What changed in this filing

/stocks — the workspaceLOADING

Item 1A. Risk Factors

2025-03-31 compared with 2024-04-01 · 202 added, 235 removed, 632 unchanged (41% of the section changed)

7 unchanged sentences

Risks Related to the Company’s Business and Industry

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

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.

2 unchanged sentences

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.

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.

We will continue to require substantial additional

3 unchanged sentences

our products under development.

We estimate that we will require additional financing

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

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

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 Berubicin;

the progress, costs, results of and timing of our

clinical trials for TPI 287 and Berubicin;

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

33 unchanged sentences

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

Our success depends greatly on the success of Berubicin’s

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 Berubicin, we do not have any other

clinical-stage drug candidates in our portfolio.

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

We cannot provide

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

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

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

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

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

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

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, 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.

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.

To date, we have devoted most of our financial

3 unchanged sentences

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

as we continue our development of and seek regulatory approvals for Berubicin and TPI 287, prepare for and begin the commercialization

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

19 unchanged sentences

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 our other drug candidate, WP1244/WP1874.

We have not yet obtained any regulatory approvals

for any of our drug candidates.

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

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

Our operating results are expected to significantly

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

Factors relating

to our business that may contribute to these fluctuations include:

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

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

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

16 unchanged sentences

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

We cannot be certain that Berubicin will receive regulatory approval,

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

Our business currently depends largely on the successful

development and commercialization of Berubicin.

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

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

We 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 currently have no products approved for sale

3 unchanged sentences

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.

28 unchanged sentences

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

Any statements in this filing indicating that Berubicin

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

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

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

Delays in the commencement, enrollment and completion of clinical

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

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.

55 unchanged sentences

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.

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.

In some instances, there can be significant variability

7 unchanged sentences

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

33 unchanged sentences

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.

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.

If any of our product candidates receives marketing

13 unchanged sentences

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

We do not have any manufacturing capabilities and

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

We utilize contract manufacturers for the production

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

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

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

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

to commercialize Berubicin if it is approved.

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

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

manufactured at that facility.

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

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 cGMP, and other requirements

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

may be subject to recalls.

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

product candidates, including:

If our manufacturers cannot

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

or 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;

85 unchanged sentences

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.

ODD from the FDA is available for drugs targeting

diseases with less than 200,000 cases per year.

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

United States.

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

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

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

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

market demand.

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

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

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

file or receive additional patent protection.

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

competition for Berubicin, which may adversely affect our operations.

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.

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

47 unchanged sentences

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.

As we advance our product candidates through preclinical studies and clinical

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

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

Our management, personnel,

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

If we are unable to successfully manage this growth

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

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.

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

28 unchanged sentences

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

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

Specifically, John M.

1 unchanged sentence

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.

Donald Picker, our chief

science officer, is the chief scientific officer at Moleculin.

In addition to our officers’ part-time status,

Silberman and Dr.

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

may encounter conflicts of interest in the future.

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

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

Silberman and Dr.

Picker are associated with,

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

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

92 unchanged sentences

of our control environment.

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

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

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

While management is working

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

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

If we are not able to maintain

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

could have a material adverse effect on our business.

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

43 unchanged sentences

These rights, preferences and privileges could negatively

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

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

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

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

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

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

of information in the marketplace about us and our securities.

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

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

EDT on May 15, 2020.

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

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

We believe in the accuracy and adequacy of our

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

of our common stock.

If we are unable to maintain compliance with the listing requirements

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

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

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

listing requirements of The Nasdaq Capital Market, and any future failure to maintain compliance could subject our common stock to be

delisted from The Nasdaq Capital Market, which could have a material adverse effect on our financial condition and could make it more

difficult for you to sell your shares.

Our common stock is listed on The Nasdaq Capital

4 unchanged sentences

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.

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.

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.

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

63 unchanged sentences

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