What changed in this filing

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Item 1A. Risk Factors

2023-03-31 compared with 2022-03-03 · 337 added, 353 removed, 505 unchanged (58% of the section changed)

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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 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

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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.

We estimate that we will require additional financing

of approximately $8.0 to $12.0 million to complete the Phase 2 trial for Berubicin (taking into account our cash on hand as of December

31, 2022 of approximately $10.1 million), approximately $5.0 million to support near-term WP1244/WP1874 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 or debt securities.

The amount and timing of our future funding requirements

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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,

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.

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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

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, 2022 that conditions exist that raise substantial doubt about our ability

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

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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 founder and significant shareholder, Dr.

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 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 founder, Dr.

Waldemar Priebe, including:

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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 sublicense agreement with Animal Life Sciences, LLC (“ALI”), 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.

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.

We entered into the above agreements related to Berubicin

with HPI, WPD (the sublicense agreement) and ALI 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 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

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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, 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.

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 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 necessary equity or debt financing to continue operations and the attainment

of profitable operations.

As of December 31, 2022 the Company has incurred an accumulated deficit of $50,715,677 since inception and had

not yet generated any revenue from operations.

Additionally, management anticipates that its cash on hand as of December 31, 2022 is sufficient

to fund its planned operations into but not beyond the third quarter of 2023.

To date, we have devoted most of our financial 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’ 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 a limited operating history and we expect a number of factors

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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.

Accordingly, the results of

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

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,

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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 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.

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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

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

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

Delays in the commencement, enrollment and completion

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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:

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:

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,

We have never completed 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

Clinical failure can occur at any stage of our clinical

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

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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.

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.

Further, 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

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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

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.

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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.

The COVID-19 outbreak has in the past and may in the future delay

recruitment in our clinical trials.

The COVID-19 outbreak has in the past and may in

the future slow potential enrollment of clinical trials and reduce the number of eligible patients for our clinical trials.

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 (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

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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

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.

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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

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.

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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.

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.

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

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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 face competition from other biotechnology and pharmaceutical

companies and our operating results will suffer if we fail to compete effectively.

The biotechnology and pharmaceutical industries

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

We face competition from other biotechnology and pharmaceutical companies

and our operating results will suffer if we fail to compete effectively.

The biotechnology and pharmaceutical industries 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.

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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.

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.

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.

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.

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.

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.

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

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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 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

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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 will need to expand our operations and increase the size of our Company,

and we may experience difficulties in managing growth.

As of March 29, 2023, we have 3 full-time employees.

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

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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 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,

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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 future.

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 future.

Certain of our key employees are currently part-time

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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.

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

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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.

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.

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 of John M.

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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,

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

facilities for clinical or commercial production of the API used in any of our drug candidates.

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

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

and quality policies and procedures or they may not be able to supply the API in commercial quantities.

If we need to find alternative

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.

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, 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 facilities

for clinical or commercial production of the API used in any of our drug candidates.

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 and commercial couriers to deliver the manufactured

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 and quality

policies and procedures or they may not be able to supply the API in commercial quantities.

If we need to find alternative 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 at all.

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

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.

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.

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.

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.

Our cash and cash equivalents could be adversely affected if the

financial institutions in which we hold our cash and cash equivalents fail.

We regularly maintain cash balances at third-party

financial institutions in excess of the Federal Deposit Insurance Corporation, or FDIC, insurance limit.

Events involving limitations

to liquidity, defaults, non-performance or other adverse developments that affect financial institutions, or concerns or rumors about

any events of these kinds or other similar risks, have in the past and may in the future lead to market-wide liquidity problems.

on March 10, 2023, the FDIC, took control and was appointed receiver of Silicon Valley Bank (to which the Company had no exposure).

other banks and financial institutions enter receivership or become insolvent in the future in response to financial conditions affecting

the banking system and financial markets, our ability to access our existing cash, cash equivalents and investments may be threatened

and could have a material adverse effect on our business and financial condition.

Risks Related to Our Common Stock

Failure to maintain effective internal control over our financial

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

reporting in accordance with Section 404 of the Sarbanes-Oxley Act has caused and may cause in the future our financial reports to be

We are required pursuant to Section 404 of the

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as of December 31, 2022, 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.

segregation of duties (resulting from the limited number of personnel available), limited access to timely and complete information regarding

the status of costs incurred in the activation of investigational sites and costs from treating patients in our study which is a result

of the use of a third-party Contract Research Organization (“CRO”) to manage the study, and the lack of formal documentation

of our control environment.

As a result of the material weakness with the third-party CRO, the Company corrected previously issued financial

statements for the periods ended December 31, 2021, March 31, 2022, June 30, 2022, and September 30, 2022 to properly reflect

research and development expenses and the related liability in these periods that were previously not recorded.

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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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.

that our internal control over financial reporting was, and continues to be, ineffective as of December 31, 2022, due to material weaknesses

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

access to timely and complete information regarding the status of costs incurred in the activation of investigational sites and costs

from treating patients in our study which is a result of the use of a third-party Contract Research Organization (“CRO”) to

manage the study, 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 mitigate the lack

of segregation of duties 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 mitigation 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 current stockholders’ ownership may be diluted if additional

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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.

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)

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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

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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.

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

We have in the past, and we may again in the future,

fail to comply with the continued listing requirements of the Nasdaq Capital Market, which would subject our common stock to being delisted.

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.

Delisting also could have other negative results, including the potential loss of employee confidence,

the loss of institutional investors or interest in business development opportunities.

We may be required to repurchase certain of our warrants upon a fundamental

transaction, which may prevent or deter a third party from acquiring us.

Certain of our warrants to purchase common stock provide

that in the event of a “Fundamental Transaction” (as defined in the related warrant agreement, which generally includes any

merger with another entity, the sale, transfer or other disposition of all or substantially all of our assets to another entity, or the

acquisition by a person of more than 50% of our common stock), each warrant holder will have the right at any time prior to the consummation

of the Fundamental Transaction to require us to repurchase the warrant for a purchase price in cash equal to the Black-Scholes value (as

calculated under the warrant agreement) of the then remaining unexercised portion of such common warrant on the date of such Fundamental

Transaction, which may materially adversely affect our financial condition and/or results of operations and may prevent or deter a third

party from acquiring us.

General Risk Factors

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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.

to be sued, it could result in substantial costs and a diversion of management’s attention and resources, which could harm our business.

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

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.

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.

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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.

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

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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” 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;

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” under SEC rules.

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;

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.

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

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors