What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-06-14 compared with 2024-03-22 · 100 added, 99 removed, 156 unchanged (56% of the section changed)

33 unchanged sentences

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 have two different technologies in research and development;

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.

On October 4, 2023, we entered into an Asset

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

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.

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

(the “Agreement”) with Oragenics, Inc.

(“Oragenics”).

Pursuant to the Agreement, we sold certain

assets and certain liabilities related to a segment of our business focused on developing medical products that treat brain

related illnesses and diseases (the “Assets”) to Oragenics.

Pursuant to the Agreement, we sold certain assets and certain

liabilities related to a segment of our business focused on developing medical products that treat brain related illnesses and diseases

(the “Assets”) to Oragenics.

The closing was completed on December 28, 2023.

and Note 4 of Notes to Condensed Consolidated Financial Statements for additional information.

See below and Note 4 of Notes to Condensed Consolidated

Financial Statements for additional information.

We plan to license, improve, and develop our products

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LPC Purchase Agreement Draws

During the six months ended January 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

During the nine months ended April 30, 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.

At December 31, 2023, the LPC Purchase Agreement expired.

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19.9% of the then outstanding Oragenics common stock.

See Note 4 of Notes to Condensed

Consolidated Financial Statements for additional information.

See Note 4 of Notes to Condensed Consolidated

Financial Statements for additional information.

Promissory Note

5 unchanged sentences

on August 15, 2023, at which time the additional $350,000 was received.

See Note 6 of Notes to Condensed

Consolidated Financial Statements for additional information.

See Note 6 of Notes to Condensed Consolidated

Financial Statements for additional information.

Going Concern

1 unchanged sentence

Significant Accounting Policies and Use of

During the six months ended January 31, 2024,

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

Summary of Significant

Accounting Policies included in Part II, Item 8.

of our Annual Report on Form 10-K for the year ended July 31, 2023, which was filed

with the Securities and Exchange Commission on October 30, 2023.

During the nine months ended April 30, 2024, there

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

Summary of Significant Accounting

Policies included in Part II, Item 8.

of our Annual Report on Form 10-K for the year ended July 31, 2023, filed with the Securities

and Exchange Commission on October 30, 2023.

Results of Operations

We do not currently sell or market any products

and we did not have any revenue in the three or six-month periods ended January 31, 2024 or 2023.

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,

In-process research and development expense

and did not have any revenue in the three or nine month periods ended April 30, 2024 or 2023.

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 April 30,

Research and development expense

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Loss from operations

Gain on sale of asset

Investment revaluation

Loss on investment

Interest expense

Other income, net

Net income (loss)

Other income (expense), net

Deemed dividend

Net income (loss) attributable to common stockholders

Net loss attributable to common stockholders

$ (1,284,102 )

Basic net income (loss) per share

Diluted net income (loss) per share

Six Months Ended January 31,

Basic net loss per share attributable to common stockholders

Diluted net loss per share attributable to common stockholders

Nine Months Ended April 30,

In-process research and development expense

3 unchanged sentences

Loss from operations

Gain on sale of asset

Investment revaluation

Gain on sale of assets

Loss on investment

Interest expense

2 unchanged sentences

Deemed dividend

Net income (loss) attributable to common stockholders

Net income (loss) attributable to common shareholders

$ (5,105,412 )

Basic net income (loss) per share

Diluted net income (loss) per share

Basic net income (loss) per share attributable to common stockholders

Diluted net income (loss) per share attributable to common stockholders

In-Process Research and Development

In-process research and development in the three

and six-month periods ended January 31, 2024, related 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.

In-process research and development in the nine-month

period ended April 30, 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 a November 2022 Option Agreement.

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 changes in Research and development expense

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

The decreases in Research and development expense

were due to the following:

January 31, 2024

compared to three

January 31, 2023

January 31, 2024

compared to six

January 31, 2023

Three months ended

Nine months ended

April 30, 2024 compared to three months ended

April 30, 2023

Increase (decrease) in:

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Phase II clinical trial

The decrease in the Phase I clinical trial as

well as the Australian research and development rebate in the six months ended January 31, 2024 compared to the six months ended January

31, 2023 is the result of the completion of the dosing of subject in the first quarter of fiscal 2023.

