What changed in this filing

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Item 1A. Risk Factors

2026-03-31 compared with 2025-03-31 · 281 added, 307 removed, 527 unchanged (53% of the section changed)

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Risks Related to the Company’s Business and Industry

We will require substantial funding to complete our clinical trials,

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 financings

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 TPI 287 and 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 TPI

287 and Berubicin would likely be delayed.

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

approval of TPI 287 and Berubicin will not increase.

Our future success depends on our ability to identify, acquire or

license new drug candidates, and we may not be successful in doing so.

A key element of our business strategy is to expand

our pipeline by acquiring or licensing rights to additional drug candidates from third parties.

The success of this strategy depends on

our ability to identify, evaluate and acquire or license suitable drug candidates on commercially reasonable terms.

Competition for attractive

drug candidates is intense, and many of our competitors have substantially greater financial, technical and human resources than we do,

which may limit our ability to identify and acquire promising therapeutic assets.

We may not be able to identify drug candidates

that meet our strategic criteria or that we believe have sufficient probability of clinical and commercial success.

Even if we identify

promising candidates, we may not be able to negotiate acquisition or licensing terms that are acceptable to us, or we may be outbid by

competitors with greater resources.

Additionally, due diligence evaluations of potential acquisition or licensing targets may not reveal

all relevant risks, liabilities or issues, and we may acquire or license drug candidates that ultimately prove to be less valuable or

more problematic than anticipated.

If we are unable to successfully identify and acquire

or license new drug candidates, our pipeline may remain limited, which could materially and adversely affect our business, financial condition,

results of operations and prospects.

Any drug candidates we acquire or license may require significant

additional development, and there can be no assurance that such candidates will prove to be safe, effective or commercially viable.

Even if we are successful in acquiring or licensing

new drug candidates, such candidates will likely require substantial additional investment and development before they could potentially

receive regulatory approval and be commercialized.

Drug development is inherently risky and uncertain.

Many drug candidates fail to demonstrate

adequate safety or efficacy in clinical trials, and there can be no assurance that any drug candidate we acquire or license will be successfully

developed, receive regulatory approval or achieve commercial success.

In addition, drug candidates we acquire or license

may have unknown liabilities, intellectual property defects or other issues that were not identified during our due diligence evaluation.

We may also face challenges integrating newly acquired or licensed assets into our organization and development programs.

factors could result in significant delays, increased costs or failure of our development programs, which could materially and adversely

affect our business, financial condition and results of operations.

We may not have access to sufficient capital to pursue acquisition

or licensing opportunities, which could limit our ability to expand our pipeline.

Acquiring or licensing drug candidates often requires

significant upfront payments, milestone payments, royalty obligations and ongoing development costs.

As a clinical-stage company with

limited financial resources, we may not have access to sufficient capital to pursue attractive acquisition or licensing opportunities

when they arise.

Our ability to raise additional capital may be limited by market conditions, investor sentiment, our financial performance

and other factors beyond our control.

If we are unable to raise sufficient capital on

acceptable terms, we may be forced to forgo attractive acquisition or licensing opportunities, reduce the scope of our business development

activities or delay or discontinue development of drug candidates we have already acquired.

Any of these outcomes could limit our ability

to expand our pipeline and materially harm our business and prospects.

We will require substantial funding to execute our new corporate

strategy, 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 primarily used the proceeds from our previous

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

In addition, we used proceeds from our previous financings

to obtain the rights to TPI 287.

Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is

Under our new corporate strategy, we will seek to obtain

rights to new investigational product candidates, which could include upfront cash payments, milestone payments, royalties, issuing shares

of our stock, assuming liabilities or a combination of any of these considerations.

It is possible that any of these considerations may

be greater than our currently available resources and require that we undertake additional financings or issue additional equity or debt

We are also evaluating TPI 287 and Berubicin as we explore the potential out-licensing of these programs but there can be

no assurances that we will be able to successfully complete an out-licensing transaction.

Potential licensors may require additional preclinical

or clinical data, CMC data, intellectual property or other considerations before undertaking a transaction.

