What changed in this filing

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Item 1. Financial Statements

2022-03-15 compared with 2021-12-14 · 500 added, 387 removed, 650 unchanged (58% of the section changed)

3 unchanged sentences

Current assets:

Cash and cash equivalents

Prepaid expenses and other current assets

13 unchanged sentences

33,333,334 shares, $ 0.0001 par value;

20,715,804 and 1,590,084 shares issued and outstanding as of October 31, 2021, and April 30, 2021, respectively

20,720,204 and 1,590,084 shares issued and outstanding as of January 31, 2022, and April 30, 2021, respectively

Additional paid-in capital

10 unchanged sentences

Three Months Ended

Six Months Ended

Nine Months Ended

Operating expenses:

8 unchanged sentences

( 2,588,038 )

( 1,831,191 )

Other expenses:

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Three Months Ended

Six Months Ended

Nine Months Ended

$ ( 811,290 )

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CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS'

SIX MONTHS ENDED OCTOBER 31, 2021, AND 2020

NINE MONTHS ENDED JANUARY 31, 2022, AND 2021

Comprehensive

21 unchanged sentences

( 109,414,659 )

Stock issued for compensation

Stock issued for services

Stock-based compensation options

Foreign currency translation adjustment

Balance, January 31, 2022

$ 201,573,368

$ ( 110,225,949 )

Balance, April 30, 2020

15 unchanged sentences

( 105,692,395 )

Stock issued for compensation

Stock issued for services

Stock-based compensation options

Foreign currency translation adjustment

Balance, January 31, 2021

$ 114,083,323

$ ( 106,449,491 )

See accompanying Notes to Condensed Consolidated

2 unchanged sentences

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

Six Months Ended October 31,

Nine Months Ended January 31,

Cash flows from operating activities:

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Net cash provided by financing activities

Effect of currency rate exchange on cash

Net increase in cash

Cash at beginning of the period

Cash at end of the period

Supplemental disclosure of cash flows information:

Effect of currency rate exchange on cash and cash equivalents

Net increase in cash and equivalents

Cash and cash equivalents at beginning of the periods

Cash and cash equivalents at end of the periods

disclosure of cash flows information:

Cash paid during the periods for income taxes

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PharmaCyte Biotech, Inc.

is a biotechnology company focused on developing cellular therapies for cancer and diabetes based upon a proprietary cellulose-based live

cell encapsulation technology known as “Cell-in-a-Box ® ”.

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 pancreatic cancer (“LAPC”)

will be developed.

(“PharmaCyte” or “Company”) is a biotechnology company focused on developing cellular therapies for cancer

and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as

“Cell-in-a-Box ® ”.

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 pancreatic cancer (“LAPC”) will

be developed.

The current generation of the Company’s product candidate is referred to as “CypCaps™”.

September 1, 2020, the Company submitted an Investigational New Drug Application (“IND”) to the U.S.

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 the Company setting forth the reasons for the clinical

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

To lift the clinical hold, the FDA has informed

the Company that it needs 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.

The Company is

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

See “The Investigational

New Drug Application and the Clinical Hold” below.

September 1, 2020, the Company submitted an Investigational New Drug Application (“IND”) to the United States 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 the Company setting

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

the clinical hold, the FDA has informed the Company that it needs to conduct several additional preclinical studies.

requested additional information regarding several topics, including DNA sequencing data, manufacturing information and product

release specifications.

The Company is also in the process of conducting these studies and gathering additional information to

submit to the FDA.

See “The Investigational New Drug Application and the Clinical Hold” below.

The Cell-in-a-Box ® encapsulation

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They are protected from environmental challenges,

such as the sheer forces associated with bioreactors and passage through catheters and needles, which the Company believes enables greater

cell growth and production of the active molecules.

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

The Company believes that this enables

greater cell growth and production of the active molecules.

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

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In this way, the Company believes 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.

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, the Company has been exploring ways

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

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

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.

On November 30, 2021, the Company announced the commencement

of a pre-clinical study to determine if the treatment the Company uses for LAPC can also delay the rate of production and accumulation

of malignant ascites.

The Company has also been developing a potential

therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes.

The Company’s product candidate for the treatment of diabetes

consists of encapsulated genetically modified insulin-producing cells.

The encapsulation will be done using the Cell-in-a-Box ® technology.

Implanting these cells in the body is designed to function as a bio-artificial pancreas for purposes of insulin production.

to delay 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 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.

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

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

The Company has also been developing a

potential therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes.

The Company’s product candidate for the treatment

of diabetes consists of encapsulated genetically modified insulin-producing cells.

The encapsulation will be done using the

Cell-in-a-Box ® technology.

Implanting these cells in the body is designed to function as a bio-artificial pancreas

for purposes of insulin production.

The Company has also been considering ways to

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The Investigational New Drug Application and the Clinical Hold

On September 1, 2020, the

Company submitted an IND to the FDA for a planned Phase 2b clinical trial in LAPC.

Shortly thereafter, the Company received Information

Requests from the FDA related to the IND.

On September 1, 2020, the Company submitted an

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

Shortly thereafter, the Company received Information Requests from the FDA

related to the IND.

The Company timely responded to all Information Requests.

On October 1, 2020, the Company

received notice that the FDA had placed the Company’s IND on clinical hold.

On October 30, 2020, the FDA

sent a letter to the Company setting forth the reasons for the clinical hold and providing specific guidance on what the Company must

do to have the clinical hold lifted.

On October 1, 2020, the Company received notice

that the FDA had placed the Company’s IND on clinical hold.

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

the Company setting forth the reasons for the clinical hold and providing specific guidance on what the Company must do to have the clinical

In order to address the clinical hold, the FDA

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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 its Master Cell Bank;

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

Provide additional detailed description of the manufacturing process of the Company’s drug product candidate;

Provide additional product release specifications for the Company’s 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 the Company’s drug product candidate:

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

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

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

Provide additional detailed description of the manufacturing process of PharmaCyte’s product candidate;

Provide additional product release specifications for PharmaCyte’s 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 PharmaCyte’s 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;

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 the Company

address the following issues as an amendment to the IND:

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

The FDA also requested that the Company address

the following issues as an amendment to the IND:

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 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 the Company’s Angiography Procedure Manual;

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

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

Clarify the language in the Pharmacy Manual regarding proper use of the syringe fill with the 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.

The Company assembled a scientific

and regulatory team of experts to address the FDA requests.

The Company assembled a scientific and regulatory

team of experts to address the FDA requests.

