What changed in this filing

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Item 7. Management’s Discussion and Analysis

2023-07-31 compared with 2022-07-28 · 147 added, 183 removed, 127 unchanged (72% of the section changed)

MANAGEMENT’S DISCUSSION AND

ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

MANAGEMENT’S DISCUSSION AND ANALYSIS

OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion may contain forward-looking

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of new cellular-based therapies in oncology and diabetes.

We are actively engaged preparing for a Phase

2b clinical trial in LAPC using encapsulated live cells like those used in the previous Phase 1/2 and Phase 2 clinical trials discussed

We are actively engaged preparing for a clinical

trial in LAPC using encapsulated live cells like those used in the previous Phase 1/2 and Phase 2 clinical trials discussed above.

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

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

On October 1, 2020, we received notice from the FDA that it 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.

For the purpose of addressing the clinical hold,

we assembled a team of regulatory and scientific experts to respond to the items requested by the FDA.

That team has been working to complete

the list of items requested by the FDA.

For a complete discussion of what the FDA requires of us and the efforts we have undertaken to

lift the clinical hold, see Item 1.

FDA for our planned clinical trial in LAPC.

On October 1, 2020, we received notice from the FDA that it had placed our IND on clinical

On October 30, 2020, the FDA sent a letter to us setting forth the reasons for the clinical hold and specific guidance on what we

must do to have the clinical hold lifted.

To address our clinical hold, we assembled a team

of regulatory and scientific experts to respond to the items requested by the FDA.

That team has been working to complete the list of

items requested by the FDA.

For a complete discussion of what the FDA requires of us and the efforts we have undertaken to lift the clinical

hold, see Item 1.

Business under the Section entitled, “Clinical Hold” of this Report.

We are also developing a way to delay the production and accumulation

of malignant ascites that results from many types of abdominal cancerous tumors.

Our therapy for malignant ascites involves using the

same encapsulated cells we employ for pancreatic cancer but placing the encapsulated cells in the peritoneal cavity of a patient and administering

ifosfamide intravenously.

We are also developing a way to delay the production

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

Our therapy for malignant ascites involves

using the same encapsulated cells we employ for pancreatic cancer but placing the encapsulated cells in the peritoneal cavity of a patient

and administering ifosfamide intravenously.

In addition to these cancer programs, we have

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Effective July 12, 2021, we filed a Certificate

of Change with the Nevada Secretary of State that authorized a 1:1500 reverse stock split of our common stock.

The reverse stock split

resulted in reducing the authorized number of shares of our common stock from 50 billion to thirty-three million three hundred thirty-three

thousand three hundred thirty-four with a par value of $0.0001 per share.

Any fractional shares resulting from the reverse stock split

were rounded up to the next whole share.

All warrants, option, share and per share information in this Report gives retroactive effect

to such 1:1500 reverse stock split.

of Change to our Articles of Incorporation, as amended (the “Articles of Incorporation”) with the Nevada Secretary of State

that authorized a 1:1500 reverse stock split of our common stock.

The reverse stock split resulted in reducing the authorized number of

shares of our common stock from 50 billion to thirty-three million three hundred thirty-three thousand three hundred thirty-four with

a par value of $0.0001 per share.

Any fractional shares resulting from the reverse stock split were rounded up to the next whole share.

All warrants, option, share and per share information in this Report gives retroactive effect to such 1:1500 reverse stock split.

Increase in Authorized Shares

On March 14, 2023, we filed a Certificate of Change

with the State of Nevada, Secretary of State, to increase the number of authorized shares of our common stock to 133,333,334 shares effective

The par value remained $0.0001 per share.

COVID-19 Impact on Our Financial Condition

and Results of Operations

COVID-19 continues to cause uncertainty and significant,

industry-wide delays in clinical trials.

The availability of vaccines holds promise for the future;

however, new variants of the virus

and potential waning immunity from vaccines may result in continued impact from COVID-19 in the future, which could adversely impact our

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

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

The impact relates to delays in:

(i) completing studies required by the FDA;

(ii) manufacturing a new batch of CypCap™ for our planned

clinical trial in LAPC;

(iii) manufacturing syringes of CypCaps™ for some of the preclinical studies to be completed and use in

our Malignant Ascites Program;

and (iv) securing third party contractors to conduct various R&D projects.

As a result, there may be

delays in generating responses to the requests from the FDA related to the clinical hold.

Many of these potential delays are also due

to the impact of COVID-19 in foreign countries where we are conducting these preclinical studies, including India, Europe, Singapore and

There have also been supply chain interruptions

due to COVID-19.

