What changed in this filing

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Item 2. Management’s Discussion and Analysis

2022-03-15 compared with 2021-12-14 · 244 added, 169 removed, 182 unchanged (69% of the section changed)

51 unchanged sentences

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

On September 1,

1, 2020, we submitted an IND to the FDA for a planned Phase 2b clinical trial in LAPC.

4 unchanged sentences

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

Application and the Clinical Hold” below.

us that we need to conduct several additional preclinical studies.

The FDA also requested additional information regarding several topics,

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

We are in the process of conducting

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

See “Our Investigational New Drug Application and the Clinical

The Cell-in-a-Box ® encapsulation

5 unchanged sentences

They are protected from environmental challenges,

such as the sheer forces associated with bioreactors and passage through catheters and needles, which we believe enables greater growth

such as the sheer forces associated with bioreactors and passage through catheters and needles.

We believe that this enables greater growth

and production.

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

the production and accumulation of malignant ascites fluid that results from many types of abdominal cancerous tumors.

Malignant ascites

fluid is secreted by abdominal cancerous tumors into the abdomen after the tumors have reached a certain stage of growth.

This fluid contains

cancer cells that can seed and form new tumors throughout the abdomen.

This fluid accumulates in the abdominal cavity, causing swelling

of the abdomen, severe breathing difficulties and extreme pain.

the production and accumulation of malignant ascites that results from many types of abdominal cancerous tumors.

Malignant ascites is

secreted by abdominal cancerous tumors into the abdomen after the tumors have reached a certain stage of growth.

This malignant ascites

contains cancer cells that can seed and form new tumors throughout the abdomen.

This fluid accumulates in the abdominal cavity, causing

swelling of the abdomen, severe breathing difficulties and extreme pain.

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

17 unchanged sentences

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 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 of our drug product candidate;

Conduct a stability study on the final product candidate as well as the cells from our Master Cell Bank (“MCB”);

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

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

Provide additional product release specifications for our encapsulated cells;

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);

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

Conduct a biocompatibility assessment using the final finished capsules after the entire 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.

Conduct an additional nonclinical study in a large animal (such as a pig) to assess the safety, activity, and distribution of our 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 generated from those studies.

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 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;

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

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

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 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.

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

We have assembled a scientific and regulatory

5 unchanged sentences

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 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;

(ii) further sequence analysis of the DNA encoding of the Cyp2B1 gene in the cells in the CypCaps™;

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

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

(iii) an Acute Systematic Toxicity study;

(iv) an Ames test (Genotoxicity Bacteria and Reverse Mutation tests);

(v) an Intracutaneous test;

(vi) a Complement Activation test;

(vii) a Hemolysis test;

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 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™;

and (iv) an extensive discussion 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.

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

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.”

· Additional Regulatory Expertise Added to IND

In addition to its established team of experts, we have retained Biologics Consulting to perform a regulatory “Gap

Analysis” and to assist with our IND submission.

Biologics Consulting is a full-service regulatory

and product development consulting firm for biologics, pharmaceuticals and medical devices and has personnel with extensive FDA

Although it took a lengthy amount of time to onboard Biologics Consulting, this should augment our ability to submit an acceptable

IND to the FDA.

· Stability Studies on PharmaCyte’s Clinical

Trial Product .

We have now successfully completed a product stability study after 3, 6, 9, 12 and 18-months of storage frozen at -80C

on our clinical trial product known as CypCaps™, including container closure integrity testing for certain timepoints.

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

This 24-month time point analysis

is ready to commence, and data will be available in the coming weeks.

· Additional Studies Requested by the FDA .

We have designed and commenced various additional studies requested by the FDA, including a stability study on the cells from its MCB

used to make the CypCaps™.

We are already at the 3-year stability timepoint for the cells from its MCB.

We are also collating existing

information on the reproducibility and quality of the filling of the MCB cells into vials ready for CypCaps™ manufacturing.

· Determination of the Exact Sequence of the

Cytochrome P450 2B1 Gene .

We have completed the determination of the exact sequence of the cytochrome P450 2B1 gene inserted at the

site previously identified on chromosome 9 using state-of-the-art nanopore sequencing, a cutting edge, unique and scalable technology

that permits real-time analysis of long DNA fragments.

The result of this analysis of the sequence data confirmed that the genes are intact.

· Further Confirmation of the Exact Sequence

of the Cytochrome P450 2B1 Gene Insert .

An additional, more finely detailed, analysis of the integration site of the cytochrome P450

2B1 gene from the augmented HEK293 cell clone that is used in its CypCaps™ product for was found to be intact.

