What changed in this filing

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Item 1. Business

2025-03-24 compared with 2024-03-19 · 253 added, 296 removed, 233 unchanged (70% of the section changed)

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 for a broad range of cancers.

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

phosphatase inhibitor, referred to as LB-100, which has been shown to have clinical anti-cancer activity at doses that produce little

or no toxicity.

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

commercializing cancer therapies.

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

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

The Company believes that

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

The Company is focusing on the

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

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

clinical use.

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

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

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

neuroblastoma, and medulloblastoma, all cancers of neural tissue.

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

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

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

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

It is therefore hoped that, when combined with

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

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

at each stage.

As the potential effectiveness of LB-100 has been documented at the clinical trial level, the Company has allocated resources

to expand the breadth and depth of its patent portfolio.

The Company’s approach has been to operate with a minimum of overhead,

moving compounds forward as efficiently and inexpensively as possible, and to raise funds to support each of these stages as certain

milestones are reached.

The Company’s longer-term objective is to secure one or more strategic partnerships or licensing agreements

with pharmaceutical companies with major programs in cancer.

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

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

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

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

operating requirements.

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chemotherapy and Immunotherapy

a small molecule potent inhibitor of PP2A was designed and developed by the Company.

Numerous preclinical studies have documented that

LB-100 potentiates most if not all anti-cancer drugs that damage DNA.

LB-100 is not associated with any increase in cytotoxicity when

given with cytotoxic drugs.

This synergy involves transient interruption of several DNA damage repair pathways by LB-100 and an increase

in cell division rate.

LB-100 has FDA Investigational New Drug status in the US and Investigational Medicinal Product Dossier approval

in the European Union.

a small molecule potent inhibitor of PP2A, was designed and developed by us.

Numerous preclinical studies have documented that LB-100

potentiates most if not all anti-cancer drugs that damage DNA.

LB-100 is not associated with any increase in cytotoxicity when given

with cytotoxic drugs.

This synergy involves transient interruption of several DNA damage repair pathways by LB-100 and an increase in

cell division rate.

LB-100 has FDA Investigational New Drug status in the US and Investigational Medicinal Product Dossier approval in

the European Union.

its initial Phase 1 clinical trial, LB-100 given alone daily for 3 days was non-toxic, except for a transient increase in serum creatinine

believed to be caused by inhibition of PP2A in the renal tubules.

In the Phase 1 clinical trial, the Maximally Tolerated Dose (“MTD”)

In the Phase 1 clinical trial, the Maximum Tolerated Dose (“MTD”)

was 2.33mg/m2 daily for 3 days every 3 weeks.

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One patient with pancreatic cancer had a partial response after 12 cycles lasting 534 days.

on the DNA damage enhancing effect of PP2A inhibition with LB-100, the Company initiated a study in Advanced Soft Tissue Sarcoma (“ASTS”)

with the Spanish Sarcoma Group (Grupo Español de Investigación en Sarcomas or “GEIS”) for a collaborative clinical

trial in Madrid, Spain.

doses of LB-100 have now been shown to enhance immune checkpoint inhibition (“ICI”) by several different mechanisms affecting

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patients with a PPP2R1A mutation in their tumors.

on the observations in ovarian clear cell carcinoma, the Company has initiated a clinical trial in this disease combining LB-100 with

a monoclonal antibody blocking PD-1, a protein found on T-cells (NCT06065462).

Further, in an ongoing Phase 1b clinical trial in previously

untreated patients with small cell lung cancer, LB-100 is being escalated with a combination of full dose carboplatin, etoposide, and

atezolizumab (NCT04560972).

This clinical trial is being sponsored and conducted at the City of Hope National Medical Center in Duarte,

on the observations in ovarian clear cell carcinoma, we have initiated a clinical trial in this disease combining LB-100 with a monoclonal

antibody blocking PD-1, a protein found on T-cells (NCT06065462).

these preclinical and clinical observations, it is likely that LB-100 may be a general way to enhance immunotherapy responses.

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was subsequently extended through a series of amendments until it terminated on April 1, 2013.

Company has also designed and developed the LB-200 series, which consists of histone deacetylase inhibitors (HDACi).

have also designed and developed the LB-200 series, which consists of histone deacetylase inhibitors (HDACi).

LB-200 has not advanced

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Sarcoma Group Collaboration Agreement

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

Group (Grupo Español de Investigación en Sarcomas or “GEIS”), Madrid, Spain, to carry out a study entitled

“Randomized phase I/II trial of LB-100 plus doxorubicin vs.

