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Item 1. Business

2022-03-21 compared with 2021-03-26 · 555 added, 543 removed, 82 unchanged (93% of the section changed)

are 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.

Our product pipeline is primarily focused on inhibitors of protein phosphatases,

used alone and in combination with cytotoxic agents and/or x-ray and immune checkpoint blockers, and encompasses two major categories

of compounds at various stages of pre-clinical and clinical development that we believe have broad therapeutic potential not only

for cancer but also for other debilitating and life-threatening diseases.

are 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.

Our product pipeline is primarily focused on inhibitors of protein phosphatases, used

alone and in combination with cytotoxic agents and/or x-ray and immune checkpoint blockers, and encompasses two major categories of compounds

at various stages of pre-clinical and clinical development that we believe have broad therapeutic potential not only for cancer but also

for other debilitating and life-threatening diseases.

have developed two series of pharmacologically active drugs, 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

In addition, compounds from both series have anti-cancer activity in animal models of glioblastoma multiforme, neuroblastoma,

and medulloblastoma, all cancers of neural tissue.

Lead compounds of the LB-100 series also have activity against melanoma, breast

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

enhancement of anti-cancer activity of these anti-cancer drugs occurs at doses of LB-100 that do not significantly increase toxicity

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.

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 use.

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

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.

activities are subject to significant risks and uncertainties, including the need for additional capital, as described below.

We have not yet commenced any revenue-generating operations, do not have positive cash flows from operations, and are dependent

on periodic infusions of equity capital to fund our operating requirements.

not yet commenced any revenue-generating operations, do not have positive cash flows from operations, and are dependent on periodic infusions

of equity capital to fund our 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.

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 humans.

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.

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.

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

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

The LB-200 series contains compounds which have

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

Gaucher’s disease, in addition to cancer and neurodegenerative diseases.

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

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

The research on these compounds was initiated in

2006 under a Cooperative Research and Development Agreement or CRADA with the National Institute of Neurologic Disorders and Stroke

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

until it terminated on April 1, 2013.

treatment of brain tumors depends upon the ability of compounds to penetrate a physiological barrier known as the “blood-brain

barrier”

which protects the brain from exposure to potentially toxic substances in the blood.

Because there is no certainty

that our compounds will be active against tumors confined to the brain, the 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.

Because the LB-100 compounds appear to exert their

ability to improve the effectiveness of different forms of chemotherapy and radiation therapy by inhibiting a process upon which

most, if not all, cancer cell types depend on to survive treatment, we believe the LB-100 series of compounds may be useful against

most, if not all, cancer types.

(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.

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

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

The LB-200 series contains compounds which have the potential

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

in addition to cancer and neurodegenerative diseases.

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

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

The research on these compounds was initiated in 2006 under

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

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

terminated on April 1, 2013.

treatment of brain tumors depends upon the ability of compounds to penetrate a physiological barrier known as the “blood-brain

barrier” which protects the brain from exposure to potentially toxic substances in the blood.

Because there is no certainty that

our compounds will be active against tumors confined to the brain, the 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.

Because the LB-100 compounds appear to exert their ability to improve the effectiveness

of different forms of chemotherapy and radiation therapy by inhibiting a process upon which most, if not all, cancer cell types depend

on to survive treatment, 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).

Many pharmaceutical companies are also developing drugs of this

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

Despite this significant competition, we have demonstrated that our HDACi have broad activity against many cancer types, have

neuroprotective activity, and have anti-fungal activity.

Many pharmaceutical companies are also developing drugs of this type,

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

significant competition, we have demonstrated that our HDACi have broad activity against many cancer types, have neuroprotective activity,

and have anti-fungal activity.

In addition, these compounds have low toxicity.

LB-200 has not yet advanced

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

Accordingly, because of 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.

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.

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

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 the case.

LB-100 was well-tolerated at doses associated with objective regression

(significant tumor shrinkage) and/or the arresting of tumor progression in patients with progressive cancers.

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

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

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.

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.

Trial Agreements

Cancer Center Clinical Trial Research Agreement

August 20, 2018, we 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 us 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 our lead anti-cancer clinical compound LB-100 to be administered intravenously in patients with low

or intermediate-1 risk myelodysplastic syndrome (MDS).

November 2018, we received approval from the FDA for our Investigational New Drug Application 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 therapy.

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.

August 20, 2018, we 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 us 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 our 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 are entered.

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 risk MDS.

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 trial would be completed over a period of four years from its

initiation, with the final analysis and reporting expected by July 2023.

However, with additional funds, our objective would be

to add two additional MDS centers to the Phase 2 portion of the study to accelerate patient accrual, with the goal of an earlier

reporting date.

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

of 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 about the efficacy and safety of LB-100 combined with doxorubicin

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.

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.

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 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.

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

studies in ASTS.

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 was to enter the first patient during the quarter ending December 31, 2020,

with approximately 150 patients to be enrolled over two years.

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 about half of the 102 events required for final analysis is reached.

order to manufacture a new inventory supply of LB-100 for the GEIS clinical trial, the Company has 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 include 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 is then transferred to a vendor that prepares the

clinical drug product (DP), also under GMP conditions documented by an independent auditor.

The DP is 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.

A formal application documenting all steps taken to prepare the DP for clinical use must be submitted

to the appropriate regulatory authorities for review and approval before being used in a clinical trial.

Company estimates that this program to provide new inventory of the DP for the Spanish sarcoma study, and potentially for subsequent

multiple trials within the European Union, will cost from $600,000 and $700,000.

The Company’s remaining aggregate commitments

under this program, less amounts previously paid to date, totaled approximately $300,000 as of December 31, 2020, which are expected

to be incurred through June 30, 2021.

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

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 was 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.

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

However, during July

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

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

These regulations

were adopted subsequent to the production of our existing LB-100 inventory.

We are in the process of obtaining approval from the

European Union regulatory authorities for new inventory of LB-100.

Accordingly, the clinical trial is now estimated to begin during

the quarter ending September 30, 2021 and to be completed by the quarter ending September 30, 2024.

The interim analysis is expected

in June 2023 and could indicate either inferiority or superiority of LB-100 plus doxorubicin as compared to doxorubicin alone.

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.

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

new batch of LB 100 has been prepared and is now undergoing the multitude of analytical studies of the formulated product necessary to

gain approval for use in the European Union.

Regulatory reviews by the European Union have been delayed, as a result of which the final

review of the clinical product by Spanish regulatory authorities will also be delayed.

Accordingly, the clinical trial is now estimated

to begin during the quarter ending June 30, 2022 and be completed by June 30, 2025.

interim analysis of this clinical trial could indicate either inferiority or superiority of LB-100 plus doxorubicin as compared to doxorubicin

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.

order to manufacture a new inventory supply of LB-100 for the GEIS clinical trial, the Company has 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 include

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 is then transferred to a vendor that prepares the clinical drug product, also under

GMP conditions documented by an independent auditor.

The clinical drug product is 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 must be submitted to the appropriate regulatory

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

November 2, 2021, the Company entered into a Development Agreement with Famar Health Care Services Madrid SA to prepare a new batch of

clinical LB-100 for use in clinical trials to be conducted in the European Union.

Pharmacologic Study

the fourth quarter of 2019, the National Cancer Institute (NCI) enrolled the first two patients of a planned eight patient pharmacologic

study of the ability of LB-100 to enter the brain and penetrate recurrent brain tumors in patients where surgical removal of the

cancers is indicated (clinical trials registry NCT03027388).

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

Research and Development Agreement with us;

additional information will be reported by us as it is provided by the NCI.

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

During the fourth quarter

of 2019, the NCI enrolled the first two patients of a planned eight patient pharmacologic study of the ability of LB-100 to enter the

brain and penetrate recurrent brain tumors in patients where surgical removal of the cancers is indicated (clinical trials registry NCT03027388).

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

to provide the LB-100 clinical compound.

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

Radiation combined with the chemotherapeutic drug temozolomide

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

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

In animal models of GBM, our novel protein phosphatase inhibitor LB-100 enhances the effectiveness of radiation,

temozolomide chemotherapy treatments and immunotherapy, raising the possibility that LB-100 may improve outcomes of standard GBM

treatment in the clinic.

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.

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

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

models of GBM, the Company’s novel protein phosphatase inhibitor, LB-100, has been found to enhance the effectiveness of radiation,

temozolomide chemotherapy treatments and immunotherapy, raising the possibility that LB-100 may improve outcomes of standard GBM treatment

in the clinic.

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 target.

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

The goal is to obtain data in up to eight patients.

As a result of the innovative design

of the NCI study, data from so 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.

As a result of the innovative design of the NCI study, data from so 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.

neurosurgical unit at the NCI, which had been closed due to the Covid-19 epidemic, has reopened, and patient accrual has resumed.

entry remains at two, with the goal to enter eight patients before analyzing results.

There is an urgent need to improve therapy for

this type of aggressive brain tumor.

If the NCI study shows that LB-100 does penetrate the brain, a clinical study of LB-100 in combination

with standard therapy for GBM, the drug temozolomide and radiation, both of which have been well documented in pre-clinical studies to

be significantly enhanced by LB-100, would be of significant interest to neuro-oncologists frustrated by decades of limited advances

in therapy for this common brain tumor in adults.

Research Support Agreement with City of Hope National Medical Center

January 18, 2021, we executed a Clinical Research Support Agreement with 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 our first-in-class protein phosphatase inhibitor, LB-100, combined with a standard regimen for 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.