As a result of COVID-19 and the mitigation efforts

to address it, we may experience additional disruptions that could adversely impact our business and clinical trial, if allowed to proceed,

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

(ii) delays or difficulties in clinical site activation, including difficulties in recruiting clinical site investigators and clinical

site personnel;

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

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

(iv) changes in local regulations as part of a response

to COVID-19 which may require us to change the ways in which our clinical trial is to be conducted, which may result in unexpected costs,

or to discontinue the clinical trial altogether;

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

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

(vi) interruption

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

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

could affect the integrity of clinical trial data;

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

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

adverse events;

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

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

(ix) limitations in employee resources that would

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

to avoid contact with large groups of people;

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

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

As a result of COVID-19, commencement of our planned

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

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 COVID-19 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

This could further adversely impact or delay our clinical development program if the FDA allows it to proceed.

Clinical trials in the biopharma industry may

be delayed due to COVID-19.

There are numerous reasons for these potential delays.

For example, patients have shown a reluctance to enroll

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

There are local,

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

These discourage and interfere with patient

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

Healthcare providers and health systems have shifted their resources

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

The FDA and other healthcare providers are making product candidates for

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

It is highly speculative in projecting the effects

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

Moreover, the various precautionary measures taken

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

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

and delivery efforts and other aspects of the global economy.

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

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

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

The effects of COVID-19 quickly

and dramatically change over time.

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

fully cease to have an impact on our operations.

We face the ongoing risk that the coronavirus

pandemic may slow our operations, our preclinical studies or the eventual enrollment of our planned clinical trial.

In order to prioritize

patient health and that of the investigators at clinical trial sites, we may need monitor enrollment of patients in our clinical study.

In addition, some patients may be unwilling to enroll in our trials or be unable to comply with clinical trial protocols if quarantines

or travel restrictions impede patient movement or interrupt healthcare services.

These and other factors outside of our control could

delay our ability to conduct clinical trials or release clinical trial results.

In addition, the effects of the ongoing coronavirus pandemic

may also increase non-trial costs such as insurance premiums, increase the demand for and cost of capital, increase loss of work time

from key personnel, and negatively impact our key clinical trial vendors.

Performance Indicators

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(iii) complete activities for producing genetically

modified human cells and having them encapsulated for our preclinical studies and the planned Phase 2b clinical trial in LAPC;

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

(v) complete all required tests and studies

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

modified human cells and having them encapsulated for our preclinical studies and the planned clinical trial in LAPC;

(iv) have regulatory

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

(v) complete all required tests and studies on the

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

(vi) ensure completion of the production of encapsulated

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and (viii) obtain approval from the FDA to lift the clinical hold on our IND that we may commence our

planned Phase 2b clinical trial in LAPC.

planned clinical trial in LAPC.

There are numerous items required to be completed

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million as of April 30, 2023, and approximately $84.8 million as of April 30, 2022.

The increase in cash is attributable to proceeds from

the sale of our common stock net of an increase in our operating expenses.

On August 9, 2021, the Company entered into an

underwriting agreement to offer and sell shares of common stock, pre-funded warrants to purchase common stock and warrants to purchase

common stock in a public offering (“First Offering”).

The gross proceeds of the First Offering were $15 million, before deduction

of underwriting discounts, commissions, and estimated offering expenses.

In August 2021, the Company received twenty-seven

(27) cash exercise notices relating to the common warrants with respect to the First Offering totaling 2,522,387 warrant shares (“Warrant

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

On August 19, 2021, the Company entered into a

securities purchase agreement (“Securities Purchase Agreement”) with certain institutional investors (“Purchasers”)

pursuant to which the Company agreed to sell in a registered direct offering (“Registered Direct Offering”), shares of the

Company’s common stock and pre-funded warrants to purchase shares of common stock.

Further, pursuant to the Securities Purchase

Agreement, in a concurrent private placement (together with the Registered Direct Offering, “Second Offering”), the Company

also agreed to issue to the Purchasers unregistered warrants (“Series A Warrants”) to purchase shares of common stock.

Company received gross proceeds from the Second Offering, before deducting placement agent fees and other estimated offering expenses

payable by the Company, of approximately $70 million.

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

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

Securities and Exchange Commission

(“Commission”).

During the year ended April 30, 2022, funding

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

Offering and the Second Offering and the Warrant Exercises.

Sales of our common stock, pre-funded warrants and exercise of Common Warrants

occurred in the First Offering, Second Offering, and the Warrant Exercises.

During the year ended April 30, 2021, the Company

sold and issued approximately 462,000 shares of common stock, pursuant to an effective S-3 registration statement, at prices ranging from

approximately $15 to $45 per share.

