What changed in this filing

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Item 1A. Risk Factors

2024-03-19 compared with 2023-03-29 · 299 added, 437 removed, 1447 unchanged (34% of the section changed)

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are engaged in early-stage research and as such might not be successful in our efforts to develop a portfolio of commercially viable

key element of our strategy is to discover new product candidates and develop LB-100 as a monotherapy or combination therapy to treat

We are seeking to do so through our internal research programs or strategic partnerships.

A significant portion of the research

or development that we are conducting involves new and unproven technologies.

Research programs to identify new disease targets and product

candidates or to develop them require substantial technical, financial and human resources whether or not any candidates or technologies

are ultimately identified or proven successful.

Our research programs might initially show promise in identifying potential product candidates,

yet fail to yield product candidates for clinical development for the following reasons:

key element of our strategy is to develop LB-100 in combination with other anti-cancer therapies to treat cancer.

We are seeking to do

so through our internal research programs or strategic partnerships.

A significant portion of the research and development that we are

conducting involves new and unproven technologies.

Research programs to identify new disease targets and product candidates or to develop

them require substantial technical, financial and human resources whether or not any candidates or technologies are ultimately identified

or proven successful.

Our research programs might initially show promise in identifying potential product candidates, yet fail to yield

product candidates for clinical development for the following reasons:

research methodology used might not be successful in identifying potential product candidates;

however, we have identified several

promising lead candidate compounds which have activity in animal models, one of which, LB-100, has completed a Phase 1 clinical trial;

candidates for drugs might on further study be shown to have harmful side effects or other characteristics that indicate they are

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or strategic partnerships, or in-license suitable products or delivery technologies on acceptable business terms, our business prospects

Even if we discover additional product candidates, and even though LB-100 has completed a Phase 1 clinical trial, subsequent

clinical trials of LB-100 or new clinical trials of one or more additional drug candidates may show that these product candidates are

unsafe or ineffective.

Even if we discover additional product candidates, new clinical trials of one or more additional drug candidates may show

that these product candidates are unsafe or ineffective.

have incurred substantial losses since our inception and anticipate that we will continue to incur substantial and increasing losses

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The Company has no recurring source of revenue

and has experienced negative operating cash flows since inception, and management has stated that substantial doubt exists about the

Company’s ability to continue as a going concern.

As a result, our independent registered public accounting firm has included an

explanatory paragraph in their report that accompanies our audited consolidated financial statements as of and for the year ended December

31, 2022, with respect to this uncertainty.

This going concern opinion could materially limit our ability to raise additional funds through

the sale of equity securities in the future, and subsequent reports by our independent registered public accounting firm on our consolidated

financial statements may also include an explanatory paragraph with respect to our ability to continue as a going concern.

and has experienced negative operating cash flows since inception, and management has determined that substantial doubt exists about

the Company’s ability to continue as a going concern.

As a result, our independent registered public accounting firm has included

an explanatory paragraph in their report with respect to this uncertainty that accompanies our audited consolidated financial statements

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

This going concern opinion could materially limit our ability to raise additional funds

through the sale of equity securities in the future, and subsequent reports by our independent registered public accounting firm on our

consolidated financial statements may also include an explanatory paragraph with respect to our ability to continue as a going concern.

need significant additional financing to fund our operations and complete the development and, if approved, the commercialization of

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including our clinical trial programs with respect to the development of our lead anti-cancer clinical compound LB-100, through approximately

December 31, 2023.

Our existing cash resources will not be sufficient to complete development of and obtain regulatory approval for our

lead product candidate, and we will need to raise significant additional capital to help us do so.

The Company estimates that it will

need to raise additional capital to fund its operations, including its various clinical trial commitments, during the latter part of

the fiscal year ending December 31, 2023.

In addition, our operating plan might change as a result of many factors currently unknown

to us, including possible additional clinical trials, and we might need additional funds sooner than planned.

September 30, 2024.

Our existing cash resources will not be sufficient to complete development of and obtain regulatory approval for

our lead product candidate, and we will need to raise significant additional capital to be able to continue our efforts in this regard.

The Company estimates that it will need to raise additional capital to fund its operations by mid-2024, including its various clinical

trial commitments, to be able to proactively manage its current business plan during the remainder of 2024 and during 2025.

our operating plan might change as a result of many factors currently unknown to us, including possible additional clinical trials, and

we might need additional funds sooner than planned.

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

additional capital.

expect to expend substantial resources for the foreseeable future to continue the clinical development and manufacturing of our lead

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complete development activities, including the necessary clinical trials;

and submit New Drug Applications, or NDAs, to the FDA and obtain U.S.

regulatory approval for indications for which there is a commercial

and submit a New Drug Application (“NDA”) to the FDA and obtain U.S.

regulatory approval for an indication for which

there is a commercial market;

and submit applications to foreign regulatory authorities;

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who are noncompliant or do not otherwise complete the trials;

with contract research organizations (each being a “CRO”) and/or with other vendors that handle

clinical trials.

with a contract research organization (a “CRO”) and/or with other vendors that are involved with our clinical trials.

might not be able to initiate or continue to support clinical trials of LB-100, our lead product candidate, for one or more indications,

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regulatory requirements for drug approvals and regulation of approved drugs in foreign countries;

stringent privacy requirements for data to be supplied to our operations in the United States, but generated outside the United States,

, General Data Protection Regulation in the European Union;

stringent privacy requirements for data to be supplied to our operations in the United States, but generated outside of the United

States, e.g., General Data Protection Regulation in the European Union;

changes in tariffs, trade barriers and regulatory requirements;

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with tax, employment, immigration and labor laws for employees living or traveling abroad;

taxes, including withholding of payroll taxes;

taxes, including withholding or payroll taxes;

payor reimbursement regimes, governmental payors or patient self-pay systems and price controls;

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affect our business, financial condition and results of operations.

success depends on the continued availability and contributions of our founder and Chief Executive Officer, Dr.

is 85 years old and is being treated for recurrent asymptomatic prostate cancer.

The loss of services of Dr.

Kovach could delay or reduce

our product development and commercialization efforts and would require that we hire a qualified replacement to fill the position of

the Chief Executive Officer.

Furthermore, recruiting and retaining qualified scientific personnel to perform future research and development

work is critical to our success.

Our inability to attract or retain qualified personnel or advisors in the future could significantly

weaken our management, harm our ability to compete effectively, and harm our business.

The competition for qualified personnel in the

pharmaceutical field is intense and, as a result, we might be unable to attract and retain qualified personnel necessary for the development

of our business.

September 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 intended products and

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

and deliver presentations concerning our product candidates;

(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;

available for consultation in drug discovery and development;

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 experience.

The Collaboration Agreement automatically renews annually unless either party

elects to terminate it.

The Collaboration Agreement is currently in effect.

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

Kovach, as President and Chief Executive Officer.

Kovach passed away on October 5, 2023.

Effective October 6, 2023, Mr.

was appointed as Chairman of the Board of Directors.

Kovach was also the Company’s Chief Scientific Officer.

our success depended, in part, on the continued availability and contributions of Dr.

Kovach, we were able to replace Dr.

timely basis with a qualified replacement in Mr.

van der Baan.

Furthermore, recruiting and retaining qualified scientific personnel to

perform future research and development work is critical to our success.

Our inability to attract or retain qualified personnel or advisors

in the future could significantly weaken our management, harm our ability to compete effectively, and harm our business.

The competition

for qualified personnel in the pharmaceutical field is intense and, as a result, we might be unable to attract and retain qualified personnel

necessary for the development of our business.

Additionally,

we employ Dr.

Miser as Chief Medical Officer and promoted Eric J.

Forman to Vice President and Chief Operating Officer.

the foreseeable future, Dr.

Miser is working with us on a half-time basis.