That team is working to complete the items requested by the FDA.

is in varying stages of addressing the studies and acquiring the information requested by the FDA.

The following provides a summary

of the activities in which the Company is engaged to have the clinical hold lifted:

The Company 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.

The Company is involved in various additional studies required by the FDA.

These include (i) a stability study on the cells from its 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.

The Company is 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, the Company had Austrianova manufacture and deliver an additional 400 syringes of empty capsules.

The Company has 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™.

The Company has 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 the Company’s 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™.

The Company plans to update its 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.

The Company has 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.

The Company has completed a complement activation study.

The study results demonstrated that the capsule material the Company uses 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.”

Finally, the Company completed a biocompatibility study which showed that the empty capsule material is not “mutagenic.”

The Company is in varying

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

The following provides a summary of the activities

in which the Company is engaged to have the clinical hold lifted:

· Additional Regulatory Expertise Added to IND Team .

to its established team of experts, the Company has retained Biologics Consulting to perform a regulatory “Gap Analysis” and

to assist with the Company’s 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 the Company’s ability

to submit an acceptable IND to the FDA.

· Stability Studies on PharmaCyte’s Clinical Trial Product .

The Company has now successfully completed a product stability

study after 3, 6, 9, 12 and 18-months of storage frozen at -80C on the Company’s clinical trial product known as CypCaps™,

including container closure integrity testing for certain timepoints.

The next 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 .

The Company has 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™.

The Company is already at the 3-year stability

timepoint for the cells from its MCB.

The Company is 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 .

The Company has 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, the Company has 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 .

The Company has 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.

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 Company is in 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 the Company

has established.

The Company 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 .

The Company has

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 systems.

· CypCaps Capsules and Cell Viability after Exposure to Radiological Contrast Medium .

Company has 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.

The contrast medium is used to visualize the blood

vessels during implantation of the CypCaps™.

· Master Drug File Information .

Austrianova 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

The Company is supporting Austrianova financially in this work.

· Additional Documentation Requested by the FDA .

The Company is in the process of updating its IND submission documentation,

including extending its discussion on immunological aspects of its treatment for LAPC.

· Pig Study .

Finally, the Company has 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 the Company’s Operations

The coronavirus SARS-Cov2

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

Although the Company is not yet in

a clinical trial, the Company has 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, the Company has assessed the impact of COVID-19 on its operations.

Currently, many clinical trials are being 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 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 Report on Form 10-Q (“Report”),

the COVID-19 pandemic has had an impact upon the Company’s operations, although the Company 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 the Company’s planned clinical trial to treat LAPC may be delayed beyond the lifting of the clinical hold

by the FDA should that occur.

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

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

Although the Company is not yet in a clinical trial, the Company has

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, the Company

has assessed the impact of COVID-19 on its operations.

Currently, many clinical trials are being 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

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 Report on Form 10-Q (“Report”), the COVID-19 pandemic has had an impact upon

the Company’s operations, although the Company believes 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.

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 the Company’s planned clinical trial to treat LAPC may be delayed beyond the lifting of the clinical hold by the FDA should that

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 the Company’s

clinical development program if the FDA allows it to proceed.

It is highly speculative in

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

of COVID-19 may 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 subside.

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 the Company’s clinical development

program if the FDA allows it to proceed.

It is highly speculative in projecting the effects

of COVID-19 on the Company’s 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 is able to say with certainty when the pandemic will

Company Operations

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The restructuring

resulted in the Company focusing all its efforts upon the development of a novel, effective and safe way to treat cancer and diabetes.

In January 2015, the Company changed its name from Nuvilex, Inc.

resulted in PharmaCyte focusing its efforts upon the development of a novel, effective and safe way to treat cancer and diabetes.

2015, the Company changed its name from Nuvilex, Inc.

to PharmaCyte Biotech, Inc.

to reflect the nature of its current business.

In October 2021, the Company moved its office to Las Vegas, Nevada.

2021, the Company moved its headquarters to Las Vegas, Nevada.

Increase in Authorized Shares

1 unchanged sentence

at the Annual Meeting of Stockholders, the Company filed with the Secretary of State of the State of Nevada a Certificate of Amendment

to its Articles of Incorporation, as amended, to increase the number of authorized shares to fifty billion ten million (50,010,000,000)

, of which fifty billion (50,000,000,000) shares, with a par value of $0.0001 per share are designated as common stock and of which ten

to its Articles of Incorporation, as amended, to increase the number of authorized shares to fifty billion ten million (50,010,000,000), of which fifty billion (50,000,000,000) shares, with a par value of $0.0001 per share, are designated as common stock and of which ten

million (10,000,000) shares, with a par value of $0.0001 per share, are designated as preferred stock.

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Nasdaq Listing

The Company’s common stock began trading

on Nasdaq on August 10, 2021, under the symbol “PMCB.” Prior to that, the Company’s common stock was quoted on the OTCQB

PharmaCyte’s common stock began trading

on Nasdaq on August 10, 2021, under the symbol “PMCB.” Prior to that, PharmaCyte’s common stock was quoted on the OTCQB

Market under the symbol “PMCB.” Following the reverse stock split (discussed below) of the Company’s common stock on

9 unchanged sentences

Except as otherwise indicated, all share and per

share information in the accompanying consolidated financial statements and related footnotes gives effect to the reverse stock split

of the Company’s common stock.

share information in the accompanying Condensed Consolidated Financial Statements and related footnotes gives effect to the reverse stock

split of the Company’s common stock.

NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING

Principles of Consolidation and Basis of Presentation

The consolidated financial statements include

the accounts of the Company and its wholly owned subsidiaries.

The Company operates independently and through four wholly owned subsidiaries:

The Condensed Consolidated Financial Statements

include the accounts of the Company and its wholly owned subsidiaries.

The Company operates independently and through four wholly owned

subsidiaries:

(i) Bio Blue Bird;

(ii) PharmaCyte Biotech Europe Limited;

(iii) PharmaCyte Biotech Australia Pty.

and (iv) Viridis Biotech, Inc.

(iii) PharmaCyte Biotech Australia Private Limited;

Viridis Biotech, Inc.

and are prepared in accordance with generally accepted accounting principles in the United States (“U.S.

GAAP”) and the rules

and regulations of the United States Securities and Exchange Commission (“Commission”).

Upon consolidation, intercompany balances

and transactions are eliminated.

The Company’s 14.5 % investment in SG Austria is presented on the cost method of accounting.

