What changed in this filing

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Item 1A. Risk Factors

2024-04-01 compared with 2023-03-31 · 346 added, 321 removed, 521 unchanged (56% 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 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 require substantial funding in the near term, 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 have used the proceeds from our previous financing

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 the near term 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

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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.

of approximately $15.0 to $17.0 million to complete the potentially pivotal Phase 2 trial for Berubicin (taking into account our cash

on hand as of December 31, 2023 of approximately $0.5 million) plus such additional working capital to fund our operations during the

pendency of the trial (with such operations estimated at $4.5 to $5.0 million per annum).

If capital is available to fund WP1244/WP1874

preclinical work to prepare for a Phase 1 trial, we would need to raise an additional $5.0 million to support near-term development of

that program.

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.

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

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.

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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, 2022 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, 2023 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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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.

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

other additional assets for development.

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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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, 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.

We entered into the above agreements related to

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

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 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 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, 2023 the Company has incurred an accumulated deficit of $69,566,903 since

inception and had not yet generated any revenue from operations.

Additionally, management anticipates that its cash on hand as of December

31, 2023, combined with capital raised subsequent to December 31, 2023, is sufficient to fund its planned operations into but not beyond

the latter half of the second quarter of 2024.

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 a limited operating history and we expect a number of factors

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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.

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

We have not yet obtained any regulatory approvals

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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

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

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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.

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:

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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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

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 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

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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.

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.

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

The results of the interim analysis of our CNS-201 trial may not

be indicative of the final results from this trial.

We reached the criteria required by the study protocol

for our CNS-201 trial to conduct a pre-planned, non-binding interim futility analysis, which an independent DSMB is responsible for conducting.

The DSMB’s charter mandated that they review the primary endpoint, Overall Survival, as well as secondary endpoints and safety data

to determine whether the efficacy data for the risk-benefit profile warrants modification or discontinuation of the study.

18, 2023, we released the DSMB’s recommendation which was to continue the study without modification.

Management remains blinded

to the data underlying the recommendation of the DSMB.

The conclusions of the DSMB may not be indicative of the final results of our CNS-201

trial, which we expect to release in the first half of 2025, although it is impossible to accurately predict how long patients on the

study may survive which could impact the timing of the release of final trial data.

Interim or preliminary data from our clinical trials that we announce

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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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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

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 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.

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.

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.

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

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

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.

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.

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.

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 March 29, 2023, 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 April 1, 2024, 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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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.

Climaco, our 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,

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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 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.

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.

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.

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

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.

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.

Our cash and cash equivalents could be adversely affected if the

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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.

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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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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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

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.

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

In particular, on August 17, 2023, we received a letter (the “Letter”) from the staff of the Listing Qualifications Department

(the “Staff”) of Nasdaq which notified us that we were not in compliance with Nasdaq’s Listing Rule 5550(b)(1) (the

“Listing Rule”), which requires that we maintain a minimum of $2.5 million in stockholders’ equity, and that we also

did not, at such time, meet the alternatives of market value of listed securities or net income from continuing operations set forth in

the Listing Rule.

The Letter did not have any immediate effect on

the listing of our common stock on Nasdaq and we had 45 calendar days to submit a plan to regain compliance.

We timely submitted our plan

to regain compliance with the Listing Rule, our plan was accepted and the Staff granted an extension until February 13, 2024 (the “Extension

Period”) to evidence compliance.

On February 14, 2024, the Staff notified the Company

that it had not complied with the Listing Rule and as such did not meet the terms of the extension.

The Staff letter stated that unless

the Company timely requests a hearing before a Hearings Panel (the “Panel”), the Company would be subject to delisting.

the Company timely requested a hearing before the Panel, with such hearing scheduled for April 18, 2024.

The hearing request automatically

stayed any suspension or delisting action pending the hearing and the expiration of any additional extension period granted by the Panel

following the hearing.

In that regard, the Panel has the discretion to grant the Company an extension not to exceed August 12, 2024.

Notwithstanding,

there can be no assurance that the Panel will grant the Company a further extension or that the Company will ultimately regain compliance

with all applicable requirements for continued listing on The Nasdaq Capital Market.

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.

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

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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.

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.

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.

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 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;

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;

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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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.

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