What changed in this filing

/stocks — the workspaceLOADING

Item 7. Management’s Discussion and Analysis

2025-03-24 compared with 2024-03-19 · 675 added, 500 removed, 371 unchanged (76% of the section changed)

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on Form 10-K.

Company is a drug discovery company that uses biomarker technology to identify enzyme targets associated with serious common diseases

and then designs novel compounds to attack those targets.

Company is a clinical-stage biopharmaceutical company focused on identifying new targets for cancer drug development and developing and

commercializing cancer therapies.

The Company’s corporate office is located in Pasadena, California.

Company’s product pipeline is primarily focused on inhibitors of protein phosphatases, used alone and in combination with cytotoxic

agents and/or x-ray and immune checkpoint blockers.

The Company believes that inhibitors of protein phosphatases have broad therapeutic

potential not only for cancer but also for other debilitating and life-threatening diseases.

The Company is directing its efforts on

clinical development of a specific protein phosphatase inhibitor, referred to as LB-100, which has been shown to have clinical anti-cancer

activity at doses that produce little or no toxicity.

Company’s product pipeline is primarily focused on inhibitors of protein phosphatase 2A, which is used to enhance cytotoxic agents,

radiation, immune checkpoint blockers and other cancer therapies.

The Company believes that inhibitors of protein phosphatases have significant

therapeutic potential for a broad range of cancers.

The Company is focusing on the clinical development of a specific protein phosphatase

inhibitor, referred to as LB-100, which has been shown to have clinical anti-cancer activity.

Company’s activities are subject to significant risks and uncertainties, including the need for additional capital.

has not yet commenced any revenue-generating operations, does not have positive cash flows from operations, relies on stock-based compensation

for a substantial portion of employee and consultant compensation, and is dependent on periodic infusions of equity capital to fund its

for a substantial portion of employee and consultant compensation, and is dependent on periodic access to equity capital to fund its

operating requirements.

and Chief Executive Officer

September 26, 2023, Bas van der Baan, a director of the Company since June 17, 2022, replaced the Company’s founder, Dr.

Kovach, as President and Chief Executive Officer.

Kovach passed away on October 5, 2023.

Effective October 6, 2023, Mr.

was appointed as Chairman of the Board of Directors.

Kovach was also the Company’s Chief Scientific Officer.

License Agreement

February 23, 2024, the Company entered into a Patent License Agreement (the “License Agreement”) with the National Institute

of Neurological Disorders and Stroke (“NINDS”) and the National Cancer Institute (“NCI”), each an institute or

center of the National Institute of Health (“NIH”).

Pursuant to the License Agreement, the Company has licensed exclusively

NIH’s intellectual property rights claimed for a Cooperative Research and Development Agreement (“CRADA”) subject invention

co-developed with the Company, and the licensed field of use, which focuses on promoting anti-cancer activity alone, or in combination

with standard anti-cancer drugs.

The scope of this clinical research extends to checkpoint inhibitors, immunotherapy, and radiation for

the treatment of cancer.

The License Agreement is effective, and shall extend, on a licensed product, licensed process, and country basis,

until the expiration of the last-to-expire valid claim of the jointly owned licensed patent rights in each such country in the licensed

territory, unless sooner terminated.

License Agreement contemplates that the Company will seek to work with pharmaceutical companies and clinical trial sites (including comprehensive

cancer centers) to initiate clinical trials within timeframes that will meet certain benchmarks.

Data from the clinical trials will be

the subject of various regulatory filings for marketing approval in applicable countries in the licensed territories.

Subject to the

receipt of marketing approval, the Company would be expected to commercialize the licensed products in markets where regulatory approval

has been obtained.

Company is obligated to pay the NIH a non-creditable, non-refundable license issue royalty of $50,000 and a first minimum annual royalty

of $30,000, within sixty days from the effective date of the Agreement.

The first minimum annual royalty may be prorated from the effective

date of the License Agreement to the next subsequent January 1.

Thereafter, the minimum annual royalty of $30,000 is due each January

1 and may be credited against any earned royalties due for sales made in that year.

Company is obligated to pay the NIH, on a country-by-country basis, earned royalties of 2% on net sales of each royalty-bearing product

and process, subject to reduction by 50% under certain circumstances relating to royalties paid by the Company to third parties, but

not less than 1%.

The Company’s obligation to pay earned royalties under the License Agreement commences on the date of the first

commercial sale of a royalty-bearing product or process and expires on the date on which the last valid claim of the licensed product

or licensed process expires in such country.

Company is obligated to pay the NIH benchmark royalties, on a one-time basis, within sixty days from the first achievement of each such

The License Agreement defines four such benchmarks, with deadlines of October 1, 2024, 2027, 2029 and 2031, respectively,

each with a different specified benchmark payment amount payable within thirty days of achieving such benchmark.

The October 31, 2024

benchmark is defined as the dosing of the first patient with a licensed product in a Phase 2 clinical study of such licensed product

in the licensed fields of use.

The total of all such benchmark payments is $1,225,000.

Company is obligated to pay the NIH sublicensing royalties of 5% on sublicensing revenue received for granting each sublicense within

sixty days of receipt of such sublicensing revenue.

Significant Developments

of News Releases

Company announced that it had added the Robert H.

Lurie Comprehensive Cancer Center (Lurie Cancer Center) of Northwestern University

as a second site in a clinical trial combining the Company’s proprietary compound LB-100 with GSK’s dostarlimab to treat

ovarian clear cell cancer.

Company announced online publication of new pre-clinical data in BioXriv and International Journal of Pharmaceutics demonstrating how

the Company’s lead clinical compound, LB-100, is converted into its active form, endothall, a protein phosphatase (PP2A) inhibitor

that has been found to be effective in cancer treatment in combination with immunotherapy.

published in BioXriv, scientists at the Netherlands Cancer Institute have discovered an enzyme that mediates the conversion of LB-100

into the active metabolite endothall.

Accordingly, this protein represents a potential biomarker to identify patients who are most likely

to respond to LB100.

The biomarker discovery study was performed in the laboratories of Professor Rene Bernards, group leader at the

Netherlands Cancer Institute and LIXTE board member.

published in the International Journal of Pharmaceutics, Dr.

Hans Rollema and colleagues, medicinal chemists and biochemists at BioPharmaWorks

LLC, a consultant to LIXTE, studied how LB-100 can spontaneously convert into the active metabolite endothall by hydrolysis.

indicate that this conversion is slow under physiological conditions.

The enzymatic conversion of LB-100 identified by the Bernards laboratory

expedites the activation of LB-100 inside the cell.

Significant Developments:

March 11, 2025, the Company entered into Amendment No.

1 to the Collaboration Agreement between the Company and GEIS that relieved the

Company of the financial obligation to support the randomized Phase 2 portion of the clinical trial contemplated in the Collaboration

Agreement of approximately $3,095,000, as more fully described below at Principal Commitments – Clinical Trial Agreements - GEIS.

the year ended December 31, 2024, the Company recorded a net loss of $3,585,965 and used cash in operations of $3,164,536.

31, 2024, the Company had cash of $1,038,952 available to fund its operations.

Because the Company is currently engaged in various early-stage

clinical trials, it is expected that it will take a significant amount of time and resources to develop any product or intellectual property

capable of generating sustainable revenues.

Accordingly, the Company’s business is unlikely to generate any sustainable operating

revenues in the next several years and may never do so.

Even if the Company is able to generate revenues through licensing its technology,

product sales or other commercial activities, there can be no assurance that the Company will be able to achieve and maintain positive

earnings and operating cash flows.

At December 31, 2023, the Company’s remaining financial contractual commitments pursuant to

clinical trial agreements and clinical trial monitoring agreements not yet incurred aggregated approximately $6,344,000, which are currently

scheduled to be incurred through approximately December 31, 2027.

Subsequently, the Company completed a securities offering

that generated gross proceeds of $1,050,003 during February 2025 before deducting the placement agent’s fees and related offering

the Company is currently engaged in various early-stage clinical trials, it is expected that it will take a significant amount of time

and resources to develop any product or intellectual property capable of generating sustainable revenues.

Accordingly, the Company’s

business is unlikely to generate any sustainable operating revenues in the next several years and may never do so.

Even if the Company

is able to generate revenues through licensing its technology, product sales or other commercial activities, there can be no assurance

that the Company will be able to achieve and maintain positive earnings and operating cash flows.

At March 14, 2025, the Company’s

remaining financial contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred

aggregated approximately $526,000, which are currently scheduled to be incurred through approximately December 31, 2027.

Company’s consolidated financial statements have been presented on the basis that it will continue as a going concern, which contemplates

the realization of assets and satisfaction of liabilities in the normal course of business.

The Company has no recurring source of revenue

and has experienced negative operating cash flows since inception.

The Company has financed its working capital requirements through

the recurring sale of its equity securities.

The consolidated financial statements also

do not reflect any adjustments relating to the recoverability of assets and liabilities that might be necessary if the Company is unable

to continue as a going concern.

The Company has no recurring source of revenues and has experienced negative operating cash flows since

The Company has financed its working capital requirements through the recurring sale of its equity securities.

on the foregoing, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern

within one year after the date that the consolidated financial statements are being issued.

In addition, our independent registered public

accounting firm has included an explanatory paragraph in their report with respect to this uncertainty that accompanies our audited consolidated

financial statements as of and for the year ended December 31, 2023.

The Company’s consolidated financial statements do not include

any adjustments that might result from the outcome of this uncertainty.

The Company’s consolidated financial

statements do not include any adjustments that might result from the outcome of this uncertainty.

Company’s ability to continue as a going concern is dependent upon its ability to raise additional equity capital to fund its research

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availability of operating capital to fund such activities.

on current operating plans, the Company estimates that its existing cash resources at December 31, 2023 will provide sufficient working

capital to fund the current clinical trial program with respect to the development of the Company’s lead anti-cancer clinical compound

LB-100 through approximately September 30, 2024.

However, existing cash resources will not be sufficient to complete the development

of and obtain regulatory approval for the Company’s product candidate, which will require that the Company raise significant additional

The Company estimates that it will need to raise additional capital to fund its operations by mid-2024 to be able to proactively

manage its current business plan during the remainder of 2024 and during 2025.

In addition, the Company’s operating plans may change

as a result of many factors that are currently unknown and/or outside of the control of the Company, and additional funds may be needed

sooner than planned.

The Company is considering various strategies and alternatives to obtain the required additional capital.

market conditions present uncertainty as to the Company’s ability to secure additional funds, there can be no assurance that the

Company will be able to secure additional financing on acceptable terms, as and when necessary, to continue to conduct operations.

on current operating plans, the Company estimates that its existing cash resources at December 31, 2024, and the funds raised subsequent

to December 31, 2024, will provide sufficient working capital to fund the current clinical trial program with respect to the development

of the Company’s lead anti-cancer clinical compound LB-100 through approximately September 30, 2025.

However, existing cash

resources will not be sufficient to complete the development of and obtain regulatory approval for the Company’s product candidate,

which will require that the Company raise significant additional capital.