We believe that this Collaboration Agreement with BioPharmaWorks

and the presence of Dr.

Miser on a half-time basis as Chief Medical Officer, and we promoted Eric J.

Forman to Vice President and Chief

Operating Officer on November 6, 2022.

We believe that Dr.

Miser and Mr.

Forman mitigate, to a certain extent, our reliance on the services of Dr.

Kovach, and would allow

us the time to replace Dr.

Kovach in the event that such a need arose.

Forman, led by Mr.

van der Baan as President and Chief Executive

Officer, are capable of managing the Company’s research and clinical activities.

expect to rely heavily on third parties for the conduct of clinical trials of our product candidates.

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our product candidates are safe and effective.

Kovach is experienced in the design and conduct of early clinical cancer trials, having been the lead investigator for a National Cancer

Institute Phase 1 clinical trial contract for ten years at the Mayo Clinic, Rochester, Minnesota.

However, we have no experience in conducting

clinical trials and expect to rely heavily on collaborative partners and CROs for their performance and management of clinical trials

of our product candidates.

Miser is experienced in the design and conduct of early stage clinical trials.

However, we expect to rely on collaborative partners and

CROs for their performance and management of clinical trials of our product candidates.

intended products under development might not be effective in treating any of our targeted disorders or might prove to have undesirable

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we will rely on third parties to manufacture our product candidates and conduct clinical trials, and similar events as those described

in the prior paragraph relating to their business systems, equipment and facilities could also have a material adverse effect on our

To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or

misappropriation or disclosure of confidential or proprietary information, we could incur liability and the further development and commercialization

previously relating to their business systems, equipment and facilities could also have a material adverse effect on our business.

the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or misappropriation

or disclosure of confidential or proprietary information, we could incur liability and the further development and commercialization

of our lead product candidate could be delayed or altogether terminated.

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arrangements with third parties.

We have entered into a number of agreements with third parties as described below under “Business,”

including a clinical trial research agreement with H.

Lee Moffitt Cancer Center and Research Institute, Inc.;

a collaboration agreement

with the Spanish Sarcoma Group;

a cooperative research and development agreement with the National Cancer Institute;

and a clinical research

support agreement with City of Hope National Medical Center.

Existing and future collaborators have significant discretion in determining

the efforts and resources they apply and might not perform their obligations as expected.

Potential third-party collaborators include

biopharmaceutical, pharmaceutical and biotechnology companies, academic institutions, government agencies and other entities.

collaborators may assist us in:

We have entered into a number of agreements with third parties as described elsewhere in this document.

Existing and future collaborators have significant discretion in determining the efforts and resources they apply and might not perform

their obligations as expected.

Potential third party collaborators include biopharmaceutical, pharmaceutical and biotechnology companies,

academic institutions, government agencies and other entities.

Third party collaborators may assist us in:

research, preclinical development, clinical trials and manufacturing;

seeking and obtaining regulatory

successfully commercializing

any future product candidates.

and obtaining regulatory approvals;

commercializing any future product candidates.

we are not able to establish further collaboration agreements, we might be required to undertake product development and commercialization

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cannot be certain we will be able to obtain patent protection to protect our product candidates and technology.

patents and patent applications are owned solely by our subsidiary Lixte Biotechnology, Inc., except in two instances jointly with one

of our collaborators.

patents and patent applications are owned solely by our wholly-owned subsidiary, Lixte Biotechnology, Inc., except in several instances

where they are jointly owned with one of our collaborators.

patent prosecution process is expensive and time-consuming, and we might not be able to file or prosecute all necessary or desirable

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The degree of future protection for our proprietary rights is uncertain.

