What changed in this filing

/stocks — the workspaceLOADING

Item 7. Management’s Discussion and Analysis

2024-03-19 compared with 2023-03-29 · 560 added, 606 removed, 311 unchanged (79% of the section changed)

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operating requirements.

following is a summary of news releases issued by the Company subsequent to December 31, 2022:

of February 7, 2023 News Release

Company announced that a team of scientists headed by Professor René Bernards at the Netherlands Cancer Institute, Amsterdam,

and member of the Board of Directors of the Company, reported that in three difficult to treat cancer types, the Company’s lead

clinical compound, LB-100, combined with an inhibitor of the WEE1 kinase, caused unexpectedly effective cancer cell killing.

Most surprisingly,

when cancer cells acquire resistance to this combination therapy, they have highly reduced cancer-causing capacity in animal models.

This observation indicates that this LB-100 combination therapy can force cells to give up their cancer-causing properties to acquire

drug resistance.

Kovach, M.D., Chief Executive Officer and Founder of the Company, was a co-author of the report (see BioRxiv (https://www.biorxiv.org/content/10.1101/2023.02.06.527335v1)

entitled “Paradoxical activation of oncogenic signaling as a cancer treatment strategy”.

following are comments by Dr.

Kovach that were included in the news release:

the past 20 years, efforts to develop better cancer therapies have focused on inhibiting the stimulatory effects of the oncogenes, but

such therapies often deliver only modest benefit to patients with advanced cancer due to development of resistance.

Matheus Henrique

Dias, working in the laboratory of Professor René Bernards at the Netherlands Cancer Institute, Amsterdam, and an international

team of collaborators, have now shown that treatment of cancer cells with the Company’s unique lead clinical compound, LB-100,

rather than inhibiting, further stimulates the signals that drive cancer cell proliferation, but paradoxically, impeding cell proliferation.

authors also show that combination of LB-100 with an inhibitor of WEE1, a regulator of stress responses in the cell, leads to highly

efficient cancer cell death in three hard-to-treat cancer models:

colorectal, pancreatic, and bile duct carcinomas.

The Bernards’

group contends that this paradoxical result stems from the fact that the survival of cancer cells depends on a balance between activated

oncogenic pathways driving tumorigenesis and engagement of stress-response programs that counteract the inherent toxicity of such aberrant

Normal cells, which are not in proliferation overdrive in the first place, apparently can tolerate transient overstimulating

signaling much better than cancer cells.

The combination of LB-100 and WEE1 inhibition suppressed the growth of patient-derived tumors

refractory to conventional therapies and was associated with only modest toxicity in animal models.

Intriguingly,

the authors present evidence to indicate that cancer cells that become resistant to this LB-100 combination therapy do so by losing some

important cancer cell characteristics and are less cancerous in animal models.

This “tumor suppressive drug resistance” still

needs to be demonstrated in patients.

However, given the safety profile in animal models of LB-100 in combination with WEE1 inhibition,

this hypothesis should be readily testable in the clinic.

of February 14, 2023 News Release

Company announced that, as recently reported in The Journal of Clinical Investigation, PP2A, the pharmacologic target of the Company’s

lead clinical compound, LB-100, when deficient, enhances the effects of immune checkpoint blockade of cancer in a mouse model by a previously

unappreciated mechanism.

article, entitled “PP2Ac/STRN4 negatively regulates STING-Type I interferon signaling in tumor associated macrophages,” was

recently published and is available online at https://www.jci.org/articles/view/162139.

The authors state that “PP2A/STRN4-YAP/TAZ

is a previously unappreciated mechanism that mediate[s] immunosuppression in tumor-associated macrophages and targeting PP2A/STRN4-YAP/TAZ

axis can sensitize tumors to immunotherapy.”

following are comments by Dr.

Kovach that were included in the news release:

paper lends additional support to the potential immunotherapy application of LB-100 in cancer treatment.

Ho, Assistant

Professor of Neurological Surgery at the UCSF School of Medicine, co-lead author of the article, and a former member of the Company’s

Board of Directors, bolsters the case for testing LB-100 in combination with immunotherapy in the clinic.

Studies in animals show that

low doses of LB-100 enhance the effectiveness of immunotherapy against a variety of cancer types by several mechanisms (Ho et al., Nature

Nature Comm 2021).

Company is currently recruiting for a clinical trial in patients with previously untreated extensive stage small cell lung cancer in

which LB-100 is first added to chemotherapy and an immune checkpoint blocker and then administered with the immune blocker alone in the

maintenance phase of treatment (NCT04560972).

The Company is presently seeking to develop other collaborative clinical studies to determine

whether LB-100 significantly enhances the effectiveness of immunotherapy of cancer in general.

Notification of Failure to Satisfy a Continued Listing Rule

June 24, 2022, the Company received an initial notification from Nasdaq related to our failure to maintain a minimum bid price of $1.00

per share for a period of 30 consecutive business days.

The Nasdaq Listing Rules provided us a compliance period of 180 calendar days

in which to regain compliance, which in the case of the initial notification was December 21, 2022.

As we did not regain compliance with

the minimum bid price requirement, by notice from Nasdaq dated December 22, 2022, we were afforded a second 180 calendar day compliance

Accordingly, if at any time from the date of this notice until June 19, 2023, the closing bid price of our common stock is at

least $1.00 per share for a minimum of 10 consecutive business days, Nasdaq will provide us with written confirmation of compliance and

the matter will be closed, although Nasdaq has the discretion to withhold such confirmation.

order to achieve compliance with the minimum closing bid price per share requirement, the Company intends to file a proxy statement to

hold a special meeting of stockholders to seek approval to effect a reverse stock split of its issued and outstanding shares of common

However, there can be no assurance that the Company will be successful in this regard and will be able to regain compliance with

the minimum closing bid price requirement by June 19, 2023, in which case the Company anticipates Nasdaq would provide a notice to the

Company that its shares of common stock and warrants are subject to delisting, and the Company’s common shares and warrants would

then be delisted.

there can be no assurance that the market price per new share of our common stock after the reverse stock split will remain unchanged

or increase in proportion to the reduction in the number of old shares of our common stock outstanding before the reverse stock split.

