What changed in this filing

/stocks — the workspaceLOADING

Item 1. Financial Statements

2020-12-11 compared with 2020-09-11 · 653 added, 658 removed, 740 unchanged (64% of the section changed)

23 unchanged sentences

2,490,000,000 shares, $0.0001 par value;

1,875,143,738 and 1,638,637,839 shares issued and outstanding as of July 31, 2020 and April 30, 2020, respectively

2,334,810,405 and 1,638,637,839 shares issued and outstanding as of October 31, 2020 and April 30, 2020, respectively

Additional paid-in capital

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CONDENSED CONSOLIDATED STATEMENTS OF

Three Months Ended July 31,

Three Months Ended

Six Months Ended

Operating expenses:

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Loss from operations

Other expense:

Other expenses:

Interest expense

2 unchanged sentences

$ (1,067,122 )

$ (1,834,136 )

$ (2,201,197 )

Basic and diluted loss per share

2 unchanged sentences

1,325,086,933

1,993,895,090

1,267,696,383

See accompanying Notes to Condensed Consolidated

3 unchanged sentences

COMPREHENSIVE LOSS

Three Months Ended July 31,

Three Months Ended

Six Months Ended

$ (1,067,122 )

$ (1,834,136 )

$ (2,201,197 )

Other comprehensive income (loss):

Foreign currency translation adjustment

Foreign currency translation

Other comprehensive income (loss)

1 unchanged sentence

$ (1,067,188 )

$ (1,834,311 )

$ (2,208,125 )

See accompanying Notes to Condensed Consolidated

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CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS'

THREE MONTHS ENDED JULY 31, 2020 AND

Comprehensive

SIX MONTHS ENDED OCTOBER 31, 2020 AND

A Preferred Stock

Comprehensive Income

Stockholders’

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$ (103,858,259 )

Stock issued for compensation

Stock issued for services

Stock issued for cash, net

Shares issued for compensation

Shares issued for services

Shares issued for cash, net

of issuance costs of $198,150

Stock-based compensation options

Stock-based compensation -

Foreign currency translation

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(104,742,203 )

Shares issued for compensation

Shares issued for services

Shares issued for cash, net

of issuances costs of $278,150

Stock-based compensation - options

Foreign currency translation

Balance, October 31,

2,334,810,405

$ 113,757,416

$ (105,692,395 )

Balance, April 30, 2019

2 unchanged sentences

$ (100,031,371 )

Stock issued for compensation

Stock issued for services

Stock issued for cash, net

Shares issued for compensation

Shares issued for services

Shares issued for cash, net

of issuance costs of $70,000

Stock-based compensation options

compensation - options

Foreign currency translation

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(101,165,446 )

Shares issued for compensation

Shares issued for services

Shares issued for cash, net

of issuances costs of $24,500

compensation - options

Foreign currency translation

Balance, October 31,

1,331,871,172

$ 106,654,628

$ (102,232,568 )

See accompanying Notes to Condensed Consolidated

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CONDENSED CONSOLIDATED STATEMENTS OF

Three Months Ended July 31,

Six Months Ended October 31,

Cash flows from operating activities:

$ (1,834,136 )

$ (2,201,197 )

Adjustments to reconcile net loss to net cash used in operating activities:

Stock issued for services

Stock issued for compensation

Shares issued for services

Shares issued for compensation

Stock-based compensation –

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Increase (decrease) in accounts payable

Decrease in accrued expenses

Increase (decrease) in accrued expenses

Net cash used in operating activities

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Cash flows from financing activities:

Use of funds for payment of insurance financing loan

Payment of insurance financing loan

Proceeds from sale of Series A Preferred Stock

Proceeds from sale of common stock, net of issuance costs

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Supplemental disclosure of cash flows information:

Cash paid during the periods for

Cash paid during the periods for income taxes

Cash paid during the periods for interest

Supplemental schedule of noncash investing and financing activity:

Issuance costs for shares issued

See accompanying Notes to Condensed Consolidated

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tumor may be optimized.

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

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

On September 4, 2020,

the Company received an Information Request from the FDA.

The Company responded to the FDA’s Information Request on September

See Note 13 “Subsequent Events”.

The Company is also examining ways to exploit

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these constituents are of the class of compounds known as “cannabinoids.”

Until the FDA allows the Company to commence the clinical trial involving LAPC described in the Company’s recently filed

IND, the Company is not spending any further resources developing this program.

Until the U.S.

Food and Drug Administration (“FDA”) allows the Company to commence the clinical trial involving LAPC

described in the Company’s recently filed Investigational New Drug Application (“IND”) for which the FDA has

placed a clinical hold, the Company is not spending any further resources developing this program.

In addition, the Company is developing

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As with the Company’s

Cannabis program, until the FDA allows it to commence the clinical trial involving LAPC described in its recently filed IND, the

Company is not spending any further resources developing this program.

Cannabis program, until the FDA allows it to commence the clinical trial involving LAPC described in its recently filed

IND for which the FDA has placed a clinical hold, the Company is not spending any further resources developing this program.

The Company is also developing a therapy

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As with the two previous programs, the Company is not spending any further resources developing this program until the FDA allows

it to commence the clinical trial involving LAPC described in its recently filed IND.

Additionally, work at the University of Technology,

Sydney (“UTS”) on the Melligen cells continues.

Melligen cells are human liver cells that have been genetically engineered

to produce, store and release insulin in response to the levels of blood sugar in the body.

the Company to commence the clinical trial involving LAPC described in its recently filed IND for which the FDA has placed a clinical

However, related work at the University of Technology, Sydney (“UTS”) on the Melligen cells continues.

cells are human liver cells that have been genetically engineered to produce, store and release insulin in response to the levels

of blood sugar in the body.

Finally, the Company has licensed (“Hai

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controlled by Hai Kang related to SARS-Cov2 COVID-19 diagnostic kits (“Kits”).

The Company’s license is both for

the sale of Kits as well as for the use of the technology underlying the Kits.

Pursuant to the Hai Kang License Agreement, the

Company may directly (or through a third party) conduct research, use, develop, market, sell, distribute, import and export Kits

and utilize their underlying technology for human and veterinary uses in North America, the United Kingdom and certain other European

A Kit is defined as any existing Kit of Hai Kang or any future Kit derived from Hai Kang’s Kits.

The Kits will be

manufactured and supplied to the Company by Hai Kang.

With respect to the Hai Kang License Agreement and related products, including

the Kits, we may not be able to (i) develop a related product candidate with our current resources, on a timely basis, or at all;

(ii) obtain the necessary regulatory authorizations or approvals for such a product candidate or for a Kit;

(iii) commercialize

any such product candidate or Kit;

or (iv) obtain reimbursement for such a product candidate or Kit in the U.S.

and elsewhere.

It is uncertain that any such product candidates or Kit will comply with U.S.

regulatory requirements or that any health care

facility or provider will be willing or able to use such product candidates or Kits.

On November 19, 2020, the Company sent

Hai Kang a letter terminating the Hai Kang License Agreement.

See Note 13- Subsequent Events.

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.

The Company timely responded to all information requests.

On October 1, 2020, the Company received

notice that the FDA 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

In order to lift the clinical hold, the

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

The FDA also requested additional

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

In addition, the FDA requested that several

items not related to the clinical hold be addressed through the submission of an IND amendment.

Specifically, the FDA requested

that the Company perform qualification studies for the drug substance filling step to ensure that the product remains sterile and

stable during the filling process.

The FDA also requested additional information, discussion and clarification on several other

There has been no further communication

with the FDA regarding the clinical hold.

The Company has assembled a scientific team to address the FDA

requests related to the clinical hold.

See Management’s Discussion and Analysis of Financial

Condition and Results of Operations-Clinical Hold for a further discussion of the clinical hold.

Impact of the COVID-19 Pandemic on the Company’s Operations

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

pandemic 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 and is awaiting a response from the FDA.

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

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.

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 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 recently submitted IND to treat LAPC.

There may be further

delays in generating responses required by the Company to comments by or requests from the FDA related to the IND.

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 believes that impact is not material.

The impact primarily relates to delays in tasks associated with the preparation of the Company’s response to the clinical

hold, including all 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.

Also, enrollment may be difficult for the reasons discussed

In addition, after enrollment in the trial, if patients contract COVID-19 during their participation in the trial or are

subject to isolation or shelter in place restrictions, this may cause them to drop out of our trial, miss scheduled therapy appointments

or follow-up visits or otherwise fail to follow the trial protocol.

If patients are unable to follow the 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 trial may be compromised or not be accepted by the FDA.

This could impact

or delay the Company’s clinical development program.

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

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

In addition, after enrollment in the trial, if patients

contract COVID-19 during their participation in the trial or are subject to isolation or shelter in place restrictions, this may

cause them to drop out of our trial, miss scheduled therapy appointments or follow-up visits or otherwise fail to follow the trial

If patients are unable to follow the 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

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

This could further adversely impact or delay the Company’s clinical

development program.

It is highly speculative in projecting

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

the pandemic will subside and life as we knew it before the pandemic will return to normal.

the pandemic will subside.

Company Background

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to reflect the nature of its current business.

Commencing in May 2011, the Company entered

into a series of agreements and amendments with SG Austria to acquire certain assets from SG Austria as well as an exclusive, worldwide

license to use, with a right to sublicense, the Cell-in-a-Box ®

technology and trademark for the development of therapies

(“SG Austria APA”)

In June 2013, the Company and SG Austria

entered a Third Addendum to the SG Austria APA (“Third Addendum”).