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.

cell lung cancer (SCLC) comprises about 15% of all lung cancers worldwide with about 30,000 new cases annually in the United States.

Although this aggressive neuroendocrine tumor is more sensitive to cytotoxic chemotherapy and radiation than the most common type

of lung cancer, SCLC patients soon relapse after treatment and have a dismal prognosis.

Recently, the addition of an immune blocker,

atezolizumab, to carboplatin plus etoposide showed for the first time in 20 years modest improvement in median progression- free

survival from 4.3 to 5.2 months and in median overall survival from 10.3 to 12.3 months.

In animal models, LB-100 significantly

enhances the antitumor activity of cytotoxic chemotherapy in general and in particular the combination of carboplatin and etoposide

against SCLC cells without enhancing toxicity.

the extensive preclinical data showing LB-100 increases the effectiveness of chemotherapy applies to patients, the Company believes

evidence of therapeutic benefit of LB-100 added to standard treatment of this very aggressive cancer could be revealed even in

this early clinical trial paving the way for a randomized Phase 3 study.

Perhaps even more important to the Company’s clinical

development of LB-100, evidence in this clinical trial of potentiation of cytotoxic therapy without an increase in toxicity simply

by the addition of LB-100 would justify clinical investigation of the added benefit of adding LB-100 to many widely used “standard”

cytotoxic regimens for a host of cancers.

Company estimates that from 24 to 30 patients will be needed to complete this clinical trial, at an estimated cost of $2,500,000

to $2,900,000, respectively.

If a significant number of patients fail during the dose-escalation process, an increase of up to

12 patients would likely be necessary, at an estimated additional cost of $800,000.

clinical trial is planned to commence during the quarter ending June 30, 2021, with patient accrual expected to take approximately

18 to 24 months to conduct.

If LB-100 does potentiate the benefit of the standard regimen, some evidence could be noted at 12

months into the clinical trial, but an assessment of potential increased activity is likely to require at least 24 months.

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.

If LB-100 does

potentiate the benefit of the standard regimen, some evidence could be noted at 12 months into the clinical trial, but an assessment

of potential increased activity is likely to require at least 24 months.

The Company is currently seeking to add two additional centers

to increase the rate of accrual.

The Company expects this clinical trial to be completed by June 30, 2024.

clinical trial is based upon a target of 42 enrollees.

If a significant number of patients fail during the dose-escalation process, an

increase of up to 12 patients would likely be necessary.

The 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 basis

Trial Monitoring Agreements

September 12, 2018, we finalized a work order agreement with Theradex Systems, Inc.

(“Theradex”), an international

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

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 trial would be completed over a period of four years from its initiation, with the final analysis and reporting expected by

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

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

February 5, 2021, we 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.

The Company estimates

that it will incur approximately $335,000 of costs under this work order agreement through September 30, 2023.

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.

and License Agreements

March 22, 2018, we entered into a Patent Assignment and Exploitation Agreement with INSERM TRANSFERT SA, acting as delegatee of

the French National Institute of Health and Medical Research, for the assignment to us of INSERM’S interest in United States

9,833,450 entitled “Oxabicyloheptanes and Oxabicycloheptenes for the Treatment of Depressive and Stress Disorders,”

which was filed with the United States Patent and Trademark Office in the name of INSERM and us as co-owners on February 19, 2016

and granted on December 5, 2017, and related patent applications and filings.

INSERM is a French public institution dedicated

to research in the field of health and medicine that had previously entered into a Material Transfer Agreement with us to allow

INSERM to conduct research on our proprietary compound LB-100 and/or its analogs for the treatment of depressive or stress disorders

Pursuant to the Agreement, we have agreed to make certain milestone payments to INSERM aggregating up to $1,750,000

March 22, 2018, the Company entered into a Patent Assignment and Exploitation Agreement with INSERM TRANSFERT SA, acting as delegatee

of the French National Institute of Health and Medical Research, for the assignment to the Company of INSERM’S interest in United

States Patent No.

9,833,450 entitled “Oxabicyloheptanes and Oxabicycloheptenes for the Treatment of Depressive and Stress Disorders”,

which was filed with the United States Patent and Trademark Office in the name of INSERM and the Company as co-owners on February 19,

2015 and granted on May 12, 2017, and related patent applications and filings.

INSERM is a French public institution dedicated to research

in the field of health and medicine that had previously entered into a Material Transfer Agreement with the Company to allow INSERM to

conduct research on the Company’s proprietary compound LB-100 and/or its analogs for the treatment of depressive or stress disorders

Pursuant to the Agreement, the Company has agreed to make certain milestone payments to INSERM aggregating up to $1,750,000

upon achievement of development milestones and up to $6,500,000 upon achievement of commercial milestones.

We also agreed to pay

INSERM certain commercial royalties on net sales of products attributed to the Agreement.

