What changed in this filing

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Item 1A. Risk Factors

2022-03-03 compared with 2021-02-12 · 740 added, 727 removed, 118 unchanged (93% of the section changed)

Risk Factors.

An investment in our securities involves

a high degree of risk.

You should consider carefully all of the material risks described below, together with the other information

contained in this Form 10-K.

If any of the following events occur, our business, financial condition, results of operations and

cash flows may be materially adversely affected.

Risks Related to the Company’s Business and Industry

An investment in our securities involves a high

degree of risk.

You should consider carefully all of the material risks described below, together with the other information contained

in this Form 10-K.

If any of the following events occur, our business, financial condition, results of operations and cash flows may be

materially adversely affected.

Risks Related to the Company’s Business and Industry

We will require substantial funding, which may not be available

to us on acceptable terms, or at all, and, if not so available, may require us to delay, limit, reduce or cease our operations.

We are using the proceeds from our IPO and

subsequent funding to, among other uses, advance Berubicin through clinical development.

Developing pharmaceutical products, including

conducting preclinical studies and clinical trials, is expensive.

We will require substantial additional future capital in order

to complete clinical development and commercialize Berubicin.

If the FDA requires that we perform additional nonclinical studies

or clinical trials, our expenses would further increase beyond what we currently expect and the anticipated timing of any potential

approval of Berubicin would likely be delayed.

Further, there can be no assurance that the costs we will need to incur to obtain

regulatory approval of Berubicin will not increase.

We will continue to require substantial

additional capital to continue our clinical development and commercialization activities.

Because successful development of our

product candidates is uncertain, we are unable to estimate the actual amount of funding we will require to complete research and

development and commercialize our products under development.

We estimate that we will require

additional financing of approximately $16.0 to $20.0 million to complete the Phase 2 trial for Berubicin, approximately $2.0

million to support near-term WP1244 preclinical work, plus such additional working capital to fund our operations during the

pendency of the trial.

The timing and costs of clinical trials are difficult to predict and as such the foregoing estimates

may prove to be inaccurate.

We have no commitments for such additional needed financing and will likely be required to raise

such financing through the sale of additional equity securities.

The amount and timing of our future funding

requirements will depend on many factors, including but not limited to:

We are using the proceeds from our IPO and subsequent

funding to, among other uses, advance Berubicin through clinical development.

Developing pharmaceutical products, including conducting

preclinical studies and clinical trials, is expensive.

We will require substantial additional future capital in order to complete clinical

development and commercialize Berubicin.

If the FDA requires that we perform additional nonclinical studies or clinical trials, our expenses

would further increase beyond what we currently expect and the anticipated timing of any potential approval of Berubicin would likely

Further, there can be no assurance that the costs we will need to incur to obtain regulatory approval of Berubicin will not

We will continue to require substantial additional

capital to continue our clinical development and commercialization activities.

Because successful development of our product candidates

is uncertain, we are unable to estimate the actual amount of funding we will require to complete research and development and commercialize

our products under development.

We estimate that we will require additional

financing of approximately $12.0 to $16.0 million to complete the Phase 2 trial for Berubicin, approximately $4.0 million to support

near-term WP1244/WP1874 preclinical work, plus such additional working capital to fund our operations during the pendency of the

The timing and costs of clinical trials are difficult to predict and as such the foregoing estimates may prove to be

We have no commitments for such additional needed financing and will likely be required to raise such financing through

the sale of additional equity or debt securities.

The amount and timing of our future funding requirements

will depend on many factors, including but not limited to:

whether our plan for clinical trials will be completed on a timely basis;

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the economic and other terms, timing of and success of our existing licensing arrangements and any collaboration, licensing or other arrangements into which we may enter in the future.

Some of these factors are outside of our

We may seek additional funding through a combination of equity offerings, debt financings, government or other third-party

funding, commercialization, marketing and distribution arrangements and other collaborations, strategic alliances and licensing

arrangements.

Additional funding may not be available to us on acceptable terms or at all.

In addition, the terms of any financing

may adversely affect the holdings or the rights of our stockholders.

If we are unable to obtain funding on a

timely basis, we may be required to significantly curtail one or more of our research or development programs.

We also could be

required to seek funds through arrangements with collaborative partners or otherwise that may require us to relinquish rights to

some of our technologies or product candidates or otherwise agree to terms unfavorable to us.

The report of our independent registered public accounting

firm expresses substantial doubt about our ability to continue as a going concern.

Such “going concern”

opinion could

impair our ability to obtain financing.

Our auditors have indicated in their report

on our financial statements for the fiscal year ended December 31, 2020 that conditions exist that raise substantial doubt about

our ability to continue as a going concern due to our recurring losses from operations.

A “going concern”

opinion could

impair our ability to finance our operations through the sale of equity, incurring debt, or other financing alternatives.

to continue as a going concern will depend upon the availability and terms of future funding.

If we are unable to achieve this

goal, our business would be jeopardized and we may not be able to continue.

If we ceased operations, it is likely that all of our

investors would lose their investment.

We have in the past completed related party transactions,

some of which that were not conducted on an arm’s length basis.

Some of these factors are outside of our control.

We may seek additional funding through a combination of equity offerings, debt financings, government or other third-party funding, commercialization,

marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements.

Additional funding may

not be available to us on acceptable terms or at all.

In addition, the terms of any financing may adversely affect the holdings or the

rights of our stockholders.

If we are unable to obtain funding on a timely

basis, we may be required to significantly curtail one or more of our research or development programs.

We also could be required to seek

funds through arrangements with collaborative partners or otherwise that may require us to relinquish rights to some of our technologies

or product candidates or otherwise agree to terms unfavorable to us.

The report of our independent registered public accounting firm

expresses substantial doubt about our ability to continue as a going concern.

Such “going concern” opinion could impair our

ability to obtain financing.

Our auditors have indicated in their report on

our financial statements for the fiscal year ended December 31, 2021 that conditions exist that raise substantial doubt about our ability

to continue as a going concern due to our recurring losses from operations.

A “going concern” opinion could impair our ability

to finance our operations through the sale of equity, incurring debt, or other financing alternatives.

Our ability to continue as a going

concern will depend upon the availability and terms of future funding.

If we are unable to achieve this goal, our business would be jeopardized

and we may not be able to continue.

If we ceased operations, it is likely that all of our investors would lose their investment.

We have in the past completed related party transactions, some of

which that were not conducted on an arm’s length basis.

We have entered into transactions with entities

affiliated with our largest shareholder, Dr.

affiliated with our founder and significant shareholder, Dr.

Waldemar Priebe, including:

We acquired the patent rights to Berubicin pursuant to a license agreement with Houston Pharmaceuticals, Inc.

We entered into a sublicense agreement with WPD Pharmaceuticals,

Inc., an entity with which Dr.

Priebe is affiliated, which granted a WPD a license to Berubicin in a specified territory (primarily

in eastern Europe and western Asia).

We entered into a sublicense agreement with WPD Pharmaceuticals, Inc., an entity with which Dr.

Priebe is affiliated, which granted a WPD a license to Berubicin in a specified territory (primarily in eastern Europe and western Asia).

We entered into a sublicense agreement with Animal Life Sciences, LLC, which granted an exclusive sublicense to Berubicin for the treatment of cancer in non-human animals.

We entered into a development agreement with WPD Pharmaceuticals, Inc., which granted us an economic interest in WPD’s development of an anti-viral portfolio.

We entered into the above agreements related

to Berubicin with HPI and WPD prior to our IPO, at a time during which we did not have an independent board of directors.

due to the related party relationship between our Company and these entities, the negotiation of these agreements was not conducted

on an arm’s length basis.

As such, it is possible that the terms were less favorable to us than in a transaction negotiated

in an arm’s length transaction.

We have never been profitable, we have no products approved

for commercial sale, and we have not generated any revenue from product sales.

As a result, our ability to reduce our losses and

reach profitability is unproven, and we may never achieve or sustain profitability.

Therefore, we may not be able to continue as

a going concern.

We have never been profitable and do not

expect to be profitable in the foreseeable future.

We have not yet submitted any drug candidates for approval by regulatory authorities

in the United States or elsewhere.

Our ability to continue as a going concern is dependent upon our generating cash flow from sales

that are sufficient to fund operations or finding adequate financing to support our operations.

To date, we have had no revenues

and have relied on equity-based financing from the sale of securities in private placements and the issuance of convertible notes.

The continuation of the Company as a going concern is dependent upon our ability to obtain continued financial support from its

stockholders, necessary equity financing to continue operations and the attainment of profitable operations.

As of December 31,

2020 the Company has incurred an accumulated deficit of $20,946,343 since inception and had not yet generated any revenue from

Additionally, management anticipates that its cash on hand as of December 31, 2020 is sufficient to fund its planned

operations through but not beyond calendar year 2021.

We entered into a development agreement with WPD Pharmaceuticals, Inc., which granted us an economic interest in WPD’s development of an anti-viral portfolio.

We entered into the above agreements related to

Berubicin with HPI and WPD prior to our IPO, at a time during which we did not have an independent board of directors.

As such, due to

the related party relationship between our Company and these entities, the negotiation of these agreements was not conducted on an arm’s

length basis.

As such, it is possible that the terms were less favorable to us than in a transaction negotiated in an arm’s length

We have never been profitable, we have no products approved for

commercial sale, and we have not generated any revenue from product sales.

As a result, our ability to reduce our losses and reach profitability

is unproven, and we may never achieve or sustain profitability.

Therefore, we may not be able to continue as a going concern.

We have never been profitable and do not expect

to be profitable in the foreseeable future.

We have not yet submitted any drug candidates for approval by regulatory authorities in the

United States or elsewhere.

Our ability to continue as a going concern is dependent upon our generating cash flow from sales that are

sufficient to fund operations or finding adequate financing to support our operations.

To date, we have had no revenues and have relied

on equity-based financing from the sale of securities in public and private placements and the issuance of convertible notes.

The continuation

of the Company as a going concern is dependent upon our ability to obtain continued financial support from its stockholders, necessary

equity or debt financing to continue operations and the attainment of profitable operations.

As of December 31, 2021 the Company has incurred

an accumulated deficit of $34,982,921 since inception and had not yet generated any revenue from operations.

Additionally, management

anticipates that its cash on hand as of December 31, 2021 is sufficient to fund its planned operations through but not beyond calendar

To date, we have devoted most of our financial

resources to corporate overhead, clinical trial preparation and marketing of our securities.

We have not generated any revenues

from product sales.

We expect to continue to incur losses for the foreseeable future, and we expect these losses to increase as

we continue our development of, and seek regulatory approvals for Berubicin, prepare for and begin the commercialization of any

approved products, and add infrastructure and personnel to support our continuing product development efforts.

resources to corporate overhead, preparing for and conducting the clinical trial and marketing of our securities.

We have not generated

any revenues from product sales.

We expect to continue to incur losses for the foreseeable future, and we expect these losses to increase

as we continue our development of and seek regulatory approvals for Berubicin and WP1244/WP1874, prepare for and begin the commercialization

of any approved products, and add infrastructure and personnel to support our continuing product development efforts.

We anticipate that

any such losses could be significant for the next several years.

