What changed in this filing

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Item 1. Business

2024-03-19 compared with 2023-03-29 · 314 added, 390 removed, 215 unchanged (77% of the section changed)

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

and then designs novel compounds to attack those targets.

Company is a clinical-stage biopharmaceutical company 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 phosphatases, used alone and in combination with cytotoxic

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

The Company believes that inhibitors of protein phosphatases have broad therapeutic

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

The Company is directing its efforts on

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

activity at doses that produce little or no toxicity.

Company’s product pipeline is primarily focused on inhibitors of protein phosphatase 2A, 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’s activities are subject to significant risks and uncertainties, including the need for additional capital.

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operating requirements.

Clinical Trial Activities

primary focus is developing new treatments for human cancers for which better therapies are urgently needed.

drug discovery process is based on discerning clues to potential new targets for disease treatments reported in the increasingly large

body of literature identifying the molecular variants which characterize human cancers and other non-cancer disorders.

We design drugs

for which there are existing data suggesting that they may affect the altered pathways of the cancer cell and may be given safely to

We seek to rapidly arrive at patentable structures through analysis of the literature rather than screening of thousands of structures

for activity against a particular biochemical pathway.

approach has led to the development of two classes of drugs for the treatment of cancer, consisting of protein phosphatase inhibitors

(PTase-i), designated by us as the LB-100 series of compounds, and histone deacetylase inhibitors (HDACi), designated by us as the LB-200

series of compounds.

Our current focus is on the clinical development of the LB-100 series of compounds.

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.

have demonstrated that the lead compound of the LB-100 series is 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.

LB-100 compounds have been studied against a variety of common and rare cancer types and have been shown to potentiate the activity of

standard anti-cancer drugs in animal models of breast and pancreatic cancer, melanoma, pheochromocytomas and sarcomas.

More recently,

the LB-100 compounds have been shown to potentiate the relatively new category of drugs called immune blockers.

Because the LB-100 compounds

appear to exert their ability to improve the effectiveness of different forms of chemotherapy, radiation therapy and immunotherapy, we

believe the LB-100 series of compounds may be useful against most, if not all, cancer types.

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

LB-200 has not yet advanced to the clinical stage and would require

additional capital to fund further development.

Accordingly, because of our focus on the clinical development of LB-100 and analogs for

cancer therapy as described below in more detail, we have decided not to actively pursue the pre-clinical development of our LB-200 series

of compounds at this time.

At this time, we intend to only maintain our composition of matter patents for LB-200 issued in the United

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 us.

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 we have shown that this is not

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.

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, we were 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.

cancer patients are treated with either chemotherapy or immunotherapy or both.

These therapies often have limited benefit and there is

a high unmet medical need to enhance their effects.

In many preclinical models we have shown that LB-100 enhances the effect of both

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.

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”)

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

Of the 25 patients with heavily-treated advanced solid tumors with measurable disease,

3 patients had stable disease for 2 cycles, 3 patients had stable disease for 4 cycles, and 3 patients had stable disease for 6 cycles.

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

the tumor compartment and immune T-cell compartment.

LB-100 increases CD8+T-cell infiltration and CD8-Treg ratio, CD8+T-cell proliferation,

and cytokine production induces microsatellite instability, neoantigen production and immune responsiveness, converting immunologically

“cold” to “hot” cancers.

clear cell carcinoma patients with inactivating mutations in PPP2R1A, a gene coding for a scaffold component of PP2A, and treated with

immune checkpoint inhibitors, were recently found to have markedly longer survival than patients without the mutation in their cancers.

Retrospective reviews of patients with a variety of cancers treated with ICI or chemotherapy show much longer survival of ICI-treated

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,

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

research on the LB-100 series was initiated in 2006 under a Cooperative Research and Development Agreement (“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.

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

LB-200 has not advanced

to the clinical stage and would require additional capital to fund further development.

Accordingly, because of our focus on the clinical

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

development of our LB-200 series of compounds at this time.

Trial Agreements

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, 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.

Sarcoma Group Collaboration Agreement

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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.

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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

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 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

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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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.

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.

Cancer Institute Pharmacologic Clinical Trial

May 2019, the National Cancer Institute (NCI) initiated a glioblastoma (GBM) pharmacologic clinical trial.

This study is being conducted

This study was 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

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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.

Research Support Agreement with 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 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.

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.

Trial Monitoring Agreements

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

(“Theradex”), an international

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

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

At the current rate of

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

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.

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.

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

Effective 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 Patents.

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

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

The clinical trial began at a single site in April

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

The Company 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.

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

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.

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.