We may determine that the

generation of additional preclinical or clinical data, CMC data or new intellectual property is not feasible or cost prohibitive relative

to potential financial considerations we could potentially receive and we may instead elect to sunset TPI 287, Berubicin or both programs.

We will continue to require substantial additional

capital to continue our clinical development and commercialization activities.

Because successful development of our product candidates

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

our products under development.

capital to execute in-licensing to expand our pipeline, clinical development and commercialization activities.

Because successful development

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

development and commercialize our products under development.

We estimate that we have sufficient capital to

take us into the first quarter of 2026, a period during which we would likely expect to initiate a trial of TPI 287, as well as complete

the Phase 2 Berubicin trial including its further analysis.

In addition, we have working capital to fund our operations during this period

(with such operations estimated at $4.5 to $5.0 million per annum).

We do not currently have a firm trial design for TPI 287 so estimates

of development cost are not available, however, regardless of trial design, the cost of bringing TPI 287 to regulatory approval for marketing

will require significant additional financing.

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 will depend on many

factors, including but not limited to:

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

whether we are successful in obtaining an accelerated approval pathway with the FDA related to Berubicin;

the progress, costs, results of and timing of our

clinical trials for TPI 287 and Berubicin;

fund operations into the third quarter of 2026.

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

to raise such financing through the sale of additional equity or debt securities.

The amount and timing of our future funding requirements

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

the cost to obtain the rights to new assets;

whether any clinical trials will be completed on a timely basis;

the progress, costs, results of and timing of preclinical studies or clinical trials for new assets;

the outcome, costs and timing of seeking and obtaining FDA and any other regulatory approvals;

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market acceptance of our product candidates;

the costs of acquiring, licensing or investing in businesses, products, product candidates and technologies;

our ability to out-license TPI 287 or Berubicin;

the costs of acquiring, licensing or investing in additional businesses, products, product candidates and technologies;

our ability to maintain, expand and enforce the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights;

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the effect of competing drug candidates and new product approvals;

our need to implement additional internal systems and infrastructure, including financial and reporting systems;

our need to implement additional internal systems and infrastructure, including quality, financial and reporting systems;

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

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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.

basis, we may not be able to execute on our in-licensing focused strategy.

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

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

Our success depends greatly on the success of TPI 287 and Berubicin’s

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

Other than TPI 287 and Berubicin, we do not have any

other clinical-stage drug candidates in our portfolio.

As such, we are dependent on the success of TPI 287 and Berubicin in the near

We cannot provide you any assurance that we will be able to successfully advance TPI 287 and Berubicin through the development

process or that we will be able to secure other additional assets for development.

We have never been profitable, we have no products

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

As a result, our ability to reduce our losses

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

Therefore, we may not be able to continue as

a going concern.

We have never been profitable and do not expect to

be profitable in the foreseeable future.

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

States or elsewhere.

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

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

To date, we have had no revenues and have relied on equity-based

financing from the sale of securities in public and private placements and the issuance of convertible notes.

The continuation of the

Company as a going concern is dependent upon our ability to obtain necessary equity or debt financing to continue operations and the attainment

of profitable operations.

As of December 31, 2024 the Company has incurred an accumulated deficit of $84,424,704 since inception and had

not yet generated any revenue from operations.

Additionally, management anticipates that its cash on hand as of December 31, 2024, combined

with capital raised subsequent to December 31, 2024, is sufficient to fund its planned operations within one year after the date that

the financial statements are issued.

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

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

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

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

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

We have never been profitable and do not expect

to be profitable in the foreseeable future.

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

United States or elsewhere.

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

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

To date, we have had no revenues and have relied

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

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, 2025 the Company has incurred an accumulated deficit of $100,275,268 since inception and had not yet generated any

revenue from operations.

Additionally, management anticipates that its cash on hand as of December 31, 2025, combined with capital raised

subsequent to December 31, 2025, is sufficient to fund its planned operations within one year after the date that the financial statements

To date, we have devoted most of our financial

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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 TPI 287, prepare for and begin the commercialization

as we in-license and initiate development of and seek regulatory approvals for new assets or programs, prepare for and begin the commercialization

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

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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.