If Berubicin or any of our other drug candidates fail in clinical

trials or do not gain regulatory approval, or if our drug candidates do not achieve market acceptance, we may never become profitable.

As a result of the foregoing, we expect to continue to experience net losses and negative cash flows for the foreseeable future.

These net losses and negative cash flows have had, and will continue to have, an adverse effect on our stockholders’

and working capital.

If Berubicin or any of our other drug candidates fail in clinical trials

or do not gain regulatory approval, or if our drug candidates do not achieve market acceptance, we may never become profitable.

of the foregoing, we expect to continue to experience net losses and negative cash flows for the foreseeable future.

These net losses

and negative cash flows have had, and will continue to have, an adverse effect on our stockholders’ equity and working capital.

Because of the numerous risks and uncertainties

associated with pharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses

or when, or if, we will be able to achieve profitability.

In addition, our expenses could increase if we are required by the FDA

to perform studies or trials in addition to those currently expected, or if there are any delays in completing our clinical trials

or the development of any of our drug candidates.

The amount of future net losses will depend, in part, on the rate of future growth

of our expenses and our ability to generate revenues.

We have no operating history and we expect a number of factors

associated with pharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses or

when, or if, we will be able to achieve profitability.

In addition, our expenses could increase if we are required by the FDA to perform

studies or trials in addition to those currently expected, or if there are any delays in completing our clinical trials or the development

of any of our drug candidates.

The amount of future net losses will depend, in part, on the rate of future growth of our expenses and

our ability to generate revenues.

We have a limited operating history and we expect a number of factors

to cause our operating results to fluctuate on an annual basis, which may make it difficult to predict our future performance.

We are a preclinical pharmaceutical company

with no operating history.

Our operations to date have been limited to acquiring our technology portfolio.

We have not yet commenced

any clinical trials or obtained any regulatory approvals for any of our drug candidates.

Consequently, any predictions made about

our future success or viability may not be as accurate as they could be if we had a longer operating history or approved products

on the market.

Our operating results are expected to significantly fluctuate from quarter to quarter or year to year due to a variety

of factors, many of which are beyond our control.

Factors relating to our business that may contribute to these fluctuations include:

We are a clinical pharmaceutical company with limited

operating history.

Our operations to date have been limited to acquiring our technology portfolio, preparing for and conducting our Berubicin

clinical trial, and pre-clinical work related to other drug candidate, WP1244/WP1874.

We have not yet obtained any regulatory approvals

for any of our drug candidates.

Consequently, any predictions made about our future success or viability may not be as accurate as they

could be if we had a longer operating history or approved products on the market.

Our operating results are expected to significantly

fluctuate from quarter to quarter or year to year due to a variety of factors, many of which are beyond our control.

Factors relating

to our business that may contribute to these fluctuations include:

any delays in regulatory review and approval of our product candidates in clinical development, including our ability to receive approval from the FDA for Berubicin;

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potential product liability claims.

These factors are our best estimates of

possible factors, but cannot be considered a complete recitation of possible factors that could affect the Company.

the results of any historical quarterly or annual periods should not be relied upon as indications of future operating performance.

We cannot be certain that Berubicin will receive regulatory

approval, and without regulatory approval we will not be able to market Berubicin.

Our business currently depends largely on

the successful development and commercialization of Berubicin.

Our ability to generate revenue related to product sales, if ever,

will depend on the successful development and regulatory approval of Berubicin for the treatment of glioblastoma.

We currently have no products approved for

sale and we cannot guarantee that we will ever have marketable products.

The development of a product candidate and issues relating

to its approval and marketing are subject to extensive regulation by the FDA in the United States and regulatory authorities in

other countries, with regulations differing from country to country.

We are not permitted to market our product candidates in the

United States until we receive approval of an NDA from the FDA.

We have not submitted any marketing applications for any of our

These factors are our best estimates of possible

factors but cannot be considered a complete recitation of possible factors that could affect the Company.

Accordingly, the results of

any historical quarterly or annual periods should not be relied upon as indications of future operating performance.

We cannot be certain that Berubicin will receive regulatory approval,

and without regulatory approval we will not be able to market Berubicin.

Our business currently depends largely on the successful

development and commercialization of Berubicin.

Our ability to generate revenue related to product sales, if ever, will depend on the

successful development and regulatory approval of Berubicin for the treatment of glioblastoma.

We currently have no products approved for sale

and we cannot guarantee that we will ever have marketable products.

The development of a product candidate and issues relating to its

approval and marketing are subject to extensive regulation by the FDA in the United States and regulatory authorities in other countries,

with regulations differing from country to country.

We are not permitted to market our product candidates in the United States until we

receive approval of an NDA from the FDA.

We have not submitted any marketing applications for any of our product candidates.

NDAs must include extensive preclinical and clinical

data and supporting information to establish the product candidate’s safety and effectiveness for each desired indication.

must also include significant information regarding the chemistry, manufacturing and controls for the product.

Obtaining approval of an

NDA is a lengthy, expensive, and uncertain process, and we may not be successful in obtaining approval.

The FDA review processes can take

years to complete, and approval is never guaranteed.

If we submit an NDA to the FDA, the FDA must decide whether to accept or reject the

submission for filing.

We cannot be certain that any submissions will be accepted for filing and review by the FDA.

Regulators in other

jurisdictions have their own procedures for approval of product candidates.

Even if a product is approved, the FDA may limit the indications

for which the product may be marketed, require extensive warnings on the product labeling or require expensive and time-consuming clinical

trials or reporting as conditions of approval.

Regulatory authorities in countries outside of the United States and Europe also have requirements

for approval of drug candidates with which we must comply with prior to marketing in those countries.

Obtaining regulatory approval for

marketing of a product candidate in one country does not ensure that we will be able to obtain regulatory approval in any other country.

In addition, delays in approvals or rejections of marketing applications in the United States, Europe or other countries may be based

upon many factors, including regulatory requests for additional analyses, reports, data, preclinical studies and clinical trials, regulatory

questions regarding different interpretations of data and results, changes in regulatory policy during the period of product development

and the emergence of new information regarding our product candidates or other products.

Also, regulatory approval for any of our product

candidates may be withdrawn.

If we are unable to obtain approval from the FDA,

or other regulatory agencies, for Berubicin and our other product candidates, or if, subsequent to approval, we are unable to successfully

commercialize Berubicin or our other product candidates, we will not be able to generate sufficient revenue to become profitable or to

continue our operations, likely resulting in the total loss of principal for our investors.

Any statements in this filing indicating that Berubicin

has demonstrated preliminary evidence of efficacy are our own and are not based on the FDA’s or any other comparable governmental

agency’s assessment of Berubicin and do not indicate that Berubicin will achieve favorable efficacy results in any later stage trials

or that the FDA or any comparable agency will ultimately determine that Berubicin is effective for purposes of granting marketing approval.

Delays in the commencement, enrollment and completion of clinical

trials could result in increased costs to us and delay or limit our ability to obtain regulatory approval for Berubicin and our other

product candidates.

NDAs must include extensive preclinical

and clinical data and supporting information to establish the product candidate’s safety and effectiveness for each desired

NDAs must also include significant information regarding the chemistry, manufacturing and controls for the product.

Obtaining approval of an NDA is a lengthy, expensive and uncertain process, and we may not be successful in obtaining approval.

The FDA review processes can take years to complete and approval is never guaranteed.

If we submit an NDA to the FDA, the FDA must

decide whether to accept or reject the submission for filing.

We cannot be certain that any submissions will be accepted for filing

and review by the FDA.

Regulators in other jurisdictions have their own procedures for approval of product candidates.

a product is approved, the FDA may limit the indications for which the product may be marketed, require extensive warnings on the

product labeling or require expensive and time-consuming clinical trials or reporting as conditions of approval.

Regulatory authorities

in countries outside of the United States and Europe also have requirements for approval of drug candidates with which we must

comply with prior to marketing in those countries.

Obtaining regulatory approval for marketing of a product candidate in one country

does not ensure that we will be able to obtain regulatory approval in any other country.

In addition, delays in approvals or rejections

of marketing applications in the United States, Europe or other countries may be based upon many factors, including regulatory

requests for additional analyses, reports, data, preclinical studies and clinical trials, regulatory questions regarding different

interpretations of data and results, changes in regulatory policy during the period of product development and the emergence of

new information regarding our product candidates or other products.

Also, regulatory approval for any of our product candidates

may be withdrawn.

If we are unable to obtain approval from

the FDA, or other regulatory agencies, for Berubicin and our other product candidates, or if, subsequent to approval, we are unable

to successfully commercialize Berubicin or our other product candidates, we will not be able to generate sufficient revenue to

become profitable or to continue our operations, likely resulting in the total loss of principal for our investors.

Any statements in this filing indicating

that Berubicin has demonstrated preliminary evidence of efficacy are our own and are not based on the FDA’s or any other

comparable governmental agency’s assessment of Berubicin and do not indicate that Berubicin will achieve favorable efficacy

results in any later stage trials or that the FDA or any comparable agency will ultimately determine that Berubicin is effective

for purposes of granting marketing approval.

Delays in the commencement, enrollment and completion of

clinical trials could result in increased costs to us and delay or limit our ability to obtain regulatory approval for Berubicin

and our other product candidates.

Delays in the commencement, enrollment and

completion of clinical trials could increase our product development costs or limit the regulatory approval of our product candidates.

We do not know whether any future trials or studies of our other product candidates will begin on time or will be completed on

schedule, if at all.

The start or end of a clinical study is often delayed or halted due to changing regulatory requirements, manufacturing

challenges, including delays or shortages in available drug product, required clinical trial administrative actions, slower than

anticipated patient enrollment, changing standards of care, availability or prevalence of use of a comparative drug or required

prior therapy, clinical outcomes or financial constraints.

For instance, delays or difficulties in patient enrollment or difficulties

in retaining trial participants can result in increased costs, longer development times or termination of a clinical trial.

trials of a new product candidate require the enrollment of a sufficient number of patients, including patients who are suffering

from the disease the product candidate is intended to treat and who meet other eligibility criteria.

The rates of patient enrollment

are affected by many factors, including the size of the patient population, the eligibility criteria for the clinical trial, that

include the age and condition of the patients and the stage and severity of disease, the nature of the protocol, the proximity

of patients to clinical sites and the availability of effective treatments and/or availability of investigational treatment options

for the relevant disease.

A product candidate can unexpectedly fail

at any stage of preclinical and clinical development.

The historical failure rate for product candidates is high due to scientific

feasibility, safety, efficacy, changing standards of medical care and other variables.

The results from preclinical testing or

early clinical trials of a product candidate may not predict the results that will be obtained in later phase clinical trials of

the product candidate.

We, the FDA or other applicable regulatory authorities may suspend clinical trials of a product candidate

at any time for various reasons, including, but not limited to, a belief that subjects participating in such trials are being exposed

to unacceptable health risks or adverse side effects, or other adverse initial experiences or findings.

We may not have the financial

resources to continue development of, or to enter into collaborations for, a product candidate if we experience any problems or

other unforeseen events that delay or prevent regulatory approval of, or our ability to commercialize, product candidates, including,

but not limited to:

Delays in the commencement, enrollment and completion

of clinical trials could increase our product development costs or limit the regulatory approval of our product candidates.

know whether any future trials or studies of our other product candidates will begin on time or will be completed on schedule, if at all.

The start or end of a clinical study is often delayed or halted due to changing regulatory requirements, manufacturing challenges, including

delays or shortages in available drug product, required clinical trial administrative actions, slower than anticipated patient enrollment,

changing standards of care, availability or prevalence of use of a comparative drug or required prior therapy, clinical outcomes or financial

For instance, delays or difficulties in patient enrollment or difficulties in retaining trial participants can result in

increased costs, longer development times or termination of a clinical trial.

Clinical trials of a new product candidate require the enrollment

of a sufficient number of patients, including patients who are suffering from the disease the product candidate is intended to treat and

who meet other eligibility criteria.

The rates of patient enrollment are affected by many factors, including the size of the patient population,

the eligibility criteria for the clinical trial, that include the age and condition of the patients and the stage and severity of disease,

the nature of the protocol, the proximity of patients to clinical sites and the availability of effective treatments and/or availability

of investigational treatment options for the relevant disease.

A product candidate can unexpectedly fail at any

stage of preclinical and clinical development.

The historical failure rate for product candidates is high due to scientific feasibility,

safety, efficacy, changing standards of medical care and other variables.

The results from preclinical testing or early clinical trials

of a product candidate may not predict the results that will be obtained in later phase clinical trials of the product candidate.

the FDA or other applicable regulatory authorities may suspend clinical trials of a product candidate at any time for various reasons,

including, but not limited to, a belief that subjects participating in such trials are being exposed to unacceptable health risks or adverse

side effects, or other adverse initial experiences or findings.

We may not have the financial resources to continue development of, or

to enter into collaborations for, a product candidate if we experience any problems or other unforeseen events that delay or prevent regulatory

approval of, or our ability to commercialize, product candidates, including, but not limited to:

inability to obtain sufficient funds required for a clinical trial;

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unfavorable FDA or other regulatory agency inspection and review of a clinical trial site or vendor.

We have never conducted a clinical trial or submitted an

NDA before, and any product candidate we advance through clinical trials may not have favorable results in later clinical trials

or receive regulatory approval.

Clinical failure can occur at any stage

of our clinical development.

Clinical trials may produce negative or inconclusive results, and our collaborators or we may decide,

or regulators may require us, to conduct additional clinical trials or nonclinical studies.

In addition, data obtained from trials

and studies are susceptible to varying interpretations, and regulators may not interpret our data as favorably as we do, which

may delay, limit or prevent regulatory approval.

Success in preclinical studies and early clinical trials does not ensure that

subsequent clinical trials will generate the same or similar results or otherwise provide adequate data to demonstrate the efficacy

and safety of a product candidate.

A number of companies in the pharmaceutical industry, including those with greater resources

and experience than us, have suffered significant setbacks in clinical trials, even after seeing promising results in earlier clinical

In addition, the design of a clinical trial

can determine whether its results will support approval of a product and flaws in the design of a clinical trial may not become

apparent until the clinical trial is well advanced.

We may be unable to design and execute a clinical trial to support regulatory

Further, clinical trials of potential products often reveal that it is not practical or feasible to continue development

If Berubicin is found to be unsafe or lack efficacy, we will

not be able to obtain regulatory approval for it and our business would be materially and possibly irreparably harmed.

In some instances, there can be significant

variability in safety and/or efficacy results between different trials of the same product candidate due to numerous factors, including

changes in trial protocols, differences in composition of the patient populations, adherence to the dosing regimen and other trial

protocols and the rate of dropout among clinical trial participants.

We do not know whether any clinical trials we or any of our

potential future collaborators may conduct will demonstrate the consistent or adequate efficacy and safety that would be required

to obtain regulatory approval and market any products.

If we are unable to bring Berubicin to market, or to acquire other products

that are on the market or can be developed, our ability to create long-term stockholder value will be limited.

Interim or preliminary data from our clinical trials that

we announce or publish from time to time may change as more patient data become available and are subject to audit and verification

procedures that could result in material changes in the final data.

We may publicly disclose preliminary data

from our clinical trials, which is based on a preliminary analysis of then-available data, and the results and related findings

and conclusions are subject to change following a full analyses of all data related to the particular trial.

We also make assumptions,

estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity

to fully and carefully evaluate all data.

As a result, the preliminary results that we report may differ from future results of

the same trials, or different conclusions or considerations may qualify such results once additional data have been received and

fully evaluated.

Preliminary data also remain subject to audit and verification procedures that may result in the final data being

materially different from the preliminary data we previously published.

As a result, preliminary data should be viewed with caution

until the final data are available.

We may also disclose interim data from our clinical trials.

Interim data from clinical trials

that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment

continues and more patient data become available.

Adverse differences between preliminary or interim data and final data could

significantly harm our business prospects.

Further, disclosure of preliminary or interim data by us could result in volatility

in the price of shares of our common stock.

In addition, others, including regulatory

agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh

the importance of data differently, which could impact the approvability of the particular drug candidate and our business in general.

In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is based on what is

typically extensive information, and you or others may not agree with what we determine is the material or otherwise appropriate

information to include in our disclosure, and any information we determine not to disclose may ultimately be deemed significant

with respect to future decisions, conclusions, views, activities or otherwise regarding a particular drug candidate or our business.

If the interim data that we report differ from actual results, or if others, including regulatory authorities, disagree with the

conclusions reached, our ability to obtain approval for and commercialize our current or any our future drug candidate, our business,

operating results, prospects or financial condition may be materially harmed.

The COVID-19 outbreak may delay recruitment in our clinical

trials and may continue or worsen, may affect the business of the FDA, EMA or other health authorities, which could result in delays

in meetings related to our planned clinical trials and ultimately of reviews and approvals of our product candidates.

The COVID-19 outbreak has delayed recruitment

in clinical trials and may continue or worsen.

Additionally, it may delay the approvals of our product candidates due to its effect

on the business of the FDA, EMA or other health authorities, which could result in delays in meetings related to planned clinical

The spread of COVID-19 may also slow potential enrollment of clinical trials and reduce the number of eligible patients

for our clinical trials.

The COVID-19 outbreak and mitigation measures also have had and may continue to have an adverse impact

on global economic conditions which could have an adverse effect on our business and financial condition, including impairing our

ability to raise capital when needed.

The extent to which the COVID-19 outbreak impacts our business and operations will depend

on future developments that are highly uncertain and cannot be predicted, including new information that may emerge concerning

the severity of the virus and the actions to contain its impact.

Our product candidates may have undesirable side effects

that may delay or prevent marketing approval, or, if approval is received, require them to be taken off the market, require them

to include safety warnings or otherwise limit their sales.

Unforeseen side effects from any of our

product candidates could arise either during clinical development or, if Berubicin is approved, after the approved product has

been marketed.

The range and potential severity of possible side effects from therapies such as Berubicin are significant.

causes undesirable or unacceptable side effects in the future, this could interrupt, delay or halt clinical trials and result in

the failure to obtain or suspension or termination of marketing approval from the FDA and other regulatory authorities, or result

in marketing approval from the FDA and other regulatory authorities only with restrictive label warnings.

If any of our product candidates receives

marketing approval and we or others later identify undesirable or unacceptable side effects caused by such products:

We have never conducted a clinical trial or submitted an NDA before,

and any product candidate we advance through clinical trials may not have favorable results in later clinical trials or receive regulatory

Clinical failure can occur at any stage of our

clinical development.

Clinical trials may produce negative or inconclusive results, and our collaborators or we may decide, or regulators

may require us, to conduct additional clinical trials or nonclinical studies.

In addition, data obtained from trials and studies are susceptible

to varying interpretations, and regulators may not interpret our data as favorably as we do, which may delay, limit, or prevent regulatory

Success in preclinical studies and early clinical trials does not ensure that subsequent clinical trials will generate the same

or similar results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate.

Many companies in

the pharmaceutical industry, including those with greater resources and experience than us, have suffered significant setbacks in clinical

trials, even after seeing promising results in earlier clinical trials.

In addition, the design of a clinical trial can

determine whether its results will support approval of a product and flaws in the design of a clinical trial may not become apparent until

the clinical trial is well advanced.

We may be unable to design and execute a clinical trial to support regulatory approval.

clinical trials of potential products often reveal that it is not practical or feasible to continue development efforts.

If Berubicin is found to be unsafe or lack efficacy, we will not

be able to obtain regulatory approval for it and our business would be materially and possibly irreparably harmed.

In some instances, there can be significant variability

in safety and/or efficacy results between different trials of the same product candidate due to numerous factors, including changes in

trial protocols, differences in composition of the patient populations, adherence to the dosing regimen and other trial protocols and

the rate of dropout among clinical trial participants.

We do not know whether any clinical trials we or any of our potential future collaborators

may conduct will demonstrate the consistent or adequate efficacy and safety that would be required to obtain regulatory approval and market

any products.

If we are unable to bring Berubicin to market, or to acquire other products that are on the market or can be developed,

our ability to create long-term stockholder value will be limited.

Interim or preliminary data from our clinical trials that we announce

or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that

could result in material changes in the final data.

We may publicly disclose preliminary data from

our clinical trials, which is based on a preliminary analysis of then-available data, and the results and related findings and conclusions

are subject to change following a full analysis of all data related to the particular trial.

We also make assumptions, estimations, calculations,

and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all

As a result, the preliminary results that we report may differ from future results of the same trials, or different conclusions

or considerations may qualify such results once additional data have been received and fully evaluated.

Preliminary data also remain subject

to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously

As a result, preliminary data should be viewed with caution until the final data are available.

We may also disclose interim

data from our clinical trials.

Interim data from clinical trials that we may complete are subject to the risk that one or more of the

clinical outcomes may materially change as patient enrollment continues and more patient data become available.

Adverse differences between

preliminary or interim data and final data could significantly harm our business prospects.

Further, disclosure of preliminary or interim

data by us could result in volatility in the price of shares of our common stock.

In addition, others, including regulatory agencies,

may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance

of data differently, which could impact the approvability of the particular drug candidate and our business in general.

In addition, the

information we choose to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information,

and you or others may not agree with what we determine is the material or otherwise appropriate information to include in our disclosure,

and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views,

activities or otherwise regarding a particular drug candidate or our business.

If the interim data that we report differ from actual results,

or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for and commercialize

our current or any our future drug candidate, our business, operating results, prospects or financial condition may be materially harmed.

The COVID-19 outbreak may delay recruitment in our clinical trials

and may continue or worsen, may affect the business of the FDA, EMA or other health authorities, which could result in delays in meetings

related to our planned clinical trials and ultimately of reviews and approvals of our product candidates.

The COVID-19 outbreak may delay recruitment in

clinical trials and may continue or worsen.

Additionally, it may delay the approvals of our product candidates due to its effect on the

business of the FDA, EMA or other health authorities, which could result in delays in meetings related to planned clinical trials.

spread of COVID-19 may also slow potential enrollment of clinical trials and reduce the number of eligible patients for our clinical trials.