Even if the reverse stock split is approved by our stockholders, there can be no assurance that we will be able to maintain compliance

with the minimum bid price requirement in the future or will otherwise be able to maintain compliance with other Nasdaq listing rules.

the Company is delisted from Nasdaq, its common stock and warrants may be eligible for trading on an over-the-counter market.

Company is not able to obtain a listing on another stock exchange or quotation service for its common stock and warrants, it may be extremely

difficult or impossible for stockholders to sell their shares of common stock and warrants.

Moreover, if the Company is delisted from

Nasdaq, but obtains a substitute listing for its common stock and warrants, it will likely be on a market with less liquidity, and therefore

experience potentially more price volatility than experienced on Nasdaq.

Stockholders may not be able to sell their shares of common

stock and warrants on any such substitute market in the quantities, at the times, or at the prices that could potentially be available

on a more liquid trading market.

As a result of these factors, if the Company’s common stock is delisted from Nasdaq, the value

and liquidity of the Company’s common stock and warrants would likely be significantly adversely affected.

A delisting of the Company’s

common stock from Nasdaq could also adversely affect the Company’s ability to obtain financing for its operations and/or could

result in a loss of confidence by investors, employees and/or business partners.

December 31, 2022, the Company had cash of $5,353,392 available to fund its operations.

Because the Company is currently engaged in Phase

2 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.

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.

the year ended December 31, 2023, the Company recorded a net loss of $5,087,029 and used cash in operations of $4,293,265.

31, 2023, the Company had cash of $4,203,488 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.

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

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the recurring sale of its equity securities.

a result, management has concluded that there is 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.

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.

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 existing cash resources 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

December 31, 2023.

Existing cash resources will not be sufficient to complete the development of and obtain regulatory approval for the

Company’s product candidate, as a result of which the Company will need to raise significant additional capital to do so.

estimates that it will need to raise additional capital to fund its operations, including its various clinical trial commitments, during

the latter part of the fiscal year ending December 31, 2023.

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

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

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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.

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

Accounting Pronouncements

December 2019, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”)

2019-12, Income Taxes (Topic 740):

Simplifying the Accounting for Income Taxes (“ASU 2019-12”).

ASU 2019-12 simplifies the

accounting for income taxes by removing certain exceptions and enhances and simplifies various aspects of the income tax accounting guidance

The Company adopted ASU 2019-12 effective January 1, 2021.

The adoption of ASU 2019-12 did not have any impact on the Company’s

consolidated financial statement presentation or disclosures.

August 2020, the FASB issued ASU 2020-06, Debt — Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts

in Entity’s Own Equity (Subtopic 815-40):

Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity

(“ASU 2020-06”).

ASU 2020-06 simplifies the accounting for convertible debt by eliminating the beneficial conversion and

cash conversion accounting models.

Upon adoption of ASU 2020-06, convertible debt proceeds, unless issued with a substantial premium

or an embedded conversion feature that is not clearly and closely related to the host contract, will no longer be allocated between debt

and equity components.

This modification will reduce the issue discount and result in less non-cash interest expense in financial statements.

ASU 2020-06 also updates the earnings per share calculation and requires entities to assume share settlement when the convertible debt

can be settled in cash or shares.

For contracts in an entity’s own equity, the type of contracts primarily affected by ASU 2020-06

are freestanding and embedded features that are accounted for as derivatives under the current guidance due to a failure to meet the

settlement assessment by removing the requirements to (i) consider whether the contract would be settled in registered shares, (ii) consider

whether collateral is required to be posted, and (iii) assess shareholder rights.

ASU 2020-06 is effective for fiscal years beginning

after December 15, 2023.

Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, and only if

adopted as of the beginning of such fiscal year.

The Company adopted ASU 2020-06 effective January 1, 2021.

The adoption of ASU 2020-06

did not have any impact on the Company’s consolidated financial statement presentation or disclosures.

May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt — Modifications and Extinguishments (Subtopic 470-50),

Compensation — Stock Compensation (Topic 718), and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic

Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (“ASU

ASU 2021-04 provides guidance as to how an issuer should account for a modification of the terms or conditions or an

exchange of a freestanding equity-classified written call option (i.e., a warrant) that remains classified after modification or exchange

as an exchange of the original instrument for a new instrument.

An issuer should measure the effect of a modification or exchange as

the difference between the fair value of the modified or exchanged warrant and the fair value of that warrant immediately before modification

or exchange and then apply a recognition model that comprises four categories of transactions and the corresponding accounting treatment

for each category (equity issuance, debt origination, debt modification, and modifications unrelated to equity issuance and debt origination

or modification).

ASU 2021-04 is effective for all entities for fiscal years beginning after December 15, 2021, including interim periods

within those fiscal years.

An entity should apply the guidance provided in ASU 2021-04 prospectively to modifications or exchanges occurring

on or after the effective date.

The Company adopted ASU 2021-04 effective January 1, 2022.