July 31, 2019, we entered into a Collaboration Agreement for an Investigator-Initiated Clinical Trial with the Spanish Sarcoma Group

(Grupo Español de Investigación en Sarcomas or “GEIS”), Madrid, Spain, to carry out a study entitled “Randomized

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

doxorubicin alone in first line of advanced soft tissue sarcoma”.

The purpose of this clinical trial is to obtain information with respect to the efficacy and safety of LB-100 combined with doxorubicin

in soft tissue sarcomas.

The purpose of

this clinical trial is to obtain information with respect to the efficacy and safety of LB-100 combined with doxorubicin in soft tissue

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 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.

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

studies in ASTS.

The Company agreed to provide GEIS with a supply of LB-100 to be utilized in the conduct of this clinical trial, as

well as to provide funding for the clinical trial.

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.

We agreed to provide GEIS with a supply of LB-100 to be utilized in the conduct of this clinical trial, as well as to

provide funding for the clinical trial.

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.

However, during July

2020, the Spanish regulatory authority advised the Company that although it had approved the scientific and ethical basis of the protocol,

it required that the Company manufacture new inventory of LB-100 under current Spanish pharmaceutical manufacturing standards.

standards were adopted subsequent to the production of the Company’s existing LB-100 inventory.

order to manufacture a new inventory supply of LB-100 for the GEIS clinical trial, the Company engaged a number of vendors to carry out

the multiple tasks needed to make and gain approval of a new clinical product for investigational study in Spain.

These tasks included

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

steps involved by an independent auditor.

The API was then transferred to a vendor that prepares the clinical drug product, also under

GMP conditions documented by an independent auditor.

The clinical drug product was then sent to a vendor to test for purity and sterility,

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 was submitted to the appropriate regulatory

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

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

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

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

Consequently, this clinical trial commenced during the quarter ended June 30, 2023 and 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).

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

Sanitarios or “AEMPS”) had authorized a Phase 1b/randomized Phase 2 study of LB-100, our lead clinical compound, plus doxorubicin,

versus doxorubicin alone, the global standard for initial treatment of advanced soft tissue sarcomas (ASTS).

Consequently, this clinical

trial commenced during the quarter ended June 30, 2023 and 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 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

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

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

A positive study

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

of doxorubicin alone.

Research Support Agreement with the City of Hope National Medical Center

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”).

LB-100 will be given in combination

with carboplatin, etoposide and atezolizumab, an FDA-approved standard of care regimen, to previously untreated ED-SCLC patients.

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.

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.

The recruitment phase of the Phase 1b portion of the protocol

was completed during the quarter ended September 30, 2024.

We expect to have data on toxicity and preliminary efficacy from this portion

of the clinical trial during the quarter ending December 31, 2025.

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

of capital resources, the Company entered into Amendment No.

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

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

Agreement of approximately $3,095,000.

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

Research Support Agreement Relating to Small Cell Lung Cancer

had executed a Clinical Research Support Agreement with the City of Hope National Medical Center to carry out a Phase 1b clinical trial

of LB-100 combined with an FDA-approved standard regiment for treatment of untreated extensive-stage disease small cell lung cancer.

The clinical trial was initiated on March 9, 2021.

However, due to the lack of patient accrual, the Company provided notice to the City

of Hope National Medical Center of the Company’s intent to terminate the Clinical Research Support Agreement effective as of July

Anderson Cancer Center Clinical Trial

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 (“OCCC”).

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 trial.

The Company currently

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

September 20, 2023, we 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 (“OCCC”).

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.

We are providing LB-100 and GSK is providing dostarlimab-gxly and financial support for the clinical

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

We currently expect that this clinical

trial will be completed by December 31, 2027.

February 25, 2025, we announced that we had added the Robert H.

Lurie Comprehensive Cancer Center (Lurie Cancer Center) of Northwestern

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

to treat ovarian clear cell cancer.

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

Cancer Institute Clinical Trial

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

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

molecule of F.

Hoffman-La Roche Ltd.

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

agreement, we will provide our lead clinical compound, LB-100, and under a separate agreement between NKI and Roche, Roche will provide

atezolizumab and financial support for the clinical trial.

We have no obligation to and will not provide any reimbursement of clinical

Pursuant to the agreement and the protocol set forth in the agreement, the clinical trial will be conducted by NKI at NKI’s

site in Amsterdam by principal investigator Neeltje Steeghs, MD, PhD, and NKI will be responsible for the recruitment of patients.

agreement provides for the protection of the respective intellectual property rights of each of Lixte, NKI and Roche.