The COVID-19 outbreak and mitigation measures also have had and may continue to have an adverse impact on global economic conditions which

could have an adverse effect on our business and financial condition, including impairing our ability to raise capital when needed.

extent to which the COVID-19 outbreak impacts our business and operations will depend on future developments that are highly uncertain

and cannot be predicted, including new information that may emerge concerning the severity of the virus and the actions to contain its

Our product candidates may have undesirable side effects that may

delay or prevent marketing approval, or, if approval is received, require them to be taken off the market, require them to include safety

warnings or otherwise limit their sales.

Unforeseen side effects from any of our product

candidates could arise either during clinical development or, if Berubicin (or our other product candidates) are approved, after the approved

product has been marketed.

The range and potential severity of possible side effects from therapies such as Berubicin (or our other product

candidates) are significant.

If Berubicin (or our other product candidates) causes undesirable or unacceptable side effects in the future,

this could interrupt, delay or halt clinical trials and result in the failure to obtain or suspension or termination of marketing approval

from the FDA and other regulatory authorities, or result in marketing approval from the FDA and other regulatory authorities only with

restrictive label warnings.

If any of our product candidates receives marketing

approval and we or others later identify undesirable or unacceptable side effects caused by such products:

regulatory authorities may require the addition of labeling statements, specific warnings, a contraindication or field alerts to physicians and pharmacies;

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our reputation may suffer.

Any of these events could prevent us or

our potential future collaborators from achieving or maintaining market acceptance of the affected product or could substantially

increase commercialization costs and expenses, which in turn could delay or prevent us from generating significant revenues from

the sale of our products.

If the FDA does not find the manufacturing facilities of

our future contract manufacturers acceptable for commercial production, we may not be able to commercialize any of our product

We do not have any manufacturing capabilities

and we do not intend to manufacture the pharmaceutical products that we plan to sell.

We utilize contract manufacturers for the

production of the active pharmaceutical ingredients and the formulation of drug product for our trials of Berubicin that we will

need to conduct prior to seeking regulatory approval.

However, we do not have agreements for supplies of Berubicin or any of our

other product candidates and we may not be able to reach agreements with these or other contract manufacturers for sufficient

supplies to commercialize Berubicin if it is approved.

Additionally, the facilities used by any contract manufacturer to manufacture

Berubicin or any of our other product candidates must be the subject of a satisfactory inspection before the FDA approves the

product candidate manufactured at that facility.

We will be completely dependent on these third-party manufacturers for compliance

with the requirements of U.S.

Any of these events could prevent us or our potential

future collaborators from achieving or maintaining market acceptance of the affected product or could substantially increase commercialization

costs and expenses, which in turn could delay or prevent us from generating significant revenues from the sale of our products.

If the FDA does not find the manufacturing facilities of our future

contract manufacturers acceptable for commercial production, we may not be able to commercialize any of our product candidates, or such

commercialization efforts may be delayed until we can contract with manufacturers with facilities acceptable to the FDA or other regulatory

We do not have any manufacturing capabilities and

we do not intend to manufacture the pharmaceutical products that we plan to sell.

We utilize contract manufacturers for the production

of the active pharmaceutical ingredients and the formulation of drug product for our pre-clinical development and clinical trials of Berubicin

that we will need to conduct prior to seeking regulatory approval.

However, we do not have agreements for supplies of Berubicin or any

of our other product candidates and we may not be able to reach agreements with these or other contract manufacturers for sufficient supplies

to commercialize Berubicin if it is approved.

Additionally, the facilities used by any contract manufacturer to manufacture Berubicin

or any of our other product candidates must be the subject of a satisfactory inspection before the FDA approves the product candidate

manufactured at that facility.

We will be completely dependent on these third-party manufacturers for compliance with the requirements

regulators for the manufacture of our finished products.

If our manufacturers cannot

successfully manufacture material that conform to our specifications and the FDA’s current good manufacturing practice standards,

or cGMP, and other requirements of any governmental agency whose jurisdiction to which we are subject, our product candidates

will not be approved or, if already approved, may be subject to recalls.

Reliance on third-party manufacturers entails risks to

which we would not be subject if we manufactured our product candidates, including:

If our manufacturers cannot successfully manufacture material

that conform to our specifications and the FDA’s current good manufacturing practice standards, or cGMP, and other requirements

of any governmental agency whose jurisdiction to which we are subject, our product candidates will not be approved or, if already approved,

may be subject to recalls.

Reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured our

product candidates, including:

the possibility that we are unable to enter into a manufacturing agreement with a third party to manufacture our product candidates;

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the possibility of termination or nonrenewal of the agreements by the third parties before we are able to arrange for a qualified replacement third-party manufacturer.

Any of these factors could cause the delay

of approval or commercialization of our product candidates, cause us to incur higher costs or prevent us from commercializing our

product candidates successfully.

Furthermore, if any of our product candidates are approved and contract manufacturers fail to

deliver the required commercial quantities of finished product on a timely basis at commercially reasonable prices and we are unable

to find one or more replacement manufacturers capable of production at a substantially equivalent cost, in substantially equivalent

volumes and quality and on a timely basis, we would likely be unable to meet demand for our products and could lose potential revenue.

It may take several years to establish an alternative source of supply for our product candidates and to have any such new source

approved by the government agencies that regulate our products.

We have no sales, marketing or distribution experience and

we will have to invest significant resources to develop those capabilities or enter into third-party sales and marketing arrangements,

the problems with which could materially harm our business at any time.

We have no sales, marketing or distribution

To develop sales, distribution and marketing capabilities, we will have to invest significant amounts of financial

and management resources, some of which will need to be committed prior to any confirmation that Berubicin or any of our other

product candidates will be approved by the FDA.

For product candidates where we decide to perform sales, marketing and distribution

functions ourselves or through third parties, we could face a number of additional risks, including that we or our third-party

sales collaborators may not be able to build and maintain an effective marketing or sales force.

If we use third parties to market

and sell our products, we may have limited or no control over their sales, marketing and distribution activities on which our future

revenues may depend.

We may not be successful in establishing and maintaining

development and commercialization collaborations, which could adversely affect our ability to develop certain of our product candidates

and our financial condition and operating results.

Because developing pharmaceutical products,

conducting clinical trials, obtaining regulatory approval, establishing manufacturing capabilities and marketing approved products

are expensive, we may seek to enter into collaborations with companies that have more experience.

Additionally, if any of our product

candidates receives marketing approval, we may enter into sales and marketing arrangements with third parties with respect to our

unlicensed territories.

If we are unable to enter into arrangements on acceptable terms, if at all, we may be unable to effectively

market and sell our products in our target markets.

Any of these factors could cause the delay of approval

or commercialization of our product candidates, cause us to incur higher costs or prevent us from commercializing our product candidates

successfully.

Furthermore, if any of our product candidates are approved and contract manufacturers fail to deliver the required commercial

quantities of finished product on a timely basis at commercially reasonable prices and we are unable to find one or more replacement manufacturers

capable of production at a substantially equivalent cost, in substantially equivalent volumes and quality and on a timely basis, we would

likely be unable to meet demand for our products and could lose potential revenue.

It may take several years to establish an alternative

source of supply for our product candidates and to have any such new source approved by the government agencies that regulate our products.

We have no sales, marketing or distribution experience and we will

have to invest significant resources to develop those capabilities or enter into third-party sales and marketing arrangements, the problems

with which could materially harm our business at any time.

We have no sales, marketing, or distribution experience.

To develop sales, distribution, and marketing capabilities, we will have to invest significant amounts of financial and management resources,

some of which will need to be committed prior to any confirmation that Berubicin or any of our other product candidates will be approved

For product candidates where we decide to perform sales, marketing, and distribution functions ourselves or through third

parties, we could face a number of additional risks, including that we or our third-party sales collaborators may not be able to build

and maintain an effective marketing or sales force.

If we use third parties to market and sell our products, we may have limited or no

control over their sales, marketing and distribution activities on which our future revenues may depend.

We may not be successful in establishing and maintaining development

and commercialization collaborations, which could adversely affect our ability to develop certain of our product candidates and our financial

condition and operating results.

Because developing pharmaceutical products, conducting

clinical trials, obtaining regulatory approval, establishing manufacturing capabilities and marketing approved products are expensive,

we may seek to enter into collaborations with companies that have more experience.

Additionally, if any of our product candidates receives

marketing approval, we may enter into sales and marketing arrangements with third parties with respect to our unlicensed territories.

If we are unable to enter into arrangements on acceptable terms, if at all, we may be unable to effectively market and sell our products

in our target markets.

We expect to face competition in seeking appropriate collaborators.

collaboration arrangements are complex and time consuming to negotiate, document and implement and they may require substantial

resources to maintain.

We may not be successful in our efforts to establish and implement collaborations or other alternative arrangements

for the development of our product candidates.

One or more of our collaboration partners

may not devote sufficient resources to the commercialization of our product candidates or may otherwise fail in their commercialization.

The terms of any collaboration or other arrangement that we establish may contain provisions that are not favorable to us, or the

favorability of which is dependent on conditions that are out of our control or unknowable at the time of execution.

any collaboration that we enter into may be unsuccessful in the development and commercialization of our product candidates.

some cases, we may be responsible for continuing preclinical and initial clinical development of a product candidate or research

program under a collaboration arrangement, and the payment we receive from our collaboration partner may be insufficient to cover

the cost of this development.

If we are unable to reach agreements with suitable collaborators for our product candidates, we would

face increased costs, we may be forced to limit the number of our product candidates we can commercially develop or the territories

in which we commercialize them.

As a result, we might fail to commercialize products or programs for which a suitable collaborator

cannot be found.

If we fail to achieve successful collaborations, our operating results and financial condition could be materially

and adversely affected.

Our success depends greatly on the success of Berubicin’s

development for the treatment of glioblastoma, and our pipeline of product candidates beyond this lead indication is extremely

early stage and limited.

Other than Berubicin, we do not have any

other clinical-stage drug candidates in our portfolio.

Moreover, collaboration arrangements are complex

and time consuming to negotiate, document and implement and they may require substantial resources to maintain.

We may not be successful

in our efforts to establish and implement collaborations or other alternative arrangements for the development of our product candidates.

One or more of our collaboration partners may not

devote sufficient resources to the commercialization of our product candidates or may otherwise fail in their commercialization.

of any collaboration or other arrangement that we establish may contain provisions that are not favorable to us, or the favorability of

which is dependent on conditions that are out of our control or unknowable at the time of execution.

In addition, any collaboration that

we enter into may be unsuccessful in the development and commercialization of our product candidates.

In some cases, we may be responsible

for continuing preclinical and initial clinical development of a product candidate or research program under a collaboration arrangement,

and the payment we receive from our collaboration partner may be insufficient to cover the cost of this development.

If we are unable

to reach agreements with suitable collaborators for our product candidates, we would face increased costs, we may be forced to limit the

number of our product candidates we can commercially develop or the territories in which we commercialize them.

As a result, we might

fail to commercialize products or programs for which a suitable collaborator cannot be found.

If we fail to achieve successful collaborations,

our operating results and financial condition could be materially and adversely affected.

