What changed in this filing

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Item 1. Financial Statements

2021-03-12 compared with 2020-12-11 · 512 added, 449 removed, 944 unchanged (50% of the section changed)

23 unchanged sentences

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

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

2,341,410,405 and 1,638,637,839 shares issued and outstanding as of January 31, 2021 and April 30, 2020, respectively

Additional paid-in capital

5 unchanged sentences

Total Liabilities and Stockholders' Equity

See accompanying Notes to Condensed

Consolidated Financial Statements.

See accompanying Notes to Condensed Consolidated

Financial Statements.

PHARMACYTE BIOTECH, INC.

1 unchanged sentence

Three Months Ended

Six Months Ended

Nine Months Ended

Operating expenses:

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$ (3,076,505 )

$ (2,201,197 )

Basic and diluted loss per share

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Three Months Ended

Six Months Ended

$ (1,067,122 )

Nine Months Ended

$ (2,591,232 )

6 unchanged sentences

$ (3,084,035 )

$ (2,208,125 )

See accompanying Notes to Condensed Consolidated

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CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS'

SIX MONTHS ENDED OCTOBER 31, 2020 AND

NINE MONTHS ENDED JANUARY 31, 2021 AND

A Preferred Stock

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Shares issued for services

Shares issued for cash, net

of issuance costs of $198,150

Stock-based compensation -

Foreign currency translation

Shares issued for cash, net of issuance costs of $198,150

Stock-based compensation - options

Foreign currency translation adjustment

Balance, July 31, 2020

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Shares issued for services

Shares issued for cash, net

of issuances costs of $278,150

Shares issued for cash, net of issuances costs of $278,150

Stock-based compensation - options

Foreign currency translation

Foreign currency translation adjustment

Balance, October 31, 2020

1 unchanged sentence

(105,692,395 )

Shares issued for compensation

Shares issued for services

Shares issued for cash

Stock-based compensation - options

Foreign currency translation adjustment

Balance, January 31, 2021

2,341,410,405

$ 113,849,337

$ (106,449,491 )

PHARMACYTE BIOTECH, INC.

CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS'

EQUITY (continued)

NINE MONTHS ENDED JANUARY 31, 2021 AND

A Preferred Stock

Comprehensive Income

Stockholders’

Balance, April 30, 2019

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Shares issued for services

Shares issued for cash, net

of issuance costs of $70,000

compensation - options

Foreign currency translation

Shares issued for cash, net of issuance costs of $70,000

Stock-based compensation - options

Foreign currency translation adjustment

Balance, July 31, 2019

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Shares issued for services

Shares issued for cash, net

of issuances costs of $24,500

compensation - options

Foreign currency translation

Shares issued for cash, net of issuances costs of $24,500

Stock-based compensation - options

Foreign currency translation adjustment

Balance, October 31, 2019

1 unchanged sentence

(102,232,568 )

Shares issued for compensation

Shares issued for services

Shares repurchased for cash

Stock-based compensation - options

Foreign currency translation adjustment

Balance, January 31, 2020

1,428,471,172

$ 107,305,733

$ (103,107,876 )

See accompanying Notes to Condensed Consolidated

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CONDENSED CONSOLIDATED STATEMENTS OF

Six Months Ended October 31,

Nine Months Ended January 31,

Cash flows from operating activities:

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Change in assets and liabilities:

(Increase) decrease in prepaid expenses and other current assets

Decrease in prepaid expenses and other current assets

Increase (decrease) in accounts payable

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Proceeds from sale of Series A Preferred Stock

Use of funds from purchase of Series A preferred stock

Proceeds from sale of common stock, net of issuance costs

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placing those capsules in the body as close as possible to the tumor.

In this way, the Company believes that when the cancer prodrug

is administered to a patient with a particular type of cancer that may be affected by the prodrug, the killing of the patient’s

tumor may be optimized.

The Company believes that when the cancer prodrug is administered

to a patient with a particular type of cancer that may be affected by the prodrug, the killing of the patient’s tumor may

be optimized.