The Company estimates that it will need to raise additional

capital to fund its operations by mid-2025 to be able to proactively manage its current business plan during the remainder of 2025 and

In addition, the Company’s operating plans may change as a result of many factors that are currently unknown and/or

outside of the control of the Company, and additional funds may be needed sooner than planned.

The Company is considering various strategies

and alternatives to obtain the required additional capital.

However, as market conditions present uncertainty as to the Company’s

ability to secure additional funds, there can be no assurance that the Company will be able to secure additional financing on acceptable

terms, as and when necessary, to continue to conduct operations.

cash resources are insufficient to satisfy the Company’s ongoing cash requirements, the Company would be required to scale back

or discontinue its clinical trial program, as well as its licensing and patent prosecution efforts and its technology and product development

efforts, or obtain funds, if available, through strategic alliances or joint ventures that could require the Company to relinquish rights

to and/or control of LB-100, or to discontinue operations entirely.

Listing and Reverse Stock Split

Company’s common stock and the warrants are traded on the Nasdaq Capital Market (“Nasdaq”) under the symbols “LIXT”

and “LIXTW”, respectively.

efforts, or obtain funds, if available, through strategic alliances, joint ventures or other transaction structures that could require

the Company to relinquish rights to and/or control of LB-100, or to curtail or discontinue operations entirely.

Reverse Stock Split

On June 2, 2023, the Company effected a 1-for-10 reverse split

of its outstanding shares of common stock.

The authorized number of shares of common stock and the par value per share were not affected

by the reverse stock split.

No fractional shares were issued in connection with the reverse stock split, with all fractional shares being

rounded up to the next whole share.

All share and per share amounts and information presented herein have been retroactively adjusted

to reflect the reverse stock split for all periods presented.

Company’s common stock and the warrants are traded on the Nasdaq Capital Market under the symbols “LIXT” and “LIXTW”,

respectively.

June 2, 2023, the Company effected a 1-for-10 reverse split of its outstanding shares of common stock in order to remain in compliance

with the $1.00 minimum closing bid price requirement of Nasdaq.

No fractional shares were issued in connection with the reverse split,

with any fractional shares resulting from the reverse split being rounded up to the next whole share.

All share and per share amounts

and information presented herein have been retroactively adjusted to reflect the reverse stock split for all periods presented.

there can be no assurances that the Company will be able to remain in compliance with the $1.00 minimum closing bid price requirement

of Nasdaq over time, or that it will be successful in maintaining compliance with any of the other continued listing requirements of

However, there can be no assurances that the Company will be able to

remain in compliance with the $1.00 minimum closing bid price requirement of Nasdaq over time.

In addition, Nasdaq has other continued

listing requirements, one of which is maintaining a minimum net stockholders’ equity of $2,500,000.

August 23, 2024, the Company received a letter from the Listing Qualifications Department (the “Staff”) of the Nasdaq Stock

Market LLC (“Nasdaq”) on August 19, 2024 indicating that the Company was not in compliance with the minimum stockholders’

equity requirement of $2,500,000 for continued listing on the Nasdaq Capital Market under Listing Rule 5550(b) (the “Stockholders’

Equity Requirement”).

October 3, 2024, the Company submitted a plan to the Staff to regain compliance with the Stockholders’ Equity Requirement, which

outlined the Company’s proposed initiatives to regain compliance by raising equity capital through various registered equity offerings.

October 21, 2024, the Staff provided notice (the “Notice”) to the Company that it had granted an extension through February

18, 2025 to regain compliance with the Stockholders’ Equity Requirement, which required that the Company complete its capital raising

initiatives and evidence compliance with the Stockholders’ Equity Requirement through filing a Current Report on Form 8-K with

the Securities and Exchange Commission (the “SEC”) providing certain required information.

of February 18, 2025, the Company had not gained compliance with the Stockholders’ Equity Requirement.

Accordingly, on February

19, 2025, the Company received a Staff determination letter from the Staff stating that the Company did not meet the terms of the extension

because it did not complete its proposed financing initiatives to regain compliance.

Company timely filed an appeal and requested a Hearing before a Nasdaq Hearings Panel (the “Panel”), which has been granted.

The Hearing request automatically stayed Nasdaq’s delisting of the Company’s common shares and warrants pending the Panel’s

Pursuant to the Nasdaq Listing Rules, the Panel has the discretion to grant the Company an additional extension through no

later than August 18, 2025.

At the upcoming hearing, the Company will present its plan for regaining and sustaining compliance with the

Stockholders’ Equity Requirement for continued listing.

However, there can be no assurances that the Hearings Panel will grant

the Company an extension of time to regain compliance, or that the Company will be able to regain compliance during any extension period.

During the appeal process the Company’s common shares and warrants will continue to trade on The Nasdaq Capital Market.

Company intends to take reasonable measures available to regain compliance under Nasdaq’s listing rules and to remain listed on

However, there can be no assurances that the Company will ultimately regain compliance with the Stockholders’ Equity Rule,

or be able to maintain compliance with all other applicable requirements for continued listing on Nasdaq.

If the Company does not regain

compliance with Nasdaq’s continued listing requirements within the time period permitted by Nasdaq, then the Company’s securities

will be delisted from Nasdaq.

Accounting Pronouncements

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represented 10% or more of general and administrative costs or research and development costs for the years ended December 31, 2024 and

2022 are described as follows.

2023 are described below.

and administrative costs for the years ended December 31, 2024 and 2023 include charges from legal firms and other vendors for general

licensing and patent prosecution costs relating to the Company’s intellectual properties representing 23.3% and 25.6% of total

general and administrative costs, respectively.

General and administrative costs for the years ended December 31, 2023 and 2022 also

included charges for the fair value of stock options granted to directors and corporate officers representing 18.4% and 30.3%, respectively,

of total general and administrative costs.

licensing and patent prosecution costs relating to the Company’s intellectual properties representing 8.6% and 23.3% of total general

and administrative costs, respectively.

General and administrative costs for the year ended December 31, 2024 also include charges from

two vendors and consultants representing 15.0% and 13.1%, respectively, of total general and administrative costs.

General and administrative

costs for the year ended December 31, 2023 also include charges from a vendor and consultant representing 10.4% of total general and

administrative costs.

General and administrative costs for the years ended December 31, 2024 and 2023 also included charges for the fair

value of stock options granted to directors and corporate officers representing 14.7% and 18.4%, respectively, of total general and administrative

and development costs for the year ended December 31, 2024 include charges from three vendors and consultants representing 39.2%, 29.0%

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Research and development costs for the year ended December 31, 2023

include charges from four vendors and consultants representing 21.0%, 19.3%, 15.1% and 12.1%, respectively, of total research and development

include charges from three vendors and consultants representing 29.9%, 25.2% and 13.7%, respectively, of total research and development

Accounting Policies and Estimates

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experienced any losses to date resulting from this policy.

Company operates and reports in one segment, which focuses on the utilization of biomarker technology to identify enzyme targets associated

with serious common diseases and then designing novel compounds to attack those targets.

The Company’s operating segment is reported

in a manner consistent with the internal reporting provided to the Chief Operating Decision Maker, which is the Company’s President

and Chief Executive Officer.

Company’s President and Chief Executive Officer is the Company’s Chief Operating Decision Maker (“CODM”) and evaluates

performance and makes operating decisions about allocating resources based on internal financial data presented on a consolidated basis.

Because the CODM evaluates financial performance on a consolidated basis, the Company has determined that it operates in a single reportable

segment, which consists of the development of a drug class called Protein Phosphatase 2A inhibitors, and is comprised of the consolidated

financial results of the Company.

The CODM uses consolidated net income (loss) as the sole measure of segment profit or loss.

November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07,

Segment Reporting (Topic 280):

Improvements to Reportable Segment Disclosure.

ASU 2023-07 amends the FASB Accounting Standards

Codification to require additional reportable segment disclosures of a public entity by requiring disclosure of significant segment expenses

that are regularly provided to the chief operating decision maker, requiring other new disclosures, and requiring enhanced interim disclosures.

ASU 2023-07 requires public entities with a single reportable segment to provide all the disclosures required by ASU 2023-07 and all

existing segment disclosures in Topic 280 on an interim and annual basis.

The Company adopted ASU 2023-07 effective January 1,

2024 for the 2024 annual period on a retrospective basis.

The adoption of ASU 2023-07 resulted in additional required segment-related

disclosures in the Company’s financial statements.

and Development

and development costs consist primarily of fees paid to consultants and contractors, and other expenses relating to the negotiation,

design, development, and management of clinical trials with respect to the Company’s clinical compound and product candidate.

and development costs also include the costs to manufacture compounds used in research and clinical trials, which are charged to operations

The Company’s inventory of LB-100 for clinical use has been manufactured separately in the United States and in the

European Union in accordance with the laws and regulations of such jurisdictions.

design, development, conduct and management of clinical trials with respect to the Company’s clinical compound and product candidate.

Research and development costs also include the costs to manufacture compounds used in research and clinical trials, which are charged

to operations as incurred.

The Company’s inventory of LB-100 for clinical use has been manufactured separately in the United States

and in the European Union in accordance with the laws and regulations of such jurisdictions.

and development costs are generally charged to operations ratably over the life of the underlying contracts, unless the achievement of

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to the significant uncertainty associated with the successful development of commercially viable products based on the Company’s

research efforts and related patent applications, all patent and licensing legal and filing fees and costs are charged to operations

Patent and licensing legal and filing fees and costs are included in general and administrative costs in the Company’s

consolidated statements of operations.

the years ended December 31, 2023 and 2022, patent and licensing legal and filing fees and costs related to the development and protection

of the Company’s intellectual property, primarily related to LB-100, were $978,244 and $1,268,308, respectively, a decrease of

$290,064, or 22.9%, in 2023 as compared to 2022.

research efforts and related patent applications, all patent and licensing legal and filing fees and costs related to the development

and protection of the Company’s intellectual property are charged to operations as incurred.

Patent and licensing legal and filing

fees and costs are included in general and administrative costs in the Company’s consolidated statement of operations.

September 2023, the Company appointed a new President and Chief Executive Officer, who, with the assistance of the Company’s management,

Board of Directors and patent legal counsel, conducted a comprehensive analysis of the Company’s extensive patent portfolio in

order to implement a program to balance patent prosecution costs with intellectual property protection benefits.

As a result, the Company

identified certain patent filings that it does not intend to continue to support in 2024 and thereafter.

The Company expects that patent

and licensing legal and filing fees and costs will continue to be a significant continuing cost in 2024 as the Company continues to develop

and expand its patent portfolio related to the clinical development of LB-100.

Board of Directors and patent legal counsel, conducted a comprehensive review and analysis of the Company’s extensive patent portfolio

in order to implement a program to balance patent prosecution costs with intellectual property protection benefits.

As a result of such

review and analysis, the Company identified certain patent filings that it decided not to continue to support in 2024 and thereafter.

In addition, the Company changed patent legal counsel in mid-2024.