Our success depends greatly on the success of Berubicin’s

development for the treatment of glioblastoma, and our pipeline of product candidates beyond this lead indication is extremely early stage

Other than Berubicin, we do not have any other

clinical-stage drug candidates in our portfolio.

As such, we are dependent on the success of Berubicin in the near term.

We cannot provide you any assurance that we will be able to successfully advance Berubicin through the development process.

We cannot provide

you any assurance that we will be able to successfully advance Berubicin through the development process.

We face competition from other biotechnology and pharmaceutical

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are intensely competitive and subject to rapid and significant technological change.

We have competitors in the United States,

Europe and other jurisdictions, including major multinational pharmaceutical companies, established biotechnology companies, specialty

pharmaceutical and generic drug companies and universities and other research institutions.

Many of our competitors have greater

financial and other resources, such as larger research and development staff and more experienced marketing and manufacturing organizations

Large pharmaceutical companies, in particular, have extensive experience in clinical testing, obtaining regulatory

approvals, recruiting patients and manufacturing pharmaceutical products.

These companies also have significantly greater research,

sales and marketing capabilities and collaborative arrangements in our target markets with leading companies and research institutions.

Established pharmaceutical companies may also invest heavily to accelerate discovery and development of novel compounds or to in-license

novel compounds that could make the product candidates that we develop obsolete.

As a result of all of these factors, our competitors

may succeed in obtaining patent protection and/or FDA approval or discovering, developing and commercializing drugs for the diseases

that we are targeting before we do or may develop drugs that are deemed to be more effective or gain greater market acceptance

Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements

with large, established companies.

In addition, many universities and private and public research institutes may become active

in our target disease areas.

Our competitors may succeed in developing, acquiring or licensing on an exclusive basis, technologies

and drug products that are more effective or less costly than any of our product candidates that we are currently developing or

that we may develop, which could render our products obsolete or noncompetitive.

If our competitors market products that

are more effective, safer or less expensive or that reach the market sooner than our future products, if any, we may not achieve

commercial success.

In addition, because of our limited resources, it may be difficult for us to stay abreast of the rapid changes

in each technology.

If we fail to stay at the forefront of technological change, we may be unable to compete effectively.

Technological

advances or products developed by our competitors may render our technologies or product candidates obsolete, less competitive

or not economical.

We have competitors in the United States, Europe,

and other jurisdictions, including major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical

and generic drug companies and universities and other research institutions.

Many of our competitors have greater financial and other

resources, such as larger research and development staff and more experienced marketing and manufacturing organizations than we do.

pharmaceutical companies, in particular, have extensive experience in clinical testing, obtaining regulatory approvals, recruiting patients

and manufacturing pharmaceutical products.

These companies also have significantly greater research, sales and marketing capabilities

and collaborative arrangements in our target markets with leading companies and research institutions.

Established pharmaceutical companies

may also invest heavily to accelerate discovery and development of novel compounds or to in-license novel compounds that could make the

product candidates that we develop obsolete.

As a result of all of these factors, our competitors may succeed in obtaining patent protection

and/or FDA approval or discovering, developing and commercializing drugs for the diseases that we are targeting before we do or may develop

drugs that are deemed to be more effective or gain greater market acceptance than ours.

Smaller or early-stage companies may also prove

to be significant competitors, particularly through collaborative arrangements with large, established companies.

In addition, many universities

and private and public research institutes may become active in our target disease areas.

Our competitors may succeed in developing, acquiring,

or licensing on an exclusive basis, technologies and drug products that are more effective or less costly than any of our product candidates

that we are currently developing or that we may develop, which could render our products obsolete or noncompetitive.

If our competitors market products that are more

effective, safer or less expensive or that reach the market sooner than our future products, if any, we may not achieve commercial success.

In addition, because of our limited resources, it may be difficult for us to stay abreast of the rapid changes in each technology.

we fail to stay at the forefront of technological change, we may be unable to compete effectively.

Technological advances or products

developed by our competitors may render our technologies or product candidates obsolete, less competitive or not economical.

Our licensed U.S.

patents expired in March 2020, the expiration

of our patents may subject us to increased competition, and the Orphan Drug Designation we received for Berubicin will not bar

approval of other similar products under certain circumstances.

of our patents may subject us to increased competition, and the Orphan Drug Designation we received for Berubicin will not bar approval

of other similar products under certain circumstances.

patents for Berubicin that we licensed

from HPI expired in March 2020, and such expiration may subject us to increased competition.

On June 10, 2020, the FDA granted

Orphan Drug Designation (“ODD”) for Berubicin for the treatment of malignant gliomas.

ODD from the FDA is available

for drugs targeting diseases with less than 200,000 cases per year.

ODD may enable market exclusivity of 7 years from the date

of approval of a NDA in the United States.

During that period the FDA generally could not approve another product containing the

same drug for the same designated indication.

Orphan drug exclusivity will not bar approval of another product under certain circumstances,

including if a subsequent product with the same active ingredient for the same indication is shown to be clinically superior to

the approved product on the basis of greater efficacy or safety, or providing a major contribution to patient care, or if the company

with orphan drug exclusivity is not able to meet market demand.

The ODD now constitutes our primary intellectual property protections

although we are exploring if there are other patents that could be filed related to Berubicin to extend additional protections.

However, we can provide no assurance that we will be able to file or receive additional patent protection.

The failure to obtain

additional patent protection will reduce the barrier to entry for competition for Berubicin, which may adversely affect our operations.

We may incur substantial costs as a result of litigation

or other proceedings relating to patent and other intellectual property rights.

We may from time to time seek to enforce

our intellectual property rights against infringers when we determine that a successful outcome is probable and may lead to an

increase in the value of the intellectual property.

If we choose to enforce our patent rights against a party, then that individual

or company has the right to ask the court to rule that such patents are invalid or should not be enforced.

Additionally, the validity

of our patents and the patents we have licensed may be challenged if a petition for post grant proceedings such as interpartes

review and post grant review is filed within the statutorily applicable time with the U.S.

On June 10, 2020, the FDA granted Orphan

Drug Designation (“ODD”) for Berubicin for the treatment of malignant gliomas.

ODD from the FDA is available for drugs targeting

diseases with less than 200,000 cases per year.

ODD may enable market exclusivity of 7 years from the date of approval of an NDA in the

United States.

During that period the FDA generally could not approve another product containing the same drug for the same designated

Orphan drug exclusivity will not bar approval of another product under certain circumstances, including if a subsequent product

with the same active ingredient for the same indication is shown to be clinically superior to the approved product on the basis of greater

efficacy or safety, or providing a major contribution to patient care, or if the company with orphan drug exclusivity is not able to meet

market demand.

The ODD now constitutes our primary intellectual property protections although we are exploring if there are other patents

that could be filed related to Berubicin to extend additional protections.

However, we can provide no assurance that we will be able to

file or receive additional patent protection.

The failure to obtain additional patent protection will reduce the barrier to entry for

competition for Berubicin, which may adversely affect our operations.

We may incur substantial costs as a result of litigation or other

proceedings relating to patent and other intellectual property rights.

We may from time to time seek to enforce our intellectual

property rights against infringers when we determine that a successful outcome is probable and may lead to an increase in the value of

the intellectual property.

If we choose to enforce our patent rights against a party, then that individual or company has the right to

ask the court to rule that such patents are invalid or should not be enforced.

Additionally, the validity of our patents and the patents

we have licensed may be challenged if a petition for post grant proceedings such as interpartes review and post grant review is filed

within the statutorily applicable time with the U.S.

Patent and Trademark Office (USPTO).

These lawsuits and proceedings are expensive and would consume time and resources and divert the attention of managerial and scientific

personnel even if we were successful in stopping the infringement of such patents.

In addition, there is a risk that the court

will decide that such patents are not valid and that we do not have the right to stop the other party from using the inventions.

There is also the risk that, even if the validity of such patents is upheld, the court will refuse to stop the other party on the

ground that such other party’s activities do not infringe our intellectual property rights.

In addition, in recent years

Supreme Court modified some tests used by the USPTO in granting patents over the past 20 years, which may decrease the

likelihood that we will be able to obtain patents and increase the likelihood of a challenge of any patents we obtain or license.

We may be subject to claims that our employees and contractors

have wrongfully used or disclosed alleged trade secrets of their former employers.

These lawsuits and proceedings are expensive

and would consume time and resources and divert the attention of managerial and scientific personnel even if we were successful in stopping

the infringement of such patents.

In addition, there is a risk that the court will decide that such patents are not valid and that we

do not have the right to stop the other party from using the inventions.

There is also the risk that, even if the validity of such patents

is upheld, the court will refuse to stop the other party on the ground that such other party’s activities do not infringe our intellectual

property rights.

In addition, in recent years the U.S.

Supreme Court modified some tests used by the USPTO in granting patents over the

past 20 years, which may decrease the likelihood that we will be able to obtain patents and increase the likelihood of a challenge of

any patents we obtain or license.

We may be subject to claims that our employees and contractors have

wrongfully used or disclosed alleged trade secrets of their former employers.

As is common in the biotechnology and pharmaceutical

industries, we employ individuals who were previously employed at other biotechnology or pharmaceutical companies, including our

competitors or potential competitors.

We may be subject to claims that these employees, or we, have used or disclosed trade secrets

or other proprietary information of their former employers.

industries, we employ individuals who were previously employed at other biotechnology or pharmaceutical companies, including our competitors

or potential competitors.

We may be subject to claims that these employees, or we, have used or disclosed trade secrets or other proprietary

information of their former employers.

Litigation may be necessary to defend against these claims.

we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.

If we are not able to adequately prevent disclosure of trade

secrets and other proprietary information, the value of our technology and products could be significantly diminished.

We rely on trade secrets to protect our

proprietary technologies, especially where we do not believe patent protection is appropriate or obtainable.

However, trade secrets

are difficult to protect.

We rely in part on confidentiality agreements with our employees, consultants, outside scientific collaborators,

and other advisors to protect our trade secrets and other proprietary information.

These agreements may not effectively prevent

disclosure of confidential information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential

In addition, others may independently discover our trade secrets and proprietary information.

Costly and time-consuming

litigation could be necessary to enforce and determine the scope of our proprietary rights, and failure to obtain or maintain trade

secret protection could adversely affect our competitive business position.

We will need to expand our operations and increase the size

of our Company, and we may experience difficulties in managing growth.

As of February 11, 2021, we have 3 full-time

Even if we are successful in defending

against these claims, litigation could result in substantial costs and be a distraction to management.

If we are not able to adequately prevent disclosure of trade secrets

and other proprietary information, the value of our technology and products could be significantly diminished.

We rely on trade secrets to protect our proprietary

technologies, especially where we do not believe patent protection is appropriate or obtainable.

However, trade secrets are difficult

We rely in part on confidentiality agreements with our employees, consultants, outside scientific collaborators, and other

advisors to protect our trade secrets and other proprietary information.

These agreements may not effectively prevent disclosure of confidential

information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information.

In addition, others

may independently discover our trade secrets and proprietary information.

Costly and time-consuming litigation could be necessary to enforce

and determine the scope of our proprietary rights, and failure to obtain or maintain trade secret protection could adversely affect our

competitive business position.