The adoption of ASU 2021-04 did not have any

impact on the Company’s consolidated financial statement presentation or disclosures.

does not believe that any other recently issued, but not yet effective, authoritative guidance, if currently adopted, would have a material

impact on the Company’s financial statement presentation or disclosures.

description of recently issued accounting pronouncements that may potentially impact the Company’s consolidated financial statements,

including their presentation and related disclosures, is provided in Note 2 to consolidated financial statements included elsewhere in

this document.

Concentration

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Charges incurred

for these services can be for a specific time period (typically one year) or for a specific project or task.

Costs and expenses incurred

that represented 10% or more of general and administrative costs or research and development costs for the years ended December 31, 2022

and 2021 are described as follows.

and administrative costs for the years ended December 31, 2022 and 2021 included charges from legal firms and other vendors for general

for these services can be for a specific period (typically one year) or for a specific project or task.

Costs and expenses incurred that

represented 10% or more of general and administrative costs or research and development costs for the years ended December 31, 2023 and

2022 are described as follows.

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

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of total general and administrative costs.

and development costs for the year ended December 30, 2022 included charges from four vendors and consultants representing 21.0%, 19.3%,

and development costs for the year ended December 31, 2023 include charges from three vendors and consultants representing 29.9%, 25.2%

and 13.7%, respectively, of total research and development costs.

Research and development costs for the year ended December 31, 2022

2021 included charges from three vendors and consultants representing 30.3%, 21.8% and 14.4%, respectively.

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

Accounting Policies and Estimates

preparation of the Company’s consolidated financial statements in conformity with generally accepted accounting principles in the

United States (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and

liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period.

Some of those judgments

can be subjective and complex, and therefore, actual results could differ materially from those estimates under different assumptions

or conditions.

Management bases its estimates on historical experience and on various assumptions that are believed to be reasonable

in relation to the financial statements taken as a whole under the circumstances, the results of which form the basis for making judgments

about the carrying values of assets and liabilities that are not readily apparent from other sources.

Management regularly evaluates

the key factors and assumptions used to develop the estimates utilizing currently available information, changes in facts and circumstances,

historical experience and reasonable assumptions.

After such evaluations, if deemed appropriate, those estimates are adjusted accordingly.

preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported

amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period.

Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates under

different assumptions or conditions.

Management bases its estimates on historical experience and on various assumptions that are believed

to be reasonable in relation to the financial statements taken, as a whole, under the circumstances, the results of which form the basis

for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.

regularly evaluates the key factors and assumptions used to develop the estimates utilizing currently available information, changes

in facts and circumstances, historical experience, and reasonable assumptions.

After such evaluations, if deemed appropriate, those estimates

are adjusted accordingly.

Actual results could differ from those estimates.

Significant estimates include those related to assumptions used in the calculation

of accruals for clinical trial costs and other potential liabilities, valuing equity instruments issued for services, and the realization

of deferred tax assets.

Significant estimates include those related to assumptions

used in the calculation of accruals for clinical trial costs and other potential liabilities, and valuing equity instruments issued for

following critical accounting policies affect the more significant judgements and estimates used in the preparation of the Company’s

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The Company’s policy is to maintain its cash

balances with financial institutions with high credit ratings and in accounts insured by the Federal Deposit Insurance Corporation (the

“FDIC”) and/or by the Securities Investor Protection Corporation (the “SIPC”).

The Company periodically has cash

balances in financial institutions in excess of the FDIC and SIPC insurance limits of $250,000 and $500,000, respectively.

Morgan Stanley

Wealth Management also maintains supplemental insurance coverage for the cash balances of its customers.

The Company has not experienced

any losses to date resulting from this policy.

balances with financial institutions in the United States with high credit ratings and in accounts insured by the Federal Deposit Insurance

Corporation (the “FDIC”) and/or by the Securities Investor Protection Corporation (the “SIPC”).

The Company periodically

has cash balances in financial institutions in excess of the FDIC and SIPC insurance limits of $250,000 and $500,000, respectively.

Stanley Wealth Management also maintains supplemental insurance coverage for the cash balances of its customers.

The Company has not

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

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

Chief Executive Officer and Chief Scientific Officer.

and Chief Executive Officer.

and Development

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

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

Research and development

costs also include the costs to manufacture the 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 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.

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

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and Licensing Legal and Filing Fees and Costs

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

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

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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 were $1,268,308 and $729,171, respectively, an increase of $539,137, or 73.9%, in 2022 as

compared to 2021.

late 2021, the Company engaged a new patent law firm that is highly regarded for its expertise in biotechnology.

This firm conducted

a comprehensive analysis of the Company’s extensive patent portfolio in order to implement a program to maximize intellectual property

protection, both domestically and internationally.

In addition, several patents were filed in 2022, reflecting potential new uses of

the Company’s lead clinical compound LB-100 in cancer therapy.

These activities resulted in an increase in patent and licensing

legal and filing fees and costs in 2022 as compared to 2021.

The Company expects that patent and licensing legal and filing fees and

costs will continue to increase in 2023 as compared to 2022, although at a slower rate of increase, as the Company continues to develop

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.

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.

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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.

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.

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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satisfy stock option exercises.

Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s

specific terms and applicable authoritative guidance in Accounting Standards Codification (“ASC”) 480, Distinguishing Liabilities

from Equity (“ASC 480”), and ASC 815, Derivatives and Hedging (“ASC 815”).

The assessment considers whether the

warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether

the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the

Company’s own common stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance

outside of the Company’s control, among other conditions for equity classification.

The Company has determined that the warrants

issued in the July 20, 2023 equity financing meet the requirements for equity classification.

This assessment, which requires the use

of professional judgment, is conducted when the warrants are issued and at the end each subsequent quarterly period while the warrants

are outstanding.