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

of patients with metastatic microsatellite stable colorectal cancer.

Immunotherapy using monoclonal antibodies like atezolizumab can

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

LB-100 has been found to improve the effectiveness

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

Blocking PP2A increases stress signals

in tumor cells expressing the PP2A protein.

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

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

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

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

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

The dose expansion phase will further investigate

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

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

Patient accrual is expected to take up to 24 months, with a maximum

of 37 patients with advanced colorectal cancer to be enrolled in this study.

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

Adverse Events (“SAEs”) observed in the clinical trial that was launched in August 2024.

The Investigational Review Board

(IRB) of the Netherlands Cancer Institute has requested additional information with respect to these SAEs and the study has been paused

for enrollment until the IRB’s questions have been, as more fully discussed at “Item 7.

Management’s Discussion and

Analysis of Financial Condition and Results of Operations – Specific Risks Associated with the Company’s Business Activities

– Serious Adverse Events”.

Cancer Institute Pharmacologic Clinical Trial

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and other aggressive brain tumors.

Cancer Center Clinical Trial Research Agreement

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 the 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.

and License Agreements

Institute of Health

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

February 23, 2024, we 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, we have 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

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 we 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.

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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.

Cancer Center

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

Pursuant to the License Agreement, Moffitt granted

the Company an exclusive license under certain patents owned by Moffitt (the “Licensed Patents”) relating to the treatment

of MDS and a non-exclusive license under inventions, concepts, processes, information, data, know-how, research results, clinical data,

and the like (other than the Licensed Patents) necessary or useful for the practice of any claim under the Licensed Patents or the use,

development, manufacture or sale of any product for the treatment of MDS which would otherwise infringe a valid claim under the Licensed

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

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.

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

Significant Agreements and Contracts

Cancer Institute

October 8, 2021, the Company entered into a Development Collaboration Agreement with the Netherlands Cancer Institute, Amsterdam (“NKI”),

October 8, 2021, we entered into a Development Collaboration Agreement with the Netherlands Cancer Institute, Amsterdam (“NKI”),

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

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

On October 3, 2023, the Company

entered into Amendment No.

2 to the Development Collaboration Agreement with NKI, which provides for additional research activities and

extends the termination date of the Development Collaboration Agreement by two years to October 8, 2026.

Development Collaboration Agreement is a preclinical study intended to identify the most promising drugs to be combined with LB-100,

and potentially LB-100 analogues, to be used to treat a range of cancers, as well as to identify the specific molecular mechanisms underlying

the identified combinations.

We agreed to fund the preclinical study, at an approximate cost of 391,000 Euros and provide a sufficient

supply of LB-100 to conduct the preclinical study.

October 3, 2023, we 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 added 500,000

Euros to the operating budget being funded by us.

October 4, 2024, we entered into Amendment No.

3 to the Development Collaboration Agreement with NKI, which suspended Amendment No.

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

of 100,000 Euros.

as of June 15, 2022, Dr.

René Bernards was appointed to the Company’s Board of Directors as an independent director.

Bernards is a leader in the field of molecular carcinogenesis and is employed by NKI.

Future Clinical Trials

objective is to initiate a Phase 1b/2 clinical trial of LB-100 in combination with immunotherapy.

Our ability to conduct such a clinical

trial, and possibly other clinical trials, is dependent on the conclusion and results of our ongoing clinical trials and is subject to

the availability of additional financial resources.

The clinical trial would study the ability of LB-100 to enhance the effectiveness

of an immunoblocker by adding LB-100 in treatment of one of several cancers in which immunotherapy alone has modest activity.

Phase 1b/2 clinical trial in LB-100 plus a PD-1 blocker in yet to be specified solid tumors would require additional financing in excess

of that currently budgeted and/or partnering relationships with other pharmaceutical companies.

From time to time, we engage in discussions

with various parties with respect to financing clinical trials evaluating the benefit of adding LB-100 to immunotherapy.

no assurance that we will be able to obtain such financing and/or partnering relationships on acceptable terms or at all.

Our longer-term

objective is to secure one or more strategic partnerships with pharmaceutical companies with major programs in cancer research and drug

products will ultimately be based on our intellectual property and are expected to be covered by our patents.

These patents now cover

sole rights to the composition and synthesis of our LB-100 series of drugs, which is the Company’s lead clinical compound in development.

The Company has filed patent applications covering the treatment of cancer with LB-100.