In this new study,

we have been able to confirm the previously elucidated structure of the integrated transgene sequence using more data points.

These studies

also set the stage for a next step analysis to determine the genetic stability of the cytochrome P450 2B1 gene at the DNA level after

multiple rounds of cell growth.

This new study has been completed in which the original Research Cell Bank (“RCB”) cells were

compared with cells from the MCB, and the analysis confirmed that the cytochrome P450 2B1 and the surrounding sequence has remained stable

with no changes detected at the DNA level.

· Biocompatibility Studies .

We have designed

and commenced 8 biocompatibility studies, 6 of which have been completed successfully.

The remaining 2 studies are underway.

Those studies

are the Acute Systemic Toxicity Study of Empty Cellulose Sulphate Capsules in Mice and the Skin Sensitization Study of Empty Cellulose

Sulphate Capsules in Guinea Pigs.

To enable these studies to be performed, Austrianova manufactured an additional 400 syringes of empty

capsules for testing.

Some of the data being generated will also be used to demonstrate comparability with the CypCaps™ successfully

used in two earlier clinical trials for pancreatic cancer.

· Micro-Compression and Swelling Testing .

This project is developing and optimizing two reproducible methods for testing and confirming the physical stability and integrity of

the CypCaps™ product candidate.

These studies required the acquisition of new equipment by Austrianova as well as validation and

integration into Austrianova’s Quality Control laboratory.

· Break Force and Glide Testing .

the process of developing a protocol to measure whether the syringe, attached to the catheter when used to expel the capsules, will still

have a break and glide force that is within the specification that we have established.

We will set this specification based on the

syringe/plunger manufacturer’s measured break and glide forces, or alternatively, accepted ranges for glide forces routinely used

in the clinic.

· CypCaps Capsules Compatibility with the Syringe

and Other Components of the Microcatheter Delivery System .

We have commenced studies designed to show that CypCaps™ are not

in any way adversely affected by the catheters used by interventional radiologists to deliver them into a patient.

Compatibility data

is being generated to demonstrate that the quality of the CypCaps™ is maintained after passage through the planned microcatheter

· CypCaps Capsules and Cell Viability after

Exposure to Radiological Contrast Medium .

We have designed and commenced a project to test the effect of the exposure of CypCaps™

to two routinely used types of contrast medium that interventional radiologists use to implant the CypCaps™ in a patient.

medium is used to visualize the blood vessels during implantation of the CypCaps™.

· Master Drug File Information .

is providing additional detailed confidential information to the FDA on the manufacturing process, including information on the improvements

and advancements made to the product candidate since the last clinical trials were conducted with respect to reproducibility and safety.

However, Austrianova has not changed the overall physical characteristics of the CypCaps™.

We are supporting Austrianova financially

in this work.

· Additional Documentation Requested by the

We are in the process of updating our IND submission documentation, including extending its discussion on immunological

aspects of its treatment for LAPC.

· Pig Study .

Finally, we have designed

a study in pigs to address biocompatibility and long-term implantation and dispersion of its CypCaps™.

We believe this animal study

will complement the positive data already available from the previous human clinical trials showing the safety of CypCaps™ implantation

in human patients.

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.

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.

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 are shifting their resources away from clinical trials toward the care of COVID-19 patients.

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

As of the date of this Report, 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 that occur.

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

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

8 unchanged sentences

work completed to enable studies and trials to be submitted to regulatory agencies;

(v) complete all required tests and studies on the

cells and capsules we plan to use in our clinical trial in patients with LAPC;

and (vi) ensure completion of the production of encapsulated

cells according to cGMP regulations to use in our planned clinical trial involving LAPC.

(v) complete all required studies on the cells and

capsules we plan to use in our clinical trial in patients with LAPC;

and (vi) ensure completion of the production of encapsulated cells

according to cGMP regulations to use in our planned clinical trial involving LAPC.

There are numerous items required to be completed

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Results of Operations

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,

Three and nine months ended January 31, 2022, compared to three

and nine months ended January 31, 2021

We had no revenues for the three and nine months ended January 31,

2022, and 2021.

Operating Expenses and Loss from Operations

The following table summarizes our operating expenses

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,

and loss from operations for the three and nine months ended January 31, 2022, and 2021:

Three Months Ended January 31,

Nine Months Ended January 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.

ended January 31, 2022, increased by $99,272 from the three months ended January 31, 2021.

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.

in R&D expense of $93,022, an increase in general and administrative (“G&A”) expenses of $130,324, an increase in

legal and professional expense of $35,038, an increase in director fees of $18,944, net of a decrease in compensation expense of $178,056.

