What changed in this filing

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Item 1A. Risk Factors

2023-03-30 compared with 2022-03-29 · 111 added, 106 removed, 294 unchanged (42% of the section changed)

business and its future performance may be affected by various factors, the most significant of which are discussed below.

Risks Related to Our Business

Related to Our Business

are a clinical-stage drug company, have no prescription drug products approved for commercial sale, have incurred substantial losses,

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$250 million in the aggregate since inception in January 2002.

We may never achieve or maintain profitability, even if we succeed in developing and commercializing one

or more of our prescription drug candidates.

We also expect to continue to incur significant operating expenditures and anticipate that

our operating and capital expenses may increase substantially in the foreseeable future as we continue to develop and seek regulatory

approval for our prescription drug candidates PV-10 and PH-10, implement additional internal systems and infrastructure, and hire additional

We may never achieve or maintain profitability, even if we succeed in

developing and commercializing one or more of our prescription drug candidates.

We also expect to continue to incur significant operating

expenditures and anticipate that our operating and capital expenses may increase substantially in the foreseeable future as we continue

to develop and seek regulatory approval for our prescription drug candidates, develop our prescription drug formulation candidates, implement

additional internal systems and infrastructure, and hire additional personnel.

also expect to experience negative operating cash flow for the foreseeable future as we fund our operating losses and any future capital

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impact the value of our common stock.

need additional capital to conduct our operations and commercialize and/or further develop our prescription drug candidates in 2022 and

beyond, and our ability to obtain the necessary funding is uncertain.

need additional capital to conduct our operations and commercialize and/or further develop our prescription drug candidates and prescription

drug formulation candidates in 2023 and beyond, and our ability to obtain the necessary funding is uncertain.

need additional capital in 2023 and beyond to continue developing and seeking to commercialize our drug product candidates.

intend to continue with the development of PV-10 and PH-10 on the basis of historical, ongoing, and prospective clinical study and

mechanism, of action results.

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

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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, 2021, the Company had received 2021 Notes proceeds of $1,460,000, of which $200,000

is from a related party investor.

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

“2021 Notes”).

As of December 31, 2021, 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.

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.

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.

cash, cash equivalents, and restricted cash were $3,106,942 at December 31, 2021, which includes $2,423,958 of restricted

cash resulting from a grant received from the State of Tennessee, compared with $97,231 at December 31, 2020.

We continue 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

PV-10 and PH-10, and to raise additional capital.

believes that we may have access to capital resources through possible public or private equity offerings, including the 2021

Financing, exchange offers, debt financings, corporate collaborations or other means.

If we are unable to raise sufficient capital, we

will not be able to pay our obligations as they become due.

investigational drug product candidates are at an early to mid-stage of development and may never obtain U.S.

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.

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.

believes that we may have access to capital resources through possible public or private equity offerings, including the 2022 Financing,

exchange offers, debt financings, corporate collaborations or other means.

If we are unable to raise sufficient capital, we will not

be able to pay our obligations as they become due.

prescription drug product candidates are at early- to mid-stages of development and may never obtain U.S.

or international regulatory

approvals required for us to commercialize our investigational drug product candidates.

will need approval of the FDA to commercialize our investigational drug product candidates in the U.S.

will need approval of the FDA to commercialize our prescription drug product candidates in the U.S.

and approvals from FDA-equivalent

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and requires substantial resources for research, development, and testing.

We cannot predict whether our research and clinical

approaches will result in drugs that the FDA considers safe for humans and effective for indicated uses.

The FDA has substantial discretion

in the drug approval process and may require us to conduct additional nonclinical and clinical testing or to perform post-marketing studies.

We cannot predict whether our research and clinical approaches

will result in drugs that the FDA considers safe for humans and effective for indicated uses.

The FDA has substantial discretion in the

drug approval process and may require us to conduct additional nonclinical and clinical testing or to perform post-marketing studies.

The approval process may also be delayed by changes in government regulation, future legislation or administrative action or changes

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an inspection of our clinical trial operations or trial sites by the FDA or other regulatory authorities, delays in reaching agreement

on acceptable terms with prospective contract research organizations (“CROs”) and clinical trial sites, delays in obtaining

required institutional review board (“IRB”) approval at each site, delays in recruiting suitable patients to participate

in a trial, delays in having subjects complete participation in a trial or return for post-treatment follow-up, delays caused by subjects

dropping out of a trial, delays caused by clinical sites dropping out of a trial, time required to add new clinical sites or to obtain

regulatory approval and open sites in geographic regions beyond the sites initially planned, and delays by our contract manufacturers

to produce and deliver sufficient supply of clinical trial materials.

on acceptable terms with prospective contract research organizations and clinical trial sites, delays in obtaining required institutional

review board approval at each site, delays in recruiting suitable patients to participate in a trial, delays in having subjects complete

participation in a trial or return for post-treatment follow-up, delays caused by subjects dropping out of a trial, delays caused by

clinical sites dropping out of a trial, time required to add new clinical sites or to obtain regulatory approval and open sites in geographic

regions beyond the sites initially planned, and delays by our contract manufacturers to produce and deliver sufficient supply of clinical

trial materials.

addition, we may experience a number of unforeseen events during clinical trials for our prescription drug candidates, including PV-10

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

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

(i) Bruce Horowitz, our COO, who is an independent

contractor, (ii) Heather Raines, CPA, our CFO, (iii) Dominic Rodrigues, who is vice chair of the Board, and (iv) Eric Wachter, Ph.D.,

our Chief Technology Officer (“CTO”).