The Company has also filed joint patent applications

with the NIH and the Netherlands Cancer Institute for the treatment of cancer using LB-100 in combination with other drugs, including,

but not limited to, immune checkpoint inhibitors and WEE1 inhibitors.

applications for the LB-100 series (oxabicycloheptanes and heptenes) have been filed in the United States and internationally under the

Patent Cooperation Treaty.

Patents for composition of matter and for several uses of the LB-100 series have been issued in the United

States, Mexico, Australia, Japan, China, Hong Kong, Canada, Germany, France, the United Kingdom, and by the European Patent Office and

the Eurasian Patent Office.

we do not plan to allocate resources to further develop our LB-200 series of drug candidates, we decided to abandon patents that cover

sole rights to the composition and synthesis of the LB-200 series of drugs, with coverage of the LB-200 series now limited to maintenance

of those patents issued in the United States.

We also decided to abandon patents that cover rights in treating other diseases than cancer,

including, but not limited to, diabetes, neurodegenerative disease and reperfusion injury.

René Bernards was appointed to our Board of Directors as an independent director.

Bernards is a leader

in the field of molecular carcinogenesis and is employed by NKI.

intellectual property includes proprietary know-how, proprietary methodologies and extensive clinical validation data and publications.

To provide legal protection of our intellectual property, we rely on a combination of patents, licenses, trade secrets, trademarks, confidentiality

and non-disclosure clauses and agreements, and other forms of intellectual property protection to define and protect our rights to our

products are expected to be covered by our patents.

These patents now cover sole rights to the composition and synthesis of our LB-100

series of drugs, which is the Company’s lead clinical compound in development.

Lixte has filed patent applications covering the

treatment of cancer with LB-100.

Lixte has also filed joint patent applications with the NIH and the Netherlands Cancer Institute for

the treatment of cancer using LB-100 in combination with other drugs like immune checkpoint inhibitors and WEE1 inhibitors (a class of

drugs that target and inhibit the WEE1 kinase enzyme that plays a crucial role in regulating cell division).

applications for the LB-100 series (oxabicycloheptanes and oxabicycloheptenes) have been filed in the United States and internationally

under the Patent Cooperation Treaty.

Patents for composition of matter and for several uses of the LB-100 series have been issued in

the United States, Mexico, Australia, Japan, China, Hong Kong, Canada, and by the European Patent Office

Company strives to protect and enhance the proprietary technology, inventions, and improvements that are commercially important to the

development of its business, including seeking, maintaining, and defending its patent rights, which are owned solely by our wholly-owned

Delaware subsidiary, Lixte Biotechnology, Inc., except in several instances where they are jointly owned with one of our collaborators.

The Company also relies on trade secrets relating to its proprietary pipeline of product candidates and on know-how and continuing technological

Delaware subsidiary, Lixte Biotechnology, Inc., except in several instances jointly with one of many of our collaborators.

also relies on trade secrets relating to its proprietary pipeline of product candidates and on know-how and continuing technological

innovation to develop and strengthen its pipeline.

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In some cases,

enforcement of these rights may depend on cooperation of the owners of our jointly owned patents and patent applications.

enforcement of these rights may depend on cooperation of the joint owners of our jointly owned patents and patent applications.

respect to both the Company’s solely and jointly owned intellectual property, the Company cannot be sure that patents will be granted

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patent portfolios for the Company’s most important programs involving the development of the LB-100 series are summarized and presented

below, along with related information, as of December 31, 2023, followed by a detailed listing of U.S.

patents that have

The projected patent expiration dates assume that that all required maintenance or annuity fees for the patents are timely

paid and that a court or agency does not determine that the patents are invalid or unenforceable.

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.

below, along with related information, as of March 10, 2025, followed by a detailed listing of U.S.

patents that have been

The projected patent expiration dates noted below assume that that all required maintenance or annuity fees for the patents are

timely paid and that a court or agency does not determine that the patents are invalid or unenforceable.

The Company’s lead compound LB-100 is covered by U.S.

8,822,461 and 7,998,957, which are solely owned by Lixte Biotechnology,

Inc., the Company’s wholly-owned subsidiary.

These patents are projected to expire in 2030 or 2028, exclusive of any available

patent term extension.

These patents are projected to expire in 2030 or 2028, exclusive of any available patent term extension.

Counterpart non-U.S.

patents are projected to expire in 2028.

Pharmaceutical compositions of LB-100 are covered

10,532,050, 10,023,587 and 8,822,461, which are solely owned by Lixte Biotechnology, Inc.