If any of our future 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

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operating history.

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

clinical trial, and preparing for and conducting our TPI 287 clinical trial.

We have not yet obtained any regulatory approvals for any

of our drug candidates.

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

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

Our operating results are expected to significantly fluctuate

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

Factors relating to our business

that may contribute to these fluctuations include:

any delays in regulatory review and approval of our

product candidates in clinical development, including our ability to receive approval from the FDA for TPI 287 and

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

We have not yet obtained any regulatory approvals for any of our drug candidates.

Consequently, any predictions made about our

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

Our operating results are expected to significantly fluctuate from quarter to quarter or year to year due to a variety of factors, many

of which are beyond our control.

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

any delays or inability to identify, evaluate, negotiate or obtain rights to new assets;

any delays or inability to conduct preclinical studies;

delays in the commencement, enrollment and timing of clinical trials;

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the success of our clinical trials through all phases of clinical development;

potential side effects of our product candidate that could delay or prevent approval or cause an approved drug to be taken off the market;

potential side effects of our product candidates that could delay or prevent approval or cause an approved drug to be taken off the market;

our ability to obtain additional funding to develop drug candidates;

our ability to identify and develop additional drug candidates beyond Berubicin;

competition from existing products or new products that continue to emerge;

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

We cannot be certain that TPI 287 and Berubicin will receive regulatory

approval, and without regulatory approval we will not be able to market TPI 287 and Berubicin.

Our business currently depends largely on the

successful development and commercialization of TPI 287 and Berubicin.

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

will depend on the successful development and regulatory approval of TPI 287 and Berubicin for the treatment of glioblastoma.

We cannot be certain that any of our future product candidates will

receive regulatory approval, and without regulatory approval we will not be able to market or commercialize them.

Our business strategy depends on identifying and in

licensing the rights to new assets focused on neurology and oncology.

There can be no assurances that we will be successful in executing

on our strategy, which could have a material adverse impact on our business.

Even if we are successful in securing rights to new assets,

the development pathway to approval may be long, have uncertainty, and require more resources than we are able to obtain.

to generate revenue related to product sales, if ever, will depend on the successful development and regulatory approval of any future

product candidates.

We currently have no products approved for sale

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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 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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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

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

product candidates or secure commercialization partners, we will not be able to generate sufficient revenue to become profitable or to

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

Any statements in this filing indicating that TPI 287

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

governmental agency’s assessment of TPI 287 and Berubicin and do not indicate that TPI 287 and Berubicin will achieve favorable

efficacy results in any later stage trials or that the FDA or any comparable agency will ultimately determine that TPI 287 and 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 TPI 287 and Berubicin and our other

product candidates.

Any statements in this filing indicating that our legacy

assets TPI 287 and Berubicin have demonstrated preliminary evidence of efficacy are our own and are not based on the FDA’s or any

other comparable governmental agency’s assessment of TPI 287 and Berubicin and do not indicate that TPI 287 and Berubicin will achieve

favorable efficacy results in any later stage trials or that the FDA or any comparable agency will ultimately determine that TPI 287 and

Berubicin is effective for purposes of granting marketing approval.

Based on our intention to explore out-licensing TPI 287 and Berubicin,

we may have limited or no ability to determine the future development or regulatory activity for these programs.

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 our product candidates.

Delays in the commencement, enrollment and completion

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

If TPI 287 and 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.

If a future product candidate is found to be unsafe or ineffective,

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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any products.

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

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

If we are unable to bring any of our future product candidates to market, or to acquire other products that are on the market

or can be developed, our ability to create long-term stockholder value will be limited.

Interim or preliminary data from our clinical trials that we announce

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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.

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warnings or otherwise limit their sales.

Unforeseen side effects from any of our product candidates

could arise either during clinical development or, if TPI 287 and 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 TPI 287 and Berubicin

(or our other product candidates) are significant.

If TPI 287 and 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.