We will need to expand our operations and increase the size of our

Company, and we may experience difficulties in managing growth.

As of February 11, 2022, we have 3 full-time employees.

We also have 2 officers serving as part-time employees.

As we advance our product candidates through preclinical studies

and clinical trials, we will need to increase our product development, scientific and administrative headcount to manage these

In addition, to meet our obligations as a public company, we may need to increase our general and administrative capabilities.

Our management, personnel and systems currently in place may not be adequate to support this future growth.

If we are unable to

successfully manage this growth and increased complexity of operations, our business may be adversely affected.

We may not be able to manage our business effectively if

we are unable to attract and retain key personnel and consultants.

We may not be able to attract or retain

qualified management, finance, scientific and clinical personnel and consultants due to the intense competition for qualified personnel

and consultants among biotechnology, pharmaceutical and other businesses.

If we are not able to attract and retain necessary personnel

and consultants to accomplish our business objectives, we may experience constraints that will significantly impede the achievement

of our development objectives, our ability to raise additional capital.

We are highly dependent on the development,

regulatory, commercialization and business development expertise of our management team, key employees and consultants.

one or more of our executive officers or key employees or consultants, our ability to implement our business strategy successfully

could be seriously harmed.

Any of our executive officers or key employees or consultants may terminate their employment at any

Replacing executive officers, key employees and consultants may be difficult and may take an extended period of time because

of the limited number of individuals in our industry with the breadth of skills and experience required to develop, gain regulatory

approval of and commercialize products successfully.

Competition to hire and retain employees and consultants from this limited

pool is intense, and we may be unable to hire, train, retain or motivate these additional key personnel and consultants.

to retain key personnel or consultants could materially harm our business.

In addition, we have scientific and clinical

advisors and consultants who assist us in formulating our research, development and clinical strategies.

These advisors are not

our employees and may have commitments to, or consulting or advisory contracts with, other entities that may limit their availability

to us and typically they will not enter into noncompete agreements with us.

If a conflict of interest arises between their work

for us and their work for another entity, we may lose their services.

In addition, our advisors may have arrangements with other

companies to assist those companies in developing products or technologies that may compete with ours.

As we advance our product candidates through preclinical studies and clinical

trials, we will need to increase our product development, scientific and administrative headcount to manage these programs.

to meet our obligations as a public company, we may need to increase our general and administrative capabilities.

Our management, personnel,

and systems currently in place may not be adequate to support this future growth.

If we are unable to successfully manage this growth

and increased complexity of operations, our business may be adversely affected.

We may not be able to manage our business effectively if we are

unable to attract and retain key personnel and consultants.

We may not be able to attract or retain qualified

management, finance, scientific and clinical personnel, and consultants due to the intense competition for qualified personnel and consultants

among biotechnology, pharmaceutical and other businesses.

If we are not able to attract and retain necessary personnel and consultants

to accomplish our business objectives, we may experience constraints that will significantly impede the achievement of our development

objectives, our ability to raise additional capital.

We are highly dependent on the development, regulatory,

commercialization and business development expertise of our management team, key employees, and consultants.

If we lose one or more of

our executive officers or key employees or consultants, our ability to implement our business strategy successfully could be seriously

Any of our executive officers or key employees or consultants may terminate their employment at any time.

Replacing executive

officers, key employees and consultants may be difficult and may take an extended period of time because of the limited number of individuals

in our industry with the breadth of skills and experience required to develop, gain regulatory approval of and commercialize products

successfully.

Competition to hire and retain employees and consultants from this limited pool is intense, and we may be unable to hire,

train, retain or motivate these additional key personnel and consultants.

Our failure to retain key personnel or consultants could materially

harm our business.

In addition, we have scientific and clinical advisors

and consultants who assist us in formulating our research, development, and clinical strategies.

These advisors are not our employees

and may have commitments to, or consulting or advisory contracts with, other entities that may limit their availability to us and typically

they will not enter into noncompete agreements with us.

If a conflict of interest arises between their work for us and their work for

another entity, we may lose their services.

In addition, our advisors may have arrangements with other companies to assist those companies

in developing products or technologies that may compete with ours.

Our chief medical officer and chief science officer are currently

working for us on a part-time basis.

Our chief executive officer, chief medical officer and chief science officer, also provide

services for other companies in our industry and such other positions may create conflicts of interest for such officers in the

Certain of our key employees are currently

part-time and/or provide services for other biotechnology development efforts, including companies, with respect to our chief executive

officer and chief medical officer, which are developing anti-cancer drug candidates.

Our chief executive officer, chief medical officer and chief science officer, also provide services

for other companies in our industry and such other positions may create conflicts of interest for such officers in the future.

Certain of our key employees are currently part-time

and/or provide services for other biotechnology development efforts, including companies, with respect to our chief executive officer

and chief medical officer, which are developing anti-cancer drug candidates.

Specifically, John M.

Climaco, our chairman

and chief executive officer, is also serving as a director for Moleculin Biotech, Inc ., a company also actively developing

anticancer drugs.

Sandra Silberman, our chief medical officer, is also the chief medical officer for New Products at Moleculin.

Donald Picker, our chief science officer, is the chief scientific officer at Moleculin.

In addition to our officers’

status, since Mr.

Climaco, our chairman and chief executive

officer, is also serving as a director for Moleculin Biotech, Inc., a company also actively developing anticancer drugs.

Sandra Silberman,

our chief medical officer, is also the chief medical officer for New Products at Moleculin.

Donald Picker, our chief science officer,

is the chief scientific officer at Moleculin.

In addition to our officers’ part-time status,

Silberman and Dr.

Picker are associated with other companies that are developing anti-cancer drug

candidates, they may encounter conflicts of interest in the future.

Although we do not believe that the drug candidates we are

currently pursuing compete with the types of drug candidates being pursued by the other companies Mr.

Silberman and

Picker are associated with, there is no assurance that such conflicts will not arise in the future.

We do not expect that our insurance policies will cover all

of our business exposures thus leaving us exposed to significant uninsured liabilities.

We do not carry insurance for all categories

of risk that our business may encounter.

There can be no assurance that we will secure adequate insurance coverage or that any

such insurance coverage will be sufficient to protect our operations to significant potential liability in the future.

Any significant

uninsured liability may require us to pay substantial amounts, which would adversely affect our financial position and results

of operations.

Although dependent on certain key personnel, we do not have

any key man life insurance policies on any such people.

Picker are associated with other companies that are developing anti-cancer drug candidates, they

may encounter conflicts of interest in the future.

Although we do not believe that the drug candidates we are currently pursuing compete

with the types of drug candidates being pursued by the other companies Mr.

Silberman and Dr.

Picker are associated with,

there is no assurance that such conflicts will not arise in the future.

We do not expect that our insurance policies will cover all of our

business exposures thus leaving us exposed to significant uninsured liabilities.

We do not carry insurance for all categories of

risk that our business may encounter.

There can be no assurance that we will secure adequate insurance coverage or that any such insurance

coverage will be sufficient to protect our operations to significant potential liability in the future.

Any significant uninsured liability

may require us to pay substantial amounts, which would adversely affect our financial position and results of operations.

Although dependent on certain key personnel, we do not have any

key man life insurance policies on any such people.

We are dependent on John M.

Climaco, Christopher

Downs, Sandra Silberman, and Donald Picker in order to conduct our operations and execute our business plan, however, we have not

purchased any insurance policies with respect to those individuals in the event of their death or disability.

Therefore, if any

Climaco, Christopher Downs, Sandra Silberman, or Donald Picker die or become disabled, we will not receive any compensation

to assist with such person’s absence.

Downs, Sandra Silberman, and Donald Picker in order to conduct our operations and execute our business plan, however, we have not purchased

any insurance policies with respect to those individuals in the event of their death or disability.

Therefore, if any of John M.

Christopher Downs, Sandra Silberman, or Donald Picker die or become disabled, we will not receive any compensation to assist with such

person’s absence.

The loss of such person could negatively affect us and our operations.

There are limited suppliers for active pharmaceutical ingredients

(“API”) used in our drug candidates.

Problems with the third parties that manufacture the API used in our drug candidates,

may delay our clinical trials or subject us to liability.

or in the supply chain between the manufacturer and CNS, may delay our clinical trials or subject us to liability.

We do not currently own or operate manufacturing

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We have no experience in API manufacturing,

and we lack the resources and the capability to manufacture any of the APIs used in our drug candidates, on either a clinical or

commercial scale.

As a result, we rely on third parties to supply the API used in each of our drug candidates.

We expect to continue

to depend on third parties to supply the API for our current and future product candidates and to supply the API in commercial

We are ultimately responsible for confirming that the APIs used in our product candidates are manufactured in accordance

with applicable regulations.

Our third-party suppliers may not carry

out their contractual obligations or meet our deadlines.

and we lack the resources and the capability to manufacture any of the APIs used in our drug candidates, on either a clinical or commercial

As a result, we rely on third parties to supply the API used in each of our drug candidates and commercial couriers to deliver

the manufactured API to us.

We expect to continue to depend on third parties to supply the API for our current and future product candidates

and to supply the API in commercial quantities.

We are ultimately responsible for confirming that the APIs used in our product candidates

are manufactured in accordance with applicable regulations.

Our third-party suppliers and couriers may not

carry out their contractual obligations or meet our deadlines.

In addition, the API they supply to us may not meet our specifications

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If we need to find alternative

suppliers for the API used in any of our product candidates, we may not bel able to contract for such supplies on acceptable terms,

Any such failure to supply or delay caused by such contract manufacturers would have an adverse effect on our ability

suppliers for the API used in any of our product candidates, we may not be able to contract for such supplies on acceptable terms, if

Any such failure to supply or delay caused by such contract manufacturers or couriers would have an adverse effect on our ability

to continue clinical development of our product candidates or commercialization of our product candidates.

If our third-party drug suppliers fail to

achieve and maintain high manufacturing standards in compliance with cGMP regulations, we could be subject to certain product liability

claims in the event such failure to comply resulted in defective product that caused injury or harm.

We may not be able to recover from any catastrophic event

affecting our suppliers.

Our suppliers may not have adequate measures

in place to minimize and recover from catastrophic events that may substantially destroy their capability to meet customer needs

and any measures they may have in place may not be adequate to recover production processes quickly enough to support critical

timelines or market demands.

These catastrophic events may include weather and geologic events such as tornadoes, earthquakes,

floods, tidal waves, volcanic eruptions, and fires as well as infectious disease epidemics, acts of war, acts of terrorism and

nationalization of private industry.

In addition, these catastrophic events may render some or all of the products at the affect

facilities unusable.

If our third-party drug suppliers fail to achieve

and maintain high manufacturing standards in compliance with cGMP regulations, we could be subject to certain product liability claims

in the event such failure to comply resulted in defective product that caused injury or harm.

We may not be able to recover from any catastrophic event affecting

our suppliers.