The exploitation of this patent for

the treatment of depressive and stress disorders in humans will require substantial additional capital and/or a joint venture

or other type of business arrangement with a pharmaceutical company with substantially greater capital and business resources

than those available to us.

As there can be no assurances that we will be able to obtain the capital or business resources necessary

to focus on the exploitation of this patent, it is uncertain when we may reach any of the development or commercialization milestones

under the Agreement, if at all.

April 2, 2018, we entered into a consulting agreement for a term of two years with Liberi Life Sciences Consultancy BV, located

in The Netherlands, for consulting and advisory services with respect to sales and licensing, as well as the procurement of investors

in China, Japan and South Korea.

The Consulting Agreement was extended for an additional period of one year.

The Consulting Agreement

provided for the payment of a fixed, one-time retainer of EURO 15,000 (US $18,348), which was paid on April 5, 2018, and 2.5%

of the net payments received by us from sales of products or licensing activities arising directly and exclusively from leads

generated by the advisor during the term of the Consulting Agreement, and any investors introduced to us by the advisor that results

in an investment in us during the term of the Consulting Agreement.

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

The Company also agreed to

pay INSERM certain commercial royalties on net sales of products attributed to the Agreement.

The Company’s initial plan was to

complete the validation process to evaluate LB-100 for the treatment of depressive or stress disorders in humans within three years;

however, the exploitation of this patent for the treatment of depressive and stress disorders in humans will require substantial additional

capital and/or a joint venture or other type of business arrangement with a pharmaceutical company with substantially greater capital

and business resources than those available to the Company.

As there can be no assurances that the Company will be able to obtain the

capital or business resources necessary to focus on the exploitation of this patent, it is uncertain as to when, if at all, the Company

may reach any of the development or commercialization milestones under the Agreement.

As of December 31, 2021 and 2020, no amounts were

due under this agreement.

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

Pursuant to the License Agreement, Moffitt granted

us an exclusive license under certain patents owned by Moffitt 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.

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

We are 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 we commence payment of minimum

royalty payments.

We have also agreed to pay non-refundable milestone payments to Moffitt, which cannot be credited against earned

royalties payable by us, 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.

of December 31, 2020, no milestones had yet been attained.

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.

Our obligation to pay earned royalties

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

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

invalid, and the obligation to pay any earned royalties under the License Agreement shall terminate on the date on which the last

valid claim of the Licensed Patents expires, lapses, or is declared to be invalid in all countries.

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

During the years ended December 31, 2021 and 2020, the Company recorded charges to operations of $24,999 and $25,001, respectively,

in connection with its obligations under the License Agreement.

As of December 31, 2021, 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.

Significant Agreements and Contracts

October 18, 2013, we entered into a Materials Cooperative Research and Development Agreement (M-CRADA) with the NINDS of the NIH

for a term of four years.

The Surgical Neurology Branch of NINDS is conducting research characterizing a variety of compounds

proprietary to us and is examining the potential of the compounds for anti-cancer activity, reducing neurological deficit due

to ischemia and brain injury, and stabilizing catalytic function of misfolded proteins for inborn brain diseases.

Under an M-CRADA,

a party provides research material, in this case proprietary compounds from our pipeline, for study by scientists at NIH.

exchange of material was for research only and did not imply any endorsement of the material on the part of either party.

the M-CRADA, the NIH grants a collaborator an exclusive option to elect an exclusive or non-exclusive commercialization license.

December 24, 2013, we entered into an agreement with NDA Consulting Corp.

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

for consultation and advice in the field of oncology

1 unchanged sentence

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

Von Hoff, M.D.,

to become a member of our Scientific Advisory Committee.

The term of the agreement was for one year and provided for a quarterly

cash fee of $4,000.

The agreement has been automatically renewed for additional one-year terms on its anniversary date since 2014.

Consulting and advisory fees charged to operations pursuant to this agreement for the years ended December 31, 2020 and 2019 were

$16,000 and $16,000, respectively.

September 14, 2015, we entered into a Collaboration Agreement with BioPharmaWorks, pursuant to which we engaged BioPharmaWorks

to perform certain services for us.

Those services include, among other things:

(a) assisting us to (i) commercialize our products

and strengthen our patent portfolio, (ii) identify large pharmaceutical companies with potential interest in our product pipeline,

and (iii) prepare and deliver presentations concerning our products;

(b) at the request of the Board of Directors, serving as

backup management for up to three months should our Chief Executive Officer and scientific leader be temporarily unable to carry

out his duties;

Von Hoff, M.D., to become

a member of the Company’s Scientific Advisory Committee.

The term of the agreement was for one year.

The agreement has been automatically

renewed for additional one-year terms on its anniversary date since 2014.