The decreases in the Phase I clinical trial and

the Australian research and development rebate in the nine months ended April 30, 2024, compared to the nine months ended April 30, 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.

Stock-Based Compensation

The decrease in Stock-based compensation for the

six months ended January 31, 2024 was due to fewer unvested awards outstanding.

The decreases in Stock-based compensation for

the three and nine months ended April 30, 2024, compared to the same periods of 2023 were due to fewer grants and unvested awards outstanding.

General and Administrative Expense

2 unchanged sentences

administrative costs related to maintaining compliance as a public company.

The decreases in General and administrative expense

The changes in General and administrative expense

were due to the following:

January 31, 2024

compared to three

January 31, 2023

January 31, 2024

compared to six

January 31, 2023

April 30, 2024

compared to three months ended

April 30, 2024

compared to three months ended

April 30, 2023

Increase (decrease) in:

6 unchanged sentences

compared to the prior fiscal year were primarily a result of the decreases in business development activities due to limited resources

and fewer employees.

Gain on Sale of Asset

The Gain on sale of asset in the fiscal 2024

periods was the result of the sale of assets pursuant to the Oragenics Asset Sale Agreement.

See Note 4 of Notes to Condensed

Consolidated Financial Statements.

The gain on sale of asset in the nine months ended

April 30, 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.

Loss on Investment

Loss on investment in the three and nine months

ended April 30, 2024 relates to the revaluation of the common stock of Oragenics held as an investment.

Interest Expense

Interest expense includes interest on debt outstanding,

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

Certain information regarding debt

outstanding was as follows:

Three Months Ended January 31,

Six Months Ended January 31,

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

Certain information regarding debt outstanding

was as follows:

Three Months Ended April 30,

Nine Months Ended April 30,

Weighted average debt outstanding

1 unchanged sentence

The decrease in the weighted average debt outstanding

for the three months ended January 31, 2024 was due to the conversion of convertible debt agreements with Mast Hill, ClearThink and the

two accredited investors.

The increase in the weighted average debt outstanding quartering the first six months of fiscal 2024 was due

to convertible debt agreements entered into with two accredited investors, offset by conversions of convertible debt.

We generated Net income in the fiscal 2024 periods

due to the Gain on sale of assets as well as lower operating expenses compared to the fiscal 2023 periods as discussed above.

for the three and nine months ended April 30, 2024, was due to the conversion of convertible debt agreements with Mast Hill, ClearThink

and the two accredited investors.

Liquidity and Capital Resources

2 unchanged sentences

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

Six Months Ended January 31,

Nine Months Ended April 30,

Net cash used in operating activities

$ (1,151,509 )

$ (1,354,850 )

Net cash provided by (used in) investing activities

Net cash provided by financing activities

Historically, we have financed our

operations primarily through debt financing, limited sales of our common stock and recently through the sale of our neurological

assets to Oragenics as discussed in Note 4 of Notes to Condensed Consolidated Financial Statements.

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.

Historically, we have financed our operations

primarily through debt financing, limited sales of our common stock and recently through the sale of our neurological assets to Oragenics

as discussed in Note 4 of Notes to Condensed Consolidated Financial Statements.

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.

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

The following notes payable were outstanding:

January 31, 2024

April 30, 2024

July 31, 2023

Convertible note issued to LGH due June 30, 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 $0.12 per share

Promissory notes issued to officers and directors due July 31,

2024, with an interest rate of 8.0% per annum and convertible at $0.12 per share

Promissory notes issued to officers and directors due July 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 Oragenics common stock held by us at $2.50 per share

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

1 unchanged sentence

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 beneficial conversion feature, debt discount and closing costs

Unamortized debt discount and closing costs

Unamortized beneficial conversion feature

Australian Research and Development Rebate

In the first six months of fiscal 2024, we incurred

In the first nine months of fiscal 2024, we incurred

$43,092 of expenses related to our Phase I clinical trial of our concussion drug device combination that are eligible for the Australian

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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