Unforeseen side effects from any of our product

candidates could arise either during clinical development or after an approved product has been marketed.

The range and potential severity

of possible side effects from therapies for neurologic or cancer indications can be significant.

If any of our 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 TPI

287 and Berubicin that we will need to conduct prior to seeking regulatory approval.

However, we do not have agreements for supplies of

TPI 287 and Berubicin or any of our other product candidates and we may not be able to reach agreements with these or other contract manufacturers

for sufficient supplies to commercialize TPI 287 or Berubicin if they are approved.

Additionally, the facilities used by any contract

manufacturer to manufacture Berubicin or any of our other product candidates must be the subject of a satisfactory inspection before the

FDA approves the product candidate manufactured at that facility.

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

compliance with the requirements of U.S.

regulators for the manufacture of our finished products.

If our manufacturers cannot

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

or GMP, and other requirements of any governmental agency whose jurisdiction to which we are subject, our product candidates will not

be approved or, if already approved, may be subject to recalls.

Reliance on third-party manufacturers entails risks to which we would

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

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 that

we will need to conduct prior to seeking regulatory approval.

However, we currently do not have agreements for supplies for any product

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

any product, even if they are approved.

Additionally, the facilities used by any contract manufacturer to manufacture any of our product

candidates must be the subject of a satisfactory inspection before the FDA approves the product candidate manufactured at that facility.

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

for the manufacture of our finished products.

If our manufacturers cannot successfully manufacture material that conform to our specifications

and the FDA’s current good manufacturing practice standards, or GMP, and other requirements of any governmental agency whose jurisdiction

to which we are subject, our product candidates will not be approved or, if already approved, may be subject to recalls.

Reliance on third-party

manufacturers entails risks to which we would not be subject if we manufactured our product candidates, including:

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

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

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

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

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

and maintain an effective marketing or sales force.

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

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

some of which will need to be committed prior to any confirmation that our product candidates will be approved by the FDA.

candidates where we decide to perform sales, marketing, and distribution functions ourselves or through third parties, we could face a

number of additional risks, including that we or our third-party sales collaborators may not be able to build and maintain an effective

marketing or sales force.

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

marketing and distribution activities on which our future revenues may depend.

We may not be successful in establishing and maintaining development

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Our licensed U.S.

patents for Berubicn expired in March 2020 and the

patents for TPI 287 will expire before commercialization is reasonably possible, and the expiration of our patents may subject us to increased

competition, and the Orphan Drug Designations for TPI 287 and Berubicin will not bar approval of other similar products under certain

circumstances.

and foreign patents for TPI 287 will all expire

in 2028 well before commercialization is reasonably possible.

patents for Berubicin that we previously licensed from Houston

Pharmaceuticals, Inc.

expired in March 2020.

Such patent expirations may subject us to increased competition.

TPI 287 held Orphan Drug

Designation when we licensed it from Cortice and on June 10, 2020, the FDA granted Orphan Drug Designation for Berubicin for the treatment

of malignant gliomas.

ODD from the FDA is available for drugs targeting diseases with less than 200,000 cases per year.

ODD may enable

market exclusivity of 7 years from the date of approval of an NDA in the United States.

During that period the FDA generally could not

approve another product containing the same drug for the same designated indication.

Orphan drug exclusivity will not bar approval of

another product under certain circumstances, including if a subsequent product with the same active ingredient for the same indication

is shown to be clinically superior to the approved product on the basis of greater efficacy or safety, or providing a major contribution

to patient care, or if the company with orphan drug exclusivity is not able to meet market demand.

The ODD now constitutes our primary

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

additional protections.

The ODD similarly strengthens our TPI 287 patent protections and would become our primary protection upon expiration

of those patents, however, we are also exploring new patent opportunities related to TPI 287.

Nevertheless, we can provide no assurance

that we will be able to file or receive additional patent protection.

