including:

or difficulties in enrolling patients in our Phase 2b clinical trial if the FDA allows us to go forward with the trial;

(ii) delays or

difficulties in clinical site activation, including difficulties in recruiting clinical site investigators and clinical site personnel;

(iii) delays in clinical sites receiving the supplies and materials needed to conduct our clinical trial, including interruption in global

shipping that may affect the transport of our clinical trial product;

(iv) changes in local regulations as part of a response to the COVID-19

pandemic which may require us to change the ways in which our clinical trial is to be conducted, which may result in unexpected costs,

or to discontinue the clinical trial altogether;

(v) diversion of healthcare resources away from the conduct of clinical trials, including

the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trial;

(vi) interruption

of key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by federal

or state governments, employers and others, or interruption of clinical trial subject visits and study procedures, the occurrence of which

could affect the integrity of clinical trial data;

(vii) risk that participants enrolled in our clinical trials will acquire COVID-19

while the clinical trial is ongoing, which could impact the results of the clinical trial, including by increasing the number of observed

adverse events;

(viii) delays in necessary interactions with local regulators, ethics committees, and other important agencies and contractors

due to limitations in employee resources or forced furlough of government employees;

(ix) limitations in employee resources that would

otherwise be focused on the conduct of our clinical trial because of sickness of employees or their families or the desire of employees

to avoid contact with large groups of people;

(x) refusal of the FDA to accept data from clinical trials in affected geographies;

(xi) interruption or delays to our clinical trial activities.

As a result of the COVID-19 pandemic, commencement

of our planned clinical trial to treat LAPC may be delayed beyond the lifting of the clinical hold by the FDA should that occur.

enrollment may be difficult for the reasons discussed above.

In addition, after enrollment in the trial, if patients contract COVID-19

during their participation in the trial or are subject to isolation or shelter in place restrictions, this may cause them to drop out

of our clinical trial, miss scheduled therapy appointments or follow-up visits or otherwise fail to follow the clinical trial protocol.

If patients are unable to follow the clinical trial protocol or if the trial results are otherwise affected by the consequences of the

COVID-19 pandemic on patient participation or actions taken to mitigate COVID-19 spread, the integrity of data from the clinical trial

may be compromised or not be accepted by the FDA.

This could further adversely impact or delay our clinical development program if the

FDA allows it to proceed.

It is highly speculative in projecting the effects

of COVID-19 on our proposed clinical development program and the Company generally.

Moreover, the various precautionary measures taken

by many governmental authorities around the world in order to limit the spread of COVID-19 has had and may continue to have an adverse

effect on the global markets and global economy, including on the availability and pricing of employees, resources, materials, manufacturing

and delivery efforts and other aspects of the global economy.

The continuation of the COVID-19 pandemic could materially disrupt our business

and operations, hamper our ability to raise additional funds or sell or securities, continue to slow down the overall economy, curtail

consumer spending, interrupt our sources of supply, and make it hard to adequately staff our operations.

The effects of COVID-19 quickly

and dramatically change over time.

Its evolution is difficult to predict, and no one is able to say with certainty when the pandemic will

cease to have an impact on our operations.

This animal study will complement the data already available from the previous human clinical trials conducted by Bavarian Nordic showing the safety of CypCaps™ implantation for up to two years in humans.

We have completed the complement activation study.

The study results demonstrated that the capsule material we use does not activate a major line of the human body’s innate defense – the complement system.

Another positive result from a completed biocompatibility showed that the empty capsule material is “non-hemolytic.”

Another completed biocompatibility study showed that the empty capsule material is not “mutagenic.”

Impact of the COVID-19 Pandemic on Operations

The coronavirus SARS-Cov2

pandemic (“COVID-19”) is causing significant, industry-wide delays in clinical trials.

Although we are not yet in a clinical

trial, we have filed an IND with the FDA to commence a clinical trial in LAPC.

While the IND has been placed on clinical hold by the FDA,

we have assessed the impact of COVID-19 on our operations.

Currently, many clinical trials are being delayed due to COVID-19.

numerous reasons for these delays.

For example, patients have shown a reluctance to enroll or continue in a clinical trial due to fear

of exposure to COVID-19 when they are in a hospital or doctor’s office.

There are local, regional, and state-wide orders and regulations

restricting usual normal activity by people.

These discourage and interfere with patient visits to a doctor’s office if the visit

is not COVID-19 related.

Healthcare providers and health systems are shifting their resources away from clinical trials toward the care

of COVID-19 patients.