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:

(a) assisting the Company to (i) commercialize

its products and strengthen its patent portfolio, (ii) identify large pharmaceutical companies with potential interest in the Company’s

product pipeline, and (iii) prepare and deliver presentations concerning the Company’s products;

(b) at the request of the Board

of Directors, serving as backup management for up to three months should the Company’s Chief Executive Officer and scientific leader

be temporarily unable to carry out his duties;

and (d) identifying providers and overseeing

tasks relating to clinical use and commercialization of new compounds.

and (d) identifying

providers and overseeing tasks relating to clinical use and commercialization of new compounds.

BioPharmaWorks

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

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, we agreed to pay BioPharmaWorks a monthly fee of $10,000, subject to our right to pay a negotiated hourly rate in lieu

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

In November 2016, it was mutually

agreed to suspend services and payments under the Collaboration Agreement, without extending its term, for the period from November

1, 2016 through March 31, 2017.

The Collaboration Agreement resumed as scheduled on April 1, 2017.

In April 2018, it was again

mutually agreed to suspend services and payments under the Collaboration Agreement, without extending its term, for the period

from February 1, 2018 through the September 13, 2019 anniversary date.

In February 2019, we subsequently agreed to resume the

Collaboration Agreement with BioPharmaWorks effective March 1, 2019, and the Collaboration Agreement is currently in effect.

August 12, 2020, we entered into a Master Service Agreement with the Foundation for Angelman Syndrome Therapy (FAST) to collaborate

in supporting preclinical 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 preclinical studies will take place at The

University of California - Davis under the direction of Dr.

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.

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 will be conducted at The University of California

- Davis under the direction of Dr.

David Segal, an internationally recognized leader in AS research.

If the preclinical studies confirm that LB-100 reduces AS signs in rodent models, we have 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 our investigational compound, LB-100.

We agreed to provide FAST with a supply of LB-100 to be utilized in the conduct

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

Conditioned on FAST’s completion of this

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

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

Clinical Trials

below are clinical trials that we would currently consider conducting over the next few years.

We expect that these potential

clinical trials, and the details thereof, will change over time as we obtain more clinical information on LB-100.

to conduct these clinical trials is subject to the availability of sufficient additional financial resources.

A Phase 1b/2 randomized clinical trial in previously untreated patients with small cell lung cancer (SCLC) comparing the standard

regimen, carboplatin/etoposide/atezolizumab, with and without LB-100.

The malignant cells of this uniformly rapidly fatal lung

cancer are genetically sensitive to PP2A inhibition (by a process termed “synthetic lethality”).

A Phase 1b/2 randomized clinical trial in patients adding LB-100 to PD-1 inhibitors against one of several cancers in which PD-1

inhibitors alone have definite but modest activity.

Phase 1b/2 clinical trials in SCLC and in LB-100 plus a PD-1 inhibitor in yet to be specified solid tumors will require additional

financing in excess of that currently budgeted to fund a Phase 1b/2 clinical trial in myelodysplastic syndrome that began in April

2019, and/or partnering relationships with other pharmaceutical companies, in order for us to undertake and complete such clinical

We are in discussions with various parties with respect to the financing of these clinical studies, although there can

be no assurances 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.

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.

has agreed to provide FAST with a supply of LB-100 to be utilized in the conduct of this study, which is 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, and the results are currently under review by FAST.

The preliminary analysis indicates that the positive results

previously reported by Chinese investigators were not confirmed in the US model.

The Company is awaiting input from FAST as to whether

it intends to continue to pursue pre-clinical studies of LB 100.

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,

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 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.

Future Clinical Trials

below is a clinical trial that we would currently consider conducting over the next few years.

We expect that this potential clinical

trial, and the details thereof, will change over time as we obtain more clinical information on LB-100.

Our ability to conduct this clinical

trial, and possibly other clinical trials, is subject to the availability of sufficient additional financial resources.

Phase 1b/2 randomized clinical trial in patients adding LB-100 to PD-1 inhibitors against

one of several cancers in which PD-1 inhibitors alone have definite but 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

of that currently budgeted to fund a Phase 1b/2 clinical trial in myelodysplastic syndrome that began in April 2019, and/or partnering

relationships with other pharmaceutical companies, in order for us to undertake and complete such clinical studies.

From time to time,

we engage discussions with various parties with respect to the financing of these clinical studies, although there can be no assurances

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.

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 the LB-100 and LB-200 series of drugs, with coverage of the LB-200 series

now limited to those patents issued in the United States.

Joint patent applications with the NIH have been filed for the treatment

of glioblastoma multiforme, medulloblastoma, and neuroblastoma.

We have also filed patent applications for the use of certain

homologs of both series of drugs for the treatment of neurodegenerative diseases such as Alzheimer’s Disease and Parkinson’s

Disease, Amyotrophic Lateral Sclerosis (ALS, or Lou Gehrig’s Disease), stroke, and traumatic brain injury, and patent applications

for the use of homologs of the LB-200 series for the treatment of serious systemic fungal infections and for the treatment of

common fungal infections of the skin and nails.