The Company is also examining ways to exploit

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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.

described in the Company’s 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 for which the FDA has placed a clinical hold, 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 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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The Company’s diabetes therapy consists of encapsulated genetically

modified human liver cells and insulin-producing stem cells.

The encapsulation for each type of cell will be done using the Cell-in-a-Box ®

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

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

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

modified insulin-producing cells.

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

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

As with the two

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

commence the clinical trial involving LAPC described in its IND for which the FDA has placed a clinical hold.

Finally, the Company had licensed (“Hai

Kang License Agreement”) from Hai Kang Life Corporation (“Hai Kang”) the right to certain technology owned or

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

On November 19, 2020, the Company sent

Hai Kang a letter terminating the Hai Kang License Agreement.

See Note 13- Subsequent Events.

On November 19, 2020, the Company terminated

the Hai Kang License Agreement.

Clinical Hold

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The FDA also requested additional

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

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

In addition, the FDA requested that several

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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.

Since October 30, 2020, 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.

That team is working through an extensive list of items that the FDA requested.

things, the Company has successfully completed a 9-month product stability study, commenced physical parameter testing for CypCaps™

and commenced additional studies for the sequence of DNA encoding of its encapsulated cells.

The Company has also designed the

biocompatibility tests for cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, subacute/subchronic

toxicity, genotoxicity and implantation.

In addition, the Company has begun a compression and swelling study of CypCaps™,

designed a study to determine if CypCaps™

are adversely affected by contrast medium and designed a study to show the catheters

used to implant CypCaps™

do not adversely impact the encapsulated cells.

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

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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.

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

hold, including all requested preclinical studies.

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

FDA related to the clinical hold.

As a result of the COVID-19 pandemic, commencement

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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.

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

the clinical trial protocol.

If patients are unable to follow the clinical trial protocol or if the trial results are otherwise

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

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

This could further adversely impact

or delay the Company’s clinical development program.

It is highly speculative in projecting

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The Company concluded that there was no

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

impairment of the carrying value of the intangibles for the nine months ended January 31, 2021 and 2020.

Impairment of Long-Lived Assets

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No impairment was identified or

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

recorded during the nine months ended January 31, 2021 and 2020.

Fair Value of Financial Instruments

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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.

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.

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.

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.

On March 27, 2020, Congress enacted the

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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

R&D expenses for the three and nine

months ended January 31, 2021 were $174,088 and $595,976, respectively, and for the three and nine months ended January 31, 2020

were $113,296 and $203,566, respectively.

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Uninsured balances aggregated approximately $2,810,000 and $618,000

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

at January 31, 2021 and April 30, 2020, respectively.

The Company has not experienced any losses in such accounts.

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Foreign Currency Translation

The Company translates the financial statements

of its foreign subsidiaries from the local (functional) currencies to U.S.

dollars in accordance with FASB ASC 830, Foreign

Currency Matters .

All assets and liabilities of the Company’s foreign subsidiaries are translated at period-end exchange

rates, while revenue and expenses are translated at average exchange rates prevailing during the period.

Adjustments for foreign

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.

The Company translates the financial

statements of its foreign subsidiaries from the local (functional) currencies to U.S.

dollars in accordance with FASB ASC

830, Foreign Currency Matters .

All assets and liabilities of the Company’s foreign subsidiaries are translated

at period-end exchange rates, while revenue and expenses are translated at average exchange rates prevailing during the

Adjustments for foreign currency translation fluctuations are excluded from net loss and are included in other

comprehensive income (loss).

Gains and losses on short-term intercompany foreign currency transactions are recognized as

Going Concern

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

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.

As of January 31, 2021, the Company has an accumulated deficit

of $106,449,491 and incurred a net loss for the nine months ended January 31, 2021 of $2,591,232.

The Company requires substantial

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be unable to continue as a going concern.

