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Item 7. Management’s Discussion and Analysis

2023-10-30 compared with 2022-10-31 · 154 added, 140 removed, 120 unchanged (71% of the section changed)

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our forward-looking statements:

our limited operating history and no revenues, on which to evaluate our ability to achieve our business objective and projected cash needs and our expected future revenues, operations and expenditures;

our limited operating history and lack of revenue, on which to evaluate our ability to achieve our business objective and projected cash needs and our expected future revenues, operations and expenditures;

our potential ability to obtain additional financing on favorable terms;

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the extent to which we acquire or invest in businesses, products, and technologies;

the scope, progress, results and costs of our clinical trials of our drug candidates and medical devices;

our ability to successfully integrate our acquired products and technologies into our business, including the possibility that the expected benefits of the transactions will not be fully realized by us or may take longer to realize than expected;

the scope, progress, results and costs of our clinical trials for our drug candidates and medical devices;

our ability to successfully integrate our acquired products and technologies into our business, including the possibility that we won’t fully realize the expected benefits of the transactions will not be fully realized by us or may take longer to realize than expected;

our ability to successfully consummate our asset purchase agreement with Oragenics;

the safety and efficacy of our product candidates;

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Food and Drug Administration (FDA) and other regulatory agencies, related to our product candidates to the satisfaction of the FDA and such other regulatory agencies;

our ability to obtain, maintain and successfully enforce adequate patent and other intellectual property or regulatory exclusivity protection of our product candidates and the ability to operate our business without infringing the intellectual property rights of others;

the costs of preparing, filing, and prosecuting patent applications and maintaining, enforcing, and defending intellectual property-related claims;

the emergence of competing technologies and other adverse market developments;

the impact of COVID-19 pandemic;

changes in accounting standards;

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channels, including third parties.

We are developing potentially life-saving technologies:

We plan to develop potentially life-saving technologies:

the CardioMap® heart monitoring and screening

the Save A Life choking rescue device, a unique neurosteroid drug compound intended to treat concussions and a unique drug compound

device, the Save A Life choking rescue device, a unique neurosteroid drug compound intended to treat concussions and a unique drug compound

to treat rare brain disorders in partnership with Prevacus, Inc.

To date, none of our product candidates has received regulatory clearance

To date, none of our product candidates have received regulatory clearance

or approval for commercial sale.

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We intend to establish agreements with distributors to get products to market quickly,

as well as to undertake and engage in our own direct marketing efforts.

We will determine the most effective method of distribution for

each unique product that we include in our portfolio.

We will engage third-party research and development firms who specialize in the

creation of our products to assist us in the development of our own products, and we will apply for trademarks and patents once we have

and undertake and engage in direct marketing efforts effort as we move closer to regulatory approvals.

We will determine the most effective

distribution method for each unique product we include in our portfolio.

We will engage third-party research and development firms that

specialize in creating products to assist us in developing our own products, and we will apply for trademarks and patents once we have

developed proprietary products.

Recent Funding

Private Placement

On February 2, 2022, we entered into an agreement

to raise money through a private investment in a public entity.

We offered up to 14,285,714 Units (the “Units”) at $0.35 per

Each Unit consisted of one share of our common stock and one-half of an accompanying warrant.

Each full warrant is exercisable for

one share of our common stock at $0.70 per share.

To date, we issued a total of 4,058,372 Units

for gross proceeds to us of $1,420,430.

No additional sales will be made pursuant to this agreement.

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.

It was contemplated, a royalty of one-half of one percent be paid to Erase

PTSD Now in perpetuity.

At this time there is no agreement in place and the parties may or may not enter into an agreement in the future.

Promissory Notes

In December 2021, we

entered into a total of five Promissory Notes (the “Notes”) with three of our directors and two officers.

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 were originally due March 31, 2022.

The due date of the notes was extended to December 31, 2022.

LPC Securities Purchase Agreement

On October 22, 2021, we entered into a Securities

Purchase Agreement (the “SPA”) with Lincoln Park Capital Fund, LLC (“LPC”) pursuant to which we received $250,000

in cash from LPC and LPC received (i) 1,500,000 restricted shares of our common stock, and (ii) 833,333 warrants exercisable at $0.50

per common share expiring in five years.

Mast Hill Fund L.P.

On December 13, 2022, we entered into a Securities

Purchase Agreement (the “SPA”) with Mast Hill Fund, L.P.