The Company expects that patent and licensing legal and filing fees

and costs will continue to be a significant continuing cost in 2025 and thereafter as the Company continues to develop and expand

its patent portfolio related to the clinical development of LB-100.

a result of such review and analysis, patent and licensing legal and filing fees and costs related to the development and protection

of the Company’s intellectual property, primarily related to LB-100, decreased to $243,186 for the year ended December 31, 2024,

as compared to $978,244 for the year ended December 31, 2023, a decrease of $735,058, or 75.1%.

descriptive summary of the patent portfolio for the Company’s most important clinical programs involving the development of LB-100,

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– Intellectual Property”.

Company periodically issues common stock and stock options to officers, directors, employees, Scientific Advisory Committee members,

contractors and consultants for services rendered.

Options vest and expire according to terms established at the issuance date of each

Stock grants, which are generally time vested, are measured at the grant date fair value and charged to operations ratably over

the vesting period.

Company accounts for stock-based payments to officers, directors, employees, Scientific Advisory Committee members, contractors, and

consultants by measuring the cost of services received in exchange for equity awards utilizing the grant date fair value of the awards,

with the cost recognized as compensation expense on the straight-line basis in the Company’s financial statements over the vesting

period of the awards.

Recognition of compensation expense for non-employees is in the same period and manner as if the Company had paid

cash for the services.

Company periodically issues common stock and stock options to officers, directors, employees, contractors and consultants for services

Options vest and expire according to terms established at the issuance date of each grant.

Stock grants, which are generally

time vested, are measured at the grant date fair value and charged to operations ratably over the vesting period.

Company accounts for stock-based payments to officers, directors, employees, contractors, and consultants by measuring the cost of services

received in exchange for equity awards utilizing the grant date fair value of the awards, with the cost recognized as compensation expense

on the straight-line basis in the Company’s financial statements over the vesting period of the awards.

Recognition of compensation

expense for non-employees is in the same period and manner as if the Company had paid cash for the services.

fair value of stock options granted as stock-based compensation is determined utilizing the Black-Scholes option-pricing model, and is

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Changes in the estimated fair value of the

warrants are recognized as a non-cash gain or loss on the statements of operations.

warrants that are liability-classified are recognized as a non-cash gain or loss in the statement of operations at each balance sheet

At December 31, 2024 and 2023, the Company did not have any liability-classified warrants.

of Business Activities and Plans

Company is a clinical-stage biopharmaceutical company dedicated to improving patients’ lives by developing a drug class called

Protein Phosphatase 2A inhibitors.

The Company’s corporate office is located in Pasadena, California.

Company’s product pipeline is primarily focused on inhibitors of protein phosphatase 2A, used in combination with cytotoxic agents

and/or x-ray, immune checkpoint blockers and other cancer therapies.

The Company believes that inhibitors of protein phosphatases have

significant therapeutic potential to enhance a broad range of anti-cancer therapies.

The Company is focusing on the clinical development

of a specific protein phosphatase inhibitor, referred to as LB-100, which has been shown to have clinical anti-cancer activity at doses

that produce little or no toxicity.

Company is focusing its development activities on its LB-100 series of drugs.

The Company believes that the mechanism by which compounds

of the LB-100 series affect cancer cell growth is different from cancer agents currently approved for clinical use.

Lead compounds of

the LB-100 series have activity against a broad spectrum of common and rarer human cancers in cell culture systems.

In addition, lead

compounds of the LB-100 series have anti-cancer activity in animal models of glioblastoma multiforme, neuroblastoma, and medulloblastoma,

all cancers of neural tissue.

Lead compounds of the LB-100 series also have activity against melanoma, breast cancer and sarcoma in animal

models and enhance the effectiveness of commonly used anti-cancer drugs in these animal models.

The enhancement of anti-cancer activity

of these anti-cancer drugs occurs at doses of LB-100 that do not significantly increase toxicity in animals.

It is therefore hoped that,

when combined with standard anti-cancer regimens against many tumor types, the Company’s compounds will improve therapeutic benefit

without unacceptable toxicity in humans.

The Company is not currently planning to allocate resources to further develop its LB-200 series

Company is a clinical-stage biopharmaceutical company focused on identifying new targets for cancer drug development and developing and

commercializing cancer therapies.

The Company’s product pipeline is primarily focused on inhibitors of protein phosphatase 2A,

which is used to enhance cytotoxic agents, radiation, immune checkpoint blockers and other cancer therapies.

The Company believes that

inhibitors of protein phosphatases have significant therapeutic potential for a broad range of cancers.

The Company is focusing on the

clinical development of a specific protein phosphatase inhibitor, referred to as LB-100, which has been shown to have clinical anti-cancer

Company believes that the mechanism by which LB-100 affects cancer cell growth is different from cancer agents currently approved for

clinical use.

LB-100 is currently being tested in clinical trials in Ovarian Clear Cell Carcinoma, Metastatic Micro Satellite Stable

(MSS) Colon Cancer, and Advanced Soft Tissue Sarcoma.

LB-100 has shown anti-cancer activity in animal models of glioblastoma multiforme,

neuroblastoma, and medulloblastoma, all cancers of neural tissue.

LB-100 has also been shown to enhance the effectiveness of commonly

used anti-cancer drugs in animal models of melanoma, breast cancer and sarcoma.

The enhancement of anti-cancer activity of these anti-cancer

drugs occurs at doses of LB-100 that do not significantly increase toxicity in animals.

It is therefore hoped that, when combined with

standard anti-cancer regimens against many tumor types, LB-100 will improve therapeutic benefit.

a compound moves through the FDA-approval process, it becomes an increasingly valuable property, but at a cost of additional investment

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Risks Associated with the Company’s Business Activities

Adverse Events

Company’s lead drug candidate, LB-100, is currently undergoing various clinical trials, and there is a risk that one or more of

these trials could be placed on hold by regulatory authorities due to serious adverse events (SAEs) related to the Company’s drug

candidate or to another company’s drug used in combination in one of the Company’s clinical trials.

It is possible that the

SAEs could be attributable to the Company’s drug candidate and could include, but not be limited to, unexpected severe side effects,

treatment-related deaths, or long-term health complications.

A dose given could result in non-tolerable adverse events defined as dose-limiting

toxicity (DLT).

When two DLTs occur at the same dose-level, that dose-level is considered too high and unsafe.

Further treatment is only

allowed at lower dose-levels that have previously been found safe.

an SAE or a pattern of SAEs is observed during the course of a clinical trial involving the Company’s drug candidate, the U.S.

Food and Drug Administration (FDA), European Medicines Agency (EMA), or other regulatory authorities may issue a clinical hold, requiring

the Company to pause or discontinue further enrollment and dosing in its clinical trial.

It is also possible that the clinical trial

could be terminated.

Any of these actions could delay or halt the development of the Company’s drug candidate, increase development

costs, and negatively impact the Company’s ability to ultimately achieve regulatory approval.

Additionally, if an SAE is confirmed

to be drug-related, the Company may be required to conduct additional studies, modify the study design, or abandon further development

of the drug candidate altogether, which could materially impact the Company’s business, financial condition, and prospects.

occurrence of an SAE and any resulting clinical hold could also harm the Company’s reputation with patients, physicians, health

institutions, and investors, diminish its ability to attract clinical trial participants, and damage its ability to interest investors

and obtain financing in the future.

There can be no assurance that the Company will not experience such SAEs in the future or that any

related clinical hold will be lifted in a timely manner, or at all.

principal investigator of the colorectal study testing LB-100 in combination with atezolizumab (Roche PD-L1 inhibitor) is currently investigating

two SAEs observed in the clinical trial that was launched in August 2024.

The Institutional Review Board (the “IRB”) of the

Netherlands Cancer Institute (“NKI”) has put the colorectal cancer study on hold.

The adverse reactions that developed in

the two patients were dyspnea (shortness of breath) due to lung toxicity possibly or probably related to the combination of LB-100 and

atezolizumab in one patient and fever and aphasia possibly or probably related to the combination of LB-100 and atezolizumab in the second

The patient who developed lung toxicity deceased due to the combination of lung metastases of colorectal cancer and dyspnea.

The patient with fever and aphasia fully recovered from the adverse events with supportive medication.

the identified adverse events in the two patients in the clinical trial, the IRB requested from the principal investigator of the study

at the NKI information as to whether the adverse events could have been caused by the combination of LB-100 and atezolizumab and information

about the mode of action of the combination of LB-100 and atezolizumab.

The principal investigator is preparing a response to the IRB

detailing the safety experience with LB-100 given alone and in combination with other cancer drugs, especially doxorubicin and dostarlimab.

Doxorubicin is a well-known chemotherapy, and dostarlimab is a well-known immunotherapy of which the mode of action is closely related

to that of atezolizumab.

reported adverse events in the colorectal cancer study have not been seen in any other patients thus far treated with LB-100 alone or

in combination with other cancer drugs.

Through February 2025, a total of 78 patient have received or are receiving experimental treatment

It is expected that it will take at least two months to prepare a detailed response to the IRB, during which time the Company

intends to update the safety overview of LB-100.

Risks Associated with the Company’s Business Activities

The global outbreak of the novel coronavirus (Covid-19) in early 2020 led to disruptions in general economic activities throughout

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and Interest Rate Risk.

The Company does not believe that inflation or increasing interest rates has had a material effect on its

operations to date, other than its impact on the general economy.

However, there is a risk that the Company’s operating costs could

become subject to inflationary and interest rate pressures in the future, which would have the effect of increasing the Company’s

The Company does not believe that inflation or increasing interest rates have had a material effect on its

operations to date, other than their impact on the general economy.

However, there is a risk that the Company’s operating costs

could become subject to inflationary and interest rate pressures in the future, which would have the effect of increasing the Company’s

operating costs (including, specifically, clinical trial costs), and which would put additional stress on the Company’s working

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publicly-traded shares.

Investor confidence, market sentiment, and access to capital may all be negatively influenced.

Investor confidence, market sentiment, and access to capital could all be negatively influenced.

Such geopolitical

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of operations may differ from current estimates.

Company is continuing to monitor these matters and will adjust its current business and financing plans as more information and guidance

become available.

Cybersecurity

The Company has established policies and processes for assessing, identifying and managing material risk from cybersecurity

threats, and has integrated these processes into its overall risk management systems and processes.

The Company routinely assesses material

risks from cybersecurity threats, including any potential unauthorized occurrence on or conducted through its information and email systems

that may result in adverse effects on the confidentiality, integrity, or availability of the Company’s information and email systems

or any information residing therein.

The Company conducts periodic risk assessments to identify cybersecurity threats, as well as assessments

in the event of a material change in the Company’s business practices that may affect information systems that are vulnerable to

such cybersecurity threats.

These risk assessments include identification of reasonably foreseeable internal and external risks, the

likelihood and potential damage that could result from such risks, and the sufficiency of existing policies, procedures, systems and

safeguards in place to manage such risks.

The Company has not encountered any cybersecurity challenges to date that have materially impaired

its operations or financial condition.

Company is continuing to monitor these matters and will adjust its current business and financing plans as more information becomes available.

of Operations

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Company’s consolidated statements of operations as discussed herein are presented below.