Our suppliers may not have adequate measures in

place to minimize and recover from catastrophic events that may substantially destroy their capability to meet customer needs and any

measures they may have in place may not be adequate to recover production processes quickly enough to support critical timelines or market

These catastrophic events may include weather and geologic events such as tornadoes, earthquakes, floods, tidal waves, volcanic

eruptions, and fires as well as infectious disease epidemics, acts of war, acts of terrorism and nationalization of private industry.

In addition, these catastrophic events may render some or all of the products at the affect facilities unusable.

We may be materially adversely affected in the event of cyber-based

attacks, network security breaches, service interruptions, or data corruption.

We rely on information technology to process

and transmit sensitive electronic information and to manage or support variety of business processes and activities.

We use technology

systems to record, process, and summarize financial information and results of operations for internal reporting purposes and to

comply with regulatory financial reporting, legal, and tax requirements.

Our information technology systems, some of which are

managed by third parties, may be susceptible to damage, disruptions or shut down student computer viruses, attacks by computer

hackers, failures during the process of upgrading or replacing software, databases or components thereof, power outages, hardware

failures, technology for communication failures, user errors or catastrophic events.

Although we have developed systems and processes

that are designed to protect proprietary or confidential information and prevent data loss and other security breaches, such measures

cannot provide absolute security.

If our systems are breached or suffer severe damage, disruption or shutdown and we are unable

to effectively resolve the issues in a timely manner, our business and operating results may significantly suffer and we may be

subject to litigation, government enforcement actions or potential liability.

Security breaches could also cause us to incur significant

remediation costs, result in product development delays, disrupt key business operations, including development of our product

candidates, and divert attention of management and key information technology resources.

We rely on information technology to process and

transmit sensitive electronic information and to manage or support variety of business processes and activities.

We use technology systems

to record, process, and summarize financial information and results of operations for internal reporting purposes and to comply with regulatory

financial reporting, legal, and tax requirements.

Our information technology systems, some of which are managed by third parties, may

be susceptible to damage, disruptions or shut down student computer viruses, attacks by computer hackers, failures during the process

of upgrading or replacing software, databases or components thereof, power outages, hardware failures, technology for communication failures,

user errors or catastrophic events.

Although we have developed systems and processes that are designed to protect proprietary or confidential

information and prevent data loss and other security breaches, such measures cannot provide absolute security.

If our systems are breached

or suffer severe damage, disruption or shutdown and we are unable to effectively resolve the issues in a timely manner, our business and

operating results may significantly suffer and we may be subject to litigation, government enforcement actions or potential liability.

Security breaches could also cause us to incur significant remediation costs, result in product development delays, disrupt key business

operations, including development of our product candidates, and divert attention of management and key information technology resources.

Risks Related to Our Common Stock

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reporting in accordance with Section 404 of the Sarbanes-Oxley Act could cause our financial reports to be inaccurate.

We are required pursuant to Section 404

of the Sarbanes-Oxley Act of 2002, or Section 404, to maintain internal control over financial reporting and to assess and report

on the effectiveness of those controls.

This assessment includes disclosure of any material weaknesses identified by our management

in our internal control over financial reporting.

Our management concluded that our internal controls over financial reporting

were, and continue to be ineffective, and as of the year ended December 31, 2020, identified a material weakness in our internal

controls due to the lack of sufficient personnel to allow for segregation of duties.

While management is working to remediate the

material weakness, there is no assurance that such changes, when economically feasible and sustainable, will remediate the identified

material weaknesses or that the controls will prevent or detect future material weaknesses.

If we are not able to maintain effective

internal control over financial reporting, our financial statements, including related disclosures, may be inaccurate, which could

have a material adverse effect on our business.

Failure to continue improving our accounting systems and

controls could impair our ability to comply with the financial reporting and internal controls requirements for publicly traded

We are required pursuant to Section 404 of the

Sarbanes-Oxley Act of 2002, or Section 404, to maintain internal control over financial reporting and to assess and report on the effectiveness

of those controls.

This assessment includes disclosure of any material weaknesses identified by our management in our internal control

over financial reporting.

Our management concluded that our internal controls over financial reporting were, and continue to be, ineffective

as of December 31, 2021, identified a material weakness in our internal controls due to the lack of sufficient personnel to allow for

segregation of duties (resulting from the limited number of personnel available) and the lack of formal documentation of our control environment.

While management is working to remediate the material weaknesses, there is no assurance that such changes, when

economically feasible and sustainable, will remediate the identified material weaknesses or that the controls will prevent or detect future

material weaknesses.

If we are not able to maintain effective internal control over financial reporting, our financial statements, including

related disclosures, may be inaccurate, which could have a material adverse effect on our business.

Failure to continue improving our accounting systems and controls

could impair our ability to comply with the financial reporting and internal controls requirements for publicly traded companies.

As a public company, we operate in an increasingly

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control over financial reporting and disclosure controls and procedures.

Effective internal controls are necessary for us to produce

reliable financial reports and are important to help prevent financial fraud.

Management performed an annual assessment

as of December 31, 2020 of the effectiveness of our internal control over financial reporting for its annual report.

Our management

concluded that our internal control over financial reporting was, and continues to be, ineffective and as of the year ended December

31, 2020, due to a material weakness in our internal controls due to the lack of segregation of duties.

For as long as we remain

an “emerging growth company”

as defined in the JOBS Act, we have and intend to consider to take advantage of certain

exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth

companies”

including, but not limited to, not being required to comply with the auditor attestation requirements of Section

404(b) of the Sarbanes-Oxley Act.

We may continue to take advantage of these reporting exemptions until we are no longer an “emerging

growth company.”

To remediate this material weakness, we engaged an outside firm to assist management with such accounting

and will continue to use outside firms as a resource to deal with other non-recurring or unusual transactions.

However, notwithstanding

our remediation efforts, there is no assurance we will not encounter accounting errors in the future.

If we cannot provide reliable

financial reports or prevent fraud, our business and results of operations could be harmed, and investors could lose confidence

in our reported financial information.

Our executive officers, directors, major stockholder and

their respective affiliates exercise significant control over us, which will limit our stockholders ability to influence corporate

matters and could delay or prevent a change in corporate control.

The holdings of our executive officers,

directors, founder and their affiliates, are, in the aggregate, approximately 42.2% of our outstanding common stock.

these stockholders will be able to influence our management and affairs and control the outcome of matters submitted to our stockholders

for approval, including the election of directors and any sale, merger, consolidation, or sale of all or substantially all of our

These stockholders acquired their shares

of common stock for substantially less than the price of the shares of common stock at the time of this report, and these stockholders

may have interests, with respect to their common stock, that are different from those of our other stockholders and the concentration

of voting power among one or more of these stockholders may have an adverse effect on the price of our common stock.

In addition, this concentration of ownership

might adversely affect the market price of our common stock by:

(1) delaying, deferring or preventing a change of control of our

Effective internal controls are necessary for us to produce reliable

financial reports and are important to help prevent financial fraud.

Management performed an annual assessment as of

December 31, 2021 of the effectiveness of our internal control over financial reporting for its annual report.

Our management concluded

that our internal control over financial reporting was, and continues to be, ineffective as of December 31, 2021, due to a material weakness

in our internal controls due to the lack of segregation of duties (resulting from the limited number of personnel available)

and the lack of formal documentation of our control environment.

For as long as we remain an “emerging growth company” as

defined in the JOBS Act, we have and intend to consider to take advantage of certain exemptions from various reporting requirements that

are applicable to other public companies that are not “emerging growth companies” including, but not limited to, not being

required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act.

We may continue to take advantage

of these reporting exemptions until we are no longer an “emerging growth company.” To remediate these material weaknesses,

we engaged an outside firm to assist management with such accounting and will continue to use outside firms as a resource to deal with

other non-recurring or unusual transactions.

However, notwithstanding our remediation efforts, there is no assurance we will not encounter

accounting errors in the future.

If we cannot provide reliable financial reports or prevent fraud, our business and results of operations

could be harmed, and investors could lose confidence in our reported financial information.

Our executive officers, directors, major stockholder and their respective

affiliates exercise significant control over us, which will limit our stockholders ability to influence corporate matters and could delay

or prevent a change in corporate control.

The holdings of our executive officers, directors,

founder and their affiliates, are, in the aggregate, approximately 23.0% of our outstanding common stock as of February 11, 2022.

result, these stockholders will be able to influence our management and affairs and may control the outcome of matters submitted to our

stockholders for approval, including the election of directors and any sale, merger, consolidation, or sale of all or substantially all

of our assets.

These stockholders acquired their shares of common

stock for substantially less than the price of the shares of common stock at the time of this report, and these stockholders may have

interests, with respect to their common stock, that are different from those of our other stockholders and the concentration of voting

power among one or more of these stockholders may have an adverse effect on the price of our common stock.

In addition, this concentration of ownership might

adversely affect the market price of our common stock by:

(1) delaying, deferring or preventing a change of control of our Company;

impeding a merger, consolidation, takeover or other business combination involving our Company;

or (3) discouraging

a potential acquirer from making a tender offer or otherwise attempting to obtain control of our Company.

Our current stockholders’

ownership may be diluted

if additional capital stock is issued to raise capital, to finance acquisitions or in connection with strategic transactions.

We intend to seek to raise additional funds,

finance acquisitions or develop strategic relationships by issuing equity or convertible debt securities, which would reduce the

percentage ownership of our existing stockholders.

Our board of directors has the authority, without action or vote of the stockholders,

to issue all or any part of our authorized but unissued shares of common or preferred stock.

Our articles of incorporation authorize

us to issue up to 75,000,000 shares of common stock and 5,000,000 shares of preferred stock.

Future issuances of common or preferred

stock would reduce your influence over matters on which stockholders vote and would be dilutive to earnings per share.

any newly issued preferred stock could have rights, preferences and privileges senior to those of the common stock.

Those rights,

preferences and privileges could include, among other things, the establishment of dividends that must be paid prior to declaring

or paying dividends or other distributions to holders of our common stock or providing for preferential liquidation rights.

rights, preferences and privileges could negatively affect the rights of holders of our common stock, and the right to convert

such preferred stock into shares of our common stock at a rate or price that would have a dilutive effect on the outstanding shares

of our common stock.

In May 2020, the SEC issued an order suspending the trading

of our common stock and Nasdaq issued a trading halt in our common stock.

On May 1, 2020, the SEC, pursuant to Section

12(k) of the Exchange Act, ordered the temporary suspension of trading in our securities because of questions regarding the accuracy

and adequacy of information in the marketplace about us and our securities.

Pursuant to the suspension order, the suspension commenced

or (3) discouraging a potential acquirer

from making a tender offer or otherwise attempting to obtain control of our Company.

Our current stockholders’ ownership may be diluted if additional

capital stock is issued to raise capital, to finance acquisitions or in connection with strategic transactions.

We intend to seek to raise additional funds, finance

acquisitions or develop strategic relationships by issuing equity or convertible debt securities, which would reduce the percentage ownership

of our existing stockholders.

Our board of directors has the authority, without action or vote of the stockholders, to issue all or any

part of our authorized but unissued shares of common or preferred stock.

Our articles of incorporation authorize us to issue up to 75,000,000

shares of common stock and 5,000,000 shares of preferred stock.

Future issuances of common or preferred stock would reduce your influence

over matters on which stockholders vote and would be dilutive to earnings per share.