For the six months ended October 31, 2020,

For the nine months ended January 31, 2021,

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

Sales of the Company’s common stock

were made under an operative Form S-3 (“S-3”) allowing for offerings of up to $50 million dollars in transactions that

are deemed to be “at the market offerings”

were made under a Form S-3 (“S-3”) allowing for offerings of up to $50 million dollars.

During the nine months ended

January 31, 2021, the Company raised funds through the Company’s S-3 pursuant to which the placement agent sells shares of

common stock “at-the-market”

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.

Act”), or in transactions of a distinct block or blocks of shares of the Company’s common stock (“Block Trade

Transactions”) in a program which is structured to provide up to $25 million to the Company less certain commissions pursuant

On August 13, 2020, the Company no longer

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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 December 31, 2021.

the Company’s operations through March 31, 2022.

Recent Accounting Pronouncements

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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.

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

allowance for credit losses.

2019-12, Simplifying the Accounting

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ACCRUED EXPENSES

Accrued expenses at October 31, 2020 and

Accrued expenses at January 31, 2021 and

April 30, 2020 are summarized below:

October 31, 2020

January 31, 2021

April 30, 2020

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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

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

The unpaid balances as of January 31, 2021 and April 30, 2020

are $0 and $113,245, respectively, which are included in accrued expenses.

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

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

The outstanding PPP loan balance as of January 31, 2021 and April

30, 2020 was $75,200.

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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,

activity and related weighted average grant date fair value information for the nine months ended January 31, 2021 and 2020 is

During the nine months ended January 31,

2020, 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 $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.

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

months ended January 31, 2021, respectively, and $0 and $19,212 for the three and nine months ended January 31, 2020, respectively.

There were zero unvested shares as of January 31, 2021.

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 $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.

consulting expense in the amount of $0 and $0 for the three and nine months ended January 31, 2021, respectively, and $0 and $12,816

for the three and nine months ended January 31, 2020, respectively.

There were zero unvested shares as of January 31, 2021 and

During the month of April 2019, two consultants

5 unchanged sentences

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 $11,910 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,

of $0 and $0 for the three and nine months ended January 31, 2021, respectively, and $0 and $11,910 for the three and nine months

ended January 31, 2020, respectively.

There were zero unvested shares as of January 31, 2021 and 2020.

During the nine months ended January 31,

2020, a consultant was issued 500,000 shares of common stock pursuant to his consulting agreement with the Company.

3 unchanged sentences

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 $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.

expense in the amount of $0 and $0 for the three and nine months ended January 31, 2021, respectively, and $0 and $17,350 for the

three and nine months ended January 31, 2020, respectively.

There were zero unvested shares as of January 31, 2021 and 2020.

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

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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,

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

During the three and nine months ended January 31, 2021, the Company recorded a non-cash compensation expense in the

amount of $0 and $0, respectively, and $69,438 and $278,891 for the three and nine months ended January 31, 2020, respectively.

There were zero unvested shares as of January 31, 2021 and 2020.

During the nine months ended January 31,

2020, 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 $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,

The Company recorded a non-cash expense of $0 and $10,561 for the three and nine months

ended January 31, 2021, respectively, and $18,988 and $46,433 for the three and nine months ended January 31, 2020, respectively.

There were zero unvested shares remaining related to these DLAs as of January 31, 2021 and 2020.

During the nine months ended January 31,

2020, 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 $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,

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

services to the Company.

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

ended January 31, 2021, respectively, and $0 and $11,851 for the three and nine months ended January 31, 2020, respectively.

were zero unvested shares remaining related to his compensation arrangement as of January 31, 2021 and 2020.

During the nine months ended January 31,

2021, four non-employee members of the Board were issued 2,000,000 shares of common stock pursuant to their DLAs in respect of

1 unchanged sentence

The shares were fully vested upon issuance.

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

$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,

The Company recorded a non-cash expense of $10,411

and $26,859 for the three and nine months ended January 31, 2021, respectively.

There were zero unvested shares remaining related

to such DLAs as of January 31, 2021.

During the nine months ended January 31,

2021 four consultants were issued 1,000,000 shares of common stock pursuant to their consulting agreements with the Company.