Upon consolidation, intercompany balances and transactions are eliminated.

The Company’s 14.3 % investment in SG Austria is presented

on the cost method of accounting.

Use of Estimates in the Preparation of Financial

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response to the COVID-19 pandemic and may change materially in future periods.

Cash and Cash Equivalents

Cash and cash equivalents include cash in banks

and short-term liquid investments purchased with maturities of three months or less.

Intangible Assets

12 unchanged sentences

The Company concluded that there was no impairment

of the carrying value of the intangible assets for the six months ended October 31, 2021, and 2020, respectively.

of the carrying value of the intangible assets for the nine months ended January 31, 2022, and 2021.

Impairment of Long-Lived Assets

4 unchanged sentences

be recorded to reduce the related asset to its estimated fair value.

No impairment was identified or recorded for six months ended October

31, 2021, and 2020.

No impairment was identified or recorded for the nine months ended

January 31, 2022, and 2021.

Fair Value of Financial Instruments

8 unchanged sentences

The carrying amounts reported

in the consolidated balance sheets for current liabilities qualify as financial instruments and are a reasonable estimate of their fair

values because of the short period between the origination of such instruments and their expected realization and their current market

rate of interest.

in the condensed consolidated balance sheets for current liabilities qualify as financial instruments and are a reasonable estimate of

their fair values because of the short period between the origination of such instruments and their expected realization and their current

market rate of interest.

The three levels of valuation hierarchy are defined as follows:

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liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment.

A valuation allowance is provided for deferred

income tax assets when, in management’s judgment, based upon currently available information and other factors, it is more likely

than not that all or a portion of such deferred income tax assets will not be realized.

The determination of the need for a valuation

allowance is based on an on-going evaluation of current information including, among other things, historical operating results, estimates

of future earnings in different taxing jurisdictions and the expected timing of the reversals of temporary differences.

The Company believes

the determination to record a valuation allowance to reduce a deferred income tax asset is a significant accounting estimate because it

is based on, among other things, an estimate of future taxable income in the U.S.

and certain other jurisdictions, which is susceptible

to change and may or may not occur, and because the impact of adjusting a valuation allowance may be material.

In determining when to

release the valuation allowance established against the Company’s net deferred income tax assets, the Company considers all available

evidence, both positive and negative.

Consistent with the Company’s policy, and because of the Company’s history of operating

losses, the Company does not currently recognize the benefit of all its deferred tax assets, including tax loss carry forwards, which

may be used to offset future taxable income.

The Company continually assesses its ability to generate sufficient taxable income during

future periods in which deferred tax assets may be realized.

When the Company believes it is more likely than not that it will recover

its deferred tax assets, the Company will reverse the valuation allowance as an income tax benefit in the statements of operations.

A valuation allowance is provided for

deferred income tax assets when, in management’s judgment, based upon currently available information and other factors, it is

more-likely-than-not that all or a portion of such deferred income tax assets will not be realized.

The determination of the need

for a valuation allowance is based on an on-going evaluation of current information including, among other things, historical

operating results, estimates of future earnings in different taxing jurisdictions and the expected timing of the reversals of

temporary differences.

The Company believes the determination to record a valuation allowance to reduce a deferred income tax asset

is a significant accounting estimate because it is based on, among other things, an estimate of future taxable income in the United

States (“U.S.”) and certain other jurisdictions, which is susceptible to change and may or may not occur, and because

the impact of adjusting a valuation allowance may be material.

In determining when to release the valuation allowance established

against the Company’s net deferred income tax assets, the Company considers all available evidence, both positive and

Consistent with the Company’s policy, and because of the Company’s history of operating losses, the Company

does not currently recognize the benefit of all its deferred tax assets, including tax loss carry forwards, which may be used to

offset future taxable income.

The Company continually assesses its ability to generate sufficient taxable income during future

periods in which deferred tax assets may be realized.

When the Company believes it is more-likely-than-not that it will recover its

deferred tax assets, the Company will reverse the valuation allowance as an income tax benefit in the statements of operations.

GAAP method of accounting for uncertain

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period in which the more-likely-than-not standard is met, the issue is resolved with the taxing authorities, or the statute of limitations

Positions previously recognized are derecognized when the Company subsequently determines the position no longer is more likely

than not to be sustained.

Positions previously recognized are derecognized when the Company subsequently determines the position no longer is more-likely-than-not to be sustained.

Evaluation of tax positions, their technical merits and measurements using cumulative probability are highly

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Aid, Relief and Economic Security Act (“CARES Act”) to provide certain relief as a result of the Coronavirus Disease 2019

The Company maintains a full valuation allowance on its United States (“U.S”) net deferred tax assets.

The Company maintains a full valuation allowance on its U.S, net deferred tax assets.

tax asset remeasurement (tax expense) was offset by a net decrease in valuation allowance, that resulted in no impact on the Company's

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Costs to acquire technologies,

including licenses, that are utilized in research and development and that have no alternative future use are expensed when incurred.

Technology developed for use in the Company’s product candidates is expensed as incurred until technological feasibility has been

R&D expenses for the three months ended October

31, 2021, and 2020 were $ 135,220 and $ 151,314 , respectively, and for the six months ended October 31, 2021, and 2020 were $ 278,833 and

$ 421,888 , respectively.

including licenses, that are utilized in R&D and that have no alternative future use are expensed when incurred.

Technology developed

for use in the Company’s product candidates is expensed as incurred until technological feasibility has been established.

R&D expenses for the three months ended

January 31, 2022, and 2021 were $ 158,039

and $ 174,088 , respectively, and for the

nine months ended January 31, 2022, and 2021 were $ 436,872

and $ 595,976 , respectively.

Stock-Based Compensation

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concentrations of credit risk such as foreign exchange contracts, options contracts, or other foreign hedging arrangements.

maintains most of its cash balance at a financial institution located in California.

Accounts at this institution are insured by the Federal

Deposit Insurance Corporation up to $250,000.

Uninsured balances aggregated approximately $ 86,658,000 as of October 31, 2021, and $ 1,921,000

as of April 30, 2021.

maintains most of its cash balance at financial institutions located throughout the U.S.

Accounts at these institutions are insured by

the Federal Deposit Insurance Corporation up to $250,000 for each financial institution.

Uninsured balances aggregated approximately $ 36,356,000

as of January 31, 2022, and $ 1,921,000 as of April 30, 2021.

The Company has not experienced any losses in such accounts.