For issued or modified warrants that meet all of the criteria for equity classification, the warrants are required to

be recorded as a component of additional paid-in capital at the time of issuance.

For issued or modified warrants that do not meet all

of the criteria for equity classification, the warrants are required to be liability classified and recorded at their initial fair value

on the date of issuance and remeasured at fair value at each balance sheet date thereafter.

Changes in the estimated fair value of the

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

of Business Activities and Plans

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.

The 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, and encompasses

two major categories of compounds at various stages of pre-clinical and clinical development that the Company believes have broad therapeutic

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

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.

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

Lead compounds from

each series have activity against a broad spectrum of common and rarer human cancers in cell culture systems.

In addition, compounds

from both 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 enhancing toxicity in humans.

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

LB-100 series consists of novel structures which have the potential to be first in their class and may be useful in the treatment of

not only several types of cancer but also vascular and metabolic diseases.

The LB-200 series contains compounds which have the potential

to be the most effective in its class and may be useful for the treatment of chronic hereditary diseases, such as Gaucher’s disease,

in addition to cancer and neurodegenerative diseases.

Company has demonstrated that lead compounds of both the LB-100 series and the LB-200 are active against a broad spectrum of human cancers

in cell culture and against several types of human cancers in animal models.

The research on these compounds was initiated in 2006 under

a Cooperative Research and Development Agreement, or CRADA, with the National Institute of Neurologic Disorders and Stroke, or NINDS,

of the National Institutes of Health, or NIH, dated March 22, 2006 that was subsequently extended through a series of amendments until

it terminated on April 1, 2013.

As discussed below, the Company’s primary focus is on the clinical development of LB-100.

LB-200 series consists of histone deacetylase inhibitors (HDACi).

Many pharmaceutical companies are also developing drugs of this type,

and at least two companies have HDACi approved for clinical use, in both cases for the treatment of a type of lymphoma.

significant competition, the Company has demonstrated that its HDACi have broad activity against many cancer types, have neuroprotective

activity, and have anti-fungal activity.

In addition, these compounds have low toxicity.

LB-200 has not yet advanced to the clinical

stage and would require additional capital to fund further development.

Accordingly, because of the Company’s focus on the clinical

development of LB-100 and analogs for cancer therapy as described below in more detail, the Company has decided not to actively pursue

the pre-clinical development of the LB-200 series of compounds.

At this time, the Company intends to only maintain composition and synthesis

patents on the LB-200 series of compounds in the United States.

Collaborations

with leading academic research centers in the United States, Europe and Asia have established the breadth of activity of LB-100 in pre-clinical

models of several major cancers.

There is considerable scientific interest in LB-100 because it exerts its activity by a novel mechanism

and is the first of its type to be evaluated so broadly in multiple animal models of cancer and now in human beings.

LB-100 is one of

a series of serine/threonine phosphatase (s/t ptase) inhibitors designed by the Company.

The s/t ptases are ubiquitous enzymes that regulate

many cell signaling networks important to cell growth, division and death.

The s/t ptases have long been appreciated as potentially important

targets for anti-cancer drugs.

However, because of the multi- functionality of these enzymes, it had been widely held that pharmacologic

inhibitors of s/t ptases would be too toxic to allow their development as anti-cancer treatments, but the Company has shown that this

is not the case.

LB-100 was well tolerated at doses associated with objective regression (significant tumor shrinkage) and/or the arresting

of tumor progression in patients with progressive cancers.

studies showed that LB-100 itself inhibits a spectrum of human cancers and that combined with standard cytotoxic drugs and/or radiation,

LB-100 potentiates their effectiveness against hematologic and solid tumor cancers without enhancing toxicity.

Given at very low doses

in animal models of cancer, LB-100 markedly increased the effectiveness of a PD-1 blocker, one of the widely used new immunotherapy drugs.

This finding raises the possibility that LB-100 may further expand the value of the expanding field of cancer immunotherapy.

Company completed a Phase 1 clinical trial of LB-100 to evaluate its safety that showed it is associated with antitumor activity in humans

at doses that are readily tolerable.

Responses included objective regression (tumor shrinkage) lasting for 11 months of a pancreatic

cancer and cessation of growth (stabilization of disease) for 4 months or more of 9 other progressive solid tumors out of 20 patients

who had measurable disease.

As Phase 1 clinical trials are fundamentally designed to determine safety of a new compound in humans, the

Company was encouraged by these results.

The next step is to demonstrate in Phase 2 clinical trials the efficacy of LB-100 in one or

more specific tumor types, against which the compound has well documented activity in pre-clinical models.

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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the world as businesses and governments implemented broad actions to mitigate this public health crisis.

The extent to which the coronavirus

pandemic may impact the Company’s business activities and capital raising efforts will depend on future developments, which are

uncertain and cannot be predicted.

The Company is continuing to monitor this situation and will adjust its current business plans to

the extent additional information and guidance become available.

The coronavirus pandemic has also presented a challenge to medical facilities

Although the Company’s clinical trials are conducted on an outpatient basis, the coronavirus pandemic appears to have

caused some delays in the Company’s clinical trials, but the impact of the coronavirus pandemic appears to be subsiding.

The Company does not believe that inflation 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 operating costs (including, specifically,

clinical trial costs), and which would put additional stress on the Company’s working capital resources.

Although Covid-19 outbreak has

subsided, the extent to which the coronavirus pandemic may reappear and impact the Company’s clinical trial programs and capital

raising efforts in the future is uncertain and cannot be predicted.

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

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

capital resources.

Chain Issues.

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including its ongoing clinical trials.

There are various indications that the United States economy may be entering a recessionary period.