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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.

continuing to provide services under their consulting agreements.

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

of $5,409 and $15,017 for the three and nine months ended January 31, 2021, respectively.

There were 250,000 unvested shares remaining

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

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

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,

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

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

During the three and nine months ended January 31, 2021, the Company recorded a non-cash compensation expense in the

amounts of $44,881 and $179,521, respectively, and $30,800 and $30,800 for the three and nine months ended January 31, 2020, respectively.

There were zero and 6,050,000 unvested shares as of January 31, 2021 and 2020, respectively.

During the nine months ended January 31,

2021, 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.

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

Company recorded a non-cash consulting expense in the amount of $2,125 and $2,833 for the three and nine months ended January 31,

2021, respectively, and $0 and $0 for the three and nine months ended January 31, 2020, respectively.

There were zero unvested

shares remaining related to his compensation arrangement as of January 31, 2021 and 2020, respectively.

In January 2021, the Company awarded 6,600,000

shares of common stock to the executive officers of the Company as part of their compensation agreements for 2021.

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

During the three and nine months ended January 31, 2021, the Company recorded a non-cash compensation expense in the

amounts of $3,685 and $3,685, respectively.

There were 6,050,000 unvested shares as of January 31, 2021.

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 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 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.

During the nine months ended January 31,

2021 and 2020, the Company sold and issued approximately 693 million and 137 million shares of common stock, respectively, at 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 nine months ended January 31, 2021 and 2020, respectively.

A summary of the Company’s unvested

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

are as follows:

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

2021 is as follows:

Unvested, at April 30, 2020

Unvested, at October 31, 2020

Unvested, at January 31, 2021

NOTE 6 –

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Stock Options

As of October 31, 2020, the Company had

As of January 31, 2021, the Company had

62,600,000 outstanding stock options to its directors and executive officers (collectively, “Employee Options”) and

consultants (“Non-Employee Options”).

During the six months ended October 31,

During the nine months ended January 31,

2021 and 2020, the Company granted 11,000,000 and 11,000,000 Employee Options, respectively.

1 unchanged sentence

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

Six Months Ended October 31,

Nine Months Ended January 31,

Risk-free interest rate

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For stock option grants issued during the

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

nine months ended January 31, 2021 and 2020, the Company used a calculated volatility for each grant.

The Company lacks adequate

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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 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.

term of two and seven-tenths years for an average of 2.7 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 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

During the nine months ended January 31,

2021 and 2020, the Company granted zero and 1,200,000 Non-Employee Options, respectively.

During the three months ended January

31, 2021 and 2020, the Company granted zero and zero Non-Employee Options, respectively.

A summary of the Company’s stock

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

option activity and related information for the nine months ended January 31, 2021 is shown below:

Exercise Price per Share

Outstanding, April 30, 2020

Outstanding, October 31, 2020

Exercisable, October 31, 2020

(15,600,000 )

Outstanding, January 31, 2021

Exercisable, January 31, 2021

Vested and expected to vest

A summary of the activity for unvested

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

stock options during the nine months ended January 31, 2021 is as follows:

Unvested, April 30, 2020

Unvested, October 31, 2020

Unvested, January 31, 2021

The Company recorded $38,606 and $74,025

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

exchange for services during the three months ended January 31, 2021 and 2020, respectively, and $166,982 and $284,934 during the

nine months ended January 31, 2021 and 2020, respectively.

At January 31, 2021, there remained $35,148 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.

period of the remaining eleven months in the calendar year.

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

to be fully vested on December 31, 2021.

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 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 Company recorded $0 and $10,411 of

stock-based compensation related to the issuance of Non-Employee Options in exchange for services during the three months ended

January 31, 2021 and 2020, respectively, and $0 and $24,237 during the nine months ended January 31, 2021 and 2020, respectively.

There were no unvested Non-Employee Options on January 31, 2021.

The following table summarizes the outstanding

stock options by exercise price at October 31, 2020:

stock options by exercise price at January 31, 2021:

Exercise Price

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The aggregate intrinsic value of outstanding

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 October 31, 2020 of approximately $0.0089 per share.

options as of January 31, 2021 was $12,225.

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

value of the Company’s common stock on January 31, 2021 of approximately $0.018 per share.

The warrants issued by the Company are

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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’

(“Aeon”),

the Company’s placement agent under its S-3 “at-the-market”

prospectus, 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

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A summary of the Company’s warrant

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

activity and related information for the nine months ended January 31, 2021 is shown below:

Exercise Price

Outstanding, April 30, 2020

Outstanding, October 31, 2020

Exercisable, October 31, 2020

(17,000,000 )

Outstanding, January 31, 2021

Exercisable, January 31, 2021

The following table summarizes additional

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

information concerning warrants outstanding and exercisable at January 31, 2021:

Exercise Prices

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The Company had the following related party

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

transactions during the three and nine months ended January 31, 2021 and 2020.

The Company owns 14.5% of the equity in

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SG Austria has two subsidiaries:

(i) Austrianova;

and (ii) Austrianova

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.

(i) Austrianova Singapore Pte.

(“Austrianova”);

and (ii) Austrianova Thailand Company Ltd.

The Company purchased products and services from these

subsidiaries in the approximate amounts of $109,500 and $183,500 in the three and nine months ended January 31, 2021, respectively,

and $85,000 and $87,400 for the three and nine months ended January 31, 2020, respectively.

In April 2014, the Company entered the

Vin-de-Bona Consulting Agreement pursuant to which it agreed to provide professional consulting services to the Company.

is owned by Prof.

Vin-de-Bona Consulting Agreement pursuant to which Vin-de-Bona agreed to provide professional consulting services to the Company.

Vin-de-Bona is owned by Prof.

Günzburg (“Prof.

Günzburg) and Dr.

Günzburg”) and Dr.

Brian Salmons (“Dr.

Salmons”), both

of whom are involved in numerous aspects of the Company’s scientific endeavors relating to cancer and diabetes (Prof.

is the Chairman of Austrianova, and Dr.

Salmons is the Chief Executive Officer and President of Austrianova).

The term of the agreement

is for 12 months, automatically renewable for successive 12-month terms.

After the initial term, either party can terminate the

agreement by giving the other party 30 days’

written notice before the effective date of termination.

The agreement has been

automatically renewed annually.

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.

Salmons”),

both of whom are involved in numerous aspects of the Company’s scientific endeavors relating to cancer and diabetes (Prof.

Gunzburg is the Chairman and Chief Technical Officer of Austrianova, and Dr.

Salmons is the Chief Executive Officer and President

of Austrianova).

The term of the agreement was for 12 months, automatically renewable for successive 12-month terms.

initial term, either party can terminate the agreement by giving the other party 30 days’

written notice before the effective

date of termination.

The agreement has been automatically renewed annually.

The amounts incurred for the three and nine months

ended January 31, 2021 were approximately $21,000 and $65,000, respectively, and $3,000 and $18,000 for the three and nine months

ended January 31, 2020, respectively.

In addition, during the nine months ended January 31, 2021 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 $3,700 relating to this share issuance for the nine months ended January 31, 2021.

During the year ended April 30, 2020, the

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It is no longer issued and outstanding.

See Note 9 under Service Agreements for

related party disclosures.

NOTE 9 –

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entered into an office lease at 23046 Avenida de la Carlota, Suite 600, Laguna Hills, California (“Leased Premises”).

The term of the lease is for 24 months and expired on August 31, 2019.

The term of the lease was for 24 months and expired on August 31, 2019.

In May 2019, the Company entered into an additional one-year

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The term of the new lease expires on February

On December 2, 2020, the Company entered into an additional six-month lease of the Leased Premises, commencing on March

This lease expires on August 31, 2021.

Rent expenses for these offices for the

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

three months ended January 31, 2021 and 2020 were $5,288 and $7,152, respectively, and for the nine months ended January 31, 2021

and 2020 were $17,824 and $23,812, respectively.