In addition, any newly issued preferred stock could

have rights, preferences, and privileges senior to those of the common stock.

Those rights, preferences, and privileges could include,

among other things, the establishment of dividends that must be paid prior to declaring or paying dividends or other distributions to

holders of our common stock or providing for preferential liquidation rights.

These rights, preferences and privileges could negatively

affect the rights of holders of our common stock, and the right to convert such preferred stock into shares of our common stock at a rate

or price that would have a dilutive effect on the outstanding shares of our common stock.

In May 2020, the SEC issued an order suspending the trading of our

common stock and Nasdaq issued a trading halt in our common stock.

On May 1, 2020, the SEC, pursuant to Section 12(k)

of the Exchange Act, ordered the temporary suspension of trading in our securities because of questions regarding the accuracy and adequacy

of information in the marketplace about us and our securities.

Pursuant to the suspension order, the suspension commenced at 9:30 a.m.

EDT on May 4, 2020 and terminated at 11:59 p.m.

EDT on May 15, 2020.

On May 15, 2020, Nasdaq issued a trading halt

in our common stock pending the receipt of requested information, which halt was released on May 28, 2020.

We believe in the accuracy

and adequacy of our public disclosures, but can provide no assurances that we will not encounter future similar actions, which

may adversely affect the holders of our common stock.

On May 15, 2020, Nasdaq issued a trading halt in our common stock

pending the receipt of requested information, which halt was released on May 28, 2020.

We believe in the accuracy and adequacy of our

public disclosures, but can provide no assurances that we will not encounter future similar actions, which may adversely affect the holders

of our common stock.

Our currently authorized but unissued shares may be insufficient

to raise the capital needed to continue our development program.

As of March 3, 2022,

we had 40,032,481 shares of common stock outstanding, 19,790,240 shares of common stock reserved for future issuance pursuant to granted

options and warrants, and 2,135,264 shares reserved for future issuance pursuant to future grants under our equity compensation plans.

Accordingly, of our 75,000,000 authorized shares of common stock, we have 15,177,279 shares of common stock available for future financings.

We will need to raise additional financing in order to complete our ongoing clinical trial of Berubicin.

If we do not sufficient available

shares of common stock for such financings, we may not be able to raise sufficient capital to fund our operations.

If we are unable to maintain compliance with the listing requirements

of The Nasdaq Capital Market, our common stock may be delisted from The Nasdaq Capital Market which could have a material adverse effect

on our financial condition and could make it more difficult for you to sell your shares.

Our common stock is listed on The Nasdaq Capital

Market, and we are therefore subject to its continued listing requirements, including requirements with respect to the market value of

publicly-held shares, market value of listed shares, minimum bid price per share, and minimum stockholder's equity, among others, and

requirements relating to board and committee independence.

If we fail to satisfy one or more of the requirements, we may be delisted from

The Nasdaq Capital Market.

Pursuant to NASDAQ Listing Rule 5550(a)(2), we

are not currently in compliance with the $1.00 minimum closing bid price requirement set forth in such rule as our stock price is currently

trading below $1.00 and has been below such threshold since January 6, 2022.

In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we

have been provided an initial period of 180 calendar days, or until August 17, 2022, to regain compliance with the bid price requirements.

If, at any time before August 17, 2022, the bid price for our common stock closes at $1.00 or more for a minimum of 10 consecutive business

days as required under Nasdaq Listing Rules, the Nasdaq staff will provide written notification to us that we complied with the bid price

rule, unless the staff exercises its discretion to extend this 10 day period pursuant to Nasdaq Listing Rule 5810(c)(3)(H).

not in compliance with the bid price rule by August 17, 2022, we may be afforded a second 180 calendar day period to regain compliance.

To qualify, we would be required to meet the continued listing requirement for market value of publicly held shares and all other initial

listing standards for The Nasdaq Capital Market, except for the minimum bid price requirement.

In addition, we would be required to notify

Nasdaq of its intent to cure the minimum bid price deficiency, which may include, if necessary, implementing a reverse stock split.

we do not regain compliance with the bid price rule by the above deadline and if we are not eligible for an additional compliance period

at that time, the Nasdaq staff will provide written notification to us that our common stock may be delisted.

We would then be entitled

to appeal the staff’s determination to a NASDAQ Listing Qualifications Panel and request a hearing.

There can be no assurance that,

if we do appeal the delisting determination by the staff to the NASDAQ Listing Qualifications Panel, that such appeal would be successful.

Delisting from The Nasdaq Capital Market would

adversely affect our ability to raise additional financing through the public or private sale of equity securities, may significantly

affect the ability of investors to trade our securities and may negatively affect the value and liquidity of our common stock.

also could have other negative results, including the potential loss of employee confidence, the loss of institutional investors or interest

in business development opportunities.

General Risk Factors

As a biotechnology company, we may be at an increased risk

of securities class action litigation.

As a biotechnology company, we may be at an increased risk of securities

class action litigation.

Historically, securities class action litigation

has often been brought against a company following a decline in the market price of its securities.

This risk is especially relevant

for us because biotechnology and pharmaceutical companies have experienced significant stock price volatility in recent years.

If we were to be sued, it could result in substantial costs and a diversion of management’s attention and resources, which

could harm our business.

If securities or industry analysts do not publish research

or reports about us, or if they adversely change their recommendations regarding our common stock, then our stock price and trading

volume could decline.

The trading market for our common stock

will be influenced by the research and reports that industry or securities analysts publish about us, our industry and our market.

If no analyst elects to cover us and publish research or reports about us, the market for our common stock could be severely limited

and our stock price could be adversely affected.

As a small-cap company, we are more likely than our larger competitors to lack

coverage from securities analysts.

In addition, even if we receive analyst coverage, if one or more analysts ceases coverage of

us or fails to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause our

stock price or trading volume to decline.

If one or more analysts who elect to cover us issue negative reports or adversely change

their recommendations regarding our common stock, our stock price could decline.

As an “emerging growth company”

under the Jumpstart

This risk is especially relevant for

us because biotechnology and pharmaceutical companies have experienced significant stock price volatility in recent years.

to be sued, it could result in substantial costs and a diversion of management’s attention and resources, which could harm our business.

If securities or industry analysts do not publish research or reports

about us, or if they adversely change their recommendations regarding our common stock, then our stock price and trading volume could

The trading market for our common stock will be

influenced by the research and reports that industry or securities analysts publish about us, our industry and our market.

If no analyst

elects to cover us and publish research or reports about us, the market for our common stock could be severely limited and our stock price

could be adversely affected.

As a small-cap company, we are more likely than our larger competitors to lack coverage from securities analysts.

In addition, even if we receive analyst coverage, if one or more analysts ceases coverage of us or fails to regularly publish reports

on us, we could lose visibility in the financial markets, which in turn could cause our stock price or trading volume to decline.

or more analysts who elect to cover us issue negative reports or adversely change their recommendations regarding our common stock, our

stock price could decline.

As an “emerging growth company” under the Jumpstart

Our Business Startups Act, or JOBS Act, we are permitted to, and intend to, rely on exemptions from certain disclosure requirements.

As an “emerging growth company”

under the JOBS Act, we are permitted to, and intend to, rely on exemptions from certain disclosure requirements.

We are an emerging

growth company until the earliest of:

As an “emerging growth company” under

the JOBS Act, we are permitted to, and intend to, rely on exemptions from certain disclosure requirements.

We are an emerging growth company

until the earliest of:

the last day of the fiscal year during which we have total annual gross revenues of $1 billion or more;

1 unchanged sentence

the date on which we have, during the previous 3-year period, issued more than $1 billion in non-convertible debt;

the date on which we are deemed a “large accelerated issuer”

as defined under the federal securities laws.

For so long as we remain an emerging growth

company, we will not be required to:

the date on which we are deemed a “large accelerated issuer” as defined under the federal securities laws.

For so long as we remain an emerging growth company,

we will not be required to:

have an auditor report on our internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002;

comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (auditor discussion and analysis);

submit certain executive compensation matters to shareholders advisory votes pursuant to the “say on frequency”

and “say on pay”

provisions (requiring a non-binding shareholder vote to approve compensation of certain executive officers) and the “say on golden parachute”

provisions (requiring a non-binding shareholder vote to approve golden parachute arrangements for certain executive officers in connection with mergers and certain other business combinations) of the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010;

submit certain executive compensation matters to shareholders advisory votes pursuant to the “say on frequency” and “say on pay” provisions (requiring a non-binding shareholder vote to approve compensation of certain executive officers) and the “say on golden parachute” provisions (requiring a non-binding shareholder vote to approve golden parachute arrangements for certain executive officers in connection with mergers and certain other business combinations) of the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010;

include detailed compensation discussion and analysis in our filings under the Securities Exchange Act of 1934, as amended, and instead may provide a reduced level of disclosure concerning executive compensation;

may present only two years of audited financial statements and only two years of related Management’s Discussion and Analysis of Financial Condition and Results of Operations, or MD&A;

are eligible to claim longer phase-in periods for the adoption of new or revised financial accounting standards under §107 of the JOBS Act.

We intend to take advantage of all of these

reduced reporting requirements and exemptions, other than the longer phase-in periods for the adoption of new or revised financial

accounting standards under §107 of the JOBS Act.

may present only two years of audited financial statements and only two years of related Management’s Discussion and Analysis of Financial Condition and Results of Operations, or MD&A;

are eligible to claim longer phase-in periods for the adoption of new or revised financial accounting standards under §107 of the JOBS Act.

We intend to take advantage of all of these reduced

reporting requirements and exemptions, other than the longer phase-in periods for the adoption of new or revised financial accounting

standards under §107 of the JOBS Act.

Certain of these reduced reporting requirements

and exemptions were already available to us due to the fact that we also qualify as a “smaller reporting company”

For instance, smaller reporting companies are not required to obtain an auditor attestation and report regarding management’s

and exemptions were already available to us due to the fact that we also qualify as a “smaller reporting company” under SEC

For instance, smaller reporting companies are not required to obtain an auditor attestation and report regarding management’s

assessment of internal control over financial reporting;

are not required to provide a compensation discussion and analysis;

not required to provide a pay-for-performance graph or CEO pay ratio disclosure;

and may present only two years of audited financial

statements and related MD&A disclosure.

We cannot predict if investors will find

our securities less attractive due to our reliance on these exemptions.

If investors were to find our common stock less attractive

as a result of our election, we may have difficulty raising financing in the future.

are not required

to provide a pay-for-performance graph or CEO pay ratio disclosure;

and may present only two years of audited financial statements and

related MD&A disclosure.

We cannot predict if investors will find our securities

less attractive due to our reliance on these exemptions.

If investors were to find our common stock less attractive as a result of our

election, we may have difficulty raising financing in the future.

Unresolved Staff Comments.

Our corporate and executive offices are

in located in a leased facility in Houston, Texas.

We believe our facilities are sufficient to meet our current needs and that

suitable space will be available as and when needed.

Our corporate and executive offices are in located

in a leased facility in Houston, Texas.

We believe our facilities are sufficient to meet our current needs and that suitable space will

be available as and when needed.

We do not own any real property.

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