The Third Addendum materially changed the transaction

contemplated by the SG Austria APA.

Under the Third Addendum, the Company acquired 100% of the equity interests in Bio Blue Bird

and received a 14.5% equity interest in SG Austria.

The Company paid:

(i) $500,000 to retire all outstanding debt of Bio Blue Bird;

and (ii) $1.0 million to SG Austria.

The Company also paid SG Austria $1,572,193 in exchange for a 14.5% equity interest of SG

The transaction required SG Austria to return to the Company the 100,000,000 shares of our common stock held by SG Austria

and for the Company to return to SG Austria the 100,000 shares of common stock of Austrianova which the Company held.

Effective as of the same date the Company

entered into the Third Addendum, the Company and SG Austria also entered into a Clarification Agreement to the Third Addendum (“Clarification

Agreement”) to clarify and include certain language that was inadvertently left out of the Third Addendum.

Among other things,

the Clarification Agreement confirmed that the Third Addendum granted the Company an exclusive, worldwide license to use, with

a right to sublicense, the Cell-in-a-Box ®

Trademark and its Associated Technology for the development of therapies

With respect to Bio Blue Bird, Bavarian

Nordic A/S (“Bavarian Nordic”) and GSF-Forschungszentrum für Umwelt u.

Gesundheit GmbH (collectively, “Bavarian

Nordic/GSF”) and Bio Blue Bird entered into a non-exclusive License Agreement (“Bavarian Nordic/GSF License Agreement”)

in July 2005, whereby Bio Blue Bird was granted a non-exclusive license to further develop, make, have made (including services

under contract for Bio Blue Bird or a sub-licensee, by Contract Manufacturing Organizations, Contract Research Organizations, Consultants,

Logistics Companies or others), obtain marketing approval, sell and offer for sale the clinical data generated from the pancreatic

cancer clinical trials that used the cells and capsules developed by Bavarian Nordic/GSF (then known as “CapCells”)

or otherwise use the licensed patent rights related thereto in the countries in which patents had been granted.

Bio Blue Bird was

required to pay Bavarian Nordic a royalty of 3% of the net sales value of each licensed product sold by Bio Blue Bird and/or its

Affiliates and/or its sub-licensees to a buyer.

The term of the Bavarian Nordic/GSF License Agreement continued on a country by

country basis until the expiration of the last valid claim of the licensed patent rights.

Bavarian Nordic/GSF and Bio Blue Bird amended

the Bavarian Nordic License Agreement in December 2006 (“First Amendment to Bavarian Nordic/GSF License Agreement”)

to reflect that:

(i) the license granted was exclusive;

(ii) a royalty rate increased from 3% to 4.5%;

(iii) Bio Blue Bird assumed

the patent prosecution expenses for the existing patents;

and (iv) to make clear that the license will survive as a license granted

by one of the licensors if the other licensor rejects performance under the Bavarian Nordic License Agreement due to any actions

or declarations of insolvency.

In June 2013, the Company acquired from

Austrianova an exclusive, worldwide license to use the Cell-in-a-Box ®

Trademark and its Associated Technology for

the development of a therapy for Type 1 and insulin-dependent Type 2 diabetes (“Diabetes Licensing Agreement”).

allows the Company to develop a therapy to treat diabetes through encapsulation of a human cell line that has been genetically

modified to produce, store and release insulin in response to the levels of blood sugar in the human body.

In October 2014, the Company entered into

an exclusive, worldwide license agreement with the UTS (“Melligen Cell License Agreement”) in Australia to use insulin-producing

genetically engineered human liver cells developed by UTS to treat Type 1 diabetes and insulin-dependent Type 2 diabetes.

cells, named “Melligen”, were tested by UTS in mice and shown to produce insulin in direct proportion to the amount

of glucose in their surroundings.

In those studies, when Melligen cells were transplanted into immunosuppressed diabetic mice,

the blood glucose levels of the mice became normal.

In other words, the Melligen cells reportedly reversed the diabetic condition.

In December 2014, the Company acquired

from Austrianova an exclusive, worldwide license to use the Cell-in-a-Box ®

Trademark and its Associated Technology

in combination with genetically modified non-stem cell lines which are designed to activate cannabinoid prodrug molecules for development

of therapies for diseases and their related symptoms (“Cannabis Licensing Agreement”).

This allows the Company to develop

a therapy to treat cancer and other diseases and symptoms through encapsulation of genetically modified cells designed to convert

cannabinoids to their active form using the Cell-in-a-Box ®

trademark and its associated technologies.

In July 2016, the Company entered into

a Binding Memorandum of Understanding with Austrianova (“Austrianova MOU”).

Pursuant to the Austrianova MOU, Austrianova

will actively work with the Company to seek an investment partner or partners who will finance clinical trials and further develop

products for the Company’s therapy for cancer, in exchange for which the Company, Austrianova and any future investment partner

will each receive a portion of the net revenue from the sale of cancer products.

In October 2016, Bavarian Nordic/GSF and

Bio Blue Bird further amended the Bavarian Nordic License Agreement (“Second Amendment to Bavarian Nordic/GSF License Agreement”)

(i) include the right to import in the scope of the license;

(ii) reflect ownership and notification of improvements;

(iii) clarify which provisions survive expiration or termination of the Bavarian Nordic License Agreement;

(iv) provide rights

to Bio Blue Bird to the clinical data after the expiration of the licensed patent rights;

and (v) change the notice address and

recipients of Bio Blue Bird.

In May 2018, the Company entered into a

series of binding term sheet amendments (“Binding Term Sheet Amendments”).

The Binding Term Sheet Amendments provide

that the Company’s obligation to make milestone payments to Austrianova is eliminated in their entirety under the:

License Agreement;

and (ii) the Diabetes License Agreement, as amended.

The Binding Term Sheet Amendments also provide that the

Company’s obligation to make milestone payments to SG Austria for therapies for cancer to be eliminated in their entirety.

In addition, the Binding Term Sheet Amendments also provides that the scope of the Diabetes License Agreement is expanded to include

all cell types and cell lines of any kind or description now or later identified, including, but not limited to, primary cells,

mortal cells, immortal cells and stem cells at all stages of differentiation and from any source specifically designed to produce

insulin for the treatment of diabetes.

In addition, one of the Binding Term Sheet

Amendments provides that the Company will have a 5-year right of first refusal from August 30, 2017 in the event that Austrianova

chooses to sell, transfer or assign at any time during this period the Cell-in-a-Box ®

Trademark and Associated Technologies

, intellectual property, trade secrets and know-how, which includes the right to purchase any manufacturing facility used for the

Cell-in-a-Box ®

encapsulation process and a non-exclusive license to use the special cellulose sulfate utilized with

the Cell-in-a-Box ®

encapsulation process (collectively, “Associated Technologies”);

provided, however,

that the Associated Technologies subject to the right of first refusal do not include Bac-in-a-Box ®

Additionally,

for a period of one year from August 30, 2017 one of the Binding Term Sheet Amendments provides that Austrianova will not solicit,

negotiate or entertain any inquiry regarding the potential acquisition of the Cell-in-a-Box ®

and its Associated

Technologies.

The Binding Term Sheet Amendments further

provide that:

(i) the royalty payments on gross sales as specified in the SG Austria APA, the Cannabis License Agreement and the

Diabetes License Agreement are changed to 4%;

and (ii) the royalty payments on amounts received by the Company from sublicensees

on sublicensees’

gross sales under the same agreements are changed to 20% of the amount received from the sublicensees,

provided, however , that in the event the amounts received by the Company from sublicensees is 4% or less of sublicensees’

gross sales, Austrianova will receive 50% of what the Company receives (up to 2%) and then additionally 20% of any amount the

Company receives over that 4%.

One of the Binding Term Sheet Amendments

requires that the Company pay $900,000 to Austrianova ratably over a nine-month period in the amount of two $50,000 payments each

month during the nine-month period on the days of the month to be agreed upon between the parties, with a cure period of 20 calendar

days after receipt by the Company of written notice from Austrianova that the Company has failed to pay timely a monthly payment.

April 30, 2020, the $900,000 amount has been paid in full.

The Binding Term Sheet Amendments also provide that Austrianova receives

50% of any other financial and non-financial consideration received from the Company’s sublicensees of the Cell-in-a-Box ®

NOTE 2 –

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owned subsidiaries:

(i) Bio Blue Bird;

(i) Bio Blue Bird AG;

(ii) PharmaCyte Biotech Europe Limited;

(iii) PharmaCyte Biotech Australia Pty.

(iv) Viridis Biotech, Inc.

and (iv) Viridis Biotech, Inc.

and are prepared in accordance with United States Generally Accepted Accounting Principles (“U.S.

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The Company concluded that there was no

impairment of the carrying value of the intangibles for the three months ended July 31, 2020 and 2019.

impairment of the carrying value of the intangibles for the six months ended October 31, 2020 and 2019.

Impairment of Long-Lived Assets

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No impairment was identified or

recorded during the three months ended July 31, 2020 and 2019.

recorded during the six months ended October 31, 2020 and 2019.

Fair Value of Financial Instruments

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Deferred tax assets and 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 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

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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 tax positions utilizes a two-step approach to evaluate tax positions.

Step one, recognition, requires evaluation of

the tax position to determine if based solely on technical merits it is more likely than not to be sustained upon examination.

allowance as an income tax benefit in the Condensed Consolidated Statements of Operations.