The following table summarizes the Company’s

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

aggregate future minimum lease payments required under the operating leases as of January 31, 2021.

Compensation Agreements

The Company entered into executive compensation

agreements with its three executive officers in March 2015, each of which was amended in December 2015 and March 2017.

Each agreement

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.

agreements with its three executive officers in March 2015, each of which was amended in March 2017.

Each agreement had 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.

Each agreement has been renewed.

Company also entered a compensation agreement with a Board member in April 2015 which continued in effect until amended in May

In May 2017, the Company amended the compensation

agreement with the Board members and the terms continue in effect until a member is no longer on the Board.

agreement with the Board members and the term continue in effect until a member is no longer on the Board.

The Company has four independent directors.

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

Service Agreements

The Company entered into several service

agreements with independent and related parties pursuant to which services will be provided over a specified period-of-time related

to our IND which was placed on clinical hold by the FDA and proposed 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 is approximately fifty percent complete, including the container closure integrity testing of

the clinical trial product syringes.

The total cost is estimated to be approximately $437,000, of which the related party portion

will be approximately $310,000.

These amounts take into account some of the cost associated with the work and preclinical studies

required to lift the FDA’s clinical hold.

NOTE 10 - INCOME TAXES

The Company had no income tax expense for

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

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

the nine months ended January 31, 2021 and 2020, respectively.

During the nine months ended January 31, 2021 and 2020, 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 $355,000 and $449,000 for the six months ended October

allowances provided for the net deferred tax asset increased by approximately $565,000 and $270,000 for the nine months ended January

31, 2021 and 2020, respectively.

There was no material difference between

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

the effective tax rate and the projected blended statutory tax rate for the nine months ended January 31, 2021 and 2020.

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 October 31, 2020.

Accordingly, 100% of the deferred tax valuation allowance has been recorded against these assets at January 31, 2021.

The Company’s policy is to recognize

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

As of the six months ended

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

As of the nine months ended

January 31, 2021 and 2020, 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 six months ended October 31, 2020 and 2019, the Company incurred losses.

During the nine months ended January 31, 2021 and 2020, 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 October 31,

$ (1,067,122 )

Three Months Ended January 31,

Basic weighted average number of shares outstanding

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Basic and diluted loss per share

Six Months Ended October 31,

Nine Months Ended January 31,

$ (2,591,232 )

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dilutive securities:

Six Months Ended October 31,

Nine Months Ended January 31,

Excluded options

5 unchanged sentences

shares of preferred stock, with a par value of $0.0001, of which one share has been designated as "Series A Preferred Stock".

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

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

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

January 31, 2021, there are no shares of preferred stock issued and outstanding.

The description of the Series A Preferred

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SUBSEQUENT EVENTS

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.

On March 1, 2021, the Company received

notices of exercise for 26 Common Stock Purchase Warrants (“Warrants”).

The holder of the Warrants elected to exercise

the Warrants through a cashless exercise in accordance with the terms of the Warrants.

This resulted in the Company issuing 43,715,269

shares of unregistered common stock.

Management’s Discussion and Analysis

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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

April 30, 2020 and our Quarterly Reports on Form 10-Q 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;

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 LAPC;

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

the potential that results of preclinical studies

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

our dependence

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

the difficulties and expenses associated with obtaining

and maintaining regulatory approval of our product candidates;

the material adverse impact that 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

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

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 regulations.

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

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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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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 for which the FDA

has placed a clinical hold, 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 IND, 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

6 unchanged sentences

for pancreatic cancer to determine if it can prevent or delay the production and accumulation of malignant ascites fluid.

our Cannabis 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.

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

1 diabetes and insulin-dependent Type 2 diabetes.

Our diabetes therapy consists of encapsulated genetically modified human liver

cells and insulin-producing stem cells.

