What changed in this filing

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Item 7. Management’s Discussion and Analysis

2024-11-13 compared with 2023-10-30 · 149 added, 165 removed, 109 unchanged (74% of the section changed)

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identifying words.

We have based these forward-looking statements

on our current expectations and projections about future events.

Although we believe that the expectations underlying our forward-looking

statements are reasonable, these expectations may prove to be incorrect, and all of these statements are subject to risks and uncertainties.

Therefore, you should not place undue reliance on our forward-looking statements.

You should understand that the following important factors

could affect our future results and could cause those results or other outcomes to differ materially from those expressed or implied in

our forward-looking statements.

We have based these forward-looking statements

on our current expectations and projections about future events.

We have based these forward-looking statements on

our current expectations and projections about future events.

Although we believe that the expectations underlying our forward-looking

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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;

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

the safety and efficacy of our product candidates;

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Our business model is to develop or acquire unique

medical related products, engage third parties to manufacture such products and then distribute the products through various distribution

channels, including third parties.

We plan to develop potentially life-saving technologies:

the CardioMap® heart monitoring and screening

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 have received regulatory clearance

or approval for commercial sale.

We plan to license, improve, and develop our products

and identify and select distribution channels.

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

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.

medical related products, engage third parties to develop and manufacture such products and then distribute the products through various

distribution channels, including third parties.

We have two different technologies in research and development stage ;

the CardioMap®

heart monitoring and screening device, and the Save a Life choking rescue device.

To date, none of our product candidates have received

regulatory clearance or approval for commercial sale.

Upon receiving adequate funding, we plan to license

and develop our products and identify other product potentials we can develop or acquire.

We will then engage third-party research and

development firms that specialize in creating products to assist us, and we will apply for trademarks and patents at appropriate product

development advances.

Recent Funding

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.

Accredited Investor Promissory Note

In August 2024, we entered into a one-year, $300,000

promissory note with an interest rate of 18% per annum due August 14, 2025.

Accredited Investor Promissory Note

On February 13, 2024, we entered into a six-month,

$50,000 promissory note with an accredited investor, with an interest rate of 10% per annum and due August 11, 2024 and convertible into

20,000 shares of Oragenics common stock currently held by us at the investor’s option.

In June 2024, this note was amended to provide

for settlement of the note by issuing the accredited investor 30,000 shares of Oragenics common stock currently held by us at the investor’s

As of the date of this filing, this note remains outstanding.

LPC Purchase Agreement Draws

During fiscal 2023, LPC purchased a total of 3,633,591

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

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

During the year ended July 31, 2024, LPC purchased

a total of 600,000 shares of our common stock for total proceeds of $55,620 pursuant to the August 14, 2020, LPC Purchase Agreement.

December 31, 2023, the LPC Purchase Agreement expired.

Asset Agreement with Oragenics, Inc.

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

Agreement (the “Agreement”) with Oragenics, which closed on December 28, 2023.

Pursuant to the Agreement, we sold certain

assets related to the treatment of brain related illnesses and diseases (the “Assets”) with a total carrying value of $48,367

to Oragenics in exchange for (i) $1,000,000 in cash;

(ii) 8,000,000 shares of convertible Series F preferred stock;

and (iii) the assumption

of $325,672 of our accounts payable.

The total value of consideration received was $16,449,054, which resulted in a gain of $16,400,687.

The in-process research and development 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

We received $500,000 upon the execution of the Agreement

on October 4, 2023, and received the additional $500,000 on December 11, 2023, upon our stockholder approval for the sale of the Asset.

Following the closing of the Agreement on December 28, 2023, we received 8,000,000 shares of Series F preferred stock.

Upon receipt, 511,308

shares of the Series F preferred stock, which represented 19.9% of the then outstanding shares of Oragenics common stock, converted into

511,308 shares of Oragenics common stock.

At the closing, we were required to obtain the consent

of Mast Hill to consummate the closing of the Asset Agreement.

As part of the consent, we entered into a pledge agreement with Mast Hill

granting a security interest in 154,545 of the total preferred shares, and collectively with all of the common shares or other securities

into which the preferred shares are converted or exchanged into common shares, until the Mast Hill debt is paid.

The remaining shares of convertible Series F preferred

stock will convert upon Oragenics shareholder approval and upon certain listing and change in control criteria being achieved.

See Note 4 of Notes to Condensed Consolidated Financial

Statements for additional information.

Accredited Investor Note Payable

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 additional $350,000 was received.

See Note 7 of Notes to Condensed Consolidated Financial

Statements for additional information.

Going Concern

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Actual results may differ from those estimates.

Reference is made to our significant accounting

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

Reference is made to our significant accounting policies

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

Results of Operations

We do not currently sell or market any products

and we did not have any revenue for the years ended July 31, 2023 or 2022.