(“Mast Hill”).

Pursuant to the SPA, we sold Mast Hill

(i) an $870,000 face value, one-year, 10% per annum Promissory Note convertible into shares of our common stock at $0.12 per share, (ii)

a five-year share purchase warrant entitling Mast Hill to acquire 2,000,000 shares of our common stock at $0.20 per share (the “Warrant”),

and (iii) a five-year warrant for 4,000,000 shares of our common stock at $0.20 per share issuable in the event of default.

after original discount, fees and expenses, was $723,868.

On June 13, 2023, we entered into Amendment No.

1 to the SPA dated December 13, 2022.

Pursuant to the Amendment, we (i) increased the principal balance by $50,000 to a total of $920,000

to be amortized over the life of the note, (ii) issued a five-year common stock purchase warrant to Mast Hill Fund L.P.

for the purchase

of 1,000,000 shares of our common stock at $0.20 per share with a fair value of $28,448, (iii) extended the maturity dated to June 13,

2024, (iv) extended the amortization payments, and (v) changed the terms of the repayment from proceeds from other sources.

LPC Purchase Agreement Draws

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shares of our common stock for total proceeds of $580,220 pursuant to the August 14, 2020, LPC Purchase Agreement.

As of October 31, 2022,

LPC had purchased a total of 4,882,518 shares of our common stock for total proceeds of $2,260,976 and remaining purchase availability

was $7,989,024 and remaining shares available were 14,388,846.

Tysadco Partners

On August 29, 2021, we

entered into a Securities Purchase Agreement (the “SPA”) with Tysadco Partners (“Tysadco”) pursuant to which we

entered into a $250,000 face value convertible promissory note which bears interest at a one-time rate of 8.0% applied to the face value

and had an original maturity date of March 1, 2022.

We received $250,000 net cash from the issuance of the promissory note and issued

200,000 shares of common stock with a fair value of $17,718 which is being expensed over the life of the note as a component of interest

On March 31, 2022, the SPA was amended to extend the maturity date to March 1, 2023, and, as consideration, $25,000 was added

to the principal for a total $275,000.

The conversion rate of the note is $0.30 for a total of 983,333 shares of our common stock if converted

in full, including interest.

The agreement includes a leak out provision until the shares have been sold.

On October 18, 2021, we entered into a Securities

Purchase Agreement with Tysadco pursuant to which we received $250,000 in cash from Tysadco and Tysadco received (i) 1,500,000 restricted

shares of our common stock, and (ii) 833,333 warrants exercisable at $0.50 per common share expiring in five years.

See Notes 6 and 8 of Notes to Financial Statements

for additional information.

Subsequent to July

31, 2023 and through October 30, 2023, LPC purchased an additional 500,000 shares of our common stock to LPC for total proceeds of $45,820.

As of October 30, 2023, LPC had purchased a total of 7,882,518 shares of our common stock for total proceeds of $2,646,306 and the remaining

purchase availability was $7,603,694 and the remaining shares available were 11,388,846.

Promissory Note

On September 21, 2022, we entered into a promissory

note for $30,000 with a consultant for investor relations services with an interest rate of 8% per annum and a due date of December 31,

The promissory note was amended on December 30, 2022, to extend the maturity date to January 31, 2023.

On January 31, 2023, the

note was extended to June 30, 2023.

As consideration, the consultant was granted a five-year stock option for 50,000 shares of common

stock at $0.17 per share.

On June 9, 2023, we entered into Amendment No.

2 to this promissory note pursuant to which we converted the

loan into 300,000 shares of our common stock with a value of $36,000.

Note Purchase Agreement

On July 7, 2023, we received a $150,000 advance

from an accredited investor related to a $500,000 Note Purchase Agreement (the “NPA”) entered into with two accredited investors

on August 15, 2023, at which time the remaining $350,000 of the $500,000 was received.

Asset Purchase Agreement with Oragenics,

On October 4, 2023, we entered into an Asset Purchase

Agreement (the “Purchase Agreement”) with Oragenics, Inc.

(“Oragenics” the “Purchaser”).

to the Purchase Agreement, we have agreed to sell and assign, certain assets and certain liabilities related to a segment of Odyssey’s business

focused on developing medical products that treat brain related illnesses and diseases (the “Purchased Assets”) to Oragenics

in exchange for (i) $1,000,000 in cash and 8,000,000 shares of convertible Series F Preferred Stock (“Series F Preferred Stock”),

on and subject to the terms and conditions set forth therein (such transaction, the “Odyssey Asset Purchase”).