These patents and their

counterparts are projected to expire in 2034 or 2028, exclusive of any available patent term extension.

are projected to expire in 2028.

Pharmaceutical compositions of LB-100 are covered by U.S.

10,532,050, 10,023,587 and 8,822,461,

which are solely owned by Lixte Biotechnology, Inc.

These patents and their non-U.S.

counterparts are projected to expire in 2034 or

2028, exclusive of any available patent term extension.

Combination Therapy with a Checkpoint Inhibitor .

LB-100 combination therapy with a checkpoint inhibitor for treating cancer is

covered by a pending U.S.

patent application and by non-U.S.

covered by U.S.

12,168,008 and a pending U.S.

patent application, as well as by non-U.S.

patents and patent applications.

These patents and patent applications are

jointly owned by Lixte Biotechnology, Inc., and The United States of America, as represented by the Secretary, Department of Health and

Human Services.

These patents and patents issuing from these patent applications are projected to expire in 2037, exclusive of any patent

term extension.

These patents and patent applications are jointly owned by Lixte Biotechnology, Inc., and The United States of America, as represented

by the Secretary, Department of Health and Human Services.

These patents and patents issuing from these patent applications are projected

to expire in 2037, exclusive of any patent term extension.

Combination Therapy with Carboplatin, Etoposide and Atezolizumab .

LB-100 combination therapy with carboplatin, etoposide and

atezolizumab for treating small-cell lung cancer is covered by pending U.S., and non-U.S.

patent applications that are solely owned

by Lixte Biotechnology, Inc.

Patents issuing from these patent applications are projected to expire in 2041, exclusive of any patent

term extension.

atezolizumab for treating small-cell lung cancer is covered by pending U.S.

patent applications that are solely owned by

Lixte Biotechnology, Inc.

Patents issuing from these patent applications are projected to expire in 2041, exclusive of any patent term

Combination Therapy with Another Investigational Compound .

LB-100 combination therapy with one of several other investigational

compounds for treating cancer, or preventing, inhibiting or reducing risk of metastasis of the cancer, is covered by pending U.S.

patent applications that are jointly owned by Lixte Biotechnology, Inc., and Stichting Het Nederlands Kanker Instituut –

Antoni Van Leeuwenhoek Ziekenhuis.

Patents issuing from these patent applications are projected to expire in 2043, exclusive of any patent

term extension.

compounds for treating cancer, or preventing, inhibiting or reducing risk of metastasis of cancer, is covered by pending U.S.

patent applications that are jointly owned by Lixte Biotechnology, Inc., and Stichting Het Nederlands Kanker Instituut – Antoni

Van Leeuwenhoek Ziekenhuis.

Patents issuing from these patent applications are projected to expire in 2043, exclusive of any patent term

for Treating Cancer .

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9,079,917, which is solely owned by Lixte Biotechnology,

This patent and its non-U.S.

counterparts are projected to expire in 2028, exclusive of any patent term extension.

LB-100 for treating glioblastoma multiforme, medulloblastoma, ovarian cancer, kidney cancer and colorectal cancer is covered by

These patents and their non-U.S.

counterparts are projected to expire in 2028, exclusive of any patent term

Prodrugs and Analogs .

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8,822,461, 8,541,458, 8,426,444, 8,227,473 and 7,998,957, which are solely owned by Lixte Biotechnology, Inc.

These patents and their

counterparts are projected to expire in 2036, 2030 or 2028, exclusive of any patent term extension.

Pharmaceutical compositions

of LB-100 prodrugs or analogs are covered by U.S.

11,931,354, 11,236,102, 10,532,050, 10,023,587, 8,822,461, 8,227,473 and

7,998,957, which are solely owned by Lixte Biotechnology, Inc.

These patents and their non-U.S.

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in 2034, 2030 or 2028, exclusive of any patent term extension.

Pharmaceutical compositions of LB-100 prodrugs or analogs are covered

11,931,354 ,11,236,102, 10,532,050, 10,023,587, 8,822,461, 8,227,473 and 7,998,957, which are solely owned by Lixte

Biotechnology, Inc.

These patents and their non-U.S.

counterparts are projected to expire in 2034, 2030 or 2028, exclusive of any patent

term extension.

portfolio of solely or jointly owned U.S.

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We have additional U.S.

patent applications pending.

Series of Compounds - Phosphatase Inhibitors – Composition and Use in Cancer Treatment

applications pending.