These patents now cover

sole rights to the composition and synthesis of the LB-100 and LB-200 series of drugs, with coverage of the LB-200 series now limited

to those patents issued in the United States.

Joint patent applications with the NIH have been filed for the treatment of glioblastoma

multiforme, medulloblastoma, and neuroblastoma.

We have also filed patent applications for the use of certain homologs of both series

of drugs for the treatment of neurodegenerative diseases such as Alzheimer’s Disease and Parkinson’s Disease, Amyotrophic

Lateral Sclerosis (ALS, or Lou Gehrig’s Disease), stroke, and traumatic brain injury, and patent applications for the use of homologs

of the LB-200 series for the treatment of serious systemic fungal infections and for the treatment of common fungal infections of the

skin and nails.

applications for the LB-100 series (oxabicycloheptanes and heptenes) and the LB-200 series (histone deacetylase inhibitors;

have been filed in the United States and internationally under the Patent Cooperation Treaty.

Patents for composition of matter

and for several uses of both the LB-100 series and the LB-200 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

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

been filed in the United States and internationally under the Patent Cooperation Treaty.

Patents for composition of matter and for several

uses of both the LB-100 series and the LB-200 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.

For the LB-200 series,

only patents issued in the United States are being maintained.

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.

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

important technology, inventions and know-how related to its business;

defend and enforce its patents;

preserve the confidentiality of

its trade secrets;

and operate without infringing valid and enforceable patents or proprietary rights of third parties.

The Company’s

ability to stop third parties from making, using, selling, offering to sell, or importing our technology may depend on the extent to

which the Company has rights under valid and enforceable licenses, patents, or trade secrets that cover these activities.

In some cases,

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

on any of its pending patent applications or on any patent applications filed solely or jointly by the Company in the future;

be sure that any of the Company’s existing patents or any patents that may be granted to us in the future will be commercially

useful in protecting the Company’s commercial products or therapeutic method;

and the Company cannot be sure that an agency or

court would determine that the Company’s solely or jointly owned patents are valid and enforceable.

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

is presented below, followed by a detailed listing of each domestic and international patent that has been issued.

Lixte Biotechnology,

is the Company’s wholly-owned Delaware subsidiary.

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,

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.

Combination Therapy with a Checkpoint Inhibitor .

LB-100 combination therapy with a checkpoint inhibitor for treating gliomas

is covered by pending U.S.

patent applications.

These 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.

Patents issuing from these

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

Combination Therapy with Carboplatin, Etoposide or Atezolizumab .

LB-100 combination therapy with carboplatin, etoposide or atezolizumab

for treating small-cell lung cancer is covered by an international patent application that is solely owned by Lixte Biotechnology, Inc.

Patents issuing from this patent application are projected to expire in 2041, exclusive of any patent term extension.

Combination Therapy with Other Investigational Compounds .

LB-100 combination therapy with one of several other investigational

compounds for treating a wide-array of cancers is covered by a U.S.

provisional patent application that is jointly owned by Lixte Biotechnology,

and Stichting Het Nederlands Kanker Instituut – Antoni Van Leeuwenhoek Ziekenhuis.

Patents issuing from counterpart nonprovisional

applications are projected to expire in 2043, exclusive of any patent term extension.

Therapeutic Methods .

Administration of 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.

Administration of LB-100

for treating breast cancer, colon cancer, large cell lung cancer, adenocarcinoma of the lung, small cell lung cancer, stomach cancer,

liver cancer, ovary adenocarcinoma, pancreas carcinoma, prostate carcinoma, promyelocytic leukemia, chronic myelocytic leukemia or acute

lymphocytic leukemia, is covered by U.S.

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

This patent and its

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

The Company’s LB-100 prodrugs are covered by U.S.

10,618,908, 9,988,394, 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 2036, 2030 or 2028, exclusive of any patent term extension.

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

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.

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

Series of Compounds - Phosphatase Inhibitors –

Composition and Use in Cancer Treatment

We have additional domestic and international patents pending.

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

Oxabicycloheptanes

and Oxabicycloheptenes, Their Preparation and Use

Priority Date or

International Filing Date

applications)

Issue/Grant Date

Expiration Date

AU 2008214299

US 10,023,587

US 10,399,993

and LB-200 Series of Compounds –

Use in Treatment of Multiple CNS Diseases

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

Neuroprotective

Agents for the Prevention and Treatment of Neurodegenerative Diseases

Priority Date or

International Filing Date

International

applications)

Issue/Grant Date

Expiration Date

Oxabicycloheptanes

and Oxabicycloheptenes for the Treatment of Reperfusion Injury

Priority Date or

International Filing Date (non-U.S.