Although unclear at

this time, an economic recession would likely impact the general business environment and the capital markets, which could, in turn,

There are some indications that the United States economy may be at risk of entering a recessionary period.

Although unclear

at this time, an economic recession would likely impact the general business environment and the capital markets, which could, in turn,

affect the Company.

The geopolitical landscape poses inherent risks that could significantly impact the operations and financial performance of

In the event of a military conflict, supply chain disruptions, geopolitical uncertainties, and economic repercussions may

adversely affect the Company’s ability to conduct research, develop, test and manufacture products, and distribute them globally.

This could lead to delays in product development, interruptions in the supply of critical materials, and delays in clinical trials, thereby

impeding the Company’s clinical development and commercialization plans.

Furthermore, the impact of a conflict on global financial

markets may result in increased volatility and uncertainty in the capital markets, thereby affecting the valuation of the Company’s

publicly-traded shares.

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

Such geopolitical

risks are outside the control of the Company, and the actual effects on the Company’s business, financial condition and results

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

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

Years Ended December 31,

Ended December 31,

and expenses:

and administrative costs:

to related parties

and licensing legal and filing fees and costs

costs and expenses

General and administrative costs:

Compensation to related parties

Patent and licensing legal and filing fees and costs

Research and development costs

Total costs and expenses

Loss from operations

Interest income

Interest expense

Foreign currency gain (loss)

$ (6,312,535 )

$ (6,728,396 )

Net loss per common share – basic and diluted

Weighted average common shares outstanding – basic and diluted

and development costs

costs and expenses

from operations

currency gain (loss)

loss per common share – basic and diluted

average common shares outstanding – basic and diluted

Ended December 31, 2023 and 2022

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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 $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, licensing fees of $25,000, 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, and other operating

costs of $19,721.

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

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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 $92,833, licensing fees of $25,000, shareholder reporting costs of $42,792, listing fees of $58,000, filing

fees of $18,114, taxes and licenses of $16,200, investor relations of $8,760, and other operating costs of $14,107.

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 $698,504, a decrease in other consulting and professional fees of $160,603,

offset by an increase in patent and licensing legal and filing fees and costs of $539,137, an increase in cash-based director and board

committee fees of $173,187, an increase in officer’s salary and related costs of $50,636, and an increase in insurance expense

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 .

For 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 consultant of $43,264, 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 $363,829, and pre-clinical

research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $589,314.

For 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.

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 $397,642, contractor costs incurred in connection with the synthesis work done to develop a new supply of LB-100

for the Spanish clinical trial of $624,187, clinical and related oversight costs of $456,921, and pre-clinical research focused on development

of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $258,026.

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.

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.

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 consultant of $354,378, a decrease in contractor costs incurred in connection with the synthesis work

done to develop a new supply of LB-100 of $271,325, a decrease in clinical and related oversight costs of $93,092, offset by an increase

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

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.

For the year ended December 31, 2023, the Company had interest income of $17,486, as compared to interest income of $11,195

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insurance policy.

Currency Loss .

For the year ended December 31, 2022, the Company had a foreign currency loss of $3,374, as compared to a foreign

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.

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Net increase (decrease) in cash

$ (1,146,904 )

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 an increase in working capital of $374,889 for the year ended December 31, 2022.

The increase in working capital during the

year ended December 31, 2022 was the result of the Company completing the sale of 2,900,000 shares of common stock at a price of $2.00

per share in a registered direct equity offering on April 12, 2022, generating net proceeds of $5,141,384, reduced by the funding of

the Company’s ongoing research and development activities and other ongoing operating expenses, including maintaining and developing

its patent portfolio.

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.

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The amount and timing of future

cash requirements depends on the pace, design and results of the Company’s clinical trial program, which, in turn, depends on the

availability of operating capital to fund such activities.

on current operating plans, the Company estimates that existing cash resources 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

cash requirements depends on the pace, design, and results of the Company’s clinical trial program, which, in turn, depends on

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.

However, existing cash resources will not be sufficient to complete the development of and obtain regulatory approval

for the Company’s product candidate, as a result of which the Company will need to raise significant additional capital to do so.

The Company estimates that it will need to raise additional capital to fund its operations, including its various clinical trial commitments,

during the latter part of the fiscal year ending December 31, 2023.

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.

December 31, 2023, the Company did not have any transactions, obligations or relationships that could be considered off-balance sheet

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For the years ended December 31, 2023 and 2022, the Company had no investing activities.

For the year December 31, 2022, financing activities consisted of the gross proceeds from the sale of common stock in

the Company’s direct equity offering of $5,800,000, reduced by offering costs of $658,616.

For the year ended December 31, 2021,

financing activities consisted of the gross proceeds from the sale of common stock in the Company’s direct equity offering of $4,192,478,

reduced by offering costs of $502,717, $17,100 from the exercise of common stock warrants, and $201,000 from the exercise of common stock

The Company also paid public offering costs related to its November 2020 public offering of $10,467 during the year ended December

31, 2021 related to the Company’s financing activities.

December 31, 2022, the Company’s unpaid remaining contractual commitments pursuant to clinical trial agreements, and clinical trial

monitoring agreements, as described below, aggregated $7,892,000, which are currently scheduled to be incurred through December 31, 2025.

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 are frequently modified, suspended or terminated before the clinical

trial endpoint.

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 revisions over time.

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.

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”.

Trial Agreements

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, 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 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 Application

(“IND”) to conduct a Phase 1b/2 clinical trial to evaluate the 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 utilizes LB-100 as a single agent in the treatment

of patients with low and intermediate-1 risk MDS, including patients with del(5q) myelodysplastic syndrome (del5qMDS) failing first line

The bone marrow cells of patients with del5qMDS are deficient in PP2A by virtue of an acquired mutation and are especially vulnerable

to further inhibition of PP2A by LB-100.