GAAP method of accounting

for uncertain tax positions utilizes a two-step approach to evaluate tax positions.

Step one, recognition, requires

evaluation of the tax position to determine if based solely on technical merits it is more-likely-than-not to be sustained

upon examination.

Step two, measurement, is addressed only if a position is more-likely-than-not to be sustained.

In step two, the tax benefit is

measured as the largest amount of benefit, determined on a cumulative probability basis, which is more likely than not to be realized

upon ultimate settlement with tax authorities.

If a position does not meet the more likely than not threshold for recognition

in step one, no benefit is recorded until the first subsequent period in which the more likely than not standard is met, the issue

is resolved with the taxing authority or the statute of limitations expires.

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 subjective management estimates.

Actual results

could differ materially from these estimates.

two, the tax benefit is measured as the largest amount of benefit, determined on a cumulative probability basis, which is

more-likely-than-not to be realized upon ultimate settlement with tax authorities.

If a position does not meet the

more-likely-than-not threshold for recognition in step one, no benefit is recorded until the first subsequent period in which

the more-likely-than-not standard is met, the issue is resolved with the taxing authority 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.

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

probability are highly subjective management estimates.

Actual results could differ materially from these estimates.

On March 27, 2020, Congress enacted the

“Coronavirus Aid, Relief and Economic Security ("CARES") Act”

to provide certain relief as a result of the

2019 Coronavirus pandemic.

to provide certain relief as a result of COVID-19.

The Company maintains a full valuation allowance on its U.S.

net deferred tax assets.

Deferred tax asset

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

Therefore, the Company does not expect the provisions in the CARES Act will impact the Company’s Condensed Consolidated

Financial Statements.

Deferred tax asset remeasurement (tax expense)

was offset by a net decrease in valuation allowance, that resulted in no impact on the Company's income tax expense.

the Company does not expect the provisions in the CARES Act will impact the Company’s Condensed Consolidated Financial Statements.

Research and Development

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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 established.

R&D expenses for the three months ended

July 31, 2020 and 2019 were $270,574 and $72,330, respectively.

technologies, 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 and six

months ended October 31, 2020 were $151,314 and $421,888, respectively, and for the three and six months ended October 31, 2019

were $17,940 and $90,270, respectively.

Stock-Based Compensation

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Company 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.

Accounts at this institution are insured

by the Federal Deposit Insurance Corporation up to $250,000.

Uninsured balances aggregated approximately $3,439,000 and $618,000

$618,000 at July 31, 2020 and April 30, 2020, respectively.

at October 31, 2020 and April 30, 2020, respectively.

The Company has not experienced any losses in such accounts.

believes it is not exposed to any significant credit risk on cash.

Management believes

it is not exposed to any significant credit risk on cash.

Foreign Currency Translation

6 unchanged sentences

Adjustments for foreign

currency translation fluctuations are excluded from net loss and are included in other comprehensive income.

Gains and losses

on short-term intercompany foreign currency transactions are recognized as incurred.

currency translation fluctuations are excluded from net loss and are included in other comprehensive loss.

Gains and losses on

short-term intercompany foreign currency transactions are recognized as incurred.

Going Concern

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raise substantial doubt about the Company's ability to do so.

As of July 31, 2020, the Company has an accumulated deficit

of $104,742,203 and incurred a net loss for three months ended July 31, 2020 of $883,944.

The Company requires substantial additional

capital to finance its planned business operations and expects to incur operating losses in future periods due to the expenses

related to the Company’s core businesses.

The Company has not realized any revenue since it commenced doing business in the

biotechnology sector, and there can be no assurance that it will be successful in generating revenues in the future in this sector.

The Condensed Consolidated Financial Statements do not include any adjustments to reflect the possible future effects on the recoverability

and classification of assets or the amounts and classifications of liabilities that may result should the Company be unable to

continue as a going concern.

For the three months ended July 31, 2020,

As of October 31, 2020, the Company has an accumulated deficit

of $105,692,395 and incurred a net loss for the six months ended October 31, 2020 of $1,834,136.

The Company requires substantial

additional capital to finance its planned business operations and expects to incur operating losses in future periods due to the

expenses related to the Company’s core businesses.

The Company has not realized any revenue since it commenced doing business

in the biotechnology sector, and there can be no assurance that it will be successful in generating revenues in the future in this

The Condensed Consolidated Financial Statements do not include any adjustments to reflect the possible future effects on

the recoverability and classification of assets or the amounts and classifications of liabilities that may result should the Company

be unable to continue as a going concern.

For the six months ended October 31, 2020,

funding was provided by investors to maintain and expand the Company’s operations.

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are deemed to be “at the market offerings”

as defined in Rule 415 under the Securities Act or transactions structured

as a public offering of a distinct block or blocks of the shares of the Company’s common stock.

During the three months ended

July 31, 2020, the Company continued to acquire funds through the Company’s S-3 pursuant to which the placement agent sells

shares of common stock “at-the-market”

in a program which is structured to provide up to $25 million to the Company

less certain commissions pursuant to the S-3.

From May 1, 2020 through July 31, 2020 the Company raised capital of approximately

$1.9 million in Block Trade transactions and “at-the-market”

transactions.

From August 1, 2020 through August 12,

2020, the Company raised capital of approximately $2.8 million in Block Trades net of commissions.

as defined in Rule 415 under the Securities Act of 1933, as amended (“Securities

Act”) or transactions structured as a public offering of a distinct block or blocks of the shares of the Company’s

common stock.

During the six months ended October 31, 2020, the Company continued to acquire funds through the Company’s

S-3 pursuant to which the placement agent sells shares of common stock “at-the-market”

in a program which is structured

to provide up to $25 million to the Company less certain commissions pursuant to the S-3.

On August 13, 2020, the Company no longer

met the eligibility requirements to use the S-3 to raise capital, and the Company ceased to use the S-3 to raise capital after

From May 1, 2020 through August 13, 2020 the Company raised capital of approximately $4.7 million in Block Trade transactions

and “at-the-market”

transactions.

Management determined that its plans to

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in which the Company may engage in will provide sufficient capital to meet the Company’s capital requirements and to fund

the Company’s operations through September 30, 2021.

the Company’s operations through December 31, 2021.

Recent Accounting Pronouncements

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result in an impact on the Company’s Condensed Consolidated Financial Statements.

As part of the Company’s continuing

assessment of the adequacy of AU 2016-13, there are no factors to be considered at this time, as the Company does not have an allowance

for credit losses.

2019-12, Simplifying the Accounting

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ACCRUED EXPENSES

Accrued expenses at July 31, 2020 and April

30, 2020 are summarized below:

July 31, 2020

Accrued expenses at October 31, 2020 and

April 30, 2020 are summarized below:

October 31, 2020

April 30, 2020

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Director and Officer insurance financing

The Company financed the Director and

Officer insurance policy.

The Company financed the Director and Officer

insurance policy.

The term of the policy is from March 8, 2020 through March 8, 2021.

The financing agreement has an interest

rate of 4.25% per annum and requires eight monthly payments of $12,806.

The unpaid balances as of July 31, 2020 and April 30,

2020 are $75,908 and $113,245, respectively, are included in accrued expenses.

The financing agreement has an interest rate

of 4.25% per annum and requires eight monthly payments of $12,806.

The unpaid balances as of October 31, 2020 and April 30, 2020

are $38,168 and $113,245, respectively, which are included in accrued expenses.

NOTE 4 –

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On March 27, 2020, the CARES Act was enacted

to provide financial aid to family and businesses impacted by the COVID-19 pandemic.

The Company participated in the CARES

Act, and on April 15, 2020, the Company entered into a note payable with a bank under the Small Business Administration (“SBA”)

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

to provide financial aid to family and businesses impacted by COVID-19.

The Company participated in the CARES Act, and on

April 15, 2020, the Company entered into a note payable with a bank under the Small Business Administration (“SBA”)

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

This loan payable matures on April 15, 2022 with

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time that the PPP loan will be forgiven partially or in full.

If the loan is not forgiven based on the PPP guidelines to be issued

by the SBA, as defined, then, the monthly payment amount will be $4,229 beginning on October 15, 2020 through April 15, 2022.

PPP loan balance as of July 31, 2020 and April 30, 2020 was $75,200.

The outstanding PPP loan balance as of October 31, 2020 and April

30, 2020 was $75,200.

NOTE 5 –

COMMON STOCK TRANSACTIONS

A summary of the Company’s compensatory

stock activity and related weighted average grant date fair value information for the three months ended July 31, 2020 and 2019

is as follows:

During the three months ended July 31,

A summary of the Company’s stock

activity and related weighted average grant date fair value information for the six months ended October 31, 2020 and 2019 is as

During the six months ended October 31,

2019, the Company issued 2,000,000 shares of common stock to four non-employee members of the Company’s Board of Directors

(“Board”) pursuant to Director Letter Agreements (“DLAs”) with the Company for services relating to the

The shares vested upon issuance and the Company recorded a non-cash expense of $0 and $13,804 for the three months

ended July 31, 2020 and 2019, respectively.

The shares vested upon issuance and the Company recorded a non-cash expense of $0 and $0 and for the three and six

months ended October 31, 2020, respectively, and $5,408 and $19,212 for the three and six months ended October 31, 2019, respectively.

Effective July 1, 2018, the Company issued

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The Company recorded a non-cash

consulting expense in the amount of $0 and $12,816 for the three months ended July 31, 2020 and 2019, respectively.

zero unvested shares as of July 31, 2020 and 2019, respectively.

consulting expense in the amount of $0 and $0 for the three and six months ended October 31, 2020, respectively, and $0 and $12,816

for the three and six months ended October 31, 2019, respectively.

