What changed in this filing

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Item 2. Management’s Discussion and Analysis

2022-03-15 compared with 2021-12-10 · 94 added, 89 removed, 120 unchanged (60% of the section changed)

51 unchanged sentences

Recent Funding

2022, we received a donation in the amount of $500,000 in partnership with the Erase PTSD Now organization and the Glenn Greenberg and

Linda Vester Foundation.

These funds were recorded as Other income in our Statements of Operations and will be used to progress the Phase

1 human clinical trials for drug candidate PRV-002 for the treatment of concussion

Promissory Notes

On December 21, 2021

and December 22, 2021, we entered into a total of five Promissory Notes (the “Notes”) with three of our directors and two

Joseph Michael Redmond,

President and Chief Executive Officer, Ms.

Farrell, Chief Financial Officer, Mr.

Casey, Director, Mr.

Director, and Mr.

Richardson, Director, each loaned us $25,000 for total proceeds of $125,000.

The Notes bear interest at 8%

per annum and are due March 31, 2022.

LPC Securities Purchase Agreement

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LPC Purchase Agreement Draws

During the first quarter of Fiscal 2022, we sold

974,482 shares of our common stock to LPC for total proceeds of $367,035.

As of December 10, 2021, LPC purchased a total of 3,127,808

shares of our common stock pursuant to the agreement and remaining purchase availability is $8,411,489 and remaining shares available

are 16,143,556.

During the six months ended January 31, 2022,

LPC purchased a total of 974,482 shares of our common stock for total proceeds of $367,035 pursuant to the August 14, 2020 LPC Purchase

As of January 31, 2022, LPC had purchased a total of 3,127,808 shares of our common stock pursuant to the agreement and remaining

purchase availability was $8,411,489 and remaining shares available were 16,143,556.

Tysadco Partners

On August 29, 2021, we entered into a Securities

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Going Concern

Substantial doubt exists as to our ability to

continue as a going concern based on the facts that we may not have adequate working capital to finance our day-to-day operations and

we do not have any sources of revenue.

We had an accumulated deficit of $47,380,097 as of October 31, 2021 and cash of $471,140.

plans include engaging in further research and development and raising additional capital in the short term to fund such activities through

sales of its common stock.

Our continued existence depends on the success of our efforts to raise additional capital necessary to meet

our obligations as they come due and to obtain sufficient capital to execute our business plan.

We may obtain capital primarily through issuances

of debt or equity or entering into collaborative arrangements with corporate partners.

There can be no assurance that we will be successful

in completing additional financing or collaboration transactions or, if financing is available, that it can be obtained on commercially

reasonable terms.

If we are not able to obtain additional financing on a timely basis, we may be required to further scale down or cease

the operation of our business.

The issuance of additional equity securities by us could result in a significant dilution in the equity

interests of our current stockholders.

Obtaining commercial loans, assuming those loans would be available, will increase our liabilities

and future cash commitments.

Our financial statements do not include adjustments that might result from the outcome of this uncertainty.

For the foreseeable future, we expect to experience

continuing operating losses and negative cash flows from operations as our management executes our current business plan.

$471,140 available at October 31, 2021, may not provide enough working capital to meet our current operating expenses through December

If we are unable to raise additional capital

by December 10, 2022, we will adjust our current business plan.

Due to the unknown and volatile nature of the stock price and

trading volume of our common stock, is it is difficult to predict the timing and amount of availability pursuant to our equity line

of credit with LPC (see Note 7 of Notes to Financial Statements).

Given our recurring losses, negative cash flow, accumulated

deficit, and the impact of COVID-19, there is substantial doubt about our ability to continue as a going concern.

See Note 1 of Notes to Financial Statements.

Impact of COVID-19

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impact on our business operations.

The pandemic has impacted our ability to get financing, engage third-party vendors and timing of clinical

The pandemic has impacted our ability to get financing, engage third-party vendors and the timing of

our clinical trial in Australia.