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

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

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affect our operations and our financial performance.

Our business and operations are vulnerable to computer system

failures, cyber-attacks or deficiencies in our cyber-security, which could increase our expenses, divert the attention of our management

and key personnel away from our business operations and adversely affect our results of operations.

Despite the implementation of security measures, our internal computer

systems, and those of third parties on which we rely, are vulnerable to damage from:

business and operations are vulnerable to computer system failures, cyber-attacks or deficiencies in our cyber-security, which could

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

our results of operations.

the implementation of security measures, our internal computer systems, and those of third parties on which we rely, are vulnerable to

computer viruses;

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telecommunication and electrical failures;

cyber-attacks or cyber-intrusions over the Internet;

cyber-attacks or

cyber-intrusions over the Internet;

attachments to emails;

persons inside

persons inside our organization;

or persons with access to systems inside

our organization.

or persons with access to systems inside our organization.

The risk of a security breach or disruption, particularly

through cyber-attacks or cyber intrusion, including by computer hackers, foreign governments, and cyber terrorists, has generally increased

as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased.

If such an event

were to occur and cause interruptions in our operations, it could result in a material disruption of our product development programs.

For example, the loss of clinical trial data from completed or ongoing or planned clinical trials could result in delays in our regulatory

approval efforts and significantly increase our costs to recover or reproduce the data.

To the extent that any disruption or security

breach was to result in a loss of or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information,

we could incur material legal claims and liability, and damage to our reputation, and the further development of our product candidates

could be delayed.

We could be forced to expend significant 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 affect our results of operations.

Related to Our Intellectual Property

The risk of a security breach or disruption, particularly through cyber-attacks or cyber intrusion, including by computer

hackers, foreign governments, and cyber terrorists, has generally increased as the number, intensity and sophistication of attempted

attacks and intrusions from around the world have increased.

If such an event were to occur and cause interruptions in our operations,

it could result in a material disruption of our product development programs.

For example, the loss of clinical trial data from completed

or ongoing or planned clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs

to recover or reproduce the data.

To the extent that any disruption or security breach was to result in a loss of or damage to our data

or applications, or inappropriate disclosure of confidential or proprietary information, we could incur material legal claims and liability,

and damage to our reputation, and the further development of our product candidates could be delayed.

We could be forced to expend significant

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

affect our results of operations.

Related to Our Intellectual Property (“IP”)

we are unable to secure or enforce patent rights, trademarks, trade secrets or other IP, our business could be harmed.

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other personnel from performing product development duties.

also rely upon trade secrets, unpatented proprietary knowledge and continuing technological innovation to develop a competitive

We cannot assure you that others will not independently develop substantially equivalent proprietary technology and techniques

or otherwise gain access to our trade secrets and technology, or that we can adequately protect our trade secrets and technology.

also rely upon trade secrets, unpatented proprietary knowledge and continuing technological innovation to develop a competitive position.

We cannot assure you that others will not independently develop substantially equivalent proprietary technology and techniques or otherwise

gain access to our trade secrets and technology, or that we can adequately protect our trade secrets and technology.

we are unable to secure or enforce patent rights, trademarks, trade secrets, or other IP, our business, financial condition, results

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or future competitors.

Risks Related to Our Governing Documents and

Related to Our Governing Documents and Securities

Anti-takeover

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remove our current management.

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

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.

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in writing, and also specify requirements as to the form and content of a stockholder’s notice, (v) not provide for cumulative

voting rights, and (vi) provide that special meetings of our stockholders may be called only by

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

and other provisions in our certificate of incorporation, 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.

voting rights, and (vi) provide that special meetings of our stockholders may be called only by the Board or by such person or persons

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.

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

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use in our business and therefore do not anticipate paying any cash dividends on our common stock in the foreseeable future.

the event of the liquidation, winding-up or dissolution of the Company or certain mergers, corporate reorganizations or sales

of our assets, holders of Series D and Series D-1 Preferred Stock will be entitled to a preference of a multiple of their investment

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

connection with the 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 event of the liquidation, winding-up or dissolution of the Company or certain mergers, corporate reorganizations or sales of our

assets, holders of Series D and Series D-1 Preferred Stock will be entitled to a preference of a multiple of their investment amount,

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.

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

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

Company 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;

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;

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STAFF COMMENTS.

currently lease approximately 4,500 square feet of space for operations in Century Park, Knoxville, TN.

Our monthly rental charge for

these offices is approximately $6,100 per month.

The lease is for five years and expires on June 30, 2022.

information required by this item is incorporated by reference from Part II, Item 8.

Financial Statements and Supplementary Data, Notes

to Consolidated Financial Statements, Note 15 – Commitments, contingencies and litigation.

SAFETY DISCLOSURES.

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