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On November 17, 2021, the Company’s Registration Statement on Form S-3 registering

the resale of the common stock underlying the Series A Warrants was declared effective by the Commission (see Note 13 – Subsequent

the resale of the common stock underlying the Series A Warrants was declared effective by the U.S.

Securities and Exchange Commission

(“Commission”).

Deferred Offering Costs

The Company complies with the requirements of

FASB ASC 340-10-S99-1 and SEC Staff Accounting Bulletin Topic 5A — “Expenses of Offering.” Offering costs were $ 8,362,137

(including $ 7,116,445 in underwriters' fees and $ 108,979 in selling concessions), consisting principally of costs incurred in connection

with formation and preparation for the Public Offerings.

These costs, together with the underwriters’ discount were charged to additional

paid in capital upon closing of the Public Offerings on August 9 and 19, 2021.

The Company complies with the requirements

of FASB ASC 340-10-S99-1 and SEC Staff Accounting Bulletin Topic 5A — “Expenses of Offering.” Offering costs were

(including $ 7,116,445

in underwriters' fees and $ 108,979

in selling concessions), consisting principally of costs incurred in connection with formation and preparation for the Company

offering securities to the public (“Public Offerings”).

These costs, together with the

underwriters’ discount, were charged to additional paid-in capital upon closing of the Public Offerings on August 9 and 19,

Recent Accounting Pronouncements

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result in the earlier recognition of allowances for losses.

The Company’s adoption of ASU 2016-13 during the period ended October

The Company’s adoption of ASU 2016-13 during the period ended July

31, 2020, did not result in an impact on the Company’s condensed consolidated financial statements.

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by eliminating certain exceptions and implementing additional requirements which result in a more consistent application of ASC 740.

Company’s adoption of ASU 2019-12 during the period ended October 31, 2021, did not result in an impact on the Company’s condensed

Company’s adoption of ASU 2019-12 during the period ended July 31, 2021, did not result in an impact on the Company’s Condensed

Consolidated Financial Statements.

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NOTE 3 – ACCRUED EXPENSES

Accrued expenses as of October 31, 2021, and April

Accrued expenses as of January 31, 2022, and April

30, 2021, are summarized below:

Schedule of accrued expenses

October 31, 2021

January 31, 2022

April 30, 2021

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rate of 4.85 % per annum and required eight monthly payments of $ 12,829 .

The unpaid balances as of October 31, 2021, and April 30, 2021,

The unpaid balances as of January 31, 2022, and April 30, 2021,

of $ 0 and $ 50,805 , respectively, are included in accrued expenses.

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Protection Program (“PPP”) in the amount of $ 75,200 .

This PPP loan will mature on April 15, 2022 , with a fixed interest rate

of 1 % per annum with interest deferred for six months.

The PPP loan has an initial term of two years, is unsecured and guaranteed by the

This PPP loan was to mature on April 15, 2022 , with a fixed interest

rate of 1 % per annum with interest deferred for six months.

The PPP loan has an initial term of two years, is unsecured and guaranteed

The Company used the proceeds from the PPP loan

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A summary of the Company’s compensatory

stock activity and related weighted average grant date fair value information for the three and six months ended October 31, 2021, and

stock activity and related weighted average grant date fair value information for the three and nine months ended January 31, 2022, and

2021 is as follows:

During the year ended April 30, 2020, four non-employee

members of the Board were issued 1,333 shares of common stock pursuant to their Director Letter Agreements (“DLAs”) and relating

to their services for the prior year.

During the year ended April 30, 2020, four

non-employee members of the Board were issued 1,333 shares

of common stock pursuant to their Director Letter Agreements (“DLAs”) and relating to their services for the prior year.

The shares were fully vested upon issuance.

The Company recorded a non-cash expense of $ 0 and

for the three months ended October 31, 2021, and 2020, respectively, and $ 0 and $ 10,561 for the six months ended October 31, 2021, and

2020, respectively.

There were 0 zero unvested shares of common stock remaining related to these DLAs as of October 31, 2021, and 2020.

In January 2020, the Company awarded 4,400 shares

of common stock to the executive officers of the Company as part of their compensation agreements for 2020.

These shares vest monthly

over a twelve-month period and are subject to the executive officers continuing service under their respective employment agreement with

During the three months ended October 31, 2021, and 2020, respectively, the Company recorded a non-cash compensation expense

in the amount of $ 0 and $ 67,320 , respectively, and $ 0 and $ 134,640 for the six months ended October 31, 2021, and 2020, respectively.

There were 0 zero and 733 unvested shares as of October 31, 2021, and 2020, respectively.

During the six months ended October 31, 2020,

the four independent directors on the Board were issued 1,334 shares of common stock pursuant to their DLAs in respect of their service

during that year.

The shares were fully vested upon issuance.

The Company recorded a non-cash expense of $ 971 and $ 9,419 for the three

months ended October 31, 2021, and 2020, respectively, and $ 4,342 and $ 16,448 for the six months ended October 31, 2021, and 2020, respectively.

There were 0 zero unvested shares remaining related to such DLAs as of October 31, 2021, and 2020.

During the six months ended October 31, 2020,

the three months ended January 31, 2022, and 2021, respectively, and $ 0 and

the nine months ended January 31, 2022, and 2021, respectively.

There were zero unvested

shares of common stock remaining related to these DLAs as of January 31, 2022, and 2021.

In January 2020, the Company awarded 4,400

shares of common stock to the executive officers of the Company as part of their compensation agreements for 2020.

vested monthly over a twelve-month period and are subject to the executive officers continuing service under their respective employment

agreement with the Company.

During the three months ended January 31, 2022, and 2021, respectively, the Company recorded a non-cash compensation

expense in the amount of $ 0

and $ 44,881 ,

respectively, and $ 0

and $ 179,521

for the nine months ended January 31, 2022, and 2021, respectively.

There were zero

unvested shares as of January 31, 2022, and 2021.

During the nine months ended January 31, 2021,

the four independent directors on the Board were issued 1,334

shares of common stock pursuant to their DLAs in respect of their service during that year.

The shares were fully vested upon

The Company recorded a non-cash expense of $ 0

for the three months ended January 31, 2022, and 2021, respectively, and $ 4,342

for the nine months ended January 31, 2022, and 2021, respectively.

There were zero

unvested shares remaining related to such DLAs as of January 31, 2022, and 2021.

During the nine months ended January 31, 2021,

four consultants were issued 667 shares of common stock pursuant to their consulting agreements with the Company.