We do not currently sell or market any products and

we did not have any revenue for the years ended July 31, 2024 or 2023.

We will commence actively marketing products after the products

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Fiscal Year Ended July 31,

In-process research and development

Research and development

In-process research and development expense

Research and development expense

Stock-based compensation

General and administrative

Loss from operations

General and administrative expense

Gain on sale of assets

(16,400,687 )

Gain (loss) from operations

Impairment of investment

(12,955,437 )

Unrealized loss on investment

Interest expense

Other income, net

$ (5,919,421 )

Deemed dividend

Net loss attributable to common stockholders

$ (5,919,421 )

$ (5,013,650 )

Basic and diluted net loss per share

Basic net loss per share

Diluted net loss per share

In-Process Research and Development

In-process research and development in fiscal 2023

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.

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.

See Notes 2 and 5 of Notes to Consolidated Financial Statements.

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

Fiscal Year Ended July 31, 2022

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, 2024

Fiscal Year Ended

July 31, 2023

Increase (decrease) in:

Drug development

Phase 1 clinical trial

Phase I 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.

Phase II clinical trial

The decreases in the Phase I clinical trial and the

Australian research and development rebate in fiscal year 2024 compared to fiscal year 2023, were the result of the completion of the

dosing of subject in the first quarter of fiscal 2023.

No additional expenses are expected related to ONP-002 as a result of the sale

of the asset to Oragenics.

In fiscal 2024, we earned a research and development

rebate from the Australian government of $53,578 related to our Phase I clinical trial of our concussion drug device combination compared

to $330,050 in fiscal 2023.

These amounts were recorded as offsets to Research and development expense.

Stock-Based Compensation

The decrease in Stock-based compensation in fiscal

year 2024 compared to fiscal year 2023 was due to fewer grants and unvested awards outstanding.

General and Administrative

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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

The decrease in General and administrative was due

to the following:

Fiscal Year Ended July 31, 2023 compared to

Fiscal Year Ended July 31, 2022

Ended July 31, 2024 compared to Fiscal Year Ended

July 31, 2023

Increase (decrease) in:

Stock-based compensation

Business development and investor relations

Consulting fees

Financing fees

Insurance expense

Legal and professional fees

$ (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.

Public company expense

Bad debt expense

The decrease in business development, investor relations

and consulting fees was a result of decreased activities related to business development.

Legal and professional fees decreased due to

lower expense in the second half of fiscal 2024.

The decrease in wages was due to lower employee headcount for the second half of 2024.

Gain on Sale of Asset

The gain on sale of asset in fiscal 2024 relates to

our sale of our 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 to Oragenics

in December 2023.

Impairment of Investment

Impairment of investment in fiscal 2024 relates

to the revaluation to zero of the preferred stock of Oragenics held by us as an investment.

See Notes 2 and 6 of Notes to Consolidated

Financial Statements for additional information.

Unrealized Losses on Investment

Unrealized losses on investment in fiscal 2024

relates to the common stock of Oragenics held by us as an investment.

See Notes 2 and 6 of Notes to Consolidated Financial Statements

for additional information.

Interest Expense

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Weighted average interest rate

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

The decrease in interest expense was due to lower

weighted average debt outstanding, partially offset by a higher weighted average interest rate.

Liquidity and Capital Resources

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$ (1,474,696 )

Net cash used in investing activities

Net cash provided by (used in) investing activities

Net cash provided by financing activities

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In such case, we

may need to suspend research and development activities until market conditions improve.

have suspended research and development activities until market conditions improve.

Cash used in investing activities was for a patent

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The following notes payable were outstanding:

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

business and results of operations during the periods being reported on.

July 31, 2024

July 31, 2023

Convertible note issued to LGH due December 31, 2024, with a set interest amount of $84,000 through July 7, 2023, then an interest rate of 8.0% per annum of outstanding principal and convertible at $0.072 per share

Promissory notes issued to officers and directors due December 31, 2024, with an interest rate of 8.0% per annum and convertible at $0.12 per share

Accredited investor promissory note due August 11, 2024, with an interest rate of 10% per annum and convertible into 30,000 shares of Oragenics common stock held by us.

As of the date of this filing, this note remains outstanding.

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

ClearThink convertible promissory note 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 December 13, 2024, with an interest rate of 10% per annum and convertible at $0.072 per share

Unamortized debt discount and closing costs

Unamortized beneficial conversion feature

See Note 14 of Notes to Consolidated Financial Statements

for information regarding a $300,000 promissory note entered into in August 2024.

Inflation did not have a material impact on our business

and results of operations during the periods being reported on.

Off Balance Sheet Arrangements

We do not have any material off balance sheet

arrangements.

We do not have any material off balance sheet arrangements.

Quantitative and Qualitative Disclosures About Market Risk

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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