Oxabicycloheptanes

and Oxabicycloheptenes, Their Preparation and Use

Issue/Grant Date

Expiration Date

AU 2008214299

US 10,023,587

US 10,399,993

2124550 validated and pending in Germany, Spain, France, United Kingdom and Italy

of Oxabicycloheptanes and Oxabicycloheptenes

Issue/Grant Date

Expiration Date

AU 2014251087

US 10,532,050

US 11,931,354

2983661 validated and pending as Unitary Patent, and in Spain, United Kingdom and Switzerland

of Synthesizing 3-(4-Methylpiperazine-1-Carbonyl)-7-Oxabicyclo [2.2.1] Heptane-2-Carboxylic Acid

Issue/Grant Date

Expiration Date

Phosphatase 2A Inhibitors for Treating Myelodysplastic Syndromes

Issue/Grant Date

Expiration Date

US 10,071,094

US 10,434,100

Oxabicycloheptane

Issue/Grant Date

Expiration Date

AU 2016263079

US 10,364,252

US 10,618,908

3294287 validated and pending in Austria, Switzerland, Czechia, Germany, Denmark, Spain, France, United Kingdom, Hungary, Ireland, Italy,

Netherlands, and Sweden

3736275 validated and pending as Unitary Patent, and in Spain, United Kingdom and Switzerland

Oxabicycloheptanes

for Modulation of Immune Response

3551629 validated and pending in Belgium, Germany, Denmark, Spain, France, United Kingdom, Ireland, Iceland, Italy, Netherlands, Norway,

Sweden and Switzerland

believe that the mechanism by which compounds of the LB-100 series affects cancer cell growth is different from cancer agents currently

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will improve therapeutic benefit without unacceptable toxicity in humans.

is part of a pioneering effort in an entirely new field of cancer biology – activation lethality – that is advancing a new

treatment paradigm.

The Company is the only company that has a drug in clinical trials with demonstrated capacity to over-activate oncogenic

The pre-clinical data obtained with LB-100 were recently posted online in a paper titled “Paradoxical Activation of

Oncogenic Signaling as a Cancer Treatment Strategy” in the scientific journal Cancer Discovery , and were published in the

July 2024 issue of Cancer Discovery .

This study showed that LB-100 triggers hyper-activation of the signals that are responsible

for the deregulated proliferation of cancer cells, thus leading to cell death.

This approach is the opposite of most of the current generation

of cancer therapies and opens potentially new treatment strategies.

primary goal to date has been to take our primary compound, LB-100, through Phase 2 clinical trials evaluating whether LB-100 will enhance

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to substantially increase the value of our product.

and Development

development of lead compounds in addition to LB-100 will require pharmacokinetic/ pharmacodynamic characterization (i.e., how long a

drug persists in the blood and how long the drug is active at the intended target) and large animal toxicologic evaluation under conditions

meeting FDA requirements.

Most anti-cancer drugs fail in development because of unacceptable toxicity.

However, by analogy with mechanistically

related compounds, there is good reason to believe that lead compounds in addition to LB-100 will be able to be given to humans safely

by routes and at doses resulting in concentration of drug producing anti-cancer activity in animal models.

are subject to FDA regulations as it conducts clinical trials.

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and Human Capital Resources

of March 1, 2024, we had three full-time officer/employees and one part-time officer/employee.

The Company relies to a significant extent

on outside consultants and advisors with various technical skills and expertise that the Company can draw on as necessary to conduct

its research and development and clinical trial programs.

We consider our relationship with our employees to be good.

Our future performance

depends significantly upon the continued service of our key personnel and our ability to attract highly skilled employees.

our employees with opportunities for equity ownership.

of March 1, 2024, we do not operate any facilities.

We contract out research and development activities, drug production, and drug storage

to various commercial laboratories, drug manufacturers and storage facilities.

of March 14, 2025, we had two officer/employees, our Chief Executive Officer and our Chief Financial Officer, and one consultant, our

Chief Medical Officer.

The Company relies to a significant extent on outside consultants and advisors with various technical skills and

expertise that the Company can draw on as necessary to conduct its research and development and clinical trial programs.

our relationship with our employees to be good.

Our future performance depends significantly upon the continued service of our key personnel

and our ability to attract highly skilled employees.

We provide our officer/employees and consultants with opportunities for equity ownership.

of March 14, 2025, we do not operate or lease any facilities.

We contract out research and development activities, drug production, and

drug storage to various commercial laboratories, drug manufacturers and storage facilities.

business is subject to the regulations of the FDA as it conducts clinical trials.

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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 1. Business