International

Filing Date (non-U.S.

applications)

Issue/Grant Date

Expiration Date

Oxabicycloheptanes

and Oxabicycloheptenes for the Treatment of Depressive and Stress Disorders

Priority Date or

International Filing Date (non-U.S.

International

Filing Date (non-U.S.

applications)

Issue/Grant Date

Expiration Date

AU 2016219853

US 10,413,541

Priority Date or

International Filing Date

International

applications)

Issue/Grant Date

Expiration Date

Oxabicycloheptanes

and Oxabicycloheptenes for the Treatment of Diabetes

Priority Date or

International Filing Date

International

applications)

Issue/Grant Date

Expiration Date

US 10,149,847

US 10,668,062

of Oxabicycloheptanes and Oxabicycloheptenes

Priority Date or

International Filing Date

International

applications)

Issue/Grant Date

Expiration Date

AU 2014251087

US 10,532,050

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

Priority Date or

International Filing Date

International

applications)

Issue/Grant Date

Expiration Date

Phosphatase 2A Inhibitors for Treating Myelodysplastic Syndromes

Priority Date or

International Filing Date

International

applications)

Issue/Grant Date

Expiration Date

US 10,071,094

US 10,434,100

Oxabicycloheptane

Priority Date or

International Filing Date

International

applications)

Issue/Grant Date

Expiration Date

AU 2016263079

US 10,364,252

US 10,618,908

have developed two series of pharmacologically active drugs, 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

In addition, compounds from both series have anti-cancer activity in animal models of glioblastoma multiforme, neuroblastoma,

and medulloblastoma, all cancers of neural tissue.

Lead compounds of the LB-100 series also have activity against melanoma, breast

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

enhancement of anti-cancer activity of these anti-cancer drugs occurs at doses of LB-100 that do not significantly increase toxicity

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.

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 use.

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

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.

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

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.

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.

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 model systems.

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.

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.

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.

Additionally, any product for which we obtain marketing approval,

along with the manufacturing processes, post-approval clinical data and promotional activities for such product, will be subject

to continual review and periodic inspections by the FDA and other regulatory bodies.

Even if regulatory approval of a product

is granted, the approval may be subject to limitations on the indicated uses for which the product may be marketed or contain

requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the product.

Later discovery

of previously unknown problems with our products, including unanticipated adverse events or adverse events of unanticipated severity

or frequency, manufacturer or manufacturing processes, or failure to comply with regulatory requirements, may result in restrictions

on such products or manufacturing processes, withdrawal of the products from the market, voluntary or mandatory recall, fines,

suspension of regulatory approvals, product seizures, injunctions or the imposition of civil or criminal penalties.

Additionally, any product for which we obtain marketing approval, along

with the manufacturing processes, post-approval clinical data and promotional activities for such product, will be subject to continual

review and periodic inspections by the FDA and other regulatory bodies.

Even if regulatory approval of a product is granted, the approval

may be subject to limitations on the indicated uses for which the product may be marketed or contain requirements for costly post-marketing

testing and surveillance to monitor the safety or efficacy of the product.

Later discovery of previously unknown problems with our products,

including unanticipated adverse events or adverse events of unanticipated severity or frequency, manufacturer or manufacturing processes,

or failure to comply with regulatory requirements, may result in restrictions on such products or manufacturing processes, withdrawal

of the products from the market, voluntary or mandatory recall, fines, suspension of regulatory approvals, product seizures, injunctions

or the imposition of civil or criminal penalties.

life sciences industry is highly competitive and subject to rapid and profound technological change.

Our present and potential

competitors include major pharmaceutical companies, as well as specialized biotechnology and life sciences firms in the United

States and in other countries.

Most of these companies have considerably greater financial, technical and marketing resources

Additionally, mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more

resources being concentrated in our competitors.

Our existing or prospective competitors may develop processes or products that

are more effective than ours or be more effective at implementing their technologies to develop commercial products faster.

competitors may succeed in obtaining patent protection and/or receiving regulatory approval for commercializing products before

Developments by our competitors may render our product candidates obsolete or non-competitive.

Our present and potential competitors

include major pharmaceutical companies, as well as specialized biotechnology and life sciences firms in the United States and in other

Most of these companies have considerably greater financial, technical and marketing resources than we do.

Additionally, mergers

and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated in our competitors.

Our existing or prospective competitors may develop processes or products that are more effective than ours or be more effective at implementing

their technologies to develop commercial products faster.

Our competitors may succeed in obtaining patent protection and/or receiving

regulatory approval for commercializing products before we do.

Developments by our competitors may render our product candidates obsolete

or non-competitive.

also experience competition from universities and other research institutions, and we are likely to compete with others in acquiring

technology from those sources.

There can be no assurance that other organizations will not develop technologies with significant

advantages over those that we are seeking to develop.

There can be no assurance that other organizations will not develop technologies with significant advantages

over those that we are seeking to develop.