Net of underwriting discounts, legal, accounting, and other offering expenses, the Company received

proceeds of approximately $4.7 million from the sale of these shares for the year ended April 30, 2021.

On May 14, 2018, we entered into amendments to

all of the material agreements with SG Austria and Austrianova.

See Section entitled, History of the Business” in Item 1.

above for a description of these amendments.

We have no other off-balance 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 or capital resources.

The decrease in cash is attributable to the repurchase

of our common stock pursuant to the Repurchase Programs, recorded as treasury stock and an increase in our operating expenses.

2021 Underwritten Offering

On August 9, 2021, we entered into an underwriting

agreement with H.C.

Wainwright & Co.

(“Wainwright”), pursuant to which we offered and sold an aggregate of 2,630,385 shares

of common stock, and 899,027 pre-funded warrants to purchase common stock, and common warrants to purchase 4,028,528 shares of common

stock (the “First 2021 Offering”).

The common warrants sold in the First 2021 Offering have an exercise price of $4.25 per

share, were exercisable immediately upon issuance, and expire five years following the date of issuance.

The pre-funded warrants sold

in the First 2021 Offering have an exercise price of $0.001 per share, were exercisable immediately upon issuance, and do not have an

expiration date.

The gross proceeds of the First 2021 Offering were $15 million, before deduction of underwriting discounts, commissions,

and estimated offering expenses.

Wainwright acted as the exclusive placement agent

for the Second 2021 Offering pursuant to an engagement letter with the Company dated April 26, 2021 (the “Wainwright Engagement

Pursuant to the Wainwright Engagement Letter and in connection with the First 2021 Offering, we paid Wainwright a placement

agent fee equal to 7.5% of the aggregate gross proceeds and a management fee equal to 1.0% of the gross proceeds, and we issued Wainwright

warrants to purchase up to [ ] shares of common stock (the “Placement Agent Warrants”).

The Placement Agent Warrants have

an exercise price of $6.25 per share, were exercisable immediately upon issuance, and expire five years following the date of issuance.

In August 2021, we received twenty-seven (27)

exercise notices from holders of the common warrants issued in the First 2021 Offering, pursuant to which we received approximately $10,720,000

and issued 2,522,387 shares of common stock (the “2021 Warrant Exercises”).

2021 Registered Direct Offering and Concurrent

Private Placement

On August 19, 2021, we entered into a securities

purchase agreement with certain institutional investors, pursuant to which we sold (i) 8,430,000 shares of common stock and pre-funded

warrants to purchase up to 5,570,000 shares of common stock in a registered direct offering and (ii) unregistered warrants to purchase

up to 7,000,000 shares of common stock (the “Series A Warrants”) in a concurrent private placement (collectively, the “Second

2021 Offering”).

The pre-funded warrants sold in the Second 2021 Offering have an exercise price of $0.001 per share, were exercisable

immediately upon issuance, and do not have an expiration date.

The Series A Warrants have an exercise price of $5.00 per share, were exercisable

immediately upon issuance, and expire five years following the date of issuance.

Wainwright acted as the exclusive placement agent

for the Second 2021 Offering pursuant to the Wainwright Engagement Letter.

Pursuant to such engagement letter and in connection with the

Second 2021 Offering, we paid Wainwright a placement agent fee equal to 7.5% of the aggregate gross proceeds and a management fee equal

to 1.0% of the gross proceeds, and we issued Wainwright an additional 1,050,000 Placement Agent Warrants.

We received gross proceeds from

the Second 2021 Offering, before deducting placement agent fees and other estimated offering expenses payable by the Company, of approximately

On November 17, 2021, our Registration Statement on Form S-3 registering the resale of the shares of common stock underlying

the Series A Warrants and the Placement Agent Warrants was declared effective by the U.S.

Securities and Exchange Commission (“Commission”).

During the year ended April 30, 2022, we received

approximately $87.4 million from the First 2021 Offering, the Second 2021 Offering and the 2021 Warrant Exercises.

Repurchase Programs

Pursuant to the First Repurchase Program, we may

acquire up to $10 million of our outstanding shares of common stock, as determined by a formula based on the market price of the common

stock and average daily volumes.

Pursuant to the Second Repurchase Program, we may acquire up to $10 million of our outstanding shares

of common stock from time to time in open market transactions, privately negotiated block transactions or other means in accordance with

applicable securities laws.

For more information on the Repurchase Programs, see “Note 12 – Treasury Stock.”

Other Liquidity Matters

We have no other off-balance 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 or capital resources.

To meet our short and long-term liquidity needs,

we expect to use existing cash balances and a variety of other means.