or jointly with our collaborators, might not have been the first to make the inventions covered by our pending or future patent applications;

we, solely or jointly with

our collaborators, might not have been the first to file patent applications for these inventions;

others might independently

develop identical, similar or alternative technologies;

solely or jointly with our collaborators, might not have been the first to make the inventions covered by our pending or future patent

applications;

solely or jointly with our collaborators, might not have been the first to file patent applications for these inventions;

might independently develop identical, similar or alternative technologies;

is possible that our patent applications will not result in an issued patent or patents, or that the scope of protection granted

by any patents arising from our patent applications will be significantly narrower than expected;

we might be unaware of prior art that renders one or more of our patent applications unpatentable or one or more of our patents invalid;

a court might determine that we failed to disclose to a patent office prior art that we were aware of and that is material to patentability

might be unaware of prior art that renders one or more of our patent applications unpatentable or one or more of our patents invalid;

court might determine that we failed to disclose to a patent office prior art that we were aware of and that is material to patentability

and, therefore, conclude that one or more of our patents are unenforceable;

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or foreign laws;

a court or patent office might determine that two or more of our patents claim patentably indistinct subject matter, which could

adversely affect one or more of the patents’ the term, validity or enforceability;

a court or patent office

might determine that one or more patents issued to us in the future or under which we hold rights are invalid or unenforceable;

we might develop additional

proprietary technologies that are not patentable and which might not be adequately protected through trade secrets or know-how.

court or patent office might determine that two or more of our patents claim patentably indistinct subject matter, which could adversely

affect one or more of the patents’ term, validity or enforceability;

court or patent office might determine that one or more patents issued to us in the future or under which we hold rights are invalid

or unenforceable;

might develop additional proprietary technologies that are not patentable and which might not be adequately protected through trade

secrets or know-how.

addition, we solely or jointly own patents or patent applications in jurisdictions having, or that might in the future have, geopolitical

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addition, disputes might arise regarding intellectual property subject to a license agreement, including:

rights granted under the license agreement and other interpretation-related issues;

whether our technology,

product candidates or processes infringe intellectual property rights that are owned by the licensor, but that are not subject to

the licensing agreement;

our diligence obligations

under the license agreement and the activities that satisfy those obligations;

whether we are required

to sublicense to a third party rights that the license grants to us, but that we do not commercially pursue;

the ownership of inventions,

data and know-how resulting from joint creation or use of intellectual property by our licensors and us.

scope of rights granted under the license agreement and other interpretation-related issues;

our technology, product candidates or processes infringe intellectual property rights that are owned by the licensor, but that are

not subject to the licensing agreement;

diligence obligations under the license agreement and the activities that satisfy those obligations;

we are required to sublicense to a third party rights that the license grants to us, but that we do not commercially pursue;

ownership of inventions, data and know-how resulting from joint creation or use of intellectual property by our licensors and us.

disputes over intellectual property that we have licensed, or might in the future license, prevent or impair our ability to maintain

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first to invent the technology or that we were the first to file patent applications covering our technology, because:

applications in the United States are maintained in secrecy until the patents are issued;

patent applications in

the United States are typically not published until 18 months after their earliest claimed priority date;

publications in the scientific

literature often lag behind actual discoveries.

patent applications in the United States are maintained in secrecy until the patents are issued;

applications in the United States are typically not published until 18 months after their earliest claimed priority date;

in the scientific literature often lag behind actual discoveries.

competitors might have filed, and might in the future file, patent applications covering technology similar or identical to ours.

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we do not prevail in either type of litigation, we might be subject to:

paying monetary

damages related to the legal expenses of the third party;

facing additional competition

that might have a significant adverse effect on our intended-product pricing, market share, business operations, financial condition,

and the commercial viability of our intended products;

restructuring our company

or delaying or terminating select business opportunities, including, but not limited to, research and development, clinical trials,

and commercialization activities, due to a potential deterioration of our financial condition or market competitiveness.

monetary damages related to the legal expenses of the third party;

additional competition that might have a significant adverse effect on our intended-product pricing, market share, business operations,

financial condition, and the commercial viability of our intended products;

restructuring

our company or delaying or terminating select business opportunities, including, but not limited to, research and development, clinical

trials, and commercialization activities, due to a potential deterioration of our financial condition or market competitiveness.

third party might also challenge the validity, enforceability or scope of the intellectual property rights that we license or own, and

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patent offices.