Ended December 31,

and expenses:

and administrative costs:

to related parties

and licensing legal and filing fees and costs

costs and expenses

and development costs

Years Ended December 31,

Costs and expenses:

from operations

currency gain (loss)

loss per common share – basic and diluted

average common shares outstanding – basic and diluted

Research and development costs

General and administrative costs

Total costs and expenses

Loss from operations

Interest income

Interest expense

Foreign currency gain (loss)

$ (3,585,965 )

$ (5,087,029 )

Net loss per common share – basic and diluted

Weighted average common shares outstanding – basic and diluted

Ended December 31, 2024 and 2023

The Company did not have any revenues for the years ended December 31, 2024 and 2023.

and Administrative Costs .

For the year ended December 31, 2023, general and administrative costs were $4,192,136, which consisted

of the fair value of vested stock options issued to directors and officers of $773,203, patent and licensing legal and filing fees and

costs of $978,244, other consulting and professional fees of $655,854, insurance expense of $442,976, officer salaries and related costs

of $841,709, cash-based director and board committee fees of $163,479, shareholder reporting costs of $93,860, listing fees of $62,000,

filing fees of $17,125, taxes and licenses of $73,877, investor relations of $59,238, rent of $15,571 and other operating costs of $24,109,

offset by a credit to licensing fees of $9,109 relating to the termination of the Moffitt agreement.

the year ended December 31, 2022, general and administrative costs were $4,962,712, which consisted of the fair value of vested stock

options issued to directors and officers of $1,502,776, patent and licensing legal and filing fees and costs of $1,268,308, other consulting

and professional fees of $450,243, insurance expense of $453,417, officer salaries and related costs of $831,890, cash-based director

and board committee fees of $266,020, shareholder reporting costs of $40,790, listing fees of $59,500, filing fees of $12,183, taxes

and licenses of $15,071, investor relations of $17,293, rent of $937, licensing fees of $25,000, and other operating costs of $19,284.

and administrative costs decreased by $770,576, or 15.5%, in 2023 as compared to 2022, primarily as a result of a decrease in the fair

value of vested stock options issued to directors and officers of $729,573, a decrease in patent and licensing legal and filing fees

and costs of $290,064, a decrease in cash-based director and board committee fees of $102,541, a decrease in licensing fees of $27,808,

offset by an increase in consulting and professional fees of $205,611, an increase in shareholder reporting of $53,070, an increase in

taxes and licenses of $58,806, an increase in investor relations of $41,945, and an increase in rent of $14,634.

and Development Costs .

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novel anti-cancer compounds to add to the Company’s clinical pipeline of $329,438.

the year ended December 31, 2022, research and development costs were $1,349,269, which consisted of the fair value of vested stock options

issued to a consultant of $43,264, regulatory service costs of $6,770, contractor costs incurred in connection with the synthesis work

done to develop a new supply of LB-100 for the Spanish clinical trial of $352,862, clinical and related oversight costs of $356,384,

and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline

in preclinical research costs for the years ended December 31, 2023 and 2022 were $226,150 and $204,158, respectively, of costs paid

to the Netherlands Cancer Institute, which employs Dr.

in clinical and related oversight costs for the year ended December 31, 2024 is $207,004 for the cost of patients enrolled in the City

of Hope clinical trial prior to its termination on July 8, 2024.

the year ended December 31, 2023, research and development costs were $898,100, which consisted of clinical and related oversight costs

of $416,269, regulatory service costs of $18,738, and preclinical research focused on development of additional novel anti-cancer compounds

to add to the Company’s clinical pipeline of $463,093.

June 10, 2024, the Company entered into a Clinical Trial Agreement with the Netherlands Cancer Institute (“NKI”) to conduct

a Phase 1b/2 clinical trial of the Company’s protein phosphatase inhibitor, LB-100, combined with atezolizumab, a PD-L1 inhibitor,

the proprietary molecule of F.

Hoffman-La Roche Ltd.

(“Roche”), for patients with metastatic colon cancer.

NKI employs Dr.

René Bernards, a director of the Company since June 15, 2022.

8, 2021, the Company entered into a Development Collaboration Agreement with the Netherlands Cancer Institute, Amsterdam, one of the

world’s leading comprehensive cancer centers, and Oncode Institute, Utrecht, a major independent cancer research center, to identify

the most promising drugs to be combined with LB-100, and potential LB-100 analogues, to be used to treat a range of cancers, as well

as to identify the specific molecular mechanisms underlying the identified combinations.

The Company has no financial contractual commitment associated with

this clinical trial.

in preclinical research costs for the years ended December 31, 2024 and 2023 were $210,362 and $226,150, respectively, of costs paid

to the Netherlands Cancer Institute, On October 8, 2021, the Company entered into a Development Collaboration Agreement with the Netherlands

Cancer Institute, Amsterdam, one of the world’s leading comprehensive cancer centers, and Oncode Institute, Utrecht, a major independent

cancer research center, to identify the most promising drugs to be combined with LB-100, and potential LB-100 analogues, to be used to

treat a range of cancers, as well as to identify the specific molecular mechanisms underlying the identified combinations.

October 3, 2023, the Company entered into Amendment No.

2 to the Development Collaboration Agreement with the Netherlands Cancer Institute,

which provides for additional research activities, extends the termination date of the Development Collaboration Agreement by two years

to October 8, 2026, and adds 500,000 Euros (approximately $542,000 at December 31, 2023) to the operating budget being funded by the

Company (see “Principal Commitments – Other Significant Agreements and Contracts – Netherlands Cancer Institute”

and development costs decreased by $451,169, or 33.4%, in 2023 as compared to 2022, primarily as a result of a decrease in the fair value

of vested stock options issued to directors and officers of $43,264, a decrease in contractor costs incurred in connection with the synthesis

work done to develop a new supply of LB-100 for the Spanish clinical trial of $352,862, and a decrease in preclinical research focused

on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $126,896, offset by an increase

in clinical and related oversight costs of $59,885.

which provided for additional research activities, extended the termination date of the Development Collaboration Agreement by two years

to October 8, 2026, and added 500,000 Euros to the operating budget being funded by the Company.

October 4, 2024, the Company entered into Amendment No.

3 to the Development Collaboration Agreement with NKI, which suspended Amendment

2 and provided for a new study term of one year commencing upon the dosing of the first patient in the clinical trial at a project

cost of 100,000 Euros (see “Principal Commitments – Other Significant Agreements and Contracts – Netherlands Cancer

Institute” below).

and development costs decreased by $171,868, or 19.1%, in 2024 as compared to 2023, primarily as a result of a decrease in preclinical

research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $133,655.

and Administrative Costs .

For the year December 31, 2024, general and administrative costs were $2,846,557, which consisted of the

fair value of vested stock options issued to directors and officers of $418,422 (including quarterly director and board committee fees

of $55,000), patent and licensing legal and filing fees and costs of $243,186, other consulting and professional fees of $735,021, insurance

expense of $434,444, officer salaries and related costs of $691,244, cash-based director and board committee fees of $38,819, licensing

and royalties of $75,643, shareholder reporting costs of $41,488, listing fees of $49,500, filing fees of $28,012, investor relations

of $59,588, rent of $16,435, conference fees of $14,475 and other operating costs of $45,830, offset by a state franchise tax credits

the year ended December 31, 2023, general and administrative costs were $4,192,136, which consisted of the fair value of vested stock

options issued to directors and officers of $773,203, patent and licensing legal and filing fees and costs of $978,244, other consulting

and professional fees of $655,854, insurance expense of $442,976, officer salaries and related costs of $841,709, cash-based director

and board committee fees of $163,479, shareholder reporting costs of $93,860, listing fees of $62,000, filing fees of $17,125, taxes

and licenses of $73,877, investor relations of $59,238, rent of $15,571 and other operating costs of $24,109, offset by a credit to licensing

fees of $9,109 relating to the termination of the Moffitt agreement.

and administrative costs decreased by $1,345,579, or 32.1%, in 2024 as compared to 2023, primarily as a result of a decrease in the fair

value of vested stock options issued to directors and officers of $354,781, a decrease in patent and licensing legal and filing fees

and costs of $735,058, a decrease in officer salaries and related costs of $150,465, a decrease in shareholder reporting costs of $52,372,

a decrease in taxes and licenses of $119,427, and a decrease in cash-based director and board committee fees of $124,660, offset by increases

in licensing and royalties of $84,752, and in other consulting and professional fees of $79,167.

For the year ended December 31, 2024, the Company had interest income of $7,048, as compared to interest income of $17,486

for the year ended December 31, 2022, related to the investment of funds generated by the Company’s financing activities.

for the year ended December 31, 2023, related to the investment of the Company’s cash resources.

For the year ended December 31, 2024, the Company had interest expense of $16,821, as compared to interest expense of $16,233

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Currency Gain (Loss) .

For the year ended December 31, 2023, the Company had a foreign currency gain of $1,954, as compared to a foreign

currency loss of $3,374 for the year ended December 31, 2022, from foreign currency transactions.

For the year ended December 31, 2024, the Company had a foreign currency loss of $3,403, as compared to a foreign

currency gain of $1,954 for the year ended December 31, 2023, from foreign currency transactions.

For the year ended December 31, 2024, the Company incurred a net loss of $3,585,965, as compared to a net loss of $5,087,029

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Net cash provided by financing activities

Net increase (decrease) in cash

Net decrease in cash

$ (3,164,536 )

December 31, 2023, the Company had working capital of $3,994,762, as compared to working capital of $5,165,227 at December 31, 2022,

reflecting a decrease in working capital of $1,170,465 for the year ended December 31, 2023.

The decrease in working capital during the

year ended December 31, 2023 was primarily the result of the funding of the Company’s ongoing research and development activities

and other ongoing operating expenses, including maintaining and developing the Company’s patent portfolio, offset by proceeds from

the sale of securities on July 20, 2023.

At December 31, 2023, the Company had cash of $4,203,488 available to fund its operations.

$ (1,146,904 )

December 31, 2024, the Company had working capital of $827,219, as compared to working capital of $3,994,762 at December 31, 2023, reflecting

a decrease in working capital of $3,167,543 for the year ended December 31, 2024.

The decrease in working capital during the year ended

December 31, 2024 was primarily the result of the funding of the Company’s ongoing research and development activities and other

ongoing operating expenses, including maintaining and developing the Company’s patent portfolio.

At December 31, 2024, the Company

had cash of $1,038,952 available to fund its operations.

Subsequently, the Company completed a securities offering that generated gross

proceeds of $1,050,003 during February 2025 before deducting the placement agent’s fees and related offering expenses.

Company’s consolidated financial statements have been presented on the basis that it will continue as a going concern, which contemplates

the realization of assets and satisfaction of liabilities in the normal course of business.

The consolidated financial statements also

do not reflect any adjustments relating to the recoverability of assets and liabilities that might be necessary if the Company is unable

to continue as a going concern.

The Company has no recurring source of revenues and has experienced negative operating cash flows since

The Company has financed its working capital requirements through the recurring sale of its equity securities.

on the foregoing, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern

within one year after the date that the consolidated financial statements are being issued.

In addition, the Company’s independent

registered public accounting firm has included an explanatory paragraph in their report with respect to this uncertainty that accompanies

the Company’s audited consolidated financial statements as of and for the year ended December 31, 2024.