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over a twelve-month period and are subject to the consultants continuing to provide services under their consulting agreements.

recorded a non-cash consulting expense in the amount of $ 0 and $ 5,409 for the three months ended October 31, 2021, and 2020, respectively,

and $ 0 and $ 9,608 for the six months ended October 31, 2021, and 2020, respectively.

recorded a non-cash consulting expense in the amount of $ 0 and $ 5,409 for the three months ended January 31, 2022, and 2021, respectively,

and $ 0 and $ 15,017 for the nine months ended January 31, 2022, and 2021, respectively.

There were zero and 167 unvested shares remaining

related to these consulting agreements as of October 31, 2021, and 2020, respectively.

related to these consulting agreements as of January 31, 2022, and 2021, respectively.

In September 2020, a consultant was issued 333

shares of common stock in respect of his services as the Chairman of the Company’s Medical and Scientific Advisory Board with vesting

subject to the consultant continuing to provide services to the Company.

The Company recorded a non-cash consulting expense in the amount

of $ 1,417 and $ 708 for the three months ended October 31, 2021, and 2020, respectively and $ 3,542 and $ 708 for the six months ended October

31, 2021, and 2020, respectively.

There were 0 zero unvested shares remaining related to his compensation arrangement as of October 31,

shares of common stock in respect of his services as the Chairman of the Company’s Medical and Scientific Advisory Board

with vesting subject to the consultant continuing to provide services to the Company.

The Company recorded a non-cash consulting expense

in the amount of $ 0

for the three months ended January 31, 2022, and 2021, respectively, and $ 3,542

for the nine months ended January 31, 2022, and 2021, respectively.

There were zero

unvested shares remaining related to his compensation arrangement as of January 31, 2022, and 2021.

In January 2021, the Company awarded 4,400 shares

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over a twelve-month period and are subject to the executive officers continuing to provide service under their compensation agreements.

During the three and six months ended October 31, 2021, the Company recorded a non-cash compensation expense in the amount of $ 11,055

and $ 22,110 , respectively.

There were 733 unvested shares as of October 31, 2021.

During the six months ended October 31, 2021,

During the three months ended January 31, 2022, and 2021, the Company recorded a non-cash compensation expense in the amount of $ 7,370

and $ 3,685 , respectively, and $ 29,480 and $ 3,685 for the nine months ended January 31, 2022, and 2021, respectively.

There were 0 and

4,033 unvested shares as of January 31, 2022, and 2021, respectively.

During the nine months ended January 31, 2022,

four non-employee members of the Board were issued 1,336 shares of common stock pursuant to their DLAs in respect of their service during

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The Company recorded a non-cash expense of $ 6,056 and $ 16,792 for the three and

six months ended October 31, 2021, respectively.

There were zero unvested shares remaining related to such DLAs as of October 31, 2021.

During the six months ended October 31, 2021,

nine months ended January 31, 2022, respectively.

There were zero unvested shares remaining related to such DLAs as of January 31, 2022.

During the nine months ended January 31, 2022,

two consultants were issued 334 shares of common stock pursuant to their consulting agreements with the Company.

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over a twelve-month period and are subject to the consultants continuing to provide services under their consulting agreements.

recorded a non-cash consulting expense in the amount of $ 2,442 and $ 4,062 for the three and six months ended October 31, 2021, respectively.

There were 167 unvested shares remaining related to these consulting agreements as of October 31, 2021.

recorded a non-cash consulting expense in the amount of $ 2,442 and $ 6,504 for the three and nine months ended January 31, 2022, respectively.

There were 84 unvested shares remaining related to these consulting agreements as of January 31, 2022.

In September 2021, a consultant was issued 334

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The Company recorded a non-cash consulting expense in the amount

of $ 88 and $ 88 for the three and six months ended October 31, 2021, respectively.

There were zero unvested shares remaining related to

his compensation arrangement as of October 31, 2021.

of $ 265 and $ 353 for the three and nine months ended January 31, 2022, respectively.

There were zero unvested shares remaining related

to his compensation arrangement as of January 31, 20221.

In January 2022, the Company awarded 4,400 shares

of common stock to the executive officers of the Company as part of their compensation agreements for 2022.

These shares vest monthly

over a twelve-month period and are subject to the executive officers continuing to provide service under their compensation agreements.

During the three and nine months ended January 31, 2022, the Company recorded a non-cash compensation expense in the amount of $ 916 and

$ 916 , respectively.

There were 4,033 unvested shares as of January 31, 2022.

All shares were issued without registration under

the Securities Act in reliance upon the exemption afforded by Section 4(a)(2) of the Securities Act.

the Securities Act of 1933, as amended (“Securities Act”) in reliance upon the exemption afforded by Section 4(a)(2) of the

Securities Act.

On September 28, 2017, an S-3 Registration Statement

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of up to $50 million of its securities on a “shelf offering” basis.

During the six months ended October 31, 2020, the Company

During the nine months ended January 31, 2021, the Company

sold and issued approximately 462,000 shares of common stock, at prices ranging from approximately $15 to $45 per share.

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discounts, legal, accounting, and other offering expenses, the Company received proceeds of approximately $ 4.7 million from the sale of

these shares for the six months ended October 31, 2020.

these shares for the nine months ended January 31, 2021.

On April 9, 2021, the Third S-3 (“Third S-3”) was declared effective

by the Commission for a public offering of up to $100 million on a “shelf offering” basis.

During the six months ended October

During the nine months ended January

31, 2022, the Company sold and issued approximately 19.1 million shares of common stock, at prices ranging from $4.25 to $5.00 per share.

Net of underwriting discounts, legal, accounting, and other offering expenses, the Company received approximately $ 87.4 million from the

sale of these shares and the exercise of approximately 2.5 million warrant shares for the six months ended October 31, 2021.

sale of these shares and the exercise of approximately 2.5 million warrant shares for the nine months ended January 31, 2022.

A summary of the Company’s non-vested restricted

stock activity and related weighted average grant date fair value information for the six months ended October 31, 2021, are as follows:

stock activity and related weighted average grant date fair value information for the nine months ended January 31, 2022, are as follows:

Schedule of non-vested restricted stock activity

Unvested, on April 30, 2021

Unvested, on October 31, 2021

Unvested, on January 31, 2022

NOTE 6 – STOCK OPTIONS AND WARRANTS

Stock Options

As of October 31, 2021, the Company had 42,667

outstanding stock options to its directors and officers (collectively, “Employee Options”) and consultants (“Non-Employee

During the six months ended October 31, 2021,

As of January 31, 2022, the Company had 48,667

outstanding stock options to its directors and officers (“Employee Options”) and consultants (“Non-Employee Options”).