Significant Agreements and Contracts

Consulting Corp.

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

for consultation and advice

in the field of oncology research and drug development.

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

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

The term of the agreement was for one year

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

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

date since 2014.

BioPharmaWorks .

Effective September 14, 2015, the Company entered into a Collaboration Agreement with BioPharmaWorks, pursuant to which the Company engaged

BioPharmaWorks to perform certain services for the Company.

Those services included, among other things, assisting the Company to commercialize

its products and strengthen its patent portfolio;

identifying large pharmaceutical companies with a potential interest in the Company’s

product pipeline;

assisting in preparing technical presentations concerning the Company’s products;

consultation in drug discovery

and development;

and identifying providers and overseeing tasks relating to clinical development of new compounds.

BioPharmaWorks

was founded in 2015 by former Pfizer scientists with extensive multi-disciplinary research and development and drug development experience.

The Collaboration Agreement was for an initial term of two years and automatically renews for subsequent annual periods unless terminated

by a party not less than 60 days prior to the expiration of the applicable period.

In connection with the Collaboration Agreement, the

Company agreed to pay BioPharmaWorks a monthly fee of $10,000, subject to the right of the Company to pay a negotiated hourly rate in

lieu of the monthly payment, and agreed to issue to BioPharmaWorks certain equity-based compensation.

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.

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.

The Company has contracted with MRI Global for stability analysis, storage and distribution of LB-100 for clinical trials

in the United States.

On June 10, 2022, the contract was amended to reflect an estimated completion date of April 30, 2023.

October 8, 2021, the Company 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,

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 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.

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 immunotherapy clinical trial in 2023.

Our ability to conduct such a clinical trial, and possibly

other clinical trials, is subject to the availability of additional financial resources.

The clinical trial would study the ability of

LB-100 to enhance the effectiveness of adding LB-100 to an immunoblocker 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 inhibitor in yet to be specified solid tumors would require additional financing in excess

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 discussions

with various parties with respect to the financing immunotherapy clinical trials.

There is 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 development.

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.

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

Joint patent applications with the NIH have been filed for the treatment of glioblastoma multiforme, medulloblastoma, and neuroblastoma.

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

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the Eurasian Patent Office.

we do not plan to allocate resources to further develop our LB-200 series of drugs, we have 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 those patents issued in the United States.

For the LB-200 series, only patents issued in the United States are being maintained.

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.

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 two instances jointly 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 innovation to

develop and strengthen its pipeline.

The Company intends to rely on regulatory protection afforded by regulatory agencies through data

exclusivity, market exclusivity, and patent term extensions, where available.

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

innovation to develop and strengthen its pipeline.

The Company intends to rely on regulatory protection afforded by regulatory agencies

through data exclusivity, market exclusivity, and patent term extensions, where available.

Company’s success will depend in large part on its ability to obtain and maintain patent and other proprietary protection for commercially

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In some cases,

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

enforcement of these rights may depend on cooperation of the 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, 2022, followed by a detailed listing of each domestic and international patent

that has been issued.

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.

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.

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,

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

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

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

patent term extension.

Counterpart non-U.S.

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.

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.

Combination Therapy with a Checkpoint Inhibitor .

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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

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

Human Services.

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LB-100 combination therapy with carboplatin, etoposide and

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

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., Tawainese

and international patent applications that are jointly owned by Lixte Biotechnology, Inc.

and Stichting Het Nederlands Kanker Instituut

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.

for Treating Myelodysplastic Syndrome .

LB-100 for treating myelodysplastic syndrome is covered by U.S.

and 10,071,094, which are jointly owned by Lixte Biotechnology, Inc.

Lee Moffitt Cancer Center and Research Institute, Inc.

patents and their non-U.S.

counterparts are projected to expire in 2035, exclusive of any patent term extension.

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

term extension.

for Treating Cancer .

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Pharmaceutical compositions of LB-100 prodrugs or analogs are covered

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,

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 domestic and international patents issued is summarized below.

We have additional domestic and international patents pending.

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

term extension.

portfolio of solely or jointly owned U.S.

issued patents is summarized below .

We have additional U.S.

patent applications pending.