The Company’s independent

registered public accounting firm, in their report on the Company’s December 31, 2024 audited consolidated financial statements,

has expressed substantial doubt about the Company’s ability to continue as a going concern.

The Company’s consolidated

financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Company’s ability to continue as a going concern is dependent upon its ability to raise additional equity capital to fund its research

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the availability of operating capital to fund such activities.

on current operating plans, the Company estimates that its existing cash resources at December 31, 2023 will provide sufficient working

capital to fund the current clinical trial program with respect to the development of the Company’s lead anti-cancer clinical compound

LB-100 through approximately September 30, 2024.

However, existing cash resources will not be sufficient to complete the development

of and obtain regulatory approval for the Company’s product candidate, which will require that the Company raise significant additional

The Company estimates that it will need to raise additional capital to fund its operations by mid-2024 to be able to proactively

manage its current business plan during the remainder of 2024 and during 2025.

In addition, the Company’s operating plans may change

as a result of many factors that are currently unknown and/or outside of the control of the Company, and additional funds may be needed

sooner than planned.

The Company is considering various strategies and alternatives to obtain the required additional capital.

December 31, 2023, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical

trial monitoring agreements not yet incurred aggregated $6,344,000, which are currently scheduled to be incurred through approximately

December 31, 2027.

on current operating plans, the Company estimates that its existing cash resources at December 31, 2024, and the funds raised subsequent

to December 31, 2024, will provide sufficient working capital to fund the current clinical trial program with respect to the development

of the Company’s lead anti-cancer clinical compound LB-100 through approximately September 30, 2025.

However, existing cash

resources will not be sufficient to complete the development of and obtain regulatory approval for the Company’s product candidate,

which will require that the Company raise significant additional capital.

The Company estimates that it will need to raise additional

capital to fund its operations by mid-2025 to be able to proactively manage its current business plan during the remainder of 2025 and

In addition, the Company’s operating plans may change as a result of many factors that are currently unknown and/or

outside of the control of the Company, and additional funds may be needed sooner than planned.

The Company is considering various strategies

and alternatives to obtain the required additional capital.

However, as market conditions present uncertainty as to the Company’s

ability to secure additional funds, there can be no assurance that the Company will be able to secure additional financing on acceptable

terms, as and when necessary, to continue to conduct operations.

cash resources are insufficient to satisfy the Company’s ongoing cash requirements, the Company would be required to scale back

or discontinue its clinical trial program, as well as its licensing and patent prosecution efforts and its technology and product development

efforts, or obtain funds, if available, through strategic alliances, joint ventures or other transaction structures that could require

the Company to relinquish rights to and/or control of LB-100, or to curtail or discontinue operations entirely.

March 14, 2025, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical trial

monitoring agreements not yet incurred aggregated $526,000, which are currently scheduled to be incurred through approximately December

December 31, 2024, the Company did not have any transactions, obligations or relationships that could be considered off-balance sheet

4 unchanged sentences

For the years ended December 31, 2024 and 2023, the Company had no investing activities.

For the year ended December 31, 2023, financing activities consisted primarily of the gross proceeds from the sale of

securities in the Company’s registered direct offering of $3,499,964, reduced by offering costs of $362,925, and $6,281 from the

exercise of common stock options.

For the year ended December 31, 2022, financing activities consisted of the gross proceeds from the

sale of securities in the Company’s registered direct offering of $5,800,000, reduced by offering costs of $658,616.

December 31, 2023, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical

trial monitoring agreements not yet incurred, as described below, aggregated $6,412,000, including clinical trial agreements of $6,013,000

and clinical trial monitoring agreements of $399,000, which, based on current estimates, are currently scheduled to be incurred through

approximately December 31, 2027.

The Company’s ability to conduct and fund these contractual commitments is subject to the timely

availability of sufficient capital to fund such expenditures, as well as any changes in the allocation or reallocation of such funds

to the Company’s current or future clinical trial programs.

The Company expects that the full amount of these expenditures will

be incurred only if such clinical trial programs are conducted as originally designed and their respective enrollments and duration are

not modified or reduced.

Clinical trial programs, such as the types that the Company is engaged in, can be highly variable and can frequently

involve a series of changes and modifications over time as clinical data are obtained and analyzed, and are frequently modified, suspended

or terminated before the clinical trial endpoint is reached.

Accordingly, such contractual commitments as discussed herein should be

considered as estimates only based on current clinical assumptions and conditions and are typically subject to significant modifications

and revisions over time.

For the year ended December 31, 2024, the Company had no financing activities.

For the year ended December 31, 2023,

financing activities consisted primarily of the gross proceeds from the sale of securities in the Company’s registered direct offering

of $3,499,964, reduced by offering costs of $362,925, and $6,281 from the exercise of common stock options.

Trial Agreements

March 14, 2025, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical trial

monitoring agreements not yet incurred, as described below, aggregated $526,000, including clinical trial agreements of $264,000 and

clinical trial monitoring agreements of $262,000, which, based on current estimates, are currently scheduled to be incurred through approximately

December 31, 2027.

The Company’s ability to conduct and fund these contractual commitments is subject to the timely availability

of sufficient capital to fund such expenditures, as well as any changes in the allocation or reallocation of such funds to the Company’s

current or future clinical trial programs.

The Company expects that the full amount of these expenditures will be incurred only if such

clinical trial programs are conducted as originally designed and their respective enrollments and duration are not modified or reduced.

Clinical trial programs, such as the types that the Company is engaged in, can be highly variable and can frequently involve a series

of changes and modifications over time as clinical data is obtained and analyzed, and is frequently modified, suspended or terminated,

in part based on receipt or lack of receipt of an indication of clinical benefit or activity, before the clinical trial endpoint is reached.

Accordingly, such contractual commitments as discussed herein should be considered as estimates only based on current clinical assumptions

and conditions and are typically subject to significant modifications and revisions over time.

information with respect to the conduct of the Company’s clinical trial programs is provide at “ITEM 1A.

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Related to the Development and Regulatory Approval of Our Product Candidates”.

following is a summary of the contractual clinical trials discussed below as of December 31, 2023:

Estimated End Date

Study Objective

Clinical Update

LB-100 combined with carboplatin, etoposide

and atezolizumab in small cell lung cancer

City of Hope and Sarah Cannon

Determine RP2D

Three patients entered

LB-100 combined with doxorubicin in sarcoma

Determine MTD and RP2D

One patient entered

LB-100 in high grade gliomas

Phase 0 pharmacology study

National Cancer Institute

Determine the penetration of LB-100 into high grade gliomas after IV injection

No or minimal penetration of LB-100 into high grade gliomas after

Doxorubicin with or without LB-100 in sarcoma

Randomized Phase 2

Determine efficacy:

Clinical trial not yet begun (subject to completion of Phase 1b GEIS clinical

LB-100 combined with dostarlimab

in ovarian clear cell carcinoma

December 2025

Determine the survival of patients with ovarian

clear cell carcinoma

No patients entered at December 31, 2023

financial contractual commitment of the GEIS Randomized Phase 2 clinical trial is included in the financial contractual commitment

of the GEIS Phase 1b trial.

is no remaining financial contractual commitment associated with this clinical trial.

Effective January 18, 2021, the Company executed a Clinical Research Support Agreement with the City of Hope National Medical

Center, an NCI-designated comprehensive cancer center, and City of Hope Medical Foundation (collectively, “City of Hope”),

to carry out a Phase 1b clinical trial of LB-100, the Company’s first-in-class protein phosphatase inhibitor, combined with an

FDA-approved standard regimen for treatment of untreated extensive-stage disease small cell lung cancer (“ED-SCLC”).

will be given in combination with carboplatin, etoposide and atezolizumab, an FDA-approved standard of care regimen, to previously untreated

ED-SCLC patients.

The dose of LB-100 will be escalated with the standard fixed doses of the 3-drug regimen to reach a recommended Phase

2 dose (“RP2D”).

Patient entry will be expanded so that a total of 12 patients will be evaluable at the RP2D to confirm the

safety of the LB-100 combination and to look for potential therapeutic activity as assessed by objective response rate, duration of overall

response, progression-free survival and overall survival.

following is a summary of the Company’s ongoing contractual clinical trials described below as of March 14, 2025:

of Clinical Trial

of Preliminary Efficacy

combined with atezolizumab in microsatellite stable metastatic colorectal cancer (Phase 1b)

Cancer Institute (NKI)

RP2D with atezolizumab

patient entered August 2024, in total two patients entered

combined with doxorubicin in advanced soft tissue sarcoma (Phase 1b)

completed September 2024

patients entered

with or without LB-100 in advanced soft tissue sarcoma (Randomized Phase 2)

trial not yet begun (subject to completion of Phase 1b GEIS clinical trial)

combined with dostarlimab in ovarian clear cell carcinoma (Phase 1b/2)

the OS of patients with recurrent ovarian clear cell carcinoma

patients entered

Company has no financial contractual commitment associated with this clinical trial at March 14, 2025.

Cancer Institute.

Effective June 10, 2024, the Company entered into a Clinical Trial Agreement with the Netherlands Cancer Institute

(“NKI”) to conduct a Phase 1b clinical trial of the Company’s protein phosphatase inhibitor, LB-100, combined with

atezolizumab, a PD-L1 inhibitor, the proprietary molecule of F.

Hoffman-La Roche Ltd.

(“Roche”), for patients with microsatellite

stable metastatic colorectal cancer.

Under the agreement, the Company will provide its lead compound, LB-100, and under a separate agreement

between NKI and Roche, Roche will provide atezolizumab and financial support for the clinical trial.

The Company has no obligation to

and will not provide any reimbursement of clinical trial costs.

Pursuant to the agreement and the protocol set forth in the agreement,

the clinical trial will be conducted by NKI at NKI’s site in Amsterdam by principal investigator Neeltje Steeghs, MD, PhD, and

NKI will be responsible for the recruitment of patients.

The agreement provides for the protection of the respective intellectual property

rights of each of the Company, NKI and Roche.

Phase 1b clinical trial will evaluate safety, optimal dose and preliminary efficacy of LB-100 combined with atezolizumab for the treatment

of patients with metastatic microsatellite stable colorectal cancer.

Immunotherapy using monoclonal antibodies like atezolizumab can

enhance the body’s immune response against cancer and hinder tumor growth and spread.

LB-100 has been found to improve the effectiveness

of anticancer drugs in killing cancer cells by inhibiting a protein called PP2A on cell surfaces.

Blocking PP2A increases stress signals

in tumor cells expressing the PP2A protein.

Accordingly, combining atezolizumab with LB-100 may enhance treatment efficacy for metastatic

colorectal cancer, as cancer cells with heightened stress signals are more vulnerable to immunotherapy.

study comprises a dose escalation phase and a dose expansion phase.

The objective of the dose escalation phase is to determine the recommended

Phase 2 dose (RP2D) of LB-100 when combined with the standard dosage of atezolizumab.

The dose expansion phase will further investigate

the preliminary efficacy, safety, tolerability, and pharmacokinetics/dynamics of the LB-100 and atezolizumab combination.

trial opened in August 2024 with the enrollment of the first patient.

A total of two patients have been enrolled to date.

