What changed in this filing

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Item 1A. Risk Factors

2024-03-28 compared with 2023-03-30 · 45 added, 56 removed, 349 unchanged (22% of the section changed)

35 unchanged sentences

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

As of December 31, 2022, 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.

The remaining 2021 notes is $1,075,000.

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.

As of December 31, 2022, the Company had received 2022 Notes proceeds of $752,500, as defined below,

of which $677,500 is from a related party investor (a Company director) in connection with the 2022 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.

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

Company’s cash balance was $1,431,707 at December 31, 2022, which includes $1,410,102 of restricted cash resulting from a grant

received from the State of Tennessee.

The Company’s working capital deficiency was $6,293,198 and $4,258,679 as of December 31,

2022 and December 31, 2021, respectively.

Company’s cash balance was $1,026,799 at December 31, 2023, which includes $950,223 of restricted cash resulting from a grant received

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 continues to incur significant operating losses and management expects that significant

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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, (iii) Bruce Horowitz, our COO, who is an independent contractor, (iv) Eric

Wachter, Ph.D., our Chief Technology Officer (“CTO”), who is an employee, and (v) Heather Raines, CPA, our CFO, who is an

(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.

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

81 unchanged sentences

remove our current management.

certificate of incorporation, as amended, and bylaws contain provisions that could delay or prevent a change of control of our company or changes

in our board of directors that our stockholders might consider favorable.

Among other things, these provisions will (i) permit our Board

to issue up to 25,000,000 shares of preferred stock which can be created and issued by the Board without prior stockholder approval,

with rights senior to those of the common stock, (ii) provide that all vacancies on our Board, including as a result of newly created

directorships, may, except as otherwise required by law, be filled by the affirmative vote of a majority of directors then in office,

even if less than a quorum, (iii) require that any action to be taken by our stockholders must be affected at a duly called annual or

special meeting of stockholders and not be taken by written consent, (iv) provide that stockholders seeking to present proposals before

certificate of incorporation, as amended, and bylaws contain provisions that could delay or prevent a change of control of our company

or changes in our board of directors that our stockholders might consider favorable.

Among other things, these provisions will (i) permit

our Board to issue up to 25,000,000 shares of preferred stock which can be created and issued by the Board without prior stockholder

approval, with rights senior to those of the common stock, (ii) provide that all vacancies on our Board, including as a result of newly

created directorships, may, except as otherwise required by law, be filled by the affirmative vote of a majority of directors then in

office, even if less than a quorum, (iii) require that any action to be taken by our stockholders must be affected at a duly called annual

or special meeting of stockholders and not be taken by written consent, (iv) provide that stockholders seeking to present proposals before

a meeting of stockholders or to nominate candidates for election as directors at a meeting of stockholders must provide advance notice

2 unchanged sentences

requested by a majority of the Board to call such meetings.

and other provisions in our certificate of incorporation, as amended, and bylaws and Delaware law could make it more difficult for

stockholders or potential acquirers to obtain control of our Board or initiate actions that are opposed by our then-current Board,

including delaying or impeding a merger, tender offer, or proxy contest involving our company.

Any delay or prevention of a change

of control transaction or changes in our Board could cause the market price of our common stock to decline.

and other provisions in our certificate of incorporation, as amended, and bylaws and Delaware law could make it more difficult for stockholders

or potential acquirers to obtain control of our Board or initiate actions that are opposed by our then-current Board, including delaying

or impeding a merger, tender offer, or proxy contest involving our company.

Any delay or prevention of a change of control transaction

or changes in our Board could cause the market price of our common stock to decline.

stock price is below $5.00 per share and is treated as a “penny stock,” which places restrictions on broker-dealers recommending

31 unchanged sentences

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

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.

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.

Related to SARS-CoV-2

are subject to risks associated with a pandemic, epidemic or outbreak of a contagious disease, such as the ongoing SARS-CoV-2 pandemic,

which may affect our future access to liquidity and materially adversely affect our business operations, results of operations and financial

was reportedly first identified in late-2019 and subsequently declared a global pandemic by the World Health Organization on March 11,

As a result of the SARS-CoV-2 pandemic, many companies have experienced disruptions of their operations and the markets they serve.

The Company has taken several temporary precautionary measures intended to help ensure the well-being of its employees and contractors

and to minimize business disruption.

The Company considered the impact of SARS-CoV-2 pandemic on its business and operational assumptions

and estimates, and determined there were no material adverse impacts on the Company’s results of operations and financial position

at December 31, 2022.

full extent of the SARS-CoV-2 pandemic impacts on the Company’s operations and financial condition is still uncertain.

has experienced slower than normal enrollment and treatment of patients, and a prolonged SARS-CoV-2 pandemic could have a material adverse

impact on the Company’s business and financial results, including the timing and ability of the Company to raise capital, initiate

and/or complete current and/or future preclinical studies and/or clinical trials;

disrupt the Company’s regulatory activities;

and/or have other adverse effects on the Company’s clinical development.

STAFF COMMENTS.

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