The Purchased

Assets include drug candidates for treating mild traumatic brain injury (mTBI), also known as concussion, and for treating Niemann Pick

Disease Type C (NPC), as well as our proprietary powder formulation and its nasal delivery device.

We received $500,000 upon the execution of the

Purchase Agreement on October 4, 2023 and will receive the additional $500,000 upon the earlier of (a) the closing of the Purchase Agreement

(the “Closing”), (b) within three (3) business days after the date that the Company has obtained the its stockholders’

approval approving the Odyssey Asset Purchase and (c) immediately upon the Purchasers’ wrongful termination of the Purchase Agreement

in breach of the Purchase Agreement.

The closing of the Asset Purchase is expected

to be at the end of the fourth calendar quarter of 2023.

See Notes 6 and 13 of Notes to Consolidated Financial

Statements for additional information.

Going Concern

See Note 1 of Notes to Financial Statements.

Impact of COVID-19

The COVID-19 global pandemic has had an unfavorable

impact on our business operations.

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

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.

Critical Accounting Policies and Estimates

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Actual results may differ from those estimates.

We believe the following accounting policies to be critical to the

judgements and estimates used in the preparation of our consolidated financial statements.

Reference is made to our significant accounting

policies set forth in Note 2 of Notes to Financial Statements.

policies set forth in Note 2 of Notes to Consolidated Financial Statements.

Results of Operations

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Fiscal Year Ended July 31,

General and administrative expense

Research and development

In-process research and development

Research and development

Stock-based compensation

General and administrative

Loss from operations

(15,860,712 )

Interest expense

Other income, net

$ (5,919,421 )

$ (8,444,131 )

$ (2,524,710 )

Basic and diluted net loss per share

NM – Not meaningful

General and Administrative Expense

Our General and administrative expense includes

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 change in General and administrative expense

was due to the following:

In-Process Research and Development

In-process research and development in fiscal

2023 relates to the value of the 1,000,000 shares of our common stock with a value of $0.17 per share issued to Prevacus in connection

with the November 2022 Option Agreement.

Research and Development

Research and development relates to our current

projects and includes expenses for clinical research, design and manufacturing, formulation, regulatory and consultants.

The change in Research and development was due

to the following:

Fiscal Year Ended July 31, 2023 compared to

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Increase (decrease) in:

Drug development

Phase 1 clinical trial

Australian research and development rebate

Prototype phase

$ (1,115,695 )

The decreases in drug development, consultants

and prototype phase were the result of the completion of the development of the concussion drug in the fourth quarter of fiscal 2022.

The decrease in Phase I clinical trial costs were the result of the completion of dosing patients in the Phase I clinical trial of our

concussion drug device trial in first quarter of fiscal 2023.

General and Administrative

General and administrative includes expenses related

to 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 change in General and administrative was due

to the following:

Fiscal Year Ended July 31, 2023 compared to

Fiscal Year Ended July 31, 2022

Increase (decrease) in:

Stock-based compensation

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Legal and professional fees

The increase in stock-based compensation was due

to the grant of 500,000 RSUs to each of three directors and the grant of 5,595,000 stock options to officers, employees and consultants

during fiscal 2022.

The increase in Business development and investor

relations was the result of 3,745,000 shares of common stock issued in exchange for services and the increase in wages was due to bonuses

totaling $400,000 granted to our executive officers in fiscal 2022 and additional employees hired in the third quarter of fiscal 2021.

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.

The change in Research and development expense

was due to the following:

Fiscal Year Ended July 31, 2022 compared to

Fiscal Year Ended July 31, 2021

Increase (decrease) in:

Drug development

Phase 1 clinical trial

Australian research and development rebates

Prototype phase

The decreases in drug development and prototype phase are the result

of completion of those phases of the development of PRV-002 and the decrease in the phase one clinical trial is due to the timing of the

clinical trial.

The increases in consultants, and the Australian research and development and goods and services tax (“GST”)

rebates are a result of expenses incurred and amounts due related to the Phase 1 clinical trial for PRV-002.

In-Process Research and Development

In-process research and development in fiscal

2021 related to the Prevacus APA that closed on March 1, 2021.

See Note 4 of Notes to Financial Statements for additional information.