Patient accrual

is expected to take up to 24 months, with a maximum of 37 patients with advanced colorectal cancer to be enrolled in this study.

principal investigator of the colorectal study testing LB-100 in combination with atezolizumab is currently investigating two Serious

Adverse Events (“SAEs”) observed in the clinical trial (see “Specific Risks Associated with the Company’s Business

Activities – Serious Adverse Events” above for additional information).

Company has no financial contractual commitment associated with this clinical trial.

Effective January 18, 2021, the Company executed a Clinical Research Support Agreement (the “Agreement”) with

the City of Hope National Medical Center, an NCI-designated comprehensive cancer center, and City of Hope Medical Foundation (collectively,

“City of Hope”), to carry out a Phase 1b clinical trial of LB-100, the Company’s first-in-class protein phosphatase

inhibitor, combined with an FDA-approved standard regimen for treatment of untreated extensive-stage disease small cell lung cancer (“ED-SCLC”).

LB-100 was given in combination with carboplatin, etoposide and atezolizumab, an FDA-approved standard of care regimen, to previously

untreated ED-SCLC patients.

The LB-100 dose was to be escalated with the standard fixed doses of the 3-drug regimen to reach a recommended

Phase 2 dose (“RP2D”).

Patient entry was to be expanded so that a total of 12 patients would be evaluable at the RP2D to

confirm the safety of the LB-100 combination and to look for potential therapeutic activity as assessed by objective response rate, duration

of overall response, progression-free survival, and overall survival.

clinical trial was initiated on March 9, 2021, with patient accrual expected to take approximately two years to complete.

patient accrual was slower than expected, the Company has been seeking to add additional sites to increase the rate of patient accrual.

Effective March 6, 2023, the Sarah Cannon Research Institute (“SCRI”), Nashville, Tennessee, joined the City of Hope’s

ongoing Phase 1b clinical trial.

The Company is continuing its efforts to add additional sites.

The addition of SCRI is expected to expedite

and expand the accrual of patients to this clinical trial, thus reducing the time required to demonstrate the feasibility, tolerability,

and efficacy of adding LB-100 to the current standard treatment regimen.

With the addition of SCRI, the Company currently expects that

this clinical trial will be completed by March 31, 2026.

the years ended December 31, 2023 and 2022, the Company incurred costs of $69,001 and $0, respectively, pursuant to this agreement, which

are included in research and development costs in the Company’s consolidated statements of operations.

As of December 31, 2023,

total costs of $447,512 have been incurred pursuant to this agreement.

Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $2,433,000

as of December 31, 2023, which is expected to be incurred through March 31, 2026.

If a significant number of patients fail during the

dose-escalation process, an increase of up to 12 patients would likely be necessary, at an estimated additional cost of approximately

Company currently expects that enrollment in this clinical trial will range from approximately 18 to 30 enrollees, with 24 enrollees

as the most likely number.

Should fewer than 42 enrollees be required, the Company has agreed to compensate City of Hope on a per enrollee

If a significant improvement in outcome is seen with the addition of LB-100, this would be an important advance in the treatment

of a very aggressive disease.

Because patient

accrual was slower than expected, effective March 6, 2023, the Company and City of Hope added the Sarah Cannon Research Institute (“SCRI”),

Nashville, Tennessee, to the ongoing Phase 1b clinical trial.

The Company and City of Hope continued efforts to increase patient accrual

by adding additional sites and by modifying the protocol to increase the number of patients eligible for the clinical trial.

of these efforts to increase patient accrual and to decrease time to completion was evaluated in subsequent quarters.

evaluating patient accrual through June 30, 2024, the Company and City of Hope agreed to close the clinical trial.

Pursuant to the terms

of the Agreement, the Company provided notice to City of Hope of the Company’s intent to terminate the Agreement effective as of

July 8, 2024.

Upon closure, the Company incurred a prorated charge of $207,004 for the cost of patients enrolled to date, which is included

in accounts payable and accrued expenses at December 31, 2024.

the year ended December 31, 2024 and 2023, the Company incurred costs of $285,019 and $69,001, respectively, pursuant to this Agreement.

As of December 31, 2024, total costs of $732,532 had been incurred pursuant to this Agreement.

Effective July 31, 2019, the Company entered into a Collaboration Agreement for an Investigator-Initiated Clinical Trial with the

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These tasks included

the synthesis under good manufacturing practices (GMP) of the active pharmacologic ingredient (API), with documentation of each of the

the synthesis under good manufacturing practice (GMP) of the active pharmaceutical ingredient (API), with documentation of each of the

steps involved by an independent auditor.

7 unchanged sentences

for subsequent multiple trials within the European Union, had cost approximately $1,144,000.

Although the production of new inventory

has been completed, nominal trailing costs subsequent to December 31, 2023 may be incurred.

October 13, 2022, the Company announced that the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos

y Productos Sanitarios or “AEMPS”) had authorized a Phase 1b/randomized Phase 2 study of LB-100, the Company’s lead

clinical compound, plus doxorubicin, versus doxorubicin alone, the global standard for initial treatment of advanced soft tissue sarcomas

Consequently, this clinical trial commenced during the quarter ended June 30, 2023 and is expected to be completed and a report

prepared by December 31, 2026.

In April 2023, GEIS completed its first site initiation visit in preparation for the clinical trial at

Fundación Jiménez Díaz University Hospital (Madrid).

clinical compound, plus doxorubicin, versus doxorubicin alone, the global standard for initial treatment of ASTS.

Consequently, this

clinical trial commenced during the quarter ended June 30, 2023 and is expected to be completed and a report prepared by December 31,

In April 2023, GEIS completed its first site initiation visit in preparation for the clinical trial at Fundación Jiménez

Díaz University Hospital (Madrid).

Up to 170 patents will be entered into the clinical trial.

The Phase 1b portion of the protocol is expected to be completed by June 30, 2024, at which time the Company expects to have data on

both response and toxicity from this portion of the clinical trial, and subject to clinical results, anticipates that it will be able

to proceed to a related Phase 2 study.

interim analysis of this clinical trial will be done before full accrual of patients is completed to determine whether the study has

the possibility of showing superiority of the combination of LB-100 plus doxorubicin compared to doxorubicin alone.

A positive study

would have the potential to change the standard therapy for this disease after four decades of failure to improve the marginal benefit

of doxorubicin alone.

Company’s agreement with GEIS provides for various payments based on achieving specific milestones over the term of the agreement.

During the years ended December 31, 2023 and 2022, the Company incurred costs of $268,829 and $260,770, respectively, pursuant to this

Such costs, when incurred, are included in research and development costs in the Company’s consolidated statements of

Through December 31, 2023, the Company has paid GEIS an aggregate of $684,652 for work done under this agreement through

the fourth milestone.

The recruitment for the Phase 1b

portion of the protocol was extended with two patients and was completed during the quarter ended September 30, 2024.

The Company expects

to have data on toxicity and preliminary efficacy from this portion of the clinical trial during the quarter ending December 31, 2025.

the focus on the combination of LB-100 with immunotherapy in ovarian clear cell carcinoma and colorectal cancer and the availability

of capital resources, the Company entered into Amendment No.

1 to the Collaboration Agreement effective March 11, 2025 that relieved

the Company of the financial obligation to support the randomized Phase 2 portion of the clinical trial contemplated in the Collaboration

Agreement of approximately $3,095,000.

As a result, it is uncertain as to whether the Phase 2 portion of this clinical trial will proceed.

Company’s agreement with GEIS provided for various payments based on achieving specific milestones over the term of the agreement.

During the years ended December 31, 2024 and 2023, the Company incurred costs of $0 and $268,829, respectively, pursuant to this agreement.

Through December 31, 2024, the Company has incurred charges of $684,652 for work done under this agreement through the fourth milestone.

Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $264,000

as of December 31, 2023, which is expected to be incurred through December 31, 2027.

As the work is being conducted in Europe and is

paid for in Euros, final costs are subject to foreign currency fluctuations between the United States Dollar and the Euro.

Such fluctuations

are recorded in the consolidated statements of operations as foreign currency gain or loss, as appropriate.

for the Phase 1b portion of this clinical trial as of March 14, 2025, which is scheduled to be incurred through December 31, 2025.

the work is being conducted in Europe and is paid for in Euros, final costs are subject to foreign currency fluctuations between the

United States Dollar and the Euro.

Such fluctuations are recorded in the consolidated statements of operations as foreign currency gain

or loss, as appropriate, and have not been significant.

Anderson Cancer Center Clinical Trial .

On September 20, 2023, the Company announced an investigator-initiated Phase 1b/2 collaborative

clinical trial to assess whether adding LB-100 to a human programmed death receptor-1 (“PD-1”) blocking antibody of GSK plc

(“GSK”), dostarlimab-gxly, may enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma

The study objective is to determine the overall survival (“OS”) of patients with OCCC.

trial is being sponsored by The University of Texas MD Anderson Cancer Center (“MD Anderson”) and is being conducted at The

University of Texas - MD Anderson Cancer Center.

The Company is providing LB-100 and GSK is providing dostarlimab-gxly and financial

support for the clinical trial.

On January 29, 2024, the Company announced the entry of the first patient into this clinical trial.

Company currently expects that this clinical trial will be completed by December 31, 2027.

February 25, 2025, the Company announced that it has added the Robert H.

Lurie Comprehensive Cancer Center (Lurie Cancer Center) of Northwestern

University as a second site in a clinical trial combining the Company’s proprietary compound LB-100 with GSK’s dostarlimab

to treat ovarian clear cell cancer.

Patient recruitment is underway, and the first patient has been dosed.

Effective August 20, 2018, the Company entered into a Clinical Trial Research Agreement with the Moffitt Cancer Center and Research

Institute Hospital Inc., Tampa, Florida (“Moffitt”), effective for a term of five years.

Pursuant to the Clinical Trial Research

Agreement, Moffitt agreed to conduct and manage a Phase 1b/2 clinical trial to evaluate the toxicity and therapeutic benefit of the Company’s

lead anti-cancer clinical compound LB-100 to be administered intravenously in patients with low or intermediate-1 risk myelodysplastic

syndrome (“MDS”).

November 2018, the Company received approval from the U.S.

Food and Drug Administration for its Investigational New Drug (“IND”)

Application to conduct a Phase 1b/2 clinical trial to evaluate the toxicity and therapeutic benefit of LB-100 in patients with low and

intermediate-1 risk MDS who had failed or were intolerant of standard treatment.

This Phase 1b/2 clinical trial utilized LB-100 as a

single agent in the treatment of patients with low and intermediate-1 risk MDS.

clinical trial began at a single site in April 2019 and the first patient was entered into the clinical trial in July 2019.

year ended December 31, 2023, the clinical trial was closed.

Although the maximum tolerated dose (“MTD”) was not achieved,

there was no dose-limiting toxicity noted.

the years ended December 31, 2024 and 2023, the Company incurred costs of $0 and $16,165, respectively, pursuant to this agreement.

of December 31, 2024, total costs of $147,239 had been incurred pursuant to this agreement.

September 2023, the Company decided not to pursue further studies in MDS, as other, more promising, opportunities had become available

(see “Patent and License Agreements - Moffitt” below).

