What changed in this filing

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Item 7. Management’s Discussion and Analysis

2025-10-29 compared with 2024-11-13 · 104 added, 152 removed, 106 unchanged (71% of the section changed)

10 unchanged sentences

identifying words.

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 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;

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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.

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

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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 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 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.

On August 14, 2024, we entered into a $300,000

promissory note (the “Note”) with an accredited investor.

The $300,000 was received on August 22, 2024.

The Note has a one-year

maturity, becoming due on August 22, 2025, and bears interest at the rate of 18% per annum.

In addition, we issued the investor a warrant

to purchase 300,000 shares of our common stock at $0.10 per share that expires August 14, 2029, with a fair value of $13,343.

31, 2025, $300,000 in principal and $51,925 in accrued interest remained outstanding.

On August 14, 2025, this note was amended to extend

the maturity date to January 31, 2026.

Sale of Oragenics Common Stock

In the fourth quarter of fiscal 2025, we sold

all 17,044 shares of Oragenics common stock at an average price of $4.35 per share for net proceeds of $69,787 after fees and commissions.

Going Concern

See Note 1 of Notes to Financial Statements.

See Note 1 of Notes to Consolidated Financial Statements.

Critical Accounting Policies and Estimates

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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, 2024 or 2023.

We do not currently sell or market any products

and we did not have any revenue for the years ended July 31, 2025 or 2024.

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

and drugs in development have been FDA cleared or approved, however, there can be no assurance that we will be successful in obtaining

FDA clearance or approval for our products.

Fiscal Year Ended July 31,

In-process research and development expense

Research and development expense

Stock-based compensation

General and administrative expense

Gain on sale of assets

(16,400,687 )

Gain (loss) from operations

Impairment of investment

Loss from operations

Gain on sale of product candidates and related assets

(16,400,687 )

Impairment of investment in preferred stock of Oragenics, Inc.

(12,955,437 )

Unrealized loss on investment

Loss from change in fair value of Oragenics, Inc.

Interest expense

Other income, net

Other (expense) income, net

Deemed dividend

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$ (1,742,691 )

$ (5,013,650 )

Basic net loss per share

Diluted net loss per share

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.

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

Basic net loss per share attributable to common stockholders

Diluted net loss per share attributable to common stockholders

Shares used for basic net loss per share attributable to common stockholders

Shares used for diluted net loss per share attributable to common stockholders

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, 2024

Fiscal Year Ended

July 31, 2023

Increase (decrease) in:

Phase I clinical trial

Australian research and development rebate

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.

Our Research and development expense includes

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

We are not currently working on any projects and,

therefore, we did not have any Research and development expense in fiscal 2025.

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.

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

was recorded as an offset to Research and development expense.

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 decrease in General and administrative was due

to the following:

Ended July 31, 2024 compared to Fiscal Year Ended

The decrease in General and administrative was

due to the following:

Fiscal year ended

July 31, 2025

July 31, 2024

Increase (decrease) in:

Business development and investor relations

Consulting fees

Insurance expense

Stock-based compensation

Legal and professional fees

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.

$ (1,063,693 )

The decreases in wages and business development

and investor relations were due to lower salaries of executives and lower business activity.

The decrease in legal and professional fees

was due to lower legal fees incurred.

The decrease in stock-based compensation was due to no options granted in fiscal 2025 and fewer

unvested awards outstanding.

The decreases were offset by an increase in public company expense.

Gain on Sale of Product Candidates and Related

The gain on sale of product candidates and related

assets 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 in Preferred Stock

of Oragenics, Inc .

Impairment of investment in preferred stock of

Oragenics, Inc.

in fiscal 2024 relates to the revaluation of the preferred stock of Oragenics held as an investment to zero.

2 and 6 of Notes to Consolidated Financial Statements for additional information.

Loss from Change in Fair Value of Oragenics, Inc.

Loss from change in fair value of Oragenics, Inc.

common stock relates

to the value of the common stock of Oragenics that was held by us as an investment.

All shares were sold during fiscal 2025.

2 and 6 of Notes to Consolidated Financial Statements for additional information.

Interest Expense

Interest expense includes interest on debt outstanding,

as well as the amortization of unamortized debt issuance costs and debt closing costs.

Certain information regarding debt outstanding

was as follows:

as well as the amortization of beneficial conversion feature, debt discount and debt issuance costs.

Certain information regarding debt

outstanding was as follows:

Fiscal Year Ended July 31,

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The decrease in interest expense was due to lower

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

amortization of beneficial conversion feature, debt discount and debt issuance costs, partially offset by higher average interest rates.

Liquidity and Capital Resources

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$ (1,215,210 )

$ (1,474,696 )

Net cash provided by (used in) investing activities

Net cash provided by investing activities

Net cash provided by financing activities

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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

have suspended 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.

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 would suspend research and development activities until market conditions improve.

Mast Hill Conversion of Accrued Interest

On August 29, 2025, Mast Hill converted $80,618

of interest and $1,750 in fees for a total of $82,368 into 1,144,000 shares of our common stock at a price of $0.072 per share.

13 of Notes to Consolidated Financial Statements.

LGH Conversion of Accrued Interest

Conversion of LGH

Investments, LLC Convertible Note

On October 6, 2025, LGH provided notice to convert

$144,000 of their outstanding convertible note into 2,000,000 shares of our common stock at $0.072 per share.

Following the conversion,

there was $891,000 of principal and $281,875 of accrued interest outstanding.

See Note 13 of Notes to Consolidated Financial Statements.

The following notes payable were outstanding:

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

Convertible note issued to LGH due January 31, 2026, 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 January 31, 2026, with an interest rate of 8.0% per annum and convertible at $0.12 per share

Accredited investor promissory note due January 31, 2026, with an interest rate of 10% per annum and convertible into 30,000 shares of Oragenics common stock

Mast Hill convertible promissory note due April 30, 2026, with an interest rate of 10% per annum and convertible at $0.072 per share

Accredited investor promissory note due January 31, 2026, with an interest rate of 18% per annum

Total principal

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.

Inflation did not have a material impact on our

business and results of operations during the periods being reported.

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