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

the clinical trial in July 2019.

A total enrollment of 41 patients is planned.

An interim analysis will be done after the first 21 patients

If there are 3 or more responders but fewer than 7, an additional 20 patients will be entered.

If at any point there are

7 or more responders, this will be sufficient evidence to support continued development of LB-100 for the treatment of low and intermediate-1

Recruitment has been slow and the Covid-19 pandemic has further reduced recruitment of patients into the protocol.

At the current

rate of accrual, the clinical trial is expected to be completed by June 30, 2025.

However, with additional funds, the Company would consider

adding two additional MDS centers to the Phase 2 portion of the study to accelerate patient accrual.

the years ended December 31, 2022 and 2021, the Company incurred costs of $26,397 and $18,443, respectively, pursuant to this agreement,

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

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.

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.

The Company’s aggregate commitment pursuant to

this agreement, less amounts previously paid to date, totaled approximately $590,000 as of December 31, 2022, which is expected to be

incurred through December 31, 2025.

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.

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

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Doxorubicin is the global standard for initial treatment of advanced soft tissue sarcomas (“ASTS”).

Doxorubicin alone has been the mainstay of first line treatment of ASTS for over 40 years, with little therapeutic gain from adding cytotoxic

compounds to or substituting other cytotoxic compounds for doxorubicin.

In animal models, LB-100 consistently enhances the anti-tumor

activity of doxorubicin without apparent increases in toxicity.

Doxorubicin alone has been the mainstay of first line treatment of ASTS for over 40 years, with little improvement in survival from adding

cytotoxic compounds to or substituting other cytotoxic compounds for doxorubicin.

In animal models, LB-100 consistently enhances the

anti-tumor activity of doxorubicin without apparent increases in toxicity.

has a network of referral centers in Spain and across Europe that have an impressive track record of efficiently conducting innovative

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well as to provide funding for the clinical trial.

The goal is to enter approximately 150 patients in this clinical trial over a period

of two years.

As advanced sarcoma is a very aggressive disease, the design of the study assumes a median progression free survival (PFS,

no evidence of disease progression or death from any cause) of 4.5 months in the doxorubicin arm and an alternative median PFS of 7.5

months in the doxorubicin plus LB-100 arm to demonstrate a statistically significant decrease in relative risk of progression or death

by adding LB-100.

There is a planned interim analysis of the primary endpoint when approximately 50% of the 102 events required for final

analysis is reached.

The goal is to enter approximately 150 to 170 patients in this clinical trial over

a period of two to four years.

The Phase 1 portion of the study began in the quarter ended June 30, 2023 to determine the recommended

Phase 2 dose of the combination of doxorubicin and LB-100.

As advanced sarcoma is a very aggressive disease, the design of the Phase

2 portion of the study assumes a median progression-free survival (“PFS”), no evidence of disease progression or death from

any cause) of 4.5 months in the doxorubicin arm and an alternative median PFS of 7.5 months in the doxorubicin plus LB-100 arm to demonstrate

a statistically significant decrease in relative risk of progression or death by adding LB-100.

There is a planned interim analysis of

the primary endpoint when approximately 50% of the 102 events required for final analysis is reached.

Company had previously expected that this clinical trial would commence during the quarter ended June 30, 2020.

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provide appropriate labels, store the drug, and distribute the drug to the clinical centers for use in the clinical trials.

application documenting all steps taken to prepare the clinical drug product for clinical use must be submitted to the appropriate regulatory

application documenting all steps taken to prepare the clinical drug product for clinical use was submitted to the appropriate regulatory

authorities for review and approval before being used in a clinical trial.

of December 31, 2023, this program to provide new inventory of the clinical drug product for the Spanish Sarcoma Group study, and potentially

for subsequent multiple trials within the European Union, had cost $1,144,169.

While the production of new inventory has been completed,

nominal amounts of trailing costs are expected to be incurred during the year ending December 31, 2023.

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

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

Consequently, the GEIS clinical trial is currently scheduled to commence during the quarter ending June 30, 2023 and to be completed

by December 31, 2025.

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).

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

The Phase 1b section 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.

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

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

Through December 31, 2022, the Company has paid GEIS an aggregate of $415,823 for work done under this agreement through the third milestone.

the years ended December 31, 2022 and 2021, the Company incurred costs of $260,770 and $24,171, respectively, pursuant to this agreement,

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

As of December

31, 2022, total costs of $415,823 have been incurred pursuant to this agreement.

The Company’s aggregate commitment pursuant to

this agreement, less amounts previously paid to date, totaled approximately $3,743,000 as of December 31, 2022, which is expected to

be incurred through December 31, 2025.

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.

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 a standard

regimen for treatment of untreated extensive- stage disease small cell lung cancer (ED-SCLC).

LB-100 will be given in combination with

carboplatin, etoposide and atezolizumab, an FDA-approved but marginally effective 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.

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

patient accrual has been slower than expected, the Company is currently seeking to add two additional sites to increase the rate of patient

accrual, with at least one major site expected to be added by June 30, 2023.

With the additional sites, the Company expects that this

clinical trial will be completed by December 31, 2024.

Without the additional sites, the Company expects that this clinical trial will

be completed no sooner than December 31, 2025.

March 6, 2023, Sarah Cannon Research Institute (SCRI), Nashville, Tennessee, joined the City of Hope’s ongoing Phase 1b clinical

trial to assess the combination of the Company’s first-in-class protein phosphatase 2A (PP2A) inhibitor, LB-100, with a standard

regimen for previously untreated, extensive stage small cell lung cancer disease.

SCRI, one of the largest community-based cancer trial

centers in the United States, 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.

the years ended December 31, 2022 and 2021, the Company incurred costs of $0 and $378,511, respectively, pursuant to this agreement.

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

as of December 31, 2022, which is expected to be incurred through December 31, 2024, based upon a target of 42 enrollees.

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 $800,000.

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.

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.

Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $3,580,000

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.

Cancer Institute Pharmacologic Clinical Trial.

In May 2019, the National Cancer Institute (NCI) initiated a glioblastoma (GBM) pharmacologic

clinical trial.

This study is being conducted and funded by the NCI under a Cooperative Research and Development Agreement, with the

Company being required to provide the LB-100 clinical compound.

In May 2019, the National Cancer Institute (“NCI”) initiated a glioblastoma

(“GBM”) pharmacologic clinical trial.

This study was being conducted and funded by the NCI under a Cooperative Research and

Development Agreement, with the Company responsible for providing the LB-100 clinical compound.

malignant brain tumors (gliomas) are very challenging to treat.

Radiation combined with the chemotherapeutic drug temozolomide has been

the mainstay of therapy of the most aggressive gliomas (glioblastoma multiforme or GBM) for decades, with some further benefit gained

the mainstay of therapy of the most aggressive gliomas (glioblastoma multiforme or GBM) for decades, with little further benefit gained

by the addition of one or more anti-cancer drugs, but without major advances in overall survival for the majority of patients.

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Although LB-100 has proven safe in patients at doses associated with apparent anti-tumor activity against several human

cancers arising outside the brain, the ability of LB-100 to penetrate tumor tissue arising in the brain is not known.

Unfortunately,

many drugs potentially useful for GBM treatment do not enter the brain in amounts necessary for anti-cancer action.

NCI study is designed to determine the extent to which LB-100 enters recurrent malignant gliomas.

Patients having surgery to remove one

or more tumors will receive one dose of LB-100 prior to surgery and have blood and tumor tissue analyzed to determine the amount of LB-100

present and to determine whether the cells in the tumors show the biochemical changes expected to be present if LB-100 reaches its molecular

As a result of the innovative design of the NCI study, data from a few patients should be sufficient to provide a sound rationale

for conducting a larger clinical trial to determine the effectiveness of adding LB-100 to the standard treatment regimen for GBMs.

patients have been entered and analysis of the blood and tissue will now proceed.

If there is evidence in at least two of the patients

of penetration of LB 100 into tumor tissue, the study will be deemed as successful.

The results of this study are expected during 2023.

cancers arising outside the brain, the ability of LB-100 to penetrate tumor tissue arising in the brain was not known.

Many drugs potentially

useful for GBM treatment do not enter the brain in amounts necessary for anti-cancer action.

NCI study was designed to determine the extent to which LB-100 enters recurrent malignant gliomas.

Patients having surgery to remove

one or more tumors received one dose of LB-100 prior to surgery and had blood and tumor tissue analyzed to determine the amount of LB-100

present and to determine whether the cells in the tumors showed the biochemical changes expected to be present if LB-100 reached its

molecular target.

As a result of the innovative design of the NCI study, it was believed that data from a few patients would be sufficient

to provide a sound rationale for conducting a larger clinical trial to determine the effectiveness of adding LB-100 to the standard treatment

regimen for GBMs.

Blood and brain tumor tissue were analyzed from seven patients after intravenous infusion of a single dose of LB-100.

Results of the investigation demonstrated that there was virtually no entry of LB-100 into the brain tumor tissue.

Accordingly, alternative

methods of drug delivery will be required to determine if LB-100 has meaningful clinical anti-cancer activity against glioblastoma multiforme

and other aggressive brain tumors.

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.

As of December

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

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

At the current rate of

accrual, the clinical trial is expected to be completed by June 30, 2025.

under this work order agreement are estimated to be approximately $954,000, with such payments expected to be allocated approximately

94% to Theradex for services and approximately 6% for payments for pass-through costs.

The costs of the Phase 1b/2 clinical trial being

paid to or through Theradex are being recorded and charged to operations based on periodic documentation provided by the CRO.

the years ended December 31, 2022 and 2021, the Company incurred costs of $35,403 and $9,730, respectively, and as of December 31, 2022,

total costs of $127,288 have been incurred.

The Company’s aggregate commitment pursuant to this agreement, less amounts previously

paid to date, totaled approximately $842,000 as of December 31, 2022, which is expected to be incurred through June 30, 2025.

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.

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

clinical trial in small cell lung cancer in accordance with FDA requirements for oversight by the sponsoring party.

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

During the years ended December 31, 2022 and 2021, the Company

incurred costs of $33,815 and $24,626, respectively, and as of December 31, 2022, total costs of $58,441 have been incurred.

The Company’s

aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $284,000 as of December

31, 2022, which is expected to be incurred through June 30, 2025.

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

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.

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.

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 year ended December 31, 2023,

the Company incurred costs of $14,862, pursuant to this work order.

As of December 31, 2023, total costs of $14,862 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 $141,000 as of December 31, 2023, which is expected to be incurred through June 30, 2026.

and License Agreements

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

The Company is 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 has also agreed to pay non-refundable milestone payments to Moffitt, which

cannot 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.

During the years ended December 31, 2022 and 2021, the Company recorded charges to operations of $25,000 and $25,000,

respectively, in connection with its obligations under the License Agreement.

As of December 31, 2022, no milestones had yet been attained.

Company will be obligated to pay Moffitt earned royalties of 4% on worldwide cumulative net sales of royalty-bearing products, subject

to reduction to 2% under certain circumstances, on a quarterly basis, with a minimum royalty payment of $50,000 in the first four years

after sales commence, and $100,000 in year five and each year thereafter, subject to reduction by 40% under certain circumstances relating

to the status of Valid Claims, as such term is defined in the License Agreement.

The Company’s obligation to pay earned royalties

under the License Agreement commences on the date of the first sale of a royalty-bearing product, and shall automatically expire on a

country-by-country basis on the date on which the last valid claim of the Licensed Patents expires, lapses or is declared invalid, and

the obligation to pay any earned royalties under the License Agreement shall terminate on the date on which the last valid claim of the

Licensed Patents expires, lapses, or is declared to be invalid in all countries.

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

Agreement dated August 20, 2018 between the Company and Moffitt, effective September 30, 2023.

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.

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 its executive officers, consisting of Dr.

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 compensation of $640,000, payable

The employment agreements are 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 and 2022.

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

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 total aggregate annual compensation of all officers increased to $775,000, effective May

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.

effective October 1, 2022, Mr.

Forman is being paid an office rent allowance of $600 per month.

total aggregate annual compensation of all officers increased to $800,000, effective November 6, 2022.

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

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The Company recorded charges to

operations pursuant to this agreement of $120,000 and $120,000 for the years ended December 31, 2022 and 2021, respectively, which were

included in research and development costs in the consolidated statements of operations.

for Angelman Syndrome Therapy .

Effective August 12, 2020, the Company entered into a Master Service Agreement with the Foundation

for Angelman Syndrome Therapy (FAST) to collaborate in supporting pre-clinical studies of the potential benefit of LB-100 in a mouse

model of Angelman Syndrome (AS) as reported in The Proceedings of The National Academy of Science (Wang et al, June 3, 2019).

The pre-clinical

studies were to be conducted at The University of California - Davis under the direction of Dr.

David Segal, an internationally recognized

leader in AS research.

If the pre-clinical studies confirm that LB-100 reduces AS signs in rodent models, the Company has agreed to enter

into discussions with FAST with respect to possible collaborations to most efficiently assess the benefit of LB-100 in patients with

AS, which is a rare disease affecting an estimated one out of 12,000 to one out of 20,000 persons in the United States.

The genetic cause

of AS, reduced function of a specific maternal gene called Ube3, has been understood for some time, but the molecular abnormality resulting

from the genetic lesion has now been shown to be increased concentrations of protein phosphatase 2A (PP2A), a molecular target of the

Company’s investigational compound, LB-100.

The Company has agreed to provide FAST with a supply of LB-100 to be utilized in the

conduct of this study, which was initially expected to be completed within three years.

Conditioned on FAST’s completion of this

study, the Company has agreed to pay FAST five percent (5%) of all proceeds, as defined in the Master Service Agreement, received by

the Company, up to a maximum of $250,000, from the exploitation of the study results.

research team at the University of California - Davis recently completed their pre-clinical study of the potential benefit of LB-100

in a mouse model of AS.

The preliminary analysis indicates that the positive results previously reported by Chinese investigators were

not confirmed in the US model.

The Company is currently awaiting input from FAST as to whether it intends to continue to pursue pre-clinical

studies of LB 100.

To date, FAST has not indicated whether it desires to pursue further studies of LB-100, but in light of the failure

to confirm the Chinese study results, the Company does not plan to pursue further studies of AS.

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.

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 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.

has agreed to fund the study and provide a sufficient supply of LB-100 to conduct the study.

The study is expected to take approximately

two years to conduct.

During the years ended December 31, 2022 and 2021, the Company incurred charges in the amount of $204,158 and $55,248,

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, 2022, total costs of $259,406 have been incurred pursuant to this agreement.

The Company’s

aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $262,000 as of December

31, 2022, which is expected to be incurred through June 30, 2025.

Institute, Amsterdam (“NKI”), one of the world’s leading comprehensive cancer centers, and Oncode Institute, Utrecht,

a major independent cancer research center, for a term of three years.

The Development Collaboration Agreement was subsequently modified

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.

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.

the years ended December 31, 2023 and 2022, the Company incurred charges in the amount of $226,150 and $204,158, 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,

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in the United States.

On June 10, 2022, the contract was amended to reflect a new total contract price of $273,980 and an estimated completion

date of April 30, 2023.

During the years ended December 31, 2022 and 2021, the Company incurred costs of $27,702 and $17,782, respectively,

pursuant to this agreement.

As of December 31, 2022, total costs of $219,611 have been incurred pursuant to this agreement.

The Company’s

aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $55,000 as of December 31,

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

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.

Events and Uncertainties

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our pharmaceutical compounds to the extent needed to create future sales to sustain operations as contemplated herein.

can be no assurance that one or more of our pharmaceutical compounds will obtain the regulatory approvals and market acceptance to achieve

sustainable revenues sufficient to support our operations.

Even if we are able to generate revenues, there can be no assurance that we

will be able to achieve operating profitability or positive operating cash flows.

There can be no assurance that we will be able to secure

additional financing, to the extent required, on acceptable terms or at all.

If cash resources are insufficient to satisfy our ongoing

cash requirements, 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 certain of our pharmaceutical compounds, or to curtail

or discontinue our operations entirely.

can be no assurance that our pharmaceutical compound will obtain the regulatory approvals and market acceptance to achieve sustainable

revenues sufficient to support our operations.

Even if we are able to generate revenues, there can be no assurance that we will be able

to achieve operating profitability or positive operating cash flows.

There can be no assurance that we will be able to secure additional

financing, to the extent required, on acceptable terms or at all.

If cash resources are insufficient to satisfy our ongoing cash requirements,

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

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