Cancer Institute Pharmacologic Clinical Trial.

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and other aggressive brain tumors.

Trial Monitoring Agreements

Anderson Cancer Center Clinical Trial .

On September 20, 2023, the Company announced an investigator-initiated Phase 1b/2 collaborative

clinical trial to assess whether adding LB-100 to a human programmed death receptor-1 (“PD-1”) blocking antibody of GSK plc

(“GSK”), dostarlimab-gxly, may enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma

The clinical trial is being sponsored by The University of Texas MD Anderson Cancer Center (“MD Anderson”)

and is being conducted at The University of Texas - MD Anderson Cancer Center.

The Company is providing LB-100 and GSK is providing dostarlimab-gxly

and financial support for the clinical trial.

On January 29, 2024, the Company announced the entry of the first patient into this clinical

The Company currently expects that this clinical trial will be completed by July 31, 2025.

Effective August 20, 2018, the Company entered into a Clinical Trial Research Agreement with the Moffitt Cancer Center and Research

Institute Hospital Inc., Tampa, Florida (“Moffitt”), effective for a term of five years, unless terminated earlier by the

Company pursuant to 30 days written notice.

Pursuant to the Clinical Trial Research Agreement, Moffitt agreed to conduct and manage a

Phase 1b/2 clinical trial to evaluate the toxicity and therapeutic benefit of the Company’s lead anti-cancer clinical compound

LB-100 to be administered intravenously in patients with low or intermediate-1 risk myelodysplastic syndrome (“MDS”).

November 2018, the Company received approval from the U.S.

Food and Drug Administration for its Investigational New Drug (“IND”)

Application to conduct a Phase 1b/2 clinical trial to evaluate the toxicity and therapeutic benefit of LB-100 in patients with low and

intermediate-1 risk MDS who have failed or are intolerant of standard treatment.

Patients with MDS, although usually older, are generally

well except for severe anemia requiring frequent blood transfusions.

This Phase 1b/2 clinical trial utilized LB-100 as a single agent

in the treatment of patients with low and intermediate-1 risk MDS.

clinical trial began at a single site in April 2019 and the first patient was entered into the clinical trial in July 2019.

year ended December 31, 2023, the clinical trial was closed.

In this clinical trial, single agent LB-100 was used on a new schedule of

days 1, 3, and 5 every 3 weeks.

Although MTD was not achieved, there was no dose-limiting toxicity on this schedule at doses that were

greater than the MTD in the Phase 1 clinical trial of LB-100 on the Monday, Tuesday, Wednesday schedule.

the years ended December 31, 2023 and 2022, the Company incurred costs of $16,165 and $26,397, respectively, pursuant to this agreement,

which have been included in research and development costs in the Company’s consolidated statements of operations.

On May 15, 2024, the Company signed a letter of intent with Theradex to monitor the MD Andersen

investigator-initiated Phase 1b/2 collaborative clinical trial to assess whether adding LB-100 to a human programmed death receptor-1

(“PD-1”) blocking antibody of GSK plc (“GSK”), dostarlimab-gxly, may enhance the effectiveness of immunotherapy

in the treatment of ovarian clear cell carcinoma (“OCCC”).

On August 19, 2024, the Company signed a work order agreement

with Theradex to monitor the MD Anderson clinical trial.

The study oversight is expected to be completed by January 31, 2027.

under this letter of intent and related work order agreement are estimated to be approximately $95,000.

During the year ended December

31, 2024, the Company incurred costs of $26,763 pursuant to this letter of intent and subsequent work order.

As of December 31, 2024,

31, 2023, total costs of $147,239 have been incurred pursuant to this agreement.

Company has decided not to pursue further studies in MDS, as other opportunities have become available (see “Patent and License

Agreements - Moffitt” below).

Trial Monitoring Agreements

On September 12, 2018, the Company finalized a work order agreement with Theradex Systems, Inc.

(“Theradex”), an international

contract research organization (“CRO”), to monitor the Phase 1b/2 clinical trial being managed and conducted by Moffitt.

The clinical trial began in April 2019 and the first patient was entered into the clinical trial in July 2019.

costs of the Phase 1b/2 clinical trial being paid to or through Theradex have been recorded and charged to operations based on periodic

documentation provided by the CRO.

During the years ended December 31, 2023 and 2022, the Company incurred costs of $20,884 and $35,403,

respectively, pursuant to this work order.

As of December 31, 2023, total costs of $148,172 have been incurred pursuant to this work

order agreement.

a result of the closure of the Company’s Clinical Trial Research Agreement with Moffitt during the year ended December 31, 2023

(see “Clinical Trial Agreements – Moffitt” above), this work order agreement with Theradex to monitor the Clinical

Trial Research Agreement with Moffitt was similarly suspended, although nominal oversight trailing costs subsequent to December 31, 2023

are expected to be incurred relating to the closure of the Moffitt study.

total costs of $26,763 have been incurred pursuant to this letter of intent and subsequent work order.

Company’s aggregate commitment pursuant to this letter of intent, less amounts previously paid to date, totaled approximately $70,000

as of December 31, 2024, which is expected to be incurred through December 31, 2027.

On February 5, 2021, the Company signed a new work order agreement with Theradex to monitor the City of Hope investigator-initiated

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Costs under this

work order agreement are estimated to be approximately $335,000.

During the years ended December 31, 2023 and 2022, the Company incurred

costs of $20,240 and $33,815, respectively, pursuant to this work order.

As of December 31, 2023, total costs of $78,681 have been incurred

work order agreement were estimated to be approximately $335,000.

During the years December 31, 2024 and 2023, the Company incurred costs

of $10,642 and $20,240, respectively, pursuant to this work order.

As of December 31, 2024, total costs of $89,323 had been incurred

pursuant to this work order agreement.

Company’s aggregate commitment pursuant to this clinical trial monitoring agreement, less amounts previously paid to date, totaled

approximately $258,000 as of December 31, 2023, which is expected to be incurred through March 31, 2026.

a result of the closure of the Agreement with City of Hope effective July 8, 2024 (see “Clinical Trial Agreements – City

of Hope” above), the work order agreement with Theradex to monitor this clinical trial was concurrently terminated, although nominal

oversight trailing costs subsequent to July 8, 2024 are expected to be incurred relating to the closure of this study.

On June 22, 2023, the Company finalized a work order agreement with Theradex, to monitor the GEIS investigator-initiated clinical

Phase I/II randomized trial of LB-100 plus doxorubicin vs.

doxorubicin alone in first line of advanced soft tissue sarcomas.

is expected to be completed by June 30, 2026.

doxorubicin alone in first line of advanced soft tissue sarcoma.

oversight is expected to be completed by December 31, 2026.

under this work order agreement are estimated to be approximately $153,000, with such payments expected to be allocated approximately

72% to Theradex for services and approximately 28% for payments for pass-through software costs.

During the years ended December 31,

2024 and 2023, the Company incurred costs of $34,593 and $14,862, respectively, pursuant to this work order.

As of December 31, 2024,

total costs of $49,455 have been incurred pursuant to this work order agreement.

Company’s aggregate commitment pursuant to this clinical trial monitoring agreement, less amounts previously paid to date, totaled

approximately $104,000 as of December 31, 2024, which is expected to be incurred through December 31, 2026.

Cancer Institute.

On August 27, 2024, the Company finalized a work order agreement with Theradex, to monitor the NKI Phase 1b clinical

trial of LB-100 combined with atezolizumab, a PD-L1 inhibitor, for patients with microsatellite stable metastatic colorectal cancer.

The study oversight is expected to be completed by May 31, 2027.

under this work order agreement are estimated to be approximately $106,380, with such payments expected to be allocated approximately

47% to Theradex for services and approximately 53% for payments for pass-through software costs.

During the year ended December 31, 2024,

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Company’s aggregate commitment pursuant to this clinical trial monitoring agreement, less amounts previously paid to date, totaled

approximately $141,000 as of December 31, 2023, which is expected to be incurred through June 30, 2026.

approximately $88,000 as of December 31, 2024, which is expected to be incurred through May 31, 2027.

and License Agreements

Institute of Health.

Effective February 23, 2024, the Company entered into a Patent License Agreement (the “License Agreement”)

with the National Institute of Neurological Disorders and Stroke (“NINDS”) and the National Cancer Institute (“NCI”),

each an institute or center of the National Institute of Health (“NIH”).

Pursuant to the License Agreement, the Company has

licensed on an exclusive basis the NIH’s intellectual property rights claimed for a Cooperative Research and Development Agreement

(“CRADA”) subject invention co-developed with the Company, and the licensed field of use, which focuses on promoting anti-cancer

activity alone, or in combination with standard anti-cancer drugs.

The scope of this clinical research extends to checkpoint inhibitors,

immunotherapy, and radiation for the treatment of cancer.

The License Agreement is effective, and shall extend, on a licensed product,

licensed process, and country basis, until the expiration of the last-to-expire valid claim of the jointly owned licensed patent rights

in each such country in the licensed territory, estimated at twenty years, unless sooner terminated.

License Agreement contemplates that the Company will seek to work with pharmaceutical companies and clinical trial sites (including comprehensive

cancer centers) to initiate clinical trials within timeframes that will meet certain benchmarks.

Data from the clinical trials will be

the subject of various regulatory filings for marketing approval in applicable countries in the licensed territories.

Subject to the

receipt of marketing approval, the Company would be expected to commercialize the licensed products in markets where regulatory approval

has been obtained.

Company is obligated to pay the NIH a non-creditable, non-refundable license issue royalty of $50,000 and a first minimum annual royalty

within sixty days from the effective date of the Agreement.

The first minimum annual royalty of $25,643 was prorated from the effective

date of the License Agreement to the next subsequent January 1.

Thereafter, the minimum annual royalty of $30,000 is due each January

1 and may be credited against any earned royalties due for sales made in that year.

The license issue royalty of $50,000 and the first

minimum annual royalty of $25,643, were paid in April 2024.

The second minimum annual royalty for 2025 of $30,000, was paid in December

2024 and is included in other prepaid expenses at December 31, 2024 in the accompanying consolidated balance sheet.

Company is obligated to pay the NIH, on a country-by-country basis, earned royalties of 2% on net sales of each royalty-bearing product

and process, subject to reduction by 50% under certain circumstances relating to royalties paid by the Company to third parties, but

not less than 1%.

The Company’s obligation to pay earned royalties under the License Agreement commences on the date of the first

commercial sale of a royalty-bearing product or process and expires on the date on which the last valid claim of the licensed product

or licensed process expires in such country.

Company is obligated to pay the NIH benchmark royalties, on a one-time basis, within sixty days from the first achievement of each such

The License Agreement defines four such benchmarks, which the Company is required to pursue based on “commercially reasonable

efforts” as defined in the License Agreement, with deadlines of October 1, 2024, 2027, 2029 and 2031, respectively, each with a

different specified benchmark payment amount payable within thirty days of achieving such benchmark.

The October 1, 2024 benchmark of

$100,000 was defined as the dosing of the first patient with a licensed product in a Phase 2 clinical study of such licensed product

in the licensed fields of use.