The encapsulation for each type of cell will be done using the Cell-in-a-Box ®

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

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 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

Our diabetes therapy consists of encapsulated genetically modified insulin-producing

The encapsulation of the cell will be done using the Cell-in-a-Box ®

Implanting these cells

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

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 IND, which the FDA has placed a clinical hold.

Finally, we had licensed from Hai Kang

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

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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.

On November 19, 2020, we terminated the

Hai Kang License Agreement.

Clinical Hold

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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.

On October 1, 2020, we received notice

that the FDA had placed our IND on clinical hold.

On October 30, 2020, the FDA sent a letter

to us setting forth the reasons for the clinical hold and 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;

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 our 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.

Provide additional product release specifications for the encapsulated cells;

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

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

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

Conduct an additional nonclinical study 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 and extensive pig study.

The FDA also requested that we address

several issues not related to the clinical hold in an amendment to the IND, including:

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

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

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

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

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

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

Providing 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.

Since October 31, 2020, 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.

not yet determined the estimated cost or the time necessary to complete these items.

The cost and time associated with completing

these items will be significant.

Thus far, we have successfully completed a 9-month product stability

study, commenced physical parameter testing for CypCaps™

and commenced additional studies for the sequence of DNA encoding

of its encapsulated cells.

We have also designed the biocompatibility tests for cytotoxicity, sensitization, irritation, acute

systemic toxicity, material-mediated pyrogenicity, subacute/subchronic toxicity, genotoxicity and implantation.

In addition, we

have begun a compression and swelling study of CypCaps™, designed a study to determine if CypCaps™

are adversely affected

by contrast medium and designed a study to show the catheters used to implant CypCaps™

do not adversely impact the encapsulated

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 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 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, 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 potential strategic partners’

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.

COVID-19 is causing significant, industry-wide

delays in clinical trials.

Although we are not yet in a clinical trial, we have filed an IND with the FDA to commence a clinical

trial in LAPC.

While the IND has been placed on clinical hold by the FDA, we have assessed the impact of COVID-19 on our operations.

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

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

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.

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

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

impact is not material.

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

clinical hold, including all requested preclinical studies.

There may be further delays in generating responses to the requests

from the FDA related to the clinical hold.

As a result of the COVID-19 pandemic, commencement

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

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

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

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

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

This could further adversely impact or delay our clinical development

It is highly speculative in projecting

the effects of COVID-19 on our clinical development program and on us generally.

The effects of COVID-19 quickly and dramatically

change over time.

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

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

See 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.

set forth in our Form 10-K for

period ended April 30, 2020 and for the risk factors described elsewhere in this Report.

Performance Indicators

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trial in LAPC;

(iv) have regulatory work completed to enable studies and trials to be submitted to regulatory agencies;

all required tests and studies on the cells and capsules we plan to use in our clinical trial in patients with LAPC;

and (vi) ensure

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

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

(iv) respond to the issues raised by the FDA in its clinical hold on our IND and otherwise have regulatory work

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

(v) complete all required tests and studies

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

and (vi) ensure completion of the production

of encapsulated cells according to current Good Manufacturing Practices regulations

to use in our planned clinical trial involving LAPC.

There are numerous items required to be

completed successfully to ensure our final product candidate is ready for use in our planned clinical trial involving LAPC.

effects of material transactions with related parties, and certain other parties to the extent necessary for such an undertaking,

may have substantial effects on both the timeliness and success of our current and prospective financial position and operating

Nonetheless, we are actively working to ensure strong ties and interactions to minimize the inherent risks regarding success.

We do not believe there are factors which will cause materially different amounts to be reported than those presented in this Report.

We aim to assess this regularly to provide accurate information to our shareholders.

completed successfully in order for the FDA’s clinical hold on our IND to be lifted and our final product candidate is ready

for use in our planned clinical trial involving LAPC.

The effects of material transactions with related parties, and certain other

parties to the extent necessary for such an undertaking, may have substantial effects on both the timeliness and success of our

current and prospective financial position and operating results.

Nonetheless, we are actively working to ensure strong ties and

interactions to minimize the inherent risks regarding success.