The failure to obtain additional patent protection will reduce the

barrier to entry for competition for TPI 287 or Berubicin, which may adversely affect our operations.

patents for Berubicin have expired and our licensed

patents for TPI 287 will expire before commercialization is reasonably possible, and the expiration of our patents may subject us

to increased competition, and the Orphan Drug Designations for TPI 287 and Berubicin will not bar approval of other similar products under

certain circumstances.

The current U.S.

and foreign patents for TPI 287 will

all expire in 2028 well before commercialization is reasonably possible.

TPI 287 held Orphan Drug Designation when we licensed it from

Cortice and on June 10, 2020, the FDA granted Orphan Drug Designation for Berubicin for the treatment of malignant gliomas.

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

ODD may enable market exclusivity of 7 years from

the date of approval of an NDA in the United States.

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

the same drug for the same designated indication.

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

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

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

exclusivity is not able to meet market demand.

The ODD now constitutes our primary intellectual property protections although we are exploring

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

The ODD similarly strengthens our

TPI 287 patent protections and would become our primary protection upon expiration of those patents, however, we are also exploring new

patent opportunities related to TPI 287 and Berubicin.

Nevertheless, we can provide no assurance that we will be able to file

or receive additional patent protection.

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

for TPI 287 or Berubicin, which may adversely affect our operations.

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

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Company, and we may experience difficulties in managing growth.

As of March 31, 2025, we have four full-time employees.

We also have 1 officer serving as part-time employee.

As we advance our product candidates through preclinical studies and clinical trials,

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

In addition, to meet

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

Our management, personnel, and

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

If we are unable to successfully manage this growth and

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

As of March 31, 2026, we have eight full-time employees.

As we secure rights to and advance product candidates through preclinical studies and clinical trials, we will need to increase our product

development, scientific and administrative headcount to manage these programs.

In addition, to meet our obligations as a public company,

we may need to increase our general and administrative capabilities.

Our management, personnel, and systems currently in place may not

be adequate to support this future growth.

If we are unable to successfully manage this growth and increased complexity of operations,

our business may be adversely affected.

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

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in developing products or technologies that may compete with ours.

Our chief science officer is currently working for us on a part-time

Our chief executive officer and chief science officer, also provide services for other companies in our industry and such other

positions may create conflicts of interest for such officers in the future.

Certain of our key employees are currently part-time

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

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

Specifically, John M.

Climaco, our chief executive officer,

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

Donald Picker, our chief

science officer, is the chief scientific officer at Moleculin.

In addition to our officers’ part-time status,

Climaco and Dr.

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

conflicts of interest in the future.

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

of drug candidates being pursued by the other companies Mr.

Climaco and Dr.

Picker are associated with, there is no assurance that such

conflicts will not arise in the future.

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

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key man life insurance policies on any such people.

We are dependent on John M.

Climaco, Christopher

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

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

Therefore, if any of John M.

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

person’s absence.

We are dependent on our executive leadership team:

Rami Levin, Eric Faulkner, Lynne Kelley, Steve O’Loughlin and Dylan Wenke 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 our current executives die or become disabled, we will not receive any compensation to assist with such person’s

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

There are limited suppliers for active pharmaceutical ingredients

There may be limited suppliers for active pharmaceutical ingredients

(“API”) used in our drug candidates.

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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.

financial institutions.

Our cash investment strategy is intended to preserve capital and minimize cash balances that exceed the Federal

Deposit Insurance Corporation, or FDIC, insurance limit.

However, our cash balances may exceed the FDIC insurance limit from time to time.

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.

For example, on March 10, 2023, the FDIC, took control and was appointed receiver of Silicon Valley Bank (to which

the Company had no exposure).

If 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

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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.

For as long as we remain a smaller reporting company

as defined by Rule 12b-2 of the Exchange 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 a smaller reporting company 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 a smaller reporting 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.

To mitigate the lack of formal documentation of the control environment,

we have key team members review the critical reports and reconciliations as well as reporting documents.

To mitigate the 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 the study which is a result of the use of a third-party Contract Research Organization (“CRO”) to

manage the study, we have senior leaders of our finance and research teams review period end estimates.