There were zero unvested shares as of October 31, 2020 and 2019,

respectively.

During the month of April 2019, two consultants

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months which covered prior and current periods.

The shares vest monthly over a twelve-month period and are subject to the consultant

The shares vest monthly over a twelve-month period and are subject to the consultants

providing services under their respective consulting agreements.

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

of $0 and $7,209 for the three months ended July 31, 2020 and 2019, respectively.

There were zero and 83,333 unvested shares as

of July 31, 2020 and 2019, respectively.

During the three months ended July 31,

2019, a consultant was owed 500,000 shares of common stock pursuant to his consulting agreement with the Company.

The term of the

consulting agreement is for twelve months which covered prior and current periods.

of $0 and $0 for the three and six months ended October 31, 2020, respectively, and $4,701 and $11,910 for the three and six months

ended October 31, 2019, respectively.

There were zero unvested shares as of October 31, 2020 and 2019.

During the six months ended October 31,

2019, a consultant was issued 500,000 shares of common stock pursuant to his consulting agreement with the Company.

the consulting agreement is for twelve months which covered prior and current periods.

The shares vest monthly over a twelve-month

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The Company recorded a non-cash consulting

expense in the amount of $0 and $3,306 for the three months ended July 31, 2020 and 2019, respectively.

As of July 31, 2020 and

2019, zero and 500,000 shares remained unissued, respectively.

The Company awarded 6,600,000 shares of

common stock to officers as part of their compensation agreements for 2019.

These shares vest monthly over a twelve-month period

and are subject to them continuing service under the agreements.

During the three months ended July 31, 2020 and 2019, the Company

recorded a non-cash compensation expense in the amount of $0 and $104,726, respectively.

There were zero and 2,750,000 unvested

shares as of July 31, 2020 and 2019, respectively.

During the three months ended July 31,

2019, three non-employee members of the Board were issued 1,500,000 shares of common stock pursuant to their DLAs with the Company.

expense in the amount of $0 and $0 for the three and six months ended October 31, 2020, respectively, and $0 and $3,306 for the

three and six months ended October 31, 2019, respectively.

There were zero unvested shares as of October 31, 2020 and 2019.

In January 2019, the Company awarded 6,600,000

shares of common stock to executive officers of the Company as part of their compensation agreements for 2019.

These shares vest

monthly over a twelve-month period and are subject to them continuing service under their compensation agreements.

three and six months ended October 31, 2020, the Company recorded a non-cash compensation expense in the amount of $0 and $0,

respectively, and $104,727 and $209,453 for the three and six months ended October 31, 2019, respectively.

There were zero and

1,100,000 unvested shares as of October 31, 2020 and 2019, respectively.

During the six months ended October 31,

2019, four non-employee members of the Board were issued 2,000,000 shares of common stock pursuant to their DLAs with the Company.

The shares were fully vested upon issuance.

The Company recorded a non-cash expense of $7,356 and $11,642 for the three months

ended July 31, 2020 and 2019, respectively.

There were zero unvested shares of Common Stock remaining related to these DLAs as

of July 31, 2020 and 2019.

During the three months ended July 31,

The Company recorded a non-cash expense of $3,205 and $10,561 for the three and six

months ended October 31, 2020, respectively, and $15,793 and $27,435 for the three and six months ended October 31, 2019, respectively.

There were zero unvested shares remaining related to these DLAs as of October 31, 2020 and 2019.

During the six months ended October 31,

2019, a consultant was issued 2,000,000 shares of common stock in respect of his services as the Chairman of the Company’s

Medical and Scientific Advisory Board over a four-year period with their vesting subject to the consultant providing services to

The Company recorded a non-cash consulting expense in the amount of $0 and $7,150 for the three months ended July

31, 2020 and 2019, respectively.

There were zero unvested shares remaining related to these compensation agreements as of July

31, 2020 and 2019.

During the three months ended July 31,

2020, three non-employee members of the Board were issued 1,500,000 shares of Common Stock pursuant to their DLAs in respect of

The Company recorded a non-cash consulting expense in the amount of $0 and $0 for the three and six months ended October

31, 2020, respectively, and $4,701 and $11,851 for the three and six months ended October 31, 2019, respectively.

There were zero

unvested shares remaining related to his compensation arrangement as of October 31, 2020 and 2019.

During the six months ended October 31,

2020, four non-employee members of the Board were issued 2,000,000 shares of common stock pursuant to their DLAs in respect of

their service during that year.

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The Company recorded a non-cash expense of $9,419 and

$0 for the three months ended July 31, 2020 and 2019, respectively.

There were zero unvested shares remaining related to a DLA

as of July 31, 2020.

During the three months ended July 31,

2020, four consultants were issued 1,000,000 shares of restricted Common Stock pursuant to their respective consulting agreement

with the Company.

The terms of the agreements are for twelve months.

The shares vest monthly over a twelve-month period and are

subject to the consultants providing services under the consultant’s respective consulting agreement.

The Company recorded

a non-cash consulting expense in the amount of $4,199 and $0 for the three months ended July 31, 2020 and 2019, respectively.

were 750,000 unvested shares remaining related to these consulting agreements as of July 31, 2020.

$16,448 for the three and six months ended October 31, 2020, respectively, and $0 and $0 for the three and six months ended October

31, 2019, respectively.

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

During the six months ended October 31,

2020, four consultants were issued 1,000,000 shares of common stock pursuant to their consulting agreements with the Company.

terms of the agreements are for twelve months.

The shares vest monthly over a twelve-month period and are subject to the consultants

providing services under the consultant’s consulting agreements.

The Company recorded a non-cash consulting expense in the

amount of $5,409 and $9,608 for the three and six months ended October 31, 2020, respectively, and $0 and $0 for the three and

six months ended October 31, 2019, respectively.

There were 500,000 unvested shares remaining related to these consulting agreements

as of October 31, 2020.

In January 2020, the Company awarded 6,600,000

shares of common stock to officers as part of their compensation agreements.

These shares vest monthly over a twelve-month period

and are subject to them continuing service under the agreements.

During the three months ended July 31, 2020, the Company recorded

a non-cash compensation expense in the amount of $67,320.

There were 2,750,000 unvested shares as of July 31, 2020.

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

These shares vest monthly

over a twelve-month period and are subject to them continuing service under their compensation agreements.

During the three and

six months ended October 31, 2020, the Company recorded a non-cash compensation expense in the amounts of $67,320 and $134,640,

respectively.

There were 1,100,000 unvested shares as of October 31, 2020.

During the six months ended October 31,

2020, a consultant was issued 500,000 shares of common stock in respect of his services as the Chairman of the Company’s

Medical and Scientific Advisory Board with the vesting subject to the consultant providing services to the Company.

recorded a non-cash consulting expense in the amount of $708 and $708 for the three and six months ended October 31, 2020, respectively,

and $0 and $0 for the three and six months ended October 31, 2019, respectively.

There were zero unvested shares remaining related

to his compensation arrangement as of October 31, 2020 and 2019.

All shares listed above were issued without

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

During the three months ended July 31,

During the six months ended October 31,

2020 and 2019, the Company sold and issued approximately 693 million and 137 million shares of common stock, respectively, at

prices ranging from approximately $0.01 to $0.03 per share pursuant to the Company’s S-3.

Net of underwriting discounts,

legal, accounting and other offering expenses, the Company received net proceeds of approximately $1,857,000 and $558,000 from

the sale of these shares for the three months ended July 31, 2020 and 2019, respectively.

prices of approximately $0.01 per share pursuant to the Company’s S-3.

Net of underwriting discounts, legal, accounting

and other offering expenses, the Company received net proceeds of approximately $4.7 million and $884,000 from the sale of these

shares for the six months ended October 31, 2020 and 2019, respectively.

A summary of the Company’s unvested

restricted stock activity and related weighted average grant date fair value information for the three months ended July 31, 2020

restricted stock activity and related weighted average grant date fair value information for the six months ended October 31, 2020

are as follows:

Unvested, at April 30, 2020

Unvested, at July 31, 2020

Unvested, at October 31, 2020

NOTE 6 –

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Stock Options

As of July 31, 2020, the Company had 68,700,000

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

Options”).

During the three months ended July 31,

As of October 31, 2020, the Company had

69,200,000 outstanding stock options to its directors and executive officers (collectively, “Employee Options”) and

consultants (“Non-Employee Options”).

During the six months ended October 31,

2020 and 2019, the Company granted 2,000,000 and 2,000,000 Employee Options, respectively.

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at the date of grant was estimated using the Black-Scholes-Merton option-pricing model, based on the following weighted average

Three Months Ended July 31,

Six Months Ended October 31,

Risk-free interest rate

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For stock option grants issued during the

three months ended July 31, 2020 and 2019, the Company used a calculated volatility for each grant.

six months ended October 31, 2020 and 2019, 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

information about the exercise behavior and therefore 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.

term of two and one-half years for an average of 2.5 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.

During the three months ended July 31,

2020 and 2019, the Company granted no Non-Employee Options.

During the six months ended October 31,

2020 and 2019, the Company granted zero and 1,200,000 Non-Employee Options, respectively.

During the three months ended October

31, 2020 and 2019, the Company granted zero and 1,200,000 Non-Employee Options, respectively.

A summary of the Company’s stock

option activity and related information for the three months ended July 31, 2020 is shown below:

Exercise Price

option activity and related information for the six months ended October 31, 2020 is shown below:

Exercise Price per Share

Outstanding, April 30, 2020

Outstanding, July 31, 2020

Exercisable, July 31, 2020

Outstanding, October 31, 2020

Exercisable, October 31, 2020

Vested and expected to vest

A summary of the activity for unvested

stock options during the three months ended July 31, 2020 is as follows:

stock options during the six months ended October 31, 2020 is as follows:

Unvested, April 30, 2020

Unvested, July 31, 2020

Unvested, October 31, 2020

The Company recorded $56,059 and $93,995

of stock-based compensation related to the issuance of Employee Options to certain officers and directors in exchange for services

during the three months ended July 31, 2020 and 2019, respectively.

At July 31, 2020, there remained $88,526 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 five months in the calendar year.

of stock-based compensation expense related to the issuance of Employee Options to certain executive officers and directors in

exchange for services during the three months ended October 31, 2020 and 2019, respectively, and $128,376 and $210,909 during the

six months ended October 31, 2020 and 2019, respectively.

At October 31, 2020, there remained $35,410 of unrecognized compensation

expense related to unvested Employee Options granted to executive officers and directors, to be recognized as expense over a weighted-average

period of the remaining two months in the calendar year.

The unvested options vest at 750,000 shares per month and are expected

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The Company recorded $0 and $4,414 of stock-based

compensation related to the issuance of Non-Employee Options in exchange for services during the three months ended July 31, 2020

and 2019, respectively.

There were no unvested Non-Employee Options on July 31, 2020.

compensation related to the issuance of Non-Employee Options in exchange for services during the three months ended October 31,

2020 and 2019, respectively, and $0 and 13,825 during the six months ended October 31, 2020 and 2019, respectively.

no unvested Non-Employee Options on October 31, 2020.

The following table summarizes the outstanding

stock options by exercise price at July 31, 2020:

stock options by exercise price at October 31, 2020:

Exercise Price

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The aggregate intrinsic value of outstanding

options as of July 31, 2020 was zero.

options as of October 31, 2020 was zero.

This represents options whose exercise price was less than the closing fair market value

of the Company’s common stock on July 31, 2020 of approximately $0.014 per share.

of the Company’s common stock on October 31, 2020 of approximately $0.0089 per share.

The warrants issued by the Company are

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of services rendered by non-employees, the Company recognizes consulting expense in accordance with the requirements of ASC 505.

Common Stock Purchase Warrants issued in conjunction with Block Trade transactions to Aeon Capital, Inc.

(‘Aeon”) are

accounted for in accordance with ASC 815-40, with the fair value recorded to additional paid-in capital and offsetting amounts

recorded as equity issuance costs on the Condensed Consolidated Statement of Stockholders’

Effective June 13, 2019, the Company issued

a Common Stock Purchase Warrant to Aeon Capital, Inc.

(“Aeon”) for a Block Trade transaction.

The Company issued a

warrant to purchase 1,338,889 shares of common stock based upon the Block Trade transaction pursuant to the Company’s engagement

agreement with Aeon dated February 22, 2018 (“Aeon Engagement Agreement”).

a Common Stock Purchase Warrant to Aeon for a Block Trade transaction.

The Company issued a warrant to purchase 1,338,889 shares

of common stock based upon the Block Trade transaction pursuant to the Company’s engagement agreement with Aeon dated February

22, 2018 (“Aeon Engagement Agreement”).

The Company classified these warrants as equity.

The warrants have a term of

five years with an exercise price of approximately $0.01 per warrant share.

Using the Black-Scholes-Merton option pricing model,

the Company determined the aggregate fair value of these warrants to be approximately $9,000.

The warrants have a cashless exercise

Effective July 15, 2019, the Company issued

a Common Stock Purchase Warrant to Aeon for a Block Trade transaction.

The Company issued a warrant to purchase 1,944,444 shares

of common stock based upon the Block Trade pursuant to the Aeon Engagement Agreement.

The Company classified these warrants as

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have a cashless exercise feature.

Effective August 7, 2019, the Company issued

two Common Stock Purchase Warrants to Aeon for two Block Trade transactions.

The Company issued two warrants to purchase a total

of 3,500,000 shares of common stock based on two Block Trades pursuant to the Aeon Engagement Agreement.

The Company classified

these warrants as equity.

The warrants have a term of five years with an exercise price of approximately $0.01 per warrant share.

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

The warrants have a cashless exercise feature.

Effective July 10, 2020, the Company issued

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The Company classified these warrants as

The warrants have a term of five years with an exercise price of approximately $0.01 per warrant share.

The warrants have a term of five years with an exercise price of $0.01 per warrant share.

Using the Black-Scholes-Merton

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The Company classified these warrants as

The warrants have a term of five years with an exercise price of $0.01 per warrant share.

The warrants have a term of five years with an exercise price of approximately $0.01 per warrant share.

Using the Black-Scholes-Merton

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have a cashless exercise feature.

Effective July 27, 2020, the Company issued

Effective August 3, 2020, the Company issued

a Common Stock Purchase Warrant to Aeon for a Block Trade transaction.

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have a cashless exercise feature.

Effective August 6, 2020, the Company issued

a Common Stock Purchase Warrant to Aeon for a Block Trade transaction.

The Company issued a warrant to purchase 4,100,000 shares

of common stock based upon the Block Trade pursuant to the Aeon Engagement Agreement.

The Company classified these warrants as

The warrants have a term of five years with an exercise price of $0.01 per warrant share.

Using the Black-Scholes-Merton

option pricing model, the Company determined the aggregate fair value of these warrants to be approximately $29,000.

have a cashless exercise feature.

Effective August 6, 2020, the Company issued

a Common Stock Purchase Warrant to Aeon for a Block Trade transaction.

The Company issued a warrant to purchase 5,000,000 shares

of common stock based upon the Block Trade pursuant to the Aeon Engagement Agreement.

The Company classified these warrants as

The warrants have a term of five years with an exercise price of approximately $0.01 per warrant share.

Using the Black-Scholes-Merton

option pricing model, the Company determined the aggregate fair value of these warrants to be approximately $18,000.

have a cashless exercise feature.

Effective August 7, 2020, the Company issued

a Common Stock Purchase Warrant to Aeon for a Block Trade transaction.

The Company issued a warrant to purchase 2,500,000 shares

of common stock based upon the Block Trade pursuant to the Aeon Engagement Agreement.

The Company classified these warrants as

The warrants have a term of five years with an exercise price of approximately $0.01 per warrant share.

Using the Black-Scholes-Merton

option pricing model, the Company determined the aggregate fair value of these warrants to be approximately $13,000.

have a cashless exercise feature.

Effective August 7, 2020, the Company issued

a Common Stock Purchase Warrant to Aeon for a Block Trade transaction.

The Company issued a warrant to purchase 5,500,000 shares

of common stock based upon the Block Trade pursuant to the Aeon Engagement Agreement.

The Company classified these warrants as

The warrants have a term of five years with an exercise price of approximately $0.01 per warrant share.

Using the Black-Scholes-Merton

option pricing model, the Company determined the aggregate fair value of these warrants to be approximately $19,000.

have a cashless exercise feature.

Effective August 10, 2020, the Company

issued a Common Stock Purchase Warrant to Aeon for a Block Trade transaction.

The Company issued a warrant to purchase 1,333,333

shares of common stock based upon the Block Trade pursuant to the Aeon Engagement Agreement.

The Company classified these warrants

The warrants have a term of five years with an exercise price of approximately $0.01 per warrant share.

Using the Black-Scholes-Merton

option pricing model, the Company determined the aggregate fair value of these warrants to be approximately $7,000.

have a cashless exercise feature.

A summary of the Company’s warrant

activity and related information for the three months ended July 31, 2020 is shown below:

activity and related information for the six months ended October 31, 2020 is shown below:

Exercise Price

Outstanding, April 30, 2020

Outstanding, July 31, 2020

Exercisable, July 31, 2020

Outstanding, October 31, 2020

Exercisable, October 31, 2020

The following table summarizes additional

information concerning warrants outstanding and exercisable at July 31, 2020:

information concerning warrants outstanding and exercisable at October 31, 2020:

Exercise Prices

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The Company had the following related party

transactions during the three months ended July 31, 2020 and 2019.

transactions during the three and six months ended October 31, 2020 and 2019.

The Company owns 14.5% of the equity in

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and (ii) Austrianova

Thailand Pte Ltd.

The Company purchased products and services from these subsidiaries in the approximate amounts of $64,000 and

$2,400 in the three months ended July 31, 2020 and 2019, respectively.

Thailand Company Ltd.

The Company purchased products and services from these subsidiaries in the approximate amounts of $10,000

and $74,000 in the three and six months ended October 31, 2020, respectively, and $0 and $2,400 for the three and six months ended

October 31, 2019, respectively.

In April 2014, the Company entered the

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automatically renewed annually.

The amounts incurred for the three months ended July 31, 2020 and 2019 were approximately $13,000

and $13,000, respectively.

In addition, during the three months ended July 31, 2020 the Company issued 250,000 shares of common

The Company recorded a noncash consulting expense of approximately $8,000 relating to these share issuances

for the three months ended July 31, 2020.

The amounts incurred for the three and six months ended October 31, 2020 were approximately $21,000

and $44,000, respectively, and $2,000 and $15,000 for the three and six months ended October 31, 2019, respectively.

during the six months ended October 31, 2020 the Company issued 250,000 shares of common stock to Dr.