In addition, the COVID-19 outbreak has adversely affected the U.S.

and global economies and financial markets, which may result

in a long-term economic downturn that could negatively affect future performance and our ability to secure additional debt or equity funding.

and global economies and financial

markets, which may result in a long-term economic downturn that could negatively affect future performance and our ability to secure additional

debt or equity funding.

Significant Accounting Policies and Use of

During the three months ended October 31, 2021,

there were no significant changes to our significant accounting policies and estimates as described in Note 2.

During the six months ended January 31, 2022,

there were no significant changes to our significant accounting policies and estimates are described in Note 2.

Summary of Significant

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We do not currently sell or market any products

and we did not have any revenue in the three-month periods ended October 31, 2021 or 2020.

We will commence actively marketing products

after the products and drugs in development have been FDA cleared or approved, but there can be no assurance, however, that we will be

successful in obtaining FDA clearance or approval for our products.

Three Months Ended October 31,

and we did not have any revenue in the three or six month periods ended January 31, 2022 or 2021.

We will commence actively marketing

products after the products and drugs in development have been FDA cleared or approved, but there can be no assurance, however, that we

will be successful in obtaining FDA clearance or approval for our products.

Three Months Ended January 31,

Research and development expense

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Interest expense

Other income, net

$ (1,692,713 )

Basic and diluted net loss per share

Six Months Ended January 31,

Research and development expense

General and administrative expense

Loss from operations

Interest expense

Other income, net

$ (3,338,987 )

$ (1,580,814 )

$ (1,758,173 )

Basic and diluted net loss per share

Research and Development Expense

Our Research and development expense includes

expenses related to our current projects and include, clinical research, design and manufacturing, formulation, regulatory and consultants.

Research and development expense is expensed as incurred and totaled $322,504 and zero for the three months ended October 31, 2021 and

2020, respectively.

The increases in Research and development were due to expenses related to our PRV-002 drug device combination.

Research and development

expense was offset in the three and six month periods ended January 31, 2022 by research and development rebates from the government of

Australia in the amount of $6,219 and $220,339, respectively, for clinical work performed in Australia related to our Phase 1 human trial

for safety and efficacy for the treatment of concussed individuals.

General and Administrative Expense

Our General and administrative expense includes

salaries and related benefits for employees in finance, accounting, sales, and administrative activities, as well as stock-based compensation,

costs related to maintaining compliance as a public company and legal and professional fees.

The increase in General and administrative expense

in the three months ended October 31, 2021 as compared to the same period of 2021 was due to the following:

October 31, 2021

October 31, 2020

salaries and related benefits for employees in finance, accounting, sales, administrative and research and development activities, as

well as stock-based compensation, costs related to maintaining compliance as a public company and legal and professional fees.

The increases in General and administrative expense

were due to the following:

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

January 31, 2021

Six months ended January 31, 2022 compared to six months ended

January 31, 2021

Increase (decrease) in:

Board and stock

Business development and investor

Board and stock expense

Business development and investor relations

Consulting fees

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Legal and professional fees

The increase in Board and stock expense of $400,325

for the quarter ended October 31, 2021 compared to the quarter ended October 31, 2020, was due to board grants in the current year quarter,

option and restricted stock unit expense for the employees, consultants and the scientific and sports advisory boards.

The increase in

wages of $165,324 was a result of increased headcount for the quarter ended October 31, 2021, as compared to the quarter ended October

The increases were partially offset by a decrease in legal and professional fees of $108,063 in the quarter ended October 31,

2021, as compared to the quarter ended October 31, 2020.

The increases in board and stock expense were

due to the vesting of restricted stock units and the increases in wages was due to the bonus granted to our executive officers in 2022.