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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These rights, preferences and privileges could negatively

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

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

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

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

We have in the past been unable to maintain compliance with the

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The Nasdaq Capital Market.

During 2024, we were not in compliance with the requirement

to maintain a closing bid price of $1.00 per share (the “Minimum Bid Price Requirement”) pursuant to Nasdaq Listing Rule 5550(a)(2),

and we were not in compliance with the minimum $2,500,000 stockholders’ equity requirement for continued listing set forth in Listing

Rule 5550(b) (the “Equity Requirement”).

As of the date of this filing, we are in compliance with both requirements.

with respect to the Equity Requirement, pursuant to Nasdaq Listing Rule 5815(d)(4)(B), we are subject to a Mandatory Panel Monitor until

September 10, 2025.

If, within that monitoring period, the Staff finds us again out of compliance with the Equity Requirement, notwithstanding

Listing Rule 5810(c)(2), we will not be permitted to provide the Staff with a plan of compliance with respect to that deficiency and Staff

will not be permitted to grant additional time for us to regain compliance with respect to that deficiency, nor will we be afforded an

applicable cure or compliance period pursuant to Listing Rule 5810(c)(3).

With respect to the Minimum Bid Price Requirement, since we

completed a reverse split on February 21, 2025, if we fall out of compliance with the Minimum Bid Price Requirement prior to February

21, 2026, we will not be eligible for any compliance period specified in Listing Rule 5810(c)(3)(A).

In either case described in the preceding

two sentences, the Staff will issue a Delist Determination Letter and we will have an opportunity to request a hearing.

Our common stock

may be at that time be delisted from Nasdaq.

There can be no assurance

that we will continue to meet the continued listing requirements of The Nasdaq Capital Market and could be subject to delisting at a future

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.

During 2024, we experienced compliance deficiencies

with respect to the requirement to maintain a closing bid price of $1.00 per share (the “Minimum Bid Price Requirement”) pursuant

to Nasdaq Listing Rule 5550(a)(2), and the minimum $2,500,000 stockholders’ equity requirement for continued listing set forth in

Listing Rule 5550(b) (the “Equity Requirement”).

We have since remedied these deficiencies and, as of the date of this filing,

we are in compliance with all applicable Nasdaq listing requirements.

Although we are currently

in compliance with all applicable Nasdaq listing requirements, there can be no assurance that we will continue to meet such requirements

in the future, and we could be subject to delisting at a future time.

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

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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.

We are an emerging growth company

until the earliest of:

the last day of the fiscal year during which we have total annual gross revenues of $1.235 billion or more;

the last day of the fiscal year following the fifth anniversary of our IPO, which occurred in November 2019;

the date on which we have, during the previous 3-year period, issued more than $1 billion in non-convertible debt;

the date on which we are deemed a “large accelerated issuer” as defined under the federal securities laws.

For so long as we remain an emerging growth company,

we will not be required to:

have an auditor report on our internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002;

comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (auditor discussion and analysis);

submit certain executive compensation matters to shareholders advisory votes pursuant to the “say on frequency” and “say on pay” provisions (requiring a non-binding shareholder vote to approve compensation of certain executive officers) and the “say on golden parachute” provisions (requiring a non-binding shareholder vote to approve golden parachute arrangements for certain executive officers in connection with mergers and certain other business combinations) of the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010;

include detailed compensation discussion and analysis in our filings under the Securities Exchange Act of 1934, as amended, and instead may provide a reduced level of disclosure concerning executive compensation;

may present only two years of audited financial statements and only two years of related Management’s Discussion and Analysis of Financial Condition and Results of Operations, or MD&A;

are eligible to claim longer phase-in periods for the adoption of new or revised financial accounting standards under §107 of the JOBS Act.

We intend to take advantage of all of these reduced

reporting requirements and exemptions, other than the longer phase-in periods for the adoption of new or revised financial accounting

standards under §107 of the JOBS Act.

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.

We cannot predict if investors will find our securities

less attractive due to our reliance on these exemptions.

If investors were to find our common stock less attractive as a result of our

election, we may have difficulty raising financing in the future.

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