Salmons to be a member of

the Company’s Medical and Scientific Advisory Board.

The Company recorded a noncash consulting expense of approximately

$2,300 relating to this share issuance for the six months ended October 31, 2020.

During the year ended April 30, 2020, the

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lease for the Leased Premises, commencing upon the expiration of the term of the prior lease.

The term of the lease expires on

The term of the lease expired on

August 31, 2020.

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Rent expenses for these offices for the

three months ended July 31, 2020 and 2019 were $7,152 and $8,661, respectively.

three months ended October 31, 2020 and 2019 were $5,384 and $7,999, respectively, and for the six months ended October 31, 2020

and 2019 were $12,536 and $16,660, respectively.

The following table summarizes the Company’s

aggregate future minimum lease payments required under the operating lease as of July 31, 2020.

Material Agreements

The Company’s material agreements

are identified and summarized in Note 1 –

Nature of Business –

Company Background.

aggregate future minimum lease payments required under the operating lease as of October 31, 2020.

Compensation Agreements

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Each agreement

has a term of two years with automatic annual extensions thereafter unless the Company or the officer provides written notification

of termination at least ninety days prior to the end of the term or subsequent extensions.

The Company also entered a compensation

agreement with a Board member in April 2015 which continued in effect until amended in May 2017.

has a term of two years with automatic annual extensions thereafter unless the Company or the executive officer provides written

notification of termination at least ninety days prior to the end of the term or subsequent extensions.

The Company also entered

a compensation agreement with a Board member in April 2015 which continued in effect until amended in May 2017.

In May 2017, the Company amended the compensation

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The Company had no income tax expense for

the three months ended July 31, 2020 and 2019, respectively.

During the three months ended July 31, 2020 and 2019, the Company

the six months ended October 31, 2020 and 2019, respectively.

During the six months ended October 31, 2020 and 2019, 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.

allowances provided for the net deferred tax asset increased by approximately $98,000 and $201,000 for the three months ended July

allowances provided for the net deferred tax asset increased by approximately $355,000 and $449,000 for the six months ended October

31, 2020 and 2019, respectively.

There was no material difference between

the effective tax rate and the projected blended statutory tax rate for the three months ended July 31, 2020 and 2019.

the effective tax rate and the projected blended statutory tax rate for the six months ended October 31, 2020 and 2019.

Current tax laws limit the amount of loss

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biotechnology companies, the Company has concluded that is more-likely-than-not that these operating loss carryforwards will not

Accordingly, 100% of the deferred tax valuation allowance has been recorded against these assets at July 31, 2020.

Accordingly, 100% of the deferred tax valuation allowance has been recorded against these assets at October 31, 2020.

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 three months ended

July 31, 2020 and 2019, the Company had no accrued interest or penalties related to uncertain tax positions.

As of the six months ended

October 31, 2020 and 2019, the Company had no accrued interest or penalties related to uncertain tax positions.

See Note 10 of Notes to the Consolidated

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principally include stock options and warrants.

During the three months ended July 31, 2020 and 2019, the Company incurred losses.

During the six months ended October 31, 2020 and 2019, 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

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per share calculations:

Three Months Ended July 31,

Three Months Ended October 31,

$ (1,067,122 )

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Basic and diluted loss per share

Six Months Ended October 31,

$ (1,834,136 )

$ (2,201,197 )

Basic weighted average number of shares outstanding

1,993,895,090

1,267,696,383

Diluted weighted average number of shares outstanding

1,993,895,090

1,267,696,383

Basic and diluted loss per share

The table below sets forth these potentially

dilutive securities:

Three Months Ended July 31,

Six Months Ended October 31,

Excluded options

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

of July 31, 2020, there are no shares of preferred stock issued and outstanding.

of October 31, 2020, there are no shares of preferred stock issued and outstanding.

The description of the Series A Preferred

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There is one share of preferred stock designated as Series A Preferred Stock;

Preferred Stock has a number of votes at any time equal to the number of votes then held by all other shareholders of the

Company having a right to vote on any matter plus one.

The Certificate of Designations that designated the terms of the

Series A Preferred Stock cannot be amended without the consent of the holder of the Series A Preferred Stock;

The Series A Preferred Stock has a number of votes at any time equal to the number of votes then held by all other shareholders of the Company having a right to vote on any matter plus one.

The Certificate of Designations that designated the terms of the Series A Preferred Stock cannot be amended without the consent of the holder of the Series A Preferred Stock;

The Company may redeem the Series A Preferred Stock at any time for a redemption price of $1.00 paid to the holder of the share of Series A Preferred Stock;

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SUBSEQUENT EVENTS

From August 1, 2020 through August 12,

2020, the Company sold approximately 459 million shares of common stock using the S-3 structured as Block Trade transactions.

issuance of these shares resulted in gross proceeds to the Company of approximately $3 million.

Pursuant to the Aeon Engagement

Agreement, the Company paid Aeon a fee of approximately $183,000 and provided warrant coverage of 5% of the number of shares of

commons stock sold in the Block Trade transactions This amounted to approximately 34 million warrant shares with a five-year term.

The warrants have a cashless exercise feature.

In addition, the Company incurred transaction fees of approximately $96,000 to an

unrelated party.

On September 1, 2020, the Company submitted

the IND to the FDA to allow the Company to commence a Phase 2b human clinical trial involving LAPC.

Although no assurance as to

the timing of the trial can be given or whether the FDA will allow the Company to commence a Phase 2b clinical trial as opposed

to a Phase 1 clinical trial or further preclinical studies.

The IND consisted of all available preclinical information (e.g.

toxicity studies), Chemistry, Manufacturing and Controls information and other pre-clinical information about the Company’s

product candidate to treat LAPC, as well as information regarding the proposed clinical trial program and other information and

documentation required by FDA regulations.

On September 4, 2020, the Company received an Information Request from the FDA.

Company responded to the FDA’s Information Request on September 11, 2020.

On November 19, 2020, the Company sent

Hai Kang a letter terminating the Hai Kang License Agreement.

The Company did so out of concerns over the failure to timely obtain

an FDA Emergency Use Authorization for the Kits and the efficacy of the Kits.

The Company is no longer pursuing this endeavor.

On December 2, 2020, the Company entered

into a six-month office lease extension commencing on March 1, 2021.

The lease extension is for the office where the Company is

currently located in Laguna Hills, California.

The term of the new lease expires on August 31.

2021 and requires monthly lease

payments of approximately $1,300.

Management’s Discussion and Analysis

of Financial Conditions and Results of Operations

of Financial Condition and Results of Operations

Cautionary Note Regarding Forward-Looking

This Report on Form 10-Q (“Report”)

includes “forward-looking statements”

This Report includes “forward-looking

statements”

within the meaning of the federal securities laws.

All statements other than

statements of historical fact are “forward-looking statements”

for purposes of this Report, including any projections

of earnings, revenue or other financial items, any statements regarding the plans and objectives of management for future operations,

any statements concerning proposed new products or services, any statements regarding future economic conditions or performance,

any statements regarding expected benefits from any transactions and any statements of assumptions underlying any of the foregoing.

In some cases, forward-looking statements can be identified by use of terminology such as “may,”

All statements other than statements of historical fact are

“forward-looking statements”

for purposes of this Report, including any projections of earnings, revenue or other financial

items, any statements regarding the plans and objectives of management for future operations, any statements concerning proposed

new products or services, any statements regarding future economic conditions or performance, any statements regarding expected

benefits from any transactions and any statements of assumptions underlying any of the foregoing.

In some cases, forward-looking

statements can be identified by use of terminology such as “may,”

“will,”

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or “continue,”

or the negative

thereof or other comparable terminology regarding beliefs, plans, expectations or intentions regarding the future, including risks

relating to the recent outbreak of COVID-19.

Although we believe that the expectations reflected in the forward-looking statements

contained in this Report are reasonable, there can be no assurance that such expectations or any of the forward-looking statements

will prove to be correct, and actual results could differ materially from those projected or assumed in the forward-looking statements.

Thus, investors should refer to and carefully review information in future documents we file with the Commission.

Our future financial

condition and results of operations, as well as any forward-looking statements, are subject to inherent risk and uncertainties,

including, but not limited to, the risk factors set forth in “Part I, Item 1A –

or the negative thereof or other comparable terminology regarding

beliefs, plans, expectations or intentions regarding the future, including risks relating to the continuing outbreak of COVID-19.

Although we believe that the expectations reflected in the forward-looking statements contained in this Report are reasonable,

there can be no assurance that such expectations or any of the forward-looking statements will prove to be correct, and actual

results could differ materially from those projected or assumed in the forward-looking statements.

Thus, investors should refer

to and carefully review information in future documents we file with the Commission.

Our future financial condition and results

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

to, the risk factors set forth in “Part I, Item 1A –

Risk Factors”

set forth in our

Form 10-K for period ended April 30, 2020 and for the reasons described elsewhere in this Report.

Among others, these include our

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

whether the FDA approves

our recently submitted IND after it has been reviewed by the FDA so that we can commence our planned clinical trial involving LAPC;

set forth in our Form 10-K for period ended

April 30, 2020 and for the reasons described elsewhere in this Report.