The FDA and other healthcare providers are making product candidates for the treatment of COVID-19 a priority over

product candidates unrelated to COVID-19.

As of the date of this prospectus, the COVID-19 pandemic has had an impact upon our operations,

although we believe that impact is not material.

The impact primarily relates to delays in tasks associated with the preparation of the

Company’s responses to the clinical hold, including all requested preclinical studies.

There may be further delays in generating

responses to the requests from the FDA related to the clinical hold.

As a result of the COVID-19

pandemic, commencement of our planned clinical trial to treat LAPC may be delayed beyond the lifting of the clinical hold by the FDA should

Also, enrollment may be difficult for the reasons discussed above.

In addition, after enrollment in the trial, if a patient

contracts COVID-19 during his or her participation in the trial or is subject to isolation or shelter in place restrictions, this may

cause him or her to drop out of our clinical trial, miss scheduled therapy appointments or follow-up visits or otherwise fail to follow

the clinical trial protocol.

If a patient is unable to follow the clinical trial protocol or if the trial results are otherwise affected

by the consequences of the COVID-19 pandemic on patient participation or actions taken to mitigate COVID-19 spread, the integrity of data

from the clinical trial may be compromised or not be accepted by the FDA.

This could further adversely impact or delay our clinical development

program if the FDA allows it to proceed.

It is highly speculative in

projecting the effects of COVID-19 on our proposed clinical development program and the Company generally.

The effects of COVID-19 may

quickly and dramatically change over time.

Its evolution is difficult to predict, and no one can say with certainty when the pandemic

will subside.

Performance Indicators

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Results of Operations

Three months ended July 31, 2021 compared to three months

ended July 31, 2020

We had no revenues for the three months ended July 31, 2021 and

Three and six months ended October 31, 2021, compared to three

and six months ended October 31, 2020

We had no revenues for the three and six months ended October 31, 2021,

Operating Expenses and Loss from Operations

The following table summarizes our operating expenses

and loss from operations for the three months ended July 31, 2021 and 2020, respectively:

Three Months Ended July 31,

The total operating expenses for the three

months ended July 31, 2021 increased by $141,675 from the three months ended July 31, 2020.

The increase is attributable to an

increase in general and administrative (“G&A”) expenses of $243,594, an increase in legal and professional expense

of $43,992 net of a decrease in director fees of $8,865, a decrease in compensation expense of $10,085, and a decrease in R&D

expense of $126,961.

The increase in G&A expenses were mainly attributable to increases in consulting fees, filing fees and

expenses related to the annual shareholders’ meeting.

Other expense

The following table sets forth our other expense for the three

months ended July 31, 2021 and 2020:

Three Months Ended July 31,

Total other expense for the three months

ended July 31, 2021 decreased by the amount of $201 from the three months ended July 31, 2020.

The increase/decrease is attributable

to the increase of interest expense in the amount of $79, an increase in income taxes of $800 and a decrease in foreign exchange

and loss from operations for the three and six months ended October 31, 2021, and 2020:

Three Months Ended October 31,

Six Months Ended October 31,

The total operating expenses for the three months

ended October 31, 2021, increased by $55,328 from the three months ended October 31, 2020.

The increase is attributable to an increase

in general and administrative (“G&A”) expenses of $170,665, an increase in legal and professional expense of $196,470

net of a decrease in director fees of $8,263, a decrease in compensation expense of $287,450, and a decrease in R&D expense of $16,094.

The increase in G&A expenses were mainly attributable to increases in consulting fees, filing fees and expenses related to the annual

shareholders’ meeting.

The total operating expenses for the six-month

period ended October 31, 2021, increased by $197,003 from the six months ended October 31, 2020.

The increase is attributable to an increase

in G&A expenses of $414,259, an increase in legal and professional expense of $240,462 net of a decrease in director fees of $17,128,

a decrease in compensation expense of $297,535, and a decrease in R&D expense of $143,055.

The increase in G&A expenses were mainly

attributable to increases in consulting fees, filing fees and expenses related to the annual shareholders’ meeting.

Other (income) expense

The following table sets forth our other (income) expense for the

three and six months ended October 31, 2021, and 2020:

Three Months Ended October 31,

Six Months Ended October 31,

Total other (income) expense for the three months

ended October 31, 2021, decreased by the amount of $25,774 from the three months ended October 31, 2020.

The decrease is attributable

to the increase of interest income of $25,619 a decrease in interest expense in the amount of $635, net of an increase in in foreign exchange

losses of $480.

Total other (income) expense for the six months

ended October 31, 2021, decreased by the amount of $25,975 from the six months ended October 31, 2020.

