What changed in this filing

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Item 1A. Risk Factors

2021-03-02 compared with 2020-03-05 · 84 added, 92 removed, 286 unchanged (38% of the section changed)

RISK FACTORS.

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

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2021 and beyond, and our ability to obtain the necessary funding is uncertain.

We need additional capital in 2020 and beyond

to continue developing and seeking to commercialize our drug product candidates.

We 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.

need additional capital in 2021 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.

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 March 19, 2017, we entered into an exclusive Definitive Financing Commitment Term Sheet

with a group of our stockholders (the “PRH Group”), which was amended and restated effective as of March 19, 2017

(the “2017 Term Sheet”), which sets forth the terms on which such investors will use their best efforts to provide

financing to the Company in the minimum amount of $10 million and up to $20 million (the “2017 Financing”).

20, 2019, we concluded the 2017 Financing.

As of December 31, 2019, we have raised $20,067,000 through the 2017 Financing.

December 31, 2019, our Board approved a Definitive Financing Term Sheet (the “2020 Term Sheet”), which set forth the

terms under which we will use our best efforts to arrange for financing of a maximum of $20,000,000 (the “2020 Financing”).

On December 31, 2019, our Board approved a Definitive Financing Term Sheet (the “2020

Term Sheet”), which set forth the terms under which we will use our best efforts to arrange for financing of a maximum of

$20,000,000 (the “2020 Financing”).

We intend to acquire additional funding through the 2020 Financing.

We may also seek capital from public or private equity or

debt financings or other financing sources that may be available.

seek capital from public or private equity or debt financings or other financing sources that may be available.

As of December

31, 2020, we have raised $3,325,000 through the 2020 Financing.

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

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

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

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

or international

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marketing approval for their products.

are currently conducting (i) a Phase 1 trial of single-agent PV-10 and PV-10-based combination therapy for HCC and other solid

tumors metastatic to the liver, (ii) a Phase 1 trial of single-agent PV-10 for symptomatic mNET, and (iii) a Phase 1b/2 combination

therapy study of PV-10 and CI for locally advanced and widely metastatic melanoma.

Product candidates in later stages of clinical

trials may fail to show the desired safety and efficacy characteristics despite having progressed satisfactorily through pre-clinical

studies and initial clinical testing.

A number of companies in the pharmaceutical and biotechnology industries, including those

with greater resources and experience, have suffered significant setbacks in Phase 3 clinical development, even after seeing promising

results in earlier clinical trials.

Product candidates in later stages of clinical trials may fail to show the desired safety

and efficacy characteristics despite having progressed satisfactorily through pre-clinical studies and initial clinical testing.

A number of companies in the pharmaceutical and biotechnology industries, including those with greater resources and experience,

have suffered significant setbacks in Phase 3 clinical development, even after seeing promising results in earlier clinical trials.

research and development expenses may increase in connection with expanding clinical trials of our product candidates in existing

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and delays by our contract manufacturers to produce and deliver sufficient supply of clinical trial materials.

In addition, we may experience a number of

unforeseen events during clinical trials for our prescription drug candidates, including PV-10 and PH-10, that could delay or

prevent the commencement and/or completion of our clinical trials, including regulators or institutional review boards may not

authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site, the clinical

study protocol may require one or more amendments delaying study completion, clinical trials of our product candidates may produce

negative or inconclusive results, and we may decide, or regulators may require us to conduct additional clinical trials or abandon

product development programs, the number of subjects required for clinical trials of our product candidates may be larger than

we anticipate, subjects may drop out of these clinical trials at a higher rate than we anticipate and enrollment in these clinical

trials may be significantly slower than we anticipated requiring us to expand the geographic scope of enrollment of patients,

clinical investigators or study subjects may fail to comply with clinical study protocols, trial conduct and data analysis errors

may occur, including, but not limited to, data entry and/or processing errors, our third-party contractors may fail to comply

with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, we might have to suspend

or terminate clinical trials of our prescription drug candidates for various reasons, including a finding that the subjects are

being exposed to unacceptable health risks, regulators or institutional review boards may require that we or our investigators

suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements, the cost of

clinical trials of our prescription drug candidates may be greater than we anticipate, the supply or quality of our clinical trial

materials or other materials necessary to conduct clinical trials of our prescription drug candidates may be insufficient or inadequate,

and our prescription drug candidates may have undesirable side effects or other unexpected characteristics, causing us or our

investigators to suspend or terminate the trials.