We do not believe there are factors which will cause materially

different amounts to be reported than those presented in this Report.

We aim to assess this regularly to provide accurate information

to our shareholders.

Results of Operations

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

Three and nine months ended January 31, 2021 compared

to three and nine months ended January 31, 2020

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

31, 2021 and 2020.

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The following table summarizes our operating

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 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.

expenses and loss from operations for the three and nine months ended January 31, 2021 and 2020, respectively:

Three Months Ended January 31,

Nine Months Ended January 31,

The total operating expenses for

the three-month period ended January 31, 2021 decreased by $118,461 from the three months ended January 31, 2020.

is attributable to a decrease in general and administrative (“G&A”) expenses of $75,215, a decrease in director

fees of $13,316, a decrease in legal and professional expense of $20,811 a decrease in compensation expense of $69,911, net of

an increase in R&D expense of $60,792.

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

fees and travel expenses.

The total operating expenses for the nine-month

period ended January 31, 2021 decreased by $488,467 from the nine months ended January 31, 2020.

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.

a decrease in G&A expenses of $696,333, a decrease in director fees of $30,471, a decrease in compensation expense of $137,819,

a decrease in legal and professional expense of $16,254, net of an increase in R&D expense of $392,410.

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

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.

and nine months ended January 31, 2021 and 2020:

Three Months Ended January 31,

Nine Months Ended January 31,

Total other expense for the three months

ended January 31, 2021 increased by the amount of $249 from the three months ended January 31, 2020.

The increase is attributable

to the increase of interest expense in the amount of $249.

Total other expense for the nine months

ended January 31, 2021 increased by the amount of $3,194 from the nine months ended January 31, 2020.

The increase is attributable

to the increase of interest expense in the amount of $2,006, an increase in income taxes of $800 and an increase in foreign exchange

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The following table presents a summary of our sources and uses

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

Six Months Ended

October 31, 2020

October 31, 2019

of cash for the nine months ended January 31, 2021 and 2020, respectively:

Nine Months Ended

January 31, 2021

January 31, 2020

Net cash used in operating activities:

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The net cash used in operating activities

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

for the nine months ended January 31, 2021 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

for the nine months ended January 31, 2020 is a result of our net losses, offset by an increase in stock issued, a decrease in

prepaid expenses and increases in accounts payable and accrued expenses.

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Investing Activities :

There were no investing activities in the six months ended October

31, 2020 and 2019.

There were no investing activities in the nine months ended

January 31, 2021 and 2020.

Financing Activities :

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Liquidity and Capital Resources

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,

As of January 31, 2021, our cash totaled

approximately $3,091,000, compared to approximately $142,000 at January 31, 2020.

Working capital was approximately $2,492,000

at January 31, 2021 and approximately a negative $810,000 at January 31, 2020.

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 nine months ended January 31,

2021, funding was provided by investors to maintain and expand our operations and R&D.

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using the S-3.

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

During the nine months ended January 31, 2020, 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

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our ability to continue as a going concern.

However, we believe the cash on hand, the potential sales of unregistered shares of

its common stock and any public offerings of common stock 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 March 31, 2022.

Use of Estimates and Critical Accounting

For a discussion regarding the Company’s

use of estimates and critical accounting policies, see Note 2 “Summary of Significant Accounting Policies”

to our Condensed Consolidated Financial Statements contained in this Report.

Off-Balance Sheet Arrangements

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We entered into several service agreements

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.

with independent and related parties pursuant to which services will be provided over a specified period-of-time related to our

IND which was placed on clinical hold by the FDA and proposed 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 is approximately fifty percent complete.

including the container closure integrity testing of the clinical

trial product syringes.

The total cost is estimated to be approximately $437,000, of which the related party portion will be approximately

These amounts take into account some of the cost associated with the work and preclinical studies required to lift the

FDA’s clinical hold.

New Accounting Pronouncements

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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.

Quantitative and

Qualitative Disclosures About Market Risk.

The information called for by Item 3 is

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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