During the nine months ended January 31, 2022,

and 2021, the Company granted 7,334 and 7,334 Employee Options, respectively.

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Assumptions for options

Six Months Ended October 31,

Nine Months Ended January 31,

Risk-free interest rate

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is based on the historical daily volatility of its publicly traded stock.

For stock option grants issued during the six months ended October

31, 2021, and 2020, the Company used a calculated volatility for each grant.

The Company lacks adequate information about the exercise

behavior now and has determined the expected term assumption under the simplified method provided for under ASC 718, which averages the

contractual term of the Company’s stock options of five years with the average vesting term of two and one-half years for an average

of three years.

The dividend yield assumption of zero is based upon the fact the Company has never paid cash dividends and presently has

no intention of paying cash dividends.

For stock option grants issued during the nine months ended

January 31, 2022, and 2021, the Company used a calculated volatility for each grant.

The Company lacks adequate information about the

exercise behavior now and has determined the expected term assumption under the simplified method provided for under ASC 718, which averages

the contractual term of the Company’s stock options of five years with the average vesting term of two and one-half years for an

average of three years.

The dividend yield assumption of zero is based upon the fact the Company has never paid cash dividends and presently

has no intention of paying cash dividends.

The risk-free interest rate used for each grant is equal to the U.S.

Treasury rates in effect at

the time of the grant for instruments with a similar expected life.

Treasury rates in effect

at the time of the grant for instruments with a similar expected life.

A summary of the Company’s stock option

activity and related information for the six months ended October 31, 2021, are shown below:

activity and related information for the nine months ended January 31, 2022, are shown below:

Stock option activity

Exercise Price

Outstanding, April 30, 2021

Outstanding, October 31, 2021

Exercisable, October 31, 2021

Outstanding, January 31, 2022

Exercisable, January 31, 2022

Vested and expected to vest

A summary of the activity for unvested stock options

during the six months ended October 31, 2021, is as follows:

during the nine months ended January 31, 2022, is as follows:

Unvested stock option activity

Unvested, April 30, 2021

Unvested, October 31, 2021

Unvested, January 31, 2022

The Company recorded $ 7,365 and $ 38,606 of stock-based

compensation related to the issuance of Employee Options to certain officers and directors in exchange for services during the six months

ended October 31, 2021, and 2020, respectively, and $ 34,528 , and $ 128,376 during the six months ended October 31, 2021, and 2020, respectively.

On October 31, 2021, there remained $ 6,390 of unrecognized compensation expense related to unvested Employee Options granted to officers

and directors, to be recognized as expense over a weighted-average period of the remaining two months in the calendar year.

compensation related to the issuance of Employee Options to certain officers and directors in exchange for services during the three months

ended January 31, 2022, and 2021, respectively, and $ 41,893 , and $ 166,982 during the nine months ended January 31, 2022, and 2021, respectively.

On January 31, 2022, there remained $ 10,695 of unrecognized compensation expense related to unvested Employee Options granted to officers

and directors, to be recognized as expense over a weighted-average period of the remaining eleven months in the calendar year.

options vest at 500 shares per month and are expected to be fully vested on December 31, 2022.

The following table summarizes the outstanding

stock options by exercise price on October 31, 2021:

stock options by exercise price on January 31, 2022:

Schedule of options by exercise price

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The aggregate intrinsic value of outstanding options

as of October 31, 2021, was $ 0 .

as of January 31, 2022, was $ 0 .

This represents options whose exercise price was less than the closing fair market value of the Company’s

common stock on October 31, 2021, of approximately $ 2.82 per share.

common stock on January 31, 2022, of approximately $ 2.14 per share.

The warrants issued by the Company are equity-classified.

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2020-06 Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging — Contracts in

Entity’s Own Equity (Subtopic 815-40) during its second quarter ended October 31, 2021, as is effective for fiscal years

Entity’s Own Equity (Subtopic 815-40) during the period October 31, 2021, as is effective for fiscal years

beginning after December 15, 2021, including interim periods within those fiscal years, and the Company’s fiscal year began on

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Wainwright & Co., LLC (“Wainwright”).

The warrants have a term of five years with an exercise price of $ 4.25 per warrant share, are fully vested upon issuance and have a cashless exercise feature.

Using the Black-Scholes-Merton option pricing model, the Company determined the aggregate fair value of these warrants to be approximately

$ 9,385,000 .

Additionally, with respect to the First

Offering, the Company issued common stock warrant agreements to Wainwright (“Underwriter Warrants”) to purchase 264,706 shares

of common stock.

The warrants have a term of five years with an exercise price of

warrant share, are fully vested upon issuance and have a cashless exercise feature.

The Common Warrants have a term of five years with an exercise price of $ 4.25 per warrant share, are fully vested upon issuance and have

a cashless exercise feature.

Using the Black-Scholes-Merton option pricing model, the Company determined the aggregate fair value of these

warrants to be approximately $ 601,000 .

Common Warrants to be approximately $ 9,385,000 .

Additionally, with respect to the First Offering,

the Company issued common stock warrant agreements to Wainwright (“Underwriter Warrants”) to purchase 264,706 shares of common

The Underwriter Warrants have a term of five years with an exercise price of $ 5.3125 per warrant share, are fully vested upon issuance

and have a cashless exercise feature.

Using the Black-Scholes-Merton option pricing model, the Company determined the aggregate fair value

of these Underwriter Warrants to be approximately $ 601,000 .

Effective August 12, 2021, the Company issued

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institutional investors.

The warrants have a term of five years with an exercise price

of $ 5.00 per warrant share, are fully vested upon issuance, have a cashless exercise feature and are exercisable immediately.

Using the Black-Scholes-Merton option pricing model, the Company determined

the aggregate fair value of these warrants to be approximately $ 21,340,000 .

The Series A Warrants have a term of five years with an exercise price of $ 5.00 per warrant share, are fully

vested upon issuance, have a cashless exercise feature and are exercisable immediately.

Using the Black-Scholes-Merton option pricing

model, the Company determined the aggregate fair value of these Series A Warrants to be approximately $ 21,340,000 .

Effective August 23, 2021, the Company issued

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acting as placement agent.