Among others, these include our estimates regarding expenses,

future revenues, capital requirements and needs for additional financing;

whether the FDA lifts its clinical hold after we have

submitted our responses to the FDA concerns related to our IND submission so that we can commence our planned clinical trial involving

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

the potential that results of preclinical studies and clinical

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

our dependence on third parties

in the conduct of our preclinical studies and clinical trials;

the difficulties and expenses associated with obtaining and maintaining

regulatory approval of our product candidates;

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

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

of third parties with whom we conduct business;

and whether the FDA will approve our product candidates after our clinical trials

are completed, assuming the FDA allows our clinical trials to proceed after review of our IND submission for LAPC.

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

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

Except where the context otherwise

requires, in this Report, the “Company,”

the potential that results of preclinical studies

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

our dependence

on third parties in the conduct of our preclinical studies and clinical trials;

the difficulties and expenses associated with obtaining

and maintaining regulatory approval of our product candidates;

the material adverse impact that COVID-19 may have on our business,

including our efforts to have the clinical hold lifted and our planned clinical trial involving LAPC, which could materially affect

our operations as well as the business or operations of third parties with whom we conduct business;

and whether the FDA will approve

our product candidates after our clinical trials are completed, assuming the FDA allows our clinical trial to proceed after review

of our clinical hold submission.

All forward- looking statements and reasons why results may differ included in this Report are

made as of the date hereof, and we do not intend to update any forward-looking statements except as required by law or applicable

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

“we,”

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and “our”

refer to PharmaCyte

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

refer to PharmaCyte Biotech, Inc., a Nevada corporation, and, where appropriate, its subsidiaries.

Product Candidates

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be optimized.

On September 1, 2020, we submitted our

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

However, no assurance as to the timing of the trial can be given or whether

the FDA will allow us to commence a Phase 2b clinical trial as opposed to a Phase 1 clinical trial or further preclinical studies.

The IND consisted of all available preclinical information (e.g.

animal toxicity studies), Chemistry, Manufacturing and Controls

information and other pre-clinical information about our product candidate to treat LAPC, as well as information regarding our

proposed clinical trial program and other information and documentation required by FDA regulations.

On September 4, 2020, we received

an Information Request from the FDA.

We responded to the FDA’s Information Request on September 11, 2020.

We must wait a minimum of 30 calendar days

from the date of the IND submission before initiating our clinical trial.

During this time, the FDA has an opportunity to review

the IND to ensure that it is complete and that the planned clinical trial research patients will not be subject to unreasonable

It also gives the FDA time to ask for more information and clarification about the information submitted as was done with

the FDA’s September 4, 2020 Information Request.

If the FDA is not satisfied with the our September 11, 2020 response to

the Information Request or our responses to any future Information Requests or the FDA identifies other issues with the our IND,

the FDA can place a clinical hold on the clinical trial described in the IND.

If the FDA does so, we cannot initiate the clinical

trial to treat LAPC until or unless the FDA lifts the clinical hold.

It is possible that the FDA may not permit us to initiate

the clinical trial based on the available data and information.

We are also examining ways to exploit the

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these constituents are of the class of compounds known as “cannabinoids”.

Until the FDA allows us to commence the clinical trial involving LAPC described in our recently submitted IND, we will not spend

any further resources developing this program.

Until the FDA allows us to commence the clinical trial involving LAPC described in our recently submitted IND for which the FDA

has placed a clinical hold, we will not spend any further resources developing this program.

In addition, we are developing a therapy

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our Cannabis program, until the FDA allows us to commence the clinical trial involving LAPC described in our recently submitted

IND, we will not spend any further resources developing this program.

IND for which the FDA has placed a clinical hold, we will not spend any further resources developing this program.

We are also developing a therapy for Type

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As with the two previous programs, we are not spending any further resources developing this program until the FDA

allows us to commence the clinical trial involving LAPC described in our recently submitted IND.

However, work at UTS on the Melligen

cells continues.

Melligen cells are human liver cells that have been genetically engineered to produce, store and release insulin

in response to the levels of blood sugar in the body.

allows us to commence the clinical trial involving LAPC described in our recently submitted IND for which the FDA has placed a

clinical hold.

However, related work at UTS on the Melligen cells continues.

Melligen cells are human liver cells that have been

genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the body.

Finally, we have licensed from Hai Kang

the right to certain technology owned or controlled by Hai Kang related to COVID-19 diagnostic kits (“Kits”).

is both for the sale of Kits as well as for the use of the technology underlying the Kits.

Pursuant to the Hai Kang License Agreement,

we may directly (or through a third party) conduct research, use, develop, market, sell, distribute, import and export Kits and

utilize their underlying technology for human and veterinary uses in North America, the United Kingdom and certain other European

sites collectively, (“Territory”).

A “Product”

is defined as any existing Kit of Hai Kang or any future

Kit derived from Hai Kang’s Kits and includes an in vitro diagnostic test.

We are required to use its commercially

reasonable efforts to develop and commercialize at least one Product in the Territory.

This obligation to develop and commercialize

a Product includes, among other things, the performance of non-clinical and clinical studies of any Product, the preparation, filing

and prosecution of certain regulatory requests for authorization or approval for such Product (including to allow the Company to

market and sell the Product and to get the Product approved for reimbursement).

Hai Kang is responsible for all aspects of the

manufacture and supply of the Products to be developed and sold under the Hai Kang License Agreement.

During the term of the Hai Kang License

Agreement, we are required to pay a monthly fee to Hai Kang in the amount of $6,000, which monthly fee increases to $50,000 once

the first Product receives regulatory authorization or approval from the FDA.

In addition, upon the first commercial sale of a

Product, the Company is required to make quarterly royalty payments equal to 10% of Net Sales (as defined in the Hai Kang License

Agreement) of any Product sold pursuant to the Hai Kang License Agreement.

With respect to the Hai Kang License Agreement

and related products, including the Kits, we may not be able to (i) develop a related product candidate with our current resources,

on a timely basis, or at all;

(ii) obtain the necessary regulatory authorizations or approvals for such a product candidate or

(iii) commercialize any such product candidate or Kit;

or (iv) obtain reimbursement for such a product candidate or

Kit in the U.S.

and elsewhere.

It is uncertain that any such product candidates or Kit will comply with U.S.

regulatory requirements

or that any health care facility or provider will be willing or able to use such product candidates or Kits.

COVID-19 Potential Impact on the Financial

Condition and Results of Operations

the right to certain technology owned or controlled by Hai Kang related to COVID-19 diagnostic Kits.

Our license is both for the

sale of Kits as well as for the use of the technology underlying the Kits.

On November 19, 2020, we sent Hai Kang

a letter terminating the Hai Kang License Agreement.

We did so out of concerns over the failure to timely obtain an FDA Emergency

Use Authorization for the Kits and the efficacy of the Kits.

Clinical Hold

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

We timely responded to all information requests

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

the IND on clinical hold.

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

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

In order to address the clinical hold, the FDA has requested

Provide additional sequencing data and genetic stability studies;

Conduct a stability study on the final formulated drug product as

well as the cells from the Master Cell Bank;

Evaluate the compatibility of the delivery devices (i.e., the prefilled

syringe and microcatheter) with the drug product;

Provide additional detailed description of the manufacturing process;

Provide additional product release specifications for the encapsulated

Demonstrate comparability between the 1st and 2nd generation products

and ensure adequate and consistent product performance and safety between the two generations;

Conduct a biocompatibility assessment using the final finished capsules

after the entire drug product manufacturing process (but without cells);

Address insufficiencies in Chemistry, Manufacturing and Controls information

in the cross-referenced Drug Master File;

Conduct an additional nonclinical study to assess the safety, activity

and distribution of the drug product;

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;

Provide data from a new pig study.

The FDA also requested that we address several issues not related

to the clinical hold in an amendment to the IND, including:

Provide a Certificate of Analysis for pc3/2B1 plasmid that includes

tests for assessing purity, safety, and potency;

Perform qualification studies for the drug substance filling step

to ensure that the product remains sterile and stable during the filling process;

Submit an updated batch analysis for the drug product for the specific

lot that will be used for manufacturing all future drug product;

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 Angiography Procedure Manual;

Clarify the language in the Pharmacy Manual regarding proper use of

the syringe fill with the drug product;

Provide a discussion with data for the potential for cellular and

humoral immune reactivity against the heterologous rat CYP2B1 protein and potential for induction of autoimmune-mediated toxicities

in the Company’s study population.

There has been no further communication with the FDA regarding

the clinical hold.

We have assembled a scientific team to address the FDA requests

related to the clinical hold.

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

We have not yet determined the estimated

cost and the time necessary to complete these items.

The cost and time associated with completing these items will likely be significant.

COVID-19 Potential Impact on the Financial Condition and

Results of Operations

The development of our product candidates

could be disrupted and materially adversely affected in the future by a pandemic like the recent outbreak of COVID-19.

as a result of measures imposed by the governments in states affected by COVID-19, businesses and schools have been suspended due

to quarantines or stay at home orders intended to contain the pandemic.

COVID-19 continues to spread globally and, as of July 31,

could be disrupted and materially adversely affected in the future by a pandemic like the continuing outbreak of COVID-19.

example, as a result of measures imposed by the governments in states affected by COVID-19, businesses and schools have been suspended

due to quarantines or stay at home orders intended to contain the pandemic.

COVID-19 continues to spread globally and, as of October

31, 2020, has spread to over 151 countries, including the U.S.

While the COVID-19 pandemic is thought to be in its early stages, international

While COVID-19 is thought to be in its middle stages, international

stock markets continue to reflect the uncertainty associated with the slow-down in the world economies and the reduced levels of

international travel experienced since the beginning of January 2020.

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.