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

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and Oxabicycloheptenes, Their Preparation and Use

International

applications)

and LB-200 Series of Compounds – Use in Treatment of Multiple CNS Diseases

Neuroprotective

Agents for the Prevention and Treatment of Neurodegenerative Diseases

International

applications)

Oxabicycloheptanes

and Oxabicycloheptenes for the Treatment of Reperfusion Injury

International

Filing Date (non-U.S.

applications)

Oxabicycloheptanes

and Oxabicycloheptenes for the Treatment of Depressive and Stress Disorders

International

Filing Date (non-U.S.

applications)

International

applications)

Oxabicycloheptanes

and Oxabicycloheptenes for the Treatment of Diabetes

International

applications)

Issue/Grant Date

Expiration Date

AU 2008214299

US 10,023,587

US 10,399,993

of Oxabicycloheptanes and Oxabicycloheptenes

International

applications)

Issue/Grant Date

Expiration Date

AU 2014251087

US 10,532,050

US 11,931,354

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

International

applications)

Issue/Grant Date

Expiration Date

Phosphatase 2A Inhibitors for Treating Myelodysplastic Syndromes

International

applications)

Issue/Grant Date

Expiration Date

US 10,071,094

US 10,434,100

Oxabicycloheptane

International

applications)

have developed two series of pharmacologically active drugs, designated as the LB-100 series and the LB-200 series.

We believe that the

mechanism by which compounds of the LB-100 series affect cancer cell growth is different from cancer agents currently approved for clinical

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 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, our compounds will improve therapeutic benefit without enhancing

toxicity in humans.

primary goal to date has been to take our primary compound, LB-100, through Phase 2 clinical trials.

Because of the novelty and spectrum

of activity of LB-100, we believe it is reasonably likely we may find a partner in the pharmaceutical industry with interest in this

compound at some stage of its clinical development.

However, we would prefer to delay the partnering/licensing decision until the potential

value of our products are augmented by demonstrating there is no impediment to clinical evaluation and a therapeutic dose level is determined

in clinical trials.

Demonstration of clinical usefulness would be expected to substantially increase the value of our product.

Issue/Grant Date

Expiration Date

AU 2016263079

US 10,364,252

US 10,618,908

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

approved for clinical use.

Lead compounds of the LB-100 series have activity against a broad spectrum of common and rarer human cancers

in cell culture systems.

In addition, lead compounds of the LB-100 series have anti-cancer activity in animal models of glioblastoma

multiforme, neuroblastoma, and medulloblastoma, all cancers of neural tissue.

Lead compounds of the LB-100 series also have activity

against melanoma, breast cancer and sarcoma in animal models and enhance the effectiveness of commonly used anti-cancer drugs in animal

The enhancement of anti-cancer activity of these commonly-used 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 without unacceptable toxicity in humans.

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

anti-cancer therapies.

Because of the novelty and spectrum of activity of LB-100, we believe it is reasonably likely we may find a partner

in the pharmaceutical industry with interest in this compound at some stage of its clinical development.

However, we would prefer to

delay the partnering/licensing decision until the potential value of our products are augmented by demonstrating there is no impediment

to clinical evaluation and a therapeutic dose level is determined in clinical trials.

Demonstration of clinical usefulness would be expected

to substantially increase the value of our product.

and Development

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

of our most valuable resources is our scientific team, a coalition of various experts brought together through contracts and other collaborative

arrangements.

The team has expertise in cancer biology, proteomics (cancer biomarkers), medicinal and synthetic chemistry, pharmacology,

clinical oncology and drug evaluation.

In a relatively short period of time and at low cost, this group has developed lead compounds

of two different classes of drugs that are positioned for development as new treatments for several types of cancer.

are subject to FDA regulations as it conducts clinical trials.

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The dose level producing

definite but acceptable toxicity is then selected as the dose level to be evaluated in Phase 2 trials.

Thus, the goal of Phase 1 studies

is to determine the appropriate dose level for evaluation of drug efficacy in patients with the same type of tumor at comparable stages

of progression for which no beneficial treatment is established.

acceptable toxicity is then selected as the dose level to be evaluated in Phase 2 trials.

Thus, the goal of Phase 1 studies is to determine

the appropriate dose level for evaluation of drug efficacy in patients with cancer.

addition to regulations imposed by the FDA, depending on our future activities, we may become subject to regulation under various federal

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such regulations will apply to our business, or whether we or our collaborators would be able to comply with any applicable regulations.

addition, as we intend to market our products in international markets, we may be required to obtain separate regulatory approvals from

addition, as we intend to market our products in international markets, we will be required to obtain separate regulatory approvals from

the European Union and many other foreign jurisdictions.

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in any market.

may be involved from time to time in ordinary litigation, negotiation, and settlement matters that will not have a material effect on

our operations or finances.

We are not currently party to any material legal proceedings, and we are not aware of any pending or threatened

litigation against us.

Company may be subject to legal claims and actions from time to time as part of its business activities.

We are not currently subject

to any threatened or pending lawsuits, legal claims or legal proceedings.

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