The Company had not commenced a Phase 2 clinical study as of December 31, 2024.

The total of all such

benchmark payments is $1,225,000.

Company is obligated to provide annual reports to the NIH on its progress toward the development and commercialization of products under

the licensed patents.

These reports, due within sixty days following the end of each calendar year, must include updates on research

and development activities, regulatory submissions, manufacturing efforts, sublicensing, and sales initiatives.

If any deviations from

the established commercial development plan or agreed-upon benchmarks occur, the Company is obligated to provide explanation and may

amend the commercial development plan and the benchmarks, which, subject to certain conditions, the NIH shall not unreasonably withhold,

condition, or delay approval of any request of the Company to amend the commercial development plan and/or the benchmarks and to extend

the time periods of the benchmarks.

Company is obligated to pay the NIH sublicensing royalties of 5% on sublicensing revenue received for granting each sublicense within

sixty days of receipt of such sublicensing revenue.

the year ended December 31, 2024, the Company incurred costs of $75,643 in connection with its obligations under the License Agreement.

Such costs when incurred have been included in general and administrative costs in the Company’s consolidated statement of operations.

As of December 31, 2024, total costs of $75,643 have been incurred pursuant to this agreement.

The Company’s aggregate commitment

pursuant to this agreement, less amounts previously paid to date, totaled approximately $1,795,000 as of December 31, 2024, which is

expected to be incurred over approximately the next twenty years.

Effective August 20, 2018, the Company entered into an Exclusive License Agreement with Moffitt.

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the Licensed Patents.

The Company was obligated to pay Moffitt a non-refundable license issue fee of $25,000 after the first patient

was entered into a Phase 1b/2 clinical trial to be managed and conducted by Moffitt.

The clinical trial began at a single site in April

2019 and the first patient was entered into the clinical trial in July 2019.

The Company was also obligated to pay Moffitt an annual

license maintenance fee of $25,000 commencing on the first anniversary of the Effective Date and every anniversary thereafter until the

Company commences payment of minimum royalty payments.

The Company had also agreed to pay non-refundable milestone payments to Moffitt,

which could not be credited against earned royalties payable by the Company, based on reaching various clinical and commercial milestones

aggregating $1,897,000, subject to reduction by 40% under certain circumstances relating to the status of Valid Claims, as such term

is defined in the License Agreement.

October 4, 2023, the Company received a counter-signed termination letter dated September 29, 2023 with respect to the Exclusive License

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The Company and Moffitt agreed that no

termination fee shall be due or payable by the Company, and Moffitt acknowledged that no payments are owed by the Company under the Agreement.

termination fee was due or payable by the Company, and Moffitt acknowledged that no payments are owed by the Company under the Agreement.

the year ended December 31, 2023, the Company recorded a credit to operations of $9,109 representing the reversal of obligations previously

recorded with respect to the Exclusive License Agreement.

During the year ended December 31, 2022, the Company recorded charges to operations

of $25,000, in connection with its obligations under the Exclusive License Agreement.

Agreements with Officers

July and August 2020, the Company entered into one-year employment agreements with each of its executive officers at that time, consisting

Kovach, Eric J.

Miser, and Robert N.

Weingarten, which provided for aggregate annual cash compensation

of $640,000, payable monthly.

These employment agreements were automatically renewable for additional one-year periods unless terminated

by either party upon 60 days written notice prior to the end of the applicable one-year period, or by death, or by termination for cause.

These employment agreements were automatically renewed for additional one-year periods in July and August 2021, 2022 and 2023.

April 9, 2021, the Board of Directors increased the annual cash compensation of Eric J.

Miser, and Robert N.

under the employment agreements, such that the aggregate annual compensation for all officers increased to $775,000, effective May 1,

November 6, 2022, Mr.

Forman was promoted to Vice President and Chief Operating Officer, with an annual salary of $200,000.

Forman is being provided an office allowance of approximately $1,500 per month through December 31, 2023.

September 26, 2023, the Company entered into an employment agreement with Bastiaan van der Baan to act as the Company’s President

and Chief Executive Officer and as Vice Chairman of the Board of Directors with an annual salary of $150,000.

The term of the employment

agreement is for three years and is automatically renewable for additional one-year periods unless terminated by either party, subject

to early termination as described in the employment agreement.

Under the employment agreement, Mr.

van der Baan’s annual salary

may be increased from time to time at the sole discretion of the Board of Directors.

In addition, Mr.

van der Baan will be eligible to

receive an annual bonus as determined at the sole discretion of the Board of Directors.

van der Baan was appointed as Chairman of

the Board of Directors upon the death of Dr.

Kovach, who died on October 5, 2023.

aggregate annual cash compensation for all officers was $700,000 as of December 31, 2023.

Significant Agreements and Contracts

Consulting Corp.

On December 24, 2013, the Company entered into an agreement with NDA Consulting Corp.

for consultation and advice

in the field of oncology research and drug development.

As part of the agreement, NDA also agreed to cause its president, Dr.

Von Hoff, M.D., to become a member of the Company’s Scientific Advisory Committee.

The term of the agreement was for one year

and provided for a quarterly cash fee of $4,000.

The agreement has been automatically renewed for additional one-year terms on its anniversary

date since 2014.

Consulting and advisory fees charged to operations pursuant to this agreement were $16,000 and $16,000 for the years

ended December 31, 2023 and 2022, respectively, which were included in research and development costs in the consolidated statements

of operations.

On December 24, 2013, the Company entered into a consulting agreement with NDA Consulting Corp.

for consultation

and advice in the field of oncology research and drug development.

As part of the consulting agreement, NDA also agreed to cause its

president, Dr.

Von Hoff, M.D., to serve on the Company’s Scientific Advisory Committee during the term of such consulting

The term of the consulting agreement was for one year and provided for a quarterly cash fee of $4,000.

The consulting agreement

had been automatically renewed for additional one-year terms on its anniversary date, most recently on December 24, 2023, but was subsequently

terminated effective September 30, 2024.

Consulting and advisory fees charged to operations pursuant to this consulting agreement were

$12,000 and $16,000 for the years ended December 31, 2024 and 2023, respectively

BioPharmaWorks .

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Company agreed to pay BioPharmaWorks a monthly fee of $10,000, subject to the right of the Company to pay a negotiated hourly rate in

lieu of the monthly payment and agreed to issue to BioPharmaWorks certain equity-based compensation.

The Company recorded charges to

operations pursuant to this Collaboration Agreement of $120,000 and $120,000 for the years ended December 31, 2023 and 2022, respectively,

which were included in research and development costs in the consolidated statements of operations.

lieu of the monthly fee.

Effective March 1, 2024, the compensation payable under the Collaboration Agreement was converted to an hourly

rate structure.

Company recorded charges to operations pursuant to this Collaboration Agreement of $39,200 and $120,000 during the years ended December

31, 2024 and 2023, respectively, which were included in research and development costs in the consolidated statements of operations.

Cancer Institute .

4 unchanged sentences

by Amendment No.

The Development Collaboration Agreement is intended to identify the most promising drugs to be combined with

LB-100, and potentially LB-100 analogues, to be used to treat a range of cancers, as well as to identify the specific molecular mechanisms

underlying the identified combinations.

The Company agreed to fund the study, at an approximate cost of 391,000 Euros and provide a sufficient

supply of LB-100 to conduct the study.

The Development Collaboration Agreement is a preclinical study intended to identify the most promising drugs

to be combined with LB-100, and potentially LB-100 analogues, to be used to treat a range of cancers, as well as to identify the specific

molecular mechanisms underlying the identified combinations.

The Company agreed to fund the preclinical study, at an approximate cost

of 391,000 Euros and provide a sufficient supply of LB-100 to conduct the preclinical study.

October 3, 2023, the Company entered into Amendment No.

2 to the Development Collaboration Agreement with NKI, which provides for additional

research activities, extends the termination date of the Development Collaboration Agreement by two years to October 8, 2026, and adds

500,000 Euros (approximately $542,000 at December 31, 2023) to the operating budget being funded by the Company.

research activities, extends the termination date of the Development Collaboration Agreement by two years to October 8, 2026, and added

500,000 Euros to the operating budget being funded by the Company.

October 4, 2024, the Company entered into Amendment No.

3 to the Development Collaboration Agreement with NKI, which suspended Amendment

2 and provided for a new study term of one year and starts upon the dosing of the first patient in the clinical trial at a project

cost of 100,000 Euros.

the years ended December 31, 2024 and 2023, the Company incurred charges in the amount of $210,362 and $226,150, respectively, with respect

to this agreement, which amounts are included in research and development costs in the Company’s consolidated statements of operations.

As of December 31, 2023, total costs of $485,556 have been incurred pursuant to this agreement, as amended.

The Company’s aggregate

commitment pursuant to this agreement, as amended, less amounts previously paid to date, totaled approximately $595,000 as of December

31, 2023, which is expected to be incurred through October 8, 2026.

As the work is being conducted in Europe and is paid for in Euros,

final costs are subject to foreign currency fluctuations between the United States Dollar and the Euro.

The Company has contracted with MRI Global for stability analysis, storage and distribution of LB-100 for clinical trials

in the United States.

On June 10, 2022, the contract was amended to reflect a new total contract price of $273,980 for services to be

rendered through April 30, 2023.

Effective April 17, 2023, the contract was further amended to reflect a new total contract price of

$326,274 for services to be rendered through April 30, 2024.

During the years ended December 31, 2023 and 2022, the Company incurred

costs of $32,307 and $27,702, respectively, pursuant to this work order.

As of December 31, 2023, total costs of $248,298 have been incurred

As of December 31, 2024, total costs of $695,918 have been incurred pursuant to this agreement.

The Company’s aggregate commitment

pursuant to this agreement, less amounts previously paid to date, totaled approximately $104,000 as of December 31, 2024, which is expected

to be incurred through October 8, 2026.

As the work is being conducted in Europe and is paid for in Euros, final costs are subject to

foreign currency fluctuations between the United States Dollar and the Euro.

As amended, the Company has contracted with MRI Global for stability analysis, storage and distribution of LB-100 for clinical

trials in the United States.

During the years ended December 31, 2024 and 2023, the Company incurred costs of $23,308 and $32,307, respectively,

pursuant to this contract.

Company’s aggregate commitment pursuant to this contract, less amounts previously paid to date, totaled approximately $78,000 as

of December 31, 2023.

As of December 31, 2024, total costs of $340,522 have been incurred pursuant to this contract.

Company’s aggregate commitment pursuant to this contract, less amounts previously paid to date, totaled approximately $118,000

as of December 31, 2024.

Events and Uncertainties

11 unchanged sentences

we would be required to reduce or discontinue our research and development programs, or attempt to obtain funds, if available, through

strategic alliances that may require us to relinquish rights to our pharmaceutical compounds, or to curtail or discontinue our operations

strategic alliances, joint ventures or other transaction structures that could require the Company to relinquish rights to and/or control

of LB-100, or to discontinue operations entirely.

than as discussed above, we are not currently aware of any trends, events or uncertainties that are likely to have a material effect

7 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 7. Management’s Discussion and Analysis