As of the date of this Report, COVID-19 has had an impact

upon our operations, although we believe that impact is not material.

We are still assessing our business plans

and the impact COVID-19 may have on our ability to advance the development of our product candidates or to raise financing to

support the development of our product candidates, but no assurances can be given that this assessment will enable us to avoid

part or all of any impact from the spread of COVID-19 or its consequences, including downturns in the business sector generally

or in our sector in particular.

The spread of COVID-19 may also result in the inability of our suppliers to deliver components

or raw materials on a timely basis or materially and adversely affect our collaborators’

and the impact COVID-19 may have on our ability to advance the development of our product candidates or to raise financing to support

the development of our product candidates, but no assurances can be given that this assessment will enable us to avoid part or

all of any impact from the spread of COVID-19 or its consequences, including downturns in the business sector generally or in our

sector in particular.

The spread of COVID-19 may also result in the inability of our suppliers to deliver components or raw materials

on a timely basis or materially and adversely affect our collaborators’

and potential strategic partners’

ability to conduct our planned clinical trial in LAPC and our other operations.

The recent and ongoing COVID-19 pandemic could

materially affect our operations, as well as the business or operations of third parties with whom we conduct business.

could be adversely affected by the effects of other future health pandemics in regions where we or third parties on which we rely

have significant business operations.

work to have the clinical hold lifted, including the preclinical work needed to lift the clinical hold and our other operations.

COVID-19 could materially affect our operations, as well as the business or operations of third parties with whom we conduct business.

Our business could be adversely affected by the effects of other future health pandemics in regions where we or third parties on

which we rely have significant business operations.

See the risk factors set forth in “Part I, Item 1A –

Risk Factors”

forth in our Form 10-K for period ended April 30, 2020 and for the reasons described elsewhere in this Report.

set forth in our Form 10-K for period ended April 30, 2020 and for the reasons described elsewhere in this Report.

Performance Indicators

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and (vi) ensure

completion of the production of encapsulated cells according to cGMP regulations

to use in our planned clinical trial involving LAPC.

completion of the production of encapsulated cells according to current Good Manufacturing

Practices regulations to use in our planned clinical trial involving LAPC.

There are numerous items required to be

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Results of Operations

Three months ended July 31, 2020 compared to three months

ended July 31, 2019

We had no revenues for the three months ended July 31, 2020 and 2019.

Three and six months ended October 31, 2020 compared to

three and six months ended October 31, 2019

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

31, 2020 and 2019.

Operating Expenses and Loss from Operations

The following table summarizes our operating

expenses and loss from operations for the three months ended July 31, 2020 and 2019, respectively:

Three Months Ended July 31,

expenses and loss from operations for the three and six months ended October 31, 2020 and 2019, respectively:

Three Months Ended October 31,

Six Months Ended October 31,

The total operating expenses for the three-month

period ended July 31, 2020 decreased by $252,399 from the three months ended July 31, 2019.

The decrease is attributable to a decrease

in general and administrative (“G&A”) expenses of $304,400, a decrease in director fees of $3,618, a decrease in

compensation expense of $174,224 net of an increase in legal and professional expense of $31,599 and an increase in R&D expense

The decrease in G&A expenses were mainly attributable to reductions in consulting fees and travel expenses.

period ended October 31, 2020 decreased by $117,607 from the three months ended October 31, 2019.

The decrease is attributable

to a decrease in general and administrative (“G&A”) expenses of $316,718, a decrease in director fees of $13,537,

a decrease in legal and professional expense of $27,042 net of an increase in compensation expense of $106,316 and an increase

in R&D expense of $133,374.

The decrease in G&A expenses were mainly attributable to reductions in consulting fees and

travel expenses.

The total operating expenses for the six-month

period ended October 31, 2020 decreased by $370,006 from the six months ended October 31, 2019.

The decrease is attributable to

a decrease in general and administrative (“G&A”) expenses of $621,118, a decrease in director fees of $17,155,

a decrease in compensation expense of $67,908, net of an increase in legal and professional expense of $4,557, and an increase

in R&D expense of $331,618.

The decrease in G&A expenses were mainly attributable to reductions in consulting fees and

travel expenses.

Other expense

The following table sets forth our other expense for the three

months ended July 31, 2020 and 2019:

Months Ended July 31,

Total other expense for the three months

ended July 31, 2020 increased by the amount of $2,268 from the three months ended July 31, 2019.

The increase is attributable to

the increase of interest expense in the amount of $388, an increase in income taxes of $800 and an increase in foreign exchange

and six months ended October 31, 2020 and 2019:

Three Months Ended October 31,

Six Months Ended October 31,

Total other expense for the three months ended October 31,

2020 increased by the amount of $677 from the three months ended October 31, 2019.

The increase is attributable to the increase

of interest expense in the amount of $677.

Total other expense for the six months

ended October 31, 2020 increased by the amount of $2,945 from the six months ended October 31, 2019.

The increase is attributable

to the increase of interest expense in the amount of $1,757, an increase in income taxes of $800 and an increase in foreign exchange

losses of $388.

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The following table presents a summary of our sources and uses

of cash for the three months ended July 31, 2020 and 2019, respectively:

Three Months Ended

July 31, 2020

July 31, 2019

of cash for the six months ended October 31, 2020 and 2019, respectively:

Six Months Ended

October 31, 2020

October 31, 2019

Net cash used in operating activities:

Net cash used in investing activities:

$ (1,801,453 )

$ (1,346,765 )

Net cash provided by (used in) investing activities:

Net cash provided by financing activities:

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The net cash used in operating activities

for the three months ended July 31, 2020 is a result of our net losses, increases in accounts payable, a decrease in prepaid expenses

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

The cash used in operating

activities for the three months ended July 31, 2019 is a result of our net losses, offset by an increase in stock issued, an increase

to prepaid expenses and decreases in accounts payable and accrued expenses.

See Condensed Consolidated Statements of Cash Flows

for the six months ended October 31, 2020 is a result of our net losses, decreases in accounts payable, accrued expenses and a

decrease in prepaid expenses and an increase in securities issued for services and compensation.

The cash used in operating activities

for the six months ended October 31, 2019 is a result of our net losses, offset by an increase in stock issued, an increase in

prepaid expenses and increases in accounts payable and accrued expenses.

See Condensed Consolidated Statements of Cash Flows on

Investing Activities :

There were no investing activities in the three months ended

July 31, 2020 and 2019.

There were no investing activities in the six months ended October

31, 2020 and 2019.

Financing Activities :

The cash provided from financing activities

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

is mainly attributable to the proceeds from the sale of our common stock net of the use of funds for payment of director and officer

insurance financing.

Liquidity and Capital Resources

As of July 31, 2020, our cash totaled approximately

$2,167,000, compared to approximately $328,000 at July 31, 2019.

Working capital was approximately $1,116,000 at July 31, 2020

and approximately a negative $130,000 at July 31, 2019.

The increase in cash is attributable to a higher beginning cash balance,

an increase in proceeds from the sale of our common stock offset by a decrease in our operating expenses.

As of August 31, 2020,

our cash totaled approximately $4,537,000.

During the three months ended July 31,

As of October 31, 2020, our cash totaled

approximately $3,717,000, compared to approximately $45,000 at October 31, 2019.

Working capital was approximately $3,169,000 at

October 31, 2020 and approximately a negative $595,000 at October 31, 2019.

The increase in cash is attributable to a higher beginning

cash balance, an increase in proceeds from the sale of our common stock offset by a decrease in our operating expenses.

During the six months ended October 31,

2020, funding was provided by investors to maintain and expand our operations and R&D.

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using the S-3.

During the three months ended July 31, 2019, we continued to acquire funds through our S-3 pursuant to Block Trades

During the six months ended October 31, 2019, we continued to acquire funds through our S-3 pursuant to Block Trades

transactions in a program which is structured to provide up to $25 million dollars to us less certain commissions pursuant to the

8 unchanged sentences

sheet arrangements that could have a material current effect or that are reasonably likely to have a material adverse effect on

our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures

our financial condition, changes in financial conditions, revenues or expenses, results of operations, liquidity, capital expenditures

or capital resources.

On May 14, 2018, we entered into the Amendments

to all of the material agreements with SG.

Austria and Austrianova.

See “Company Background and Material Agreements”

above for a description of these Amendments.

Service Agreements

We entered into several service agreements

with both independent and related parties, pursuant to which services will be provided over the next twenty-four months related

to our IND and clinical trial involving LAPC.

The services include regulatory affairs strategy, advice and follow up work of the

IND submission to the FDA and services related to the planned LAPC trial.

They also cover a 24-month stability study, which includes

the container closure integrity testing, of the clinical trial product syringes.

The total cost is estimated to be approximately

$195,000, of which the related party portion will be approximately $80,000.

with independent and related parties pursuant to which services will be provided over the next twenty-four months related to our

IND and clinical trial involving LAPC.

The services include regulatory affairs strategy, advice and follow up work on the IND and

services related to having the clinical hold lifted.

They also cover a 24-month stability study, which includes the container closure

integrity testing, of the clinical trial product syringes.

The total cost is estimated to be approximately $100,000, of which the

related party portion will be approximately $80,000.

These amounts do not take into account the cost associated with the work and

preclinical studies required to lift the clinical hold.

New Accounting Pronouncements

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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.

Quantitative and

Qualitative Disclosures About Market Risk.

The contents of the website

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Quantitative and Qualitative Disclosures About Market Risk.

The information called for by Item 3 is

1 unchanged sentence

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