Other sources of liquidity could include additional potential issuances

of debt or equity securities in public or private financings, partnerships, collaborations and sale of assets.

Our history of operating

losses and liquidity challenges may make it difficult for us to raise capital on acceptable terms or at all.

The demand for the equity

and debt of pharmaceutical companies like ours is dependent upon many factors, including the general state of the financial markets.

times of extreme market volatility, capital may not be available on favorable terms, if at all.

Our inability to obtain such additional

capital could materially and adversely affect our business operations.

Our future capital requirements are difficult to forecast and will

depend on many factors, but we believe that our cash on hand will enable us to fund operating expenses for at least the next 12 months

following the issuance of our consolidated financial statements.

Year ended April 30, 2023, compared to year

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Operating Expenses

The total operating expenses during the year ended

April 30, 2022, increased by $769,033 to $4,392,014 from $3,622,981 in the year ended April 30, 2021.

The increase is mainly attributable

to increases in compensation expense, legal and professional expense, and consulting expense in 2022 from 2021, net of decreases in R&D

costs and director fees.

Our total operating expenses during the year ended

April 30, 2023 were $6,455,494, representing an increase of $2,063,480 compared to the year ended April 30, 2022.

The increase is mainly

attributable to increases in director fees and legal and professional expenses, net of decreases in R&D costs and compensation expense.

Operating expenses:

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Loss from operations during the year ended April

30, 2022, increased by $769,033 to $4,392,014 from $3,622,981 in the year ended April 30, 2021.

The increase is mainly attributable to

increases in compensation expense, legal and professional expense, and consulting expense in 2022 from 2021, net of decreases in R&D

costs and director fees.

30, 2023 was $6,455,494, an increase of $2,063,480 compared to the year ended April 30, 2022.

The increase is mainly attributable to increases

in director fees and legal and professional expenses, and consulting expenses in 2023 from 2022, net of decreases in R&D costs and

compensation expense.

See the table under “ Operating Expenses ” above for more detail.

Other Income (Expenses), Net

Other income, net for the year ended April 30,

2022, was $152,853 as compared to other expense, net of $71,745 in the year ended April 30, 2021.

2023, was $2,139,501, as compared to other income, net of $152,853 in the year ended April 30, 2022.

Other income, net for the year ended

April 30, 2022, is attributable to interest income of $157,645 net of interest expense and other expenses of $4,792.

Other income, net

for the year ended April 30, 2021, is attributable to the forgiveness of the Paycheck Protection Program loan and accrued interest of

$75,979 net of interest and other expenses of $4,234.

April 30, 2023 is attributable to interest income of $1,937,499 net settlement of accounts payable of $152,976 and net of other income

and expense of $49,026.

Other income, net for the year ended April 30, 2022 is attributable to interest income of $157,645 net of interest

expense and other expenses of $4,792.

Discussion of Operating, Investing and Financing

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Net cash used in operating activities:

$ (4,117,319 )

$ (3,330,889 )

Net cash used in investing activities:

Net cash provided by financing activities:

Net cash provided by (used in) financing activities:

Effect of currency rate exchange

Increase in cash

Increase (decrease) in cash

Operating Activities:

The cash used in operating activities for the

years ended April 30, 2022, and 2021, is a result of our net losses offset by securities issued for services and compensation, changes

to prepaid expenses, accounts payable and accrued expenses.

years ended April 30, 2023 and 2022 is a result of our net losses offset by securities issued for services and compensation, changes to

prepaid expenses, accounts payable and accrued expenses.

Investing Activities :

We had no investing

activities for the years ended April 30, 2022, and 2021.

We had no investing activities for the years ended

April 30, 2023, and 2022.

Financing Activities:

The cash provided from financing activities for

the years ended April 30, 2022, and 2021, is mainly attributable to the proceeds from the sale of our common stock.

The cash used in financing activities for the

year ended April 30, 2023 was mainly attributable to the Repurchase Programs, and the cash provided for the year ended April 30, 2022,

is mainly attributable to the proceeds from the First 2021 Offering and the Second 2021 Offering.

Critical Accounting Estimates and Policies

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New Accounting Pronouncements

For a discussion of all recently adopted and recently

issued but not yet adopted accounting pronouncements, see “Recent Accounting Pronouncements” in Note 2 of our Notes to our

Consolidated Financial Statements included in Item 8, “Financial Statements and Supplementary Data” of this Report.

During the current and prior year, there were

no new accounting pronouncements that need to be disclosed in the Company’s consolidated financial statements.

QUANTITATIVE AND QUALITATIVE DISCLOSURES

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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-K

Item 7. Management’s Discussion and Analysis