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

PV-10 and PH-10, that could delay or prevent the commencement and/or completion of our clinical trials, including regulators or

institutional review boards may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial

at a prospective trial site, the clinical study protocol may require one or more amendments delaying study completion, clinical

trials of our product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us

to conduct additional clinical trials or abandon product development programs, the number of subjects required for clinical trials

of our product candidates may be larger than we anticipate, subjects may drop out of these clinical trials at a higher rate than

we anticipate and enrollment in these clinical trials may be significantly slower than we anticipated requiring us to expand the

geographic scope of enrollment of patients, clinical investigators or study subjects may fail to comply with clinical study protocols,

trial conduct and data analysis errors may occur, including, but not limited to, data entry and/or processing errors, our third-party

contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or

at all, we might have to suspend or terminate clinical trials of our prescription drug candidates for various reasons, including

a finding that the subjects are being exposed to unacceptable health risks, regulators or institutional review boards may require

that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory

requirements, the cost of clinical trials of our prescription drug candidates may be greater than we anticipate, the supply or

quality of our clinical trial materials or other materials necessary to conduct clinical trials of our prescription drug candidates

may be insufficient or inadequate, and our prescription drug candidates may have undesirable side effects or other unexpected

characteristics, causing us or our investigators to suspend or terminate the trials.

we or the FDA may suspend our clinical trials at any time if it appears we are exposing participants to unacceptable health risks

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milestones and royalties, all of which could have a material adverse effect on our business.

The results of our clinical trials may

not support acceptable label claims concerning our prescription drug candidates.

results of our clinical trials may not support acceptable label claims concerning our prescription drug candidates.

if our clinical trials are completed as planned, we cannot be certain that their results will support acceptable label claims

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are safe for humans or effective for indicated uses.

This failure could cause us to abandon

a prescription drug candidate and may delay development of other prescription drug candidates.

Any delay in, or termination of,

our clinical trials will delay our ability to commercialize our prescription drug candidates and generate product revenues.

addition, we anticipate that our clinical trials will involve only a small patient population.

Accordingly, the results of such

trials may not be indicative of future results over a larger patient population.

failure could cause us to abandon a prescription drug candidate and may delay development of other prescription drug candidates.

Any delay in, or termination of, our clinical trials will delay our ability to commercialize our prescription drug candidates

and generate product revenues.

In addition, we anticipate that our clinical trials will involve only a small patient population.

Accordingly, the results of such trials may not be indicative of future results over a larger patient population.

and patients may not accept and use our prescription drug candidates.

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

We may not be successful in securing or maintaining

proprietary patent protection for our prescription drug candidates and technologies we develop or license.

In addition, our competitors

may develop prescription drug candidates similar to ours using methods and technologies that are beyond the scope of our IP protection,

which could reduce our anticipated sales.

While some of our drug product candidates have proprietary patent protection, a challenge

to these patents can subject us to expensive litigation.

Litigation concerning patents, other forms of IP, and proprietary technology

is becoming more widespread and can be protracted and expensive and can distract management and other personnel from performing

product development duties.

may not be successful in securing or maintaining proprietary patent protection for our prescription drug candidates and technologies

we develop or license.

In addition, our competitors may develop prescription drug candidates similar to ours using methods and

technologies that are beyond the scope of our IP protection, which could reduce our anticipated sales.

While some of our drug

product candidates have proprietary patent protection, a challenge to these patents can subject us to expensive litigation.

concerning patents, other forms of IP, and proprietary technology is becoming more widespread and can be protracted and expensive

and can distract management and other personnel from performing product development duties.

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

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

Our 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 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”).

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

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such meetings.

These 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.

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.

stock price is below $5.00 per share and is treated as a “penny stock,”

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although we intend to issue shares of common stock in satisfaction of the dividend payments due on our Series B Preferred Stock.

In the event of the sale, liquidation or

dissolution of the Company or any of our assets, holders of shares of a yet-to-be designated Series D 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.

In connection with the 2017 Financing

and 2020 Financing, we have issued convertible notes that will become convertible into shares of a yet-to-be designated

Series D Preferred Stock.

The Series D Preferred Stock will have a first priority right to receive proceeds from the sale,

liquidation or dissolution of us or any 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 Preferred Stock (the “Date of Issuance”), the holders of

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

the event of the sale, liquidation or dissolution of the Company or any of our assets, holders of shares of a yet-to-be designated

Series D 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 2017 Financing and 2020 Financing, we have issued convertible notes that will become convertible into shares

of a yet-to-be designated Series D Preferred Stock.

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

from the sale, liquidation or dissolution of us or any of our assets (each, a “Company Event”).

If a Company Event

occurs after the second (2nd) anniversary of the Date of Issuance, the holders of the Series D 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 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.

occurs within two (2) years of the date of issuance of the Series D Preferred Stock (the “Date of Issuance”), the

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

Event occurs after the second (2nd) anniversary of the Date of Issuance, the holders of the Series D 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 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

of SARS-CoV-2.

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

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

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, 2020.

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

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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-K

Item 1A. Risk Factors