Interest Expense

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was as follows:

Three Months Ended October 31,

Three Months Ended January 31,

Six Months Ended January 31,

Weighted average debt outstanding

Weighted average interest rate

The increase in interest expense for the three-month

period ended October 31, 2021 compared to the same period of 2020 was due to LGH and Tysadco investments in April 2021 and October 2021,

respectively.

Net loss increased in the three-month period ended

October 31, 2021 compared to the same period of 2020 due to increased board and stock expense, research and development and wages, as

well increased interest expense, partially offset by the lower weighted average interest rate.

The increases in interest expense for the three

and six-month periods ended January 31, 2022 compared to the same periods of 2021 were due to LGH and Tysadco investments in April 2021

and October 2021, respectively, and the issuance of promissory notes in December 2021.

Other Income, net

Other income, net includes a donation

in the amount of $500,000 in partnership with the Erase PTSD Now organization and the Glenn Greenberg and Linda Vester Foundation and

foreign exchange gains and losses related to invoices denominated and paid in foreign currencies.

Net loss increased in the three and six months

ended January 31, 2022, compared to the same periods of the prior year due to increased research and development expense, general and

administrative expense and interest expense as discussed above.

Liquidity and Capital Resources

See Recent Funding above for a discussion of our recent debt and equity

The following table sets forth the primary sources and uses of cash:

Three Months Ended October 31,

Six Months Ended January 31,

Net cash used in operating activities

$ (1,584,793 )

Net cash used in investing activities

Net cash provided by financing activities

To date, we have financed our operations primarily

through debt financing and limited sales of our common stock.

Our ability to continue to access capital could be affected adversely by

various factors, including general market and other economic conditions, interest rates, the perception of our potential future earnings

and cash distributions, any unwillingness on the part of lenders to make loans to us and any deterioration in the financial position

of lenders that might make them unable to meet their obligations to us.

If these conditions continue and we cannot raise funds through

a public or private debt financing, or an equity offering, our ability to grow our business may be negatively affected.

In such case,

we may need to suspend the creation of new products until market conditions improve.

through debt financing and sales of our common stock.

Our ability to continue to access capital could be affected adversely by various

factors, including general market and other economic conditions, interest rates, the perception of our potential future earnings and cash

distributions, any unwillingness on the part of lenders to make loans to us and any deterioration in the financial position of lenders

that might make them unable to meet their obligations to us.

If these conditions continue and we cannot raise funds through a public or

private debt financing, or an equity offering, our ability to grow our business may be negatively affected.

In such case, we may need

to suspend the creation of new products until market conditions improve.

Cash used in investing activities in the first

six months of fiscal 2022 were primarily for a patent related to our PRV-002 drug device combination.

The following notes payable were outstanding:

October 31, 2021

Convertible note issued to LGH due February 5,

2022 with an interest rate of 8.0% and convertible at $1.00 per share

January 31, 2022

Note issued to Labrys due August 14, 2021 with an interest rate of 12%

Convertible note issued to LGH due February 5, 2022 with an interest rate of 8.0% and convertible at $1.00 per share (1)

Promissory notes issued to officers and directors due March 31, 2022 with an interest rate of 8.0%

Tysadco convertible promissory note payable due March 1, 2022 with an interest rate of 8.0% and convertible at $0.30 per share (2)

Unamortized debt discount and closing costs

Australian Research and Development Rebate

On November 2, 2021, we received a research and

development rebate from the government of Australia in the amount of $284,981 AUD ($214,120 USD) for clinical work performed in Australia

related to our Phase 1 human trial for safety and efficacy for the treatment of concussed individuals.

The $214,120 is accounted for as

an offset to research and development expense, which is a component of General and administrative on our Statements of Operations.

(1) Effective February 1, 2022, the maturity date of this note was extended to May 31, 2022 and $200,000 was

added to the principal.

See Note 13 of Notes to Financial Statements for additional information.

(2) As of March 15, 2022, the loan has not been repaid or converted.

Inflation did not have a material impact on our

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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 2. Management’s Discussion and Analysis