The warrants have a term of five years with an exercise price

of $ 6.25 per warrant share, are fully vested upon issuance, have a cashless exercise feature and are exercisable immediately.

Using the Black-Scholes-Merton option pricing model, the Company determined

the aggregate fair value of these warrants to be approximately $ 3,151,000 .

The Placement Agent Warrants have a term of five years with an exercise price of $ 6.25 per warrant share, are

fully vested upon issuance, have a cashless exercise feature and are exercisable immediately.

Using the Black-Scholes-Merton option pricing

model, the Company determined the aggregate fair value of these Placement Agent Warrants to be approximately $ 3,151,000 .

Effective August 23, 2021, the Company issued

Pre-funded Warrants pursuant to the registered direct offering to purchase 5,570,000 shares of common stock in the amount of approximately $ 27,844,000 which required

payments upon

issuance of $4.999 per warrant share.

The Pre-funded Warrants have an exercise price of $ 0.001 per share, are fully vested upon issuance, are immediately exercisable,

have a cashless exercise feature and do not have an expiration date.

As of October 31, 2021, 4,620,000 of the Pre-funded Warrants have

been exercised for aggregate gross proceeds of $ 4,620 .

Pre-funded Warrants pursuant to the Registered Direct Offering to purchase 5,570,000 shares of common stock in the amount of approximately

$ 27,844,000 which required payments upon issuance of $4.999 per warrant share.

The Pre-funded Warrants have an exercise price of $ 0.001

per share, are fully vested upon issuance, are immediately exercisable, have a cashless exercise feature and do not have an expiration

As of January 31, 2022, 4,620,000 of the Pre-funded Warrants have been exercised for aggregate gross proceeds of $ 4,620 .

In August 2021, the Company received twenty-seven

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received approximately $ 10,720,000 and issued 2,522,387 shares of common stock as a result of the exercise notices.

Series A Warrants and Placement Agent Warrants

were issued pursuant to the Securities Purchase Agreement dated as of August 19, 2021.

At the time the Series A Warrants and the Placement

Agent Warrants were issued, neither the Series A Warrants, the Placement Agent Warrants nor the underlying common stock was registered

pursuant to the Securities Act.

The Company registered the common stock underlying the Series A Warrants and the Placement Agent Warrants

pursuant to a Registration Statement on Form S-3 (“Registration Statement”) filed with the Commission on November 8, 2021.

The Registration Statement became effective on November 17, 2021.

A summary of the Company’s warrant activity

and related information for the six months ended October 31, 2021, are shown below:

and related information for the nine months ended January 31, 2022, are shown below:

Warrant activity

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( 8,041,414 )

Outstanding, October 31, 2021

Exercisable, October 31, 2021

Outstanding, January 31, 2022

Exercisable, January 31, 2022

The following table summarizes additional information

concerning warrants outstanding and exercisable on October 31, 2021:

concerning warrants outstanding and exercisable on January 31, 2022:

Schedule of warrants outstanding and exercisable

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Exercisable at

October 31, 2021

January 31, 2022

Exercise Price

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The Company had the following related party transactions

during the three and six months ended October 31, 2021, and 2020.

during the three and nine months ended January 31, 2022, and 2021.

The Company owns 14.3 % of the equity in SG Austria

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The Company purchased products and services from

these companies in the approximate amounts of $ 53,000 and $ 111,000 in the three and six months ended October 31, 2021, respectively, and

$ 10,000 and $ 74,000 in the three and six months ended October 31, 2020, respectively.

these companies in the approximate amounts of $ 63,000 and $ 174,000 in the three and nine months ended January 31, 2022, respectively,

and $ 110,000 and $ 184,000 in the three and nine months ended January 31, 2021, respectively.

In April 2014, the Company entered a Consulting

Agreement with Vin-de-Bona Trading Company, Pte.

(“Vin-de Bona”) pursuant to which it agreed to provide professional

(“Vin-de Bona”) pursuant to which Vin-de-Bona agreed to provide professional

consulting services to the Company.

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The agreement has been automatically renewed annually.

The amounts incurred for the three and six months ended October 31, 2021, were

approximately $ 18,000 and $ 50,000 , respectively, and $ 21,000 and $ 44,000 for the three and six months ended October 31, 2020, respectively.

In addition, during the six months ended October 31, 2021, and 2020 the Company issued 0 and 167 shares of common stock, respectively,

The Company recorded a noncash consulting expense of approximately $ 0 and $ 2,300 relating to these share issuances for

the six months ended October 31, 2021, and 2020, respectively.

The amounts incurred for the three and nine months ended January 31, 2022, were

approximately $ 29,000 and $ 79,000 , respectively, and $ 21,000 and $ 65,000 for the three and nine months ended January 31, 2021, respectively.

In addition, during the nine months ended January 31, 2022, and 2021 the Company issued 0 and 167 shares of common stock, to Dr.

The Company recorded a noncash consulting expense of approximately $ 0 and $ 2,300 relating to these share issuances for the nine months

ended January 31, 2022, and 2021, respectively.

NOTE 9 – COMMITMENTS AND CONTINGENCIES

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six-month lease of this office space, commencing on September 1, 2021, which expires on February 28, 2022.

In October 2021, the Company entered into a lease

for its office space in Las Vegas, Nevada.

In October 2021, the Company moved the Company’s

headquarter from Laguna Hills, California to Las Vegas.

In doing so, the Company entered into a lease for office space in Las

Vegas, Nevada.

The term of the lease expires on April 30, 2022.

Rent expense for the office leases for the

three and six months ended October 31, 2021, were $ 4,154

and $ 7,892 ,

respectively, and for the three and six months ended October 31, 2020, were $ 5,384

and $ 12,536 ,

respectively.

In January 2022, the Company entered into an additional

six-month lease of the Las Vegas, Nevada office space, commencing on May 1, 2022, which expires on October 31, 2022.

Rent expense for the office leases for the three

and nine months ended January 31, 2022, were $ 6,103 and $ 13,995 , respectively, and for the three and nine months ended January 31, 2021,

were $ 5,288 and $ 17,824 , respectively.

The following table summarizes the Company’s

aggregate future minimum lease payments required under the operating lease as of:

Schedule of future minimum rental payments for operating leases

Period Ending April 30, 2022

Schedule of future minimum lease payments

Periods Ending

April 30, 2022

April 30, 2023

Compensation Agreements

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agreements with the Board members, and the terms of each compensation agreement continues in effect until a member is no longer on the

The Company has four independent directors.

director receives the same compensation:

As of January 31, 2022, the Company had four independent

Each director receives the same compensation:

(i) $12,500 in cash for each calendar quarter of service on the Board;

(ii) 333 fully paid, non-assessable

shares of the Company’s restricted common stock (“Shares”) annually;

and (iii) a five-year option to purchase 333 Shares

annually at an exercise price equal to the fair market value of the Shares on the date of grant.