The increase in G&A expenses were mainly attributable to increases in consulting fees, filing fees and expenses related to our 2021

annual shareholders’ meeting.

The total operating expenses for the nine-month

period ended January 31, 2022, increased by $296,275 from the nine months ended January 31, 2021.

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.

in R&D expense of $205,031, an increase in G&A expenses of $544,583, an increase in legal and professional expense of $275,500,

an increase in director fees of $1,816 net of a decrease in compensation expense of $730,655.

The increase in G&A expenses were mainly

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

attributable to increases in consulting fees, filing fees and expenses related to our 2021 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,

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

and nine months ended January 31, 2022, and 2021:

Three Months Ended January 31,

Nine Months Ended January 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.

ended January 31, 2022, decreased by the amount of $45,078 from the three months ended January 31, 2021.

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.

to the increase of interest income of $45,459, a decrease in interest expense in the amount of $249, net of an increase in in foreign

exchange losses of $630.

Total other (income) expense for the nine months

ended January 31, 2022, decreased by the amount of $71,053 from the nine months ended January 31, 2021.

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.

the increase of interest income of $71,078, a decrease in interest expense in the amount of $1,497 net of an increase in income taxes

of $800 and an increase in foreign exchange losses of $722.

Discussion of Operating, Investing and Financing

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

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

Six Months Ended

October 31, 2021

October 31, 2020

for the nine months ended January 31, 2022, and 2021:

Nine Months Ended

January 31, 2022

January 31, 2021

Net cash used in operating activities:

4 unchanged sentences

Effect of currency rate exchange

Net increase in cash

Net increase in cash and cash equivalents

Operating Activities :

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

the nine months ended January 31, 2022, 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.

in operating activities for the nine months ended January 31, 2021, is a result of our net losses, an increase in securities issued for

services and compensation, decreases to prepaid expenses, accounts payable and accrued expenses.

See Condensed Consolidated Statements

of Cash Flows on page 7.

Investing Activities :

There were no investing activities in the six months ended October

There were no investing activities in the nine months ended January

31, 2022, and 2021.

1 unchanged sentence

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 issuance costs for the six

months ended October 31, 2021.

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 nine

months ended January 31, 2022.

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.

common stock, net of issuance costs and insurance financing for the nine months ended January 31, 2021.

Liquidity and Capital Resources

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.

As of January 31, 2022, our cash totaled approximately

$86.6 million, compared to approximately $3.1 million as of January 31, 2021.

Working capital was approximately $87 million as of January

31, 2022, and approximately $2.5 million as of January 31, 2021.

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,

During the nine months ended January 31, 2022,

funding in the amount of approximately $86.2 million was provided by investors to maintain and expand our operations and R&D.

1 unchanged sentence

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.

During the nine months ended January 31, 2021, 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

9 unchanged sentences

The total cost is estimated to be approximately $281,000, of which the related party portion will be approximately $215,000.

Critical Accounting Estimates and Policies

Our Condensed Consolidated Financial Statements

are prepared in accordance with U.S.

generally accepted accounting principles (“U.S.

We are required to make assumptions

and estimates about future events and apply judgments that affect the reported amounts of assets, liabilities, revenue and expenses and

the related disclosures.

We base our assumptions, estimates and judgments on historical experience, current trends and other factors that

management believes to be relevant at the time our Condensed Consolidated Financial Statements are prepared.

On a regular basis, management

reviews the accounting policies, assumptions, estimates and judgments to ensure that our Condensed Consolidated Financial Statements are

presented fairly and in accordance with U.S.

However, because future events and their effects cannot be determined with certainty,

actual results could differ from our assumptions and estimates, and such differences could be material.

Our significant accounting policies are described

in more detail in the Notes to our Condensed Consolidated Financial Statements of this Report.

Management believes that the following

accounting estimates are the most critical to aid in fully understanding and evaluating our reported financial results and require management’s

most difficult, subjective or complex judgments resulting from the need to make estimates about the effects of matters that are inherently

Management has reviewed these critical accounting estimates and related disclosures with our Board.

Our significant accounting

policies are described in more detail in the notes to our unaudited interim condensed financial statements.

New Accounting Pronouncements

4 unchanged sentences

Our website is located at www.PharmaCyte.com.

In addition, all our filings submitted to the Commission, including our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current

Reports on Form 8-K and all our other reports and statements filed with the Commission are available on the Commission’s web site

at www.sec.gov.

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

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.

In addition, all our filings submitted to the United States Securities Commission (“Commission”), including our Annual Reports

on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and all our other reports and statements filed with the Commission

are available on the Commission’s web site at www.sec.gov .

Such filings are also available for download free of charge on

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