What changed in this filing

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Item 1A. Risk Factors

2025-03-28 compared with 2024-03-28 · 28 added, 49 removed, 345 unchanged (18% of the section changed)

25 unchanged sentences

to continue with the development of our prescription drug candidates and prescription drug formulation candidates on the basis of historical,

ongoing, and prospective clinical and preclinical study results.

have based our estimate of capital needs on assumptions that may prove to be wrong, and we cannot assure you that estimates and assumptions

will remain unchanged.

On August 13, 2021, the Board approved a Financing Term Sheet (the “2021 Term Sheet”), which sets

forth the terms under which the Company will use its best efforts to arrange for financing of a maximum of $5,000,000 (the “2021

Financing”), which amounts will be obtained in several tranches and evidenced by convertible promissory notes (collectively, the

“2021 Notes”).

As of December 31, 2023, the Company had received 2021 Notes proceeds of $1,460,000, of which $200,000 is

from a related party investor.

September 20, 2022, the Board approved the closure of the 2021 Financing.

Through December 31, 2023, the Company had received 2021

Notes proceeds of $2,335,000, of which $525,000 is from a related party investor (a Company officer and Company director), however

$1,260,000 of these notes were converted to Series D-1 Preferred Shares during the 4 th quarter 2022 and $875,000 of these

notes were converted to Series D-1 Preferred Shares during the year ended December 31, 2023.

As of December 31, 2023, the

remaining 2021 Note balance was $200,000.

September 20, 2022, the Board approved a Financing Term Sheet (the “2022 Term Sheet”), which set forth the terms under

which the Company will use its best efforts to arrange for financing of a maximum of $5,000,000 (the “2022 Financing”),

which amounts will be obtained in several tranches.

Through December 31, 2023, the Company had received 2022 Notes proceeds of

$3,227,500, as defined below, of which $2,352,500 is from a related party investor (a Company director), however, $752,500 of these

notes were converted to Series D-1 Preferred Shares during the year ended December 31, 2023.

As of December 31, 2023, the remaining

2022 Notes balance was $2,475,000.

additional financing may not be available on acceptable terms, or at all.

ongoing, and prospective clinical and non-clinical study results.

However, we need to raise additional capital through public or private offerings, debt financing, or other means

in order to successfully implement our business plan and develop and market our products.

Such financing may not be available on acceptable terms, or at all.

As discussed in more detail below, additional equity financing

8 unchanged sentences

from the State of Tennessee.

The Company’s working capital deficiency was $7,652,098 and $6,293,198 as of December 31, 2023 and

December 31, 2022, respectively.

The Company’s working capital deficiency was $5,998,712 and $7,652,098 as of December 31, 2024 and 2023, respectively.

The Company continues to incur significant operating losses and management expects that significant

46 unchanged sentences

Failure to obtain FDA approval of any of our prescription drug candidates will severely undermine our business by reducing our number

of salable drug products and, therefore, corresponding revenues.

of saleable drug products and, therefore, corresponding revenues.

international jurisdictions, we must receive approval from the appropriate regulatory authorities before we can commercialize our prescription

115 unchanged sentences

Many of the pharmaceutical companies developing and marketing these competing products have greater financial resources and expertise

than we do in research and development, manufacturing, preclinical and clinical testing, obtaining regulatory approvals, and marketing.

than we do in research and development, manufacturing, non-clinical and clinical testing, obtaining regulatory approvals, and marketing.

companies may also prove to be competitors, particularly through collaborative arrangements with larger and more established companies

14 unchanged sentences

we lose any of our key personnel, we may be unable to successfully execute our business plan.

business is presently managed by key Board members, employees, and independent contractors:

(i) Ed Pershing, who is chairman of the

Board, (ii) Dominic Rodrigues, who is vice chairman of the Board and chief operations consultant, (iii) Eric Wachter, Ph.D., our Chief Technology Officer (“CTO”), who is an employee, and (iv) Heather Raines, CPA, our

CFO, who is an employee.

business is presently managed by key Board members and employees:

(i) Ed Pershing, who is CEO and chairman of the Board, (ii) Dominic

Rodrigues, who is President and vice chairman of the Board, (iii) Eric Wachter, Ph.D., our CTO, and (iv) Heather Raines, CPA, our CFO.

order to successfully execute our business plan, our management and Board must succeed in all of the following critical areas:

40 unchanged sentences

resources in response to a cyber security breach, including repairing system damage, increasing cyber security protection costs by deploying

additional personnel and protection technologies, paying regulatory fines, and resolving legal claims and regulatory actions, all of which

would increase our expenses, divert the attention of our management and key personnel away from our business operations and adversely

additional personnel and protection technologies, paying regulatory fines, and resolving legal claims and regulatory actions, all of

which would increase our expenses, divert the attention of our management and key personnel away from our business operations and adversely

affect our results of operations.

84 unchanged sentences

which will reduce the proceeds to be received by holders of our common stock.

connection with the 2022, 2021, 2020 and 2017 Financings, we have issued convertible notes that converted or are convertible into shares

of Series D and Series D-1 Preferred Stock.

The Series D and Series D-1 Preferred Stock will have a first priority right to receive proceeds

from the liquidation, winding-up or dissolution of us or certain mergers, corporate reorganizations, or sales of our assets (each, a

“Company Event”).

If a Company Event occurs within two (2) years of the date of issuance of the Series D and Series D-1 Preferred

Stock (the “Date of Issuance”), the holders of Series D and Series D-1 Preferred Stock will receive a preference of four

times (4x) their respective investment amount.

If a Company Event occurs after the second (2nd) anniversary of the Date of Issuance,

the holders of the Series D and Series D-1 Preferred Stock will receive a preference of six times (6x) their respective investment amount.

As a result, upon the occurrence of a Company Event, the holders of Series D and Series D-1 Preferred Stock would have the right to receive

proceeds from any such transaction before our common stockholders.

The payment of this preference could result in our common stockholders

not receiving any consideration in connection with a Company Event.

connection with the 2025, 2024, 2022, 2021, 2020 and 2017 Financings, we have issued convertible notes that converted or are

convertible into shares of Series D and Series D-1 Preferred Stock.

The Series D and Series D-1 Preferred Stock will have a first

priority right to receive proceeds from the liquidation, winding-up or dissolution of us or certain mergers, corporate

reorganizations, or sales of our assets (each, a “Company Event”).

If a Company Event occurs within two (2) years of the

date of issuance of the Series D and Series D-1 Preferred Stock (the “Date of Issuance”), the holders of Series D and

Series D-1 Preferred Stock will receive a preference of four times (4x) their respective investment amount.

If a Company Event

occurs after the second (2nd) anniversary of the Date of Issuance, the holders of the Series D and Series D-1 Preferred Stock will

receive a preference of six times (6x) their respective investment amount.

As a result, upon the occurrence of a Company Event, the

holders of Series D and Series D-1 Preferred Stock would have the right to receive proceeds from any such transaction before our

common stockholders.

The payment of this preference could result in our common stockholders not receiving any consideration in

connection with a Company Event.

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 1A. Risk Factors