Any such development could harm our business.

compete with universities and other research institutions engaged in research in these areas.

Many of our competitors have greater

technical and financial resources than we do.

Many of our competitors have greater technical

and financial resources than we do.

ability to compete successfully is based on numerous factors, including:

2 unchanged sentences

relative speed with which we are able to bring any product resulting from its research to market in our target markets.

we are unable to distinguish our products from competing products, or if competing products reach the market first, we may be

unable to compete successfully with current or future competitors.

we are unable to distinguish our products from competing products, or if competing products reach the market first, we may be unable

to compete successfully with current or future competitors.

and Human Capital Resources

of March 12, 2021, we had three full-time employees and one part-time employee.

We consider our relationship with our employees

Our future performance depends significantly upon the continued service of our key personnel and our ability to attract

highly skilled employees.

We provide our employees with opportunities for equity ownership.

of March 12, 2021, we do not operate any facilities, but contract out research and development activities, drug production, and

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

done under the CRADA were carried out in compliance with applicable Statutes, Executive Capital Orders, HHS regulations and all

FDA, CDC, and NIH policies as specified in Article 13, 13.1 and 13.2, of the PHS CRADA.

of March 11, 2022, 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 11, 2022, 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.

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

Clinical trials are research studies to answer

specific questions about new therapies or new ways of using known treatments.

Clinical trials determine whether new drugs or treatments

are both safe and effective and the FDA has determined that carefully conducted clinical trials are the fastest and safest way

to find treatments that work in people.

FDA also requires that an independent review body consider the benefits and risks of a clinical trial and grant approval for the

proposed study including selecting of initial doses, plans for escalation of dose, plans for modification of dose if toxicity

is encountered, plans for monitoring the wellbeing of individuals participating in the study, and for defining and measuring,

to the extent possible, any untoward effects related to drug administration.

Serious adverse effects, such as life-threatening

toxicities and death, are immediately reportable to the review body and to the FDA.

To minimize risk when studying a new drug,

the initial dose is well below that expected to cause any toxicity.

Clinical trials are research studies to answer specific

questions about new therapies or new ways of using known treatments.

Clinical trials determine whether new drugs or treatments are both

safe and effective and the FDA has determined that carefully conducted clinical trials are the fastest and safest way to find treatments

that work in people.

FDA also requires that an independent review body consider the benefits and risks of a clinical trial and grant approval for the proposed

study including selecting of initial doses, plans for escalation of dose, plans for modification of dose if toxicity is encountered,

plans for monitoring the wellbeing of individuals participating in the study, and for defining and measuring, to the extent possible,

any untoward effects related to drug administration.

Serious adverse effects, such as life-threatening toxicities and death, are immediately

reportable to the review body and to the FDA.

To minimize risk when studying a new drug, the initial dose is well below that expected

to cause any toxicity.

No more than three patients are entered at a given dose.

general, a dose is not escalated within an individual patient.

Once safety is established by the absence of toxicity or low toxicity

in a group of three patients, a planned higher dose is then evaluated in a subsequent group of three individuals and so on until

dose-limiting toxicity is encountered.

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.

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

federal and state statutes and regulations, such as the Occupational Safety and Health Act, the Environmental Protection Act,

the Toxic Substances Control Act, the Research Conservation and Recovery Act, national restrictions on technology transfer, and

import, export and customs regulations.

From time to time, other federal agencies and congressional committees have indicated

an interest in implementing further regulation of biotechnology applications.

We are not able to predict whether any such regulations

will be adopted or whether, if adopted, 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 the European Union and many other foreign jurisdictions.

Approval by the FDA does not ensure approval by regulatory authorities

in other countries, and approval by one foreign regulatory authority does not ensure approval by regulatory authorities in other

foreign countries or by the FDA.

We may not be able to file for regulatory approvals and may not receive necessary approvals to

commercialize our products 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.

In general, a dose is not escalated within an individual

Once safety is established by the absence of toxicity or low toxicity in a group of three patients, a planned higher dose is

then evaluated in a subsequent group of three individuals and so on until dose-limiting toxicity is encountered.

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.

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

and state statutes and regulations, such as the Occupational Safety and Health Act, the Environmental Protection Act, the Toxic Substances

Control Act, the Research Conservation and Recovery Act, national restrictions on technology transfer, and import, export and customs

From time to time, other federal agencies and congressional committees have indicated an interest in implementing further

regulation of biotechnology applications.

We are not able to predict whether any such regulations will be adopted or whether, if adopted,

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

the European Union and many other foreign jurisdictions.

Approval by the FDA does not ensure approval by regulatory authorities in other

countries, and approval by one foreign regulatory authority does not ensure approval by regulatory authorities in other foreign countries

or by the FDA.

We may not be able to file for regulatory approvals and may not receive necessary approvals to commercialize our products

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.

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