The decrease is attributable to

the increase of interest income of $25,619 a decrease in interest expense in the amount of $1,248, an increase in income taxes of $800

and an increase in foreign exchange losses of $92.

Discussion of Operating, Investing and Financing

The following table presents a summary of our sources and uses of cash

for the three months ended July 31, 2021 and 2020, respectively:

Three Months Ended

July 31, 2021

July 31, 2020

for the six months ended October 31, 2021, and 2020, respectively:

Six Months Ended

October 31, 2021

October 31, 2020

Net cash used in operating activities:

$ (2,626,834 )

$ (1,801,453 )

Net cash used in investing activities:

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Effect of currency rate exchange

Net increase (decrease) in cash

$ (1,242,836 )

Net increase in cash

Operating Activities :

The net cash used in operating activities

for the three months ended July 31, 2021 is a result of our net losses, increases in accounts payable, an increase in prepaid

expenses and an increase in securities issued for services and compensation, net of a decrease in accrued expenses.

The cash used in

operating activities for the three months ended July 31, 2020 is a result of our net losses, increase in accounts payable offset by

an increase in stock issued, decreases to prepaid expenses and accrued expenses.

See Condensed Consolidated Statements of Cash Flows

The net cash used in operating activities for

the six months ended October 31, 2021, is a result of our net losses, increases in rent deposit, an increase in prepaid expenses and

an increase in securities issued for services and compensation, net of decreases in accounts payable and accrued expenses.

The cash used

in operating activities for the six months ended October 31, 2020, is a result of our net losses, an increase in prepaid expenses, an

increase in securities issued for services and compensation, decreases to accounts payable and accrued expenses.

See Condensed Consolidated

Statements of Cash Flows on page 7.

Investing Activities :

There were no investing activities in the three months ended July

There were no investing activities in the six months ended October

31, 2021, and 2020.

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The cash provided from financing activities is

mainly attributable to the proceeds from the sale of our common stock net of the use of funds for payment of insurance financing for the

three months ended July 31, 2020.

mainly attributable to the proceeds from the sale of our common stock net of the use of funds for payment of issuance costs for the six

months ended October 31, 2021.

The cash provided from financing activities is mainly attributable to the proceeds from the sale of our

common stock, net of issuance costs and insurance financing for the six months ended October 31, 2020.

Liquidity and Capital Resources

As of July 31, 2021, our cash totaled approximately

$959,000, compared to approximately $2,167,000 at July 31, 2020.

Working capital was approximately $583,000 at July 31, 2021 and approximately

$1,116,000 at July 31, 2020.

The decrease in cash is attributable to a lower beginning cash balance, no proceeds from the sale of our

common stock and an increase in our operating expenses.

As a result of the proceeds of the First and Second Offerings and resulting warrant

exercises, as of September 13, 2021, our cash totaled approximately $88 million.

During the three months ended July 31, 2021,

no funding was provided by investors to maintain and expand our operations and R&D.

Sales of our common stock were consummated

using the Third S-3 and a private placement in August 2021.

During the three months ended July 31, 2020, we continued to acquire

funds through our Second S-3 pursuant to Block Trades transactions in a program which is structured to provide up to $25 million

dollars to us less certain commissions.

As of October 31, 2021, our cash totaled approximately

$86.9 million, compared to approximately $3.7 million as of October 31, 2020.

Working capital was approximately $87 million as of October

31, 2021, and approximately $1.6 million as of October 31, 2020.

The increase in cash is attributable to proceeds from the sale of our

common stock net of an increase in our operating expenses.

During the six months ended October 31, 2021,

funding in the amount of approximately $87.4 million, was provided by investors to maintain and expand our operations and R&D.

of our common stock, Pre-funded warrants and exercise of Common Warrants were consummated using the Third S-3 and the Registered Direct

Offering in August 2021.

During the six months ended October 31, 2020, we continued to acquire funds through our Second S-3 pursuant to

Block Trades transactions in a program which was structured to provide up to $25 million dollars to us less certain commissions.

Off-Balance Sheet Arrangements

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Such filings are also available for download free of charge on our website.

of the website are not, and are not intended to be, incorporated by reference into this Report or any other report or document filed with

the Commission or furnished by us, and any reference to the websites are intended to be inactive textual references only.

The contents of the website are not, and are

not intended to be, incorporated by reference into this Report or any other report or document filed with the Commission or furnished

by us, and any reference to the websites are intended to be inactive textual references only.

Quantitative and Qualitative

3 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