$ (1,846,870 )

The increase in stock-based compensation was

due to the vesting of restricted stock units and the granting of stock options in fiscal 2023.

The decrease in business development

and investor relations was a result of decreased activities related to business development.

The decrease in wages was due to the

$400,000 bonus granted to our executive officers in January 2022.

Interest Expense

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Weighted average interest rate

The increase in interest expense was due to LGH

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

The increase in weighted average debt outstanding

was due to the issuance of an $870,000 promissory note during the second quarter of fiscal 2023 and a $150,000 deposit received on a note

purchase agreement during the fourth quarter of fiscal 2023.

In addition, the increase to the weighted average debt outstanding is due

to the addition of principal to the LGH, ClearThink and Mast Hill notes in exchange for extending the maturity dates on the notes.

The weighted average interest rate decreased due

to the extension of maturity dates on the LGH and ClearThink notes that have set dollar amounts of interest.

Other Income, net

Other income, net in fiscal 2022 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.

Other income, net in fiscal 2021 represents the

forgiveness of our SBA Paycheck Protection Program Loan.

Other income, net in fiscal 2022 included a $500,000

donation in partnership with the Erase PTSD Now organization and the Glenn Greenberg and Linda Vester

Other income, net in both periods included foreign exchange gains and losses related to invoices denominated and paid

in foreign currencies.

Net loss decreased in fiscal 2023 compared to

fiscal 2021 due to the in-process research and development charge in fiscal 2021, the donation received in fiscal 2022 and research and

development rebates received from the Australian government, partially offset by increased general and administrative expense and interest

expense in fiscal 2022 as discussed above.

fiscal 2022 due to decreased research and development, general and administrative and interest expense as discussed above.

Liquidity and Capital Resources

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To date, we have financed our operations primarily

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 fiscal 2022

was for a patent related to our PRV-002 drug device combination.

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 research and development activities until market conditions improve.

Cash used in investing activities was for a patent

related to our ONP-002 drug device combination.

The following notes payable were outstanding:

July 31, 2022

Convertible note issued to LGH due December 31, 2022 with a fixed interest rate of 8.0% over the term of the note (annual interest rate of 5.22%) and convertible at $0.20 per share

Promissory notes issued to officers and directors due December 31, 2022 with a fixed interest rate of 8.0% per annum (see Note 6)

Tysadco convertible promissory note payable due March 1, 2023 with a fixed interest rate of 8.0% over the term of the note (annual interest rate of 5.09%) and convertible at $0.30 per share

Unamortized debt discount, closing costs and beneficial conversion feature

Convertible note issued to LGH due December 31, 2023, with a set interest amount of $84,000 through July 6, 2023, then an interest rate of 8.0% per annum of the then outstanding principal of $1,055,000 and convertible at $0.12 per share

Promissory notes issued to officers and directors due October 31, 2023, with an interest rate of 8.0% per annum (see Note 10)

Note purchase agreement issued to an accredited investor due August 15, 2024, with an interest rate of 12% per annum

ClearThink convertible promissory note payable due December 31, 2023, with a set interest amount of $20,000 and convertible at $0.20 per share

Mast Hill convertible promissory note due June 13, 2024, with an interest rate of 10% per annum and convertible at $0.12 per share

Unamortized beneficial conversion feature, debt discount and closing costs

Research and Development Rebate due from

Australian Government

In fiscal 2023, we incurred $495,414 of expenses

related to our Phase I clinical trial of our concussion drug device combination that are eligible for the Australian research and development

rebate for a rebate due of $261,238, which was recorded as an offset to Research and development expense.

On November 18, 2022, we received a research and

development rebate from the government of Australia in the amount of $313,709 for clinical work performed in Australia related to our

Phase I human clinical trial during the fiscal year ended July 31, 2022.

On December 8, 2022, we received a goods and service

tax refund, which was accrued as part of our research and development rebate due from the Australian government, in the amount of $82,705

related to our Phase I human clinical trial during July, August and September 2022.

On February 10, 2023, we received a goods and

service tax refund, which was accrued as part of our research and development rebate due from the Australian government, in the amount

of $9,231 related to our Phase I human clinical trial during October, November and December 2022.

On July 3, 2023, we received a goods and service

tax refund, which was accrued as part of our research and development rebate due from the Australian government, in the amount of $3,908,

related to our Phase I human clinical trial during January, February and March 2023.

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-K

Item 7. Management’s Discussion and Analysis