What changed in this filing

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Item 1A. Risk Factors

2026-03-26 compared with 2025-03-28 · 43 added, 38 removed, 335 unchanged (19% of the section changed)

26 unchanged sentences

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

could result in significant dilution to stockholders.

Further, in the event that additional funds are obtained through licensing or other

arrangements, these arrangements may require us to relinquish rights to some of our products, product candidates, and technologies that

we would otherwise seek to develop and commercialize ourselves.

If sufficient capital is not available, we may be required to delay,

reduce the scope of, or eliminate one or more of our programs, any of which could have a material adverse effect on our business.

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.

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

As discussed in more detail below, additional equity financing could result

in significant dilution to stockholders.

Further, in the event that additional funds are obtained through licensing or other arrangements,

these arrangements may require us to relinquish rights to some of our products, product candidates, and technologies that we would otherwise

seek to develop and commercialize ourselves.

If sufficient capital is not available, we may be required to delay, reduce the scope of,

or eliminate one or more of our programs, any of which could have a material adverse effect on our business.

is substantial doubt as to our ability to continue as a going concern.

Company’s cash balance was $489,726 at December 31, 2024, which includes $182,284 of restricted cash resulting from a grant received

from the State of Tennessee.

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

on-going operating expenditures will be necessary to successfully implement our business plan and develop and market our products.

circumstances raise substantial doubt about our ability to continue as a going concern for a period of one year from the date that the

consolidated financial statements included elsewhere in this Annual Report on Form 10-K are issued.

Implementation of our plans and our

ability to continue as a going concern will depend upon our ability to develop our prescription drug candidates and prescription drug

formulation candidates, and to raise additional capital.

Company’s cash balance was $251,291 at December 31, 2025.

Cash balances as of December 31, 2024 included $182,284 of

restricted cash associated with a grant received from the State of Tennessee.

There was no restricted cash associated with the grant

received from the State of Tennessee as of December 31, 2025 due to the completion of the grant award program during 2025.

The Company’s working

capital deficit was $6,329,503 and $5,998,712 as of December 31, 2025 and 2024, respectively.

The Company continues to incur

significant operating losses and management expects that significant on-going operating expenditures will be necessary to

successfully implement our business plan and develop and market our products.

These circumstances raise substantial doubt about our

ability to continue as a going concern for a period of one year from the date that the consolidated financial statements included

elsewhere in this Annual Report on Form 10-K are issued.

Implementation of our plans and our ability to continue as a going concern

will depend upon our ability to develop our prescription drug candidates and prescription drug formulation candidates, and to raise

additional capital.

believes that we may have access to capital resources through possible public or private equity offerings, including the 2025 Financing,

136 unchanged sentences

payers, and effectiveness of marketing and distribution efforts by us and our licensees and distributors, if any.

we expect sales or licensure of our prescription drug candidates, if approved, to generate substantially all of our revenues if they

are approved, the failure of any of these drugs to find market acceptance would harm our business and could require us to seek additional

we expect sales or licensure of our prescription drug candidates to generate substantially all of our revenues if they are approved,

the failure of any of these drugs to find market acceptance would harm our business and could require us to seek additional financing.

have no sales, marketing, or distribution capabilities for our prescription drug candidates.

167 unchanged sentences

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

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.

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