The Shares and the option Shares fully

vest on the date of the grants.

fully paid, non-assessable shares of the Company’s restricted common stock (“Shares”) annually;

and (iii) a five-year

option to purchase 333 Shares annually at an exercise price equal to the fair market value of the Shares on the date of grant.

and the option Shares fully vest on the date of the grants.

NOTE 10 - INCOME TAXES

The Company had income tax expense for the six months ended October

31, 2021, and 2020, of $ 1,600 and $ 800 , respectively.

During the six months ended October 31, 2021, and 2020, the Company had a net operating

loss (“NOL”) for each period which generated deferred tax assets for NOL carryforwards.

The Company provided valuation

allowances against the net deferred tax assets including the deferred tax assets for NOL carryforwards.

The Company had income tax expense for the nine

months ended January 31, 2022, and 2021, of $ 1,600 and $ 800 , respectively.

During the nine months ended January 31, 2022, and 2021, the

Company had a net operating loss (“NOL”) for each period which generated deferred tax assets for NOL carryforwards.

provided valuation allowances against the net deferred tax assets including the deferred tax assets for NOL carryforwards.

Valuation allowances

provided for the net deferred tax asset increased by approximately $ 583,000 and

$ 355,000 for

the six months ended October 31, 2021, and 2020, respectively.

provided for the net deferred tax asset increased by approximately $ 814,000 and $ 565,000 for the nine months ended January 31, 2022, and

2021, respectively.

There was no material difference between the effective

tax rate and the projected blended statutory tax rate for the six months ended October 31, 2021, and 2020.

tax rate and the projected blended statutory tax rate for the nine months ended January 31, 2022, and 2021.

Current tax laws limit the amount of loss available

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Accordingly, 100% of the deferred

tax valuation allowance has been recorded against these assets as of October 31, 2021.

tax valuation allowance has been recorded against these assets as of January 31, 2022.

The Company’s policy is to recognize any

interest and penalties related to unrecognized tax benefits as a component of income tax expense.

As of the six months ended October 31,

As of the nine months ended January

31, 2022, and 2021, the Company had no accrued interest or penalties related to uncertain tax positions.

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income taxes.

11 – EARNINGS (LOSS) PER SHARE

NOTE 11 – EARNINGS (LOSS) PER SHARE

Basic earnings (loss) per share is computed by

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Potential shares of common stock outstanding principally include stock options and warrants.

the periods ended October 31, 2021, and 2020, the Company incurred losses.

the periods ended January 31, 2022, and 2021, the Company incurred losses.

Accordingly, the effect of any common stock equivalent would

be anti-dilutive during those periods and are not included in the calculation of diluted weighted average number of shares outstanding.

As of October 31, 2021, Pre-funded warrants to

As of January 31, 2022, Pre-Funded Warrants to

purchase 950,000 shares of common stock that were issued in connection with the Registered Direct Offering with an effective date of August

5 unchanged sentences

Earnings per share calculations

Three Months Ended October 31,

Three Months Ended January 31,

$ ( 811,290 )

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Basic and diluted loss per share

Six Months Ended October 31,

Nine Months Ended January 31,

$ ( 2,816,454 )

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Schedule of potentially dilutive securities

Six Months Ended October 31,

Nine Months Ended January 31,

Excluded options

5 unchanged sentences

share of Series A Preferred Stock was issued on October 30, 2019, and repurchased by the Company on December 3, 2019.

As of October 31,

As of January 31,

2022, there are no shares of preferred stock issued and outstanding.

8 unchanged sentences

NOTE 13 – SUBSEQUENT EVENTS

Registration of Series A Warrant Shares and

Placement Agent Warrant Shares

Series A Warrants and Placement Agent

Warrants were issued pursuant to the Securities Purchase Agreement dated as of August 19, 2021.

Each Series A Warrant allows

the holder to purchase one share of the Company’s common stock at an exercise price of $5.00 per share.

Each Placement Agent

Warrant allows the holder to purchase one share of the Company’s stock at an exercise price of $6.25 per share.

the Series A Warrants and the Placement Agent Warrants were issued, neither the Series A Warrants, the Placement Agent Warrants nor

the underlying common stock was registered pursuant to the Securities Act of 1933, as amended.

The Company registered the common

stock underlying the Series A Warrants and the Placement Agent Warrants pursuant to a Registration Statement on Form S-3

(“Registration Statement”) filed with the Commission on November 8, 2021.

The Registration Statement became effective on

November 17, 2021.

On February 13, 2022, Mr.

a member of the Board of Directors of the Company, passed away.

Yuen served as an independent member of the Board and as a member

of the Board’s Compensation Committee and Nominating Committee (of which he was the Chairman).

On February 15, 2022, the Company notified the

Nasdaq Stock Market (“Nasdaq”) of Mr.

Yuen’s death and that, because of the loss, the Company is temporarily not in

compliance with the continued listing requirements as set forth in Nasdaq Listing Rule 5605(b)(1), regarding the composition of the Board.

This is because a majority of the Board is, as a result of Mr.

Yuen’s death, not comprised of independent directors.

In accordance with Nasdaq Listing Rule 5605(b)(1)(A),

the Company has an automatic cure period in order to regain compliance.

The Company expects to regain compliance with such rule by filling

Yuen’s vacancy on the Board with a new independent director who satisfies the applicable requirements of the Nasdaq Listing

Rules prior to the expiration of the cure period provided under Nasdaq Listing Rule 5605.

Nasdaq rules require that a majority of the Board

of Directors be independent directors.

The Company is technically no longer in compliance with Nasdaq rules.

As required, the Company

filed an 8-K with the SEC on Feb.

17 disclosing this.

On February 24, 2022, the Company received a letter

from Nasdaq confirming that we are not in compliance with Nasdaq rules.

The Company expected to receive this letter.

The letter also sets

forth the cure period the Company was given to regain compliance:

the earlier of the Company’s next annual shareholders’ meeting or February 13, 2023;

if the next annual shareholders’ meeting is held before August 12, 2022, then the Company must provide evidence of compliance no

later than August 12, 2022.

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 1. Financial Statements