The patent offices require compliance with many procedural,

Patent offices require compliance with many procedural,

documentary, fee payment and other requirements during the patent application process and after a patent issues or grants.

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following factors are important to our success:

receiving patent

protection for our product candidates;

preventing others from

infringing our intellectual property rights;

maintaining our patent

rights and trade secrets.

patent protection for our product candidates;

others from infringing our intellectual property rights;

our patent rights and trade secrets.

will be able to protect our intellectual property rights in patents and trade secrets from unauthorized use by third parties only to

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of any product candidates for which we receive approval depends on a number of factors, including:

and safety of such product candidates as demonstrated in clinical trials;

indications and patient populations for which the product candidate is approved;

acceptance by physicians,

major cancer treatment centers and patients of the drug as a safe and effective treatment;

the adoption of novel immunotherapies

by physicians, hospitals and third-party payors;

the potential and perceived

advantages of product candidates over alternative treatments;

the safety of product candidates

seen in a broader patient group, including our use outside the approved indications;

any restrictions on use

together with other medications;

the prevalence and severity

of any side effects;

product labeling or product

insert requirements of the FDA or other regulatory authorities;

the timing of market introduction

of our intended product as well as competitive products;

the development of manufacturing

and distribution processes for commercial scale manufacturing for our lead product candidate and any future product candidates;

the cost of treatment in

relation to alternative treatments;

the availability of coverage

and adequate reimbursement from third-party payors and government authorities;

relative convenience and

ease of administration;

the effectiveness of our

sales and marketing efforts and those of our collaborators.

efficacy and safety of such product candidates as demonstrated in clinical trials;

clinical indications and patient populations for which the product candidate is approved;

by physicians, major cancer treatment centers and patients of the drug as a safe and effective treatment;

adoption of novel immunotherapies by physicians, hospitals and third party payors;

potential and perceived advantages of product candidates over alternative treatments;

safety of product candidates seen in a broader patient group, including our use outside the approved indications;

restrictions on use together with other medications;

prevalence and severity of any side effects;

labeling or product insert requirements of the FDA or other regulatory authorities;

timing of market introduction of our intended product as well as competitive products;

development of manufacturing and distribution processes for commercial scale manufacturing for our lead product candidate and any

future product candidates;

cost of treatment in relation to alternative treatments;

availability of coverage and adequate reimbursement from third party payors and government authorities;

convenience and ease of administration;

effectiveness of our sales and marketing efforts and those of our collaborators.

our lead product candidate and any future product candidates are approved but fail to achieve market acceptance among physicians, patients,

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private health insurers and other organizations.

payors determine which medications they will cover and establish reimbursement levels.

A primary trend in the healthcare industry is

cost containment.

party payors determine which medications they will cover and establish reimbursement levels.

A primary trend in the healthcare industry

is cost containment.

Third party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular

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legislative measures aimed at reducing healthcare costs might have a material adverse effect on our business and results of operations.

payors, whether domestic or foreign, or governmental or commercial, are developing increasingly sophisticated methods of controlling

party payors, whether domestic or foreign, or governmental or commercial, are developing increasingly sophisticated methods of controlling

healthcare costs.

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costs of healthcare and/or impose price controls might adversely affect:

for our lead product candidate, if we obtain regulatory approval;

to receive or set a price that we believe is fair for our intended product;

our ability to generate

revenue and achieve or maintain profitability;

the level of taxes that

we are required to pay;

the availability of capital.

demand for our lead product candidate, if we obtain regulatory approval;

ability to receive or set a price that we believe is fair for our intended product;

ability to generate revenue and achieve or maintain profitability;

level of taxes that we are required to pay;

availability of capital.

expect that the ACA, as well as other healthcare reform measures that might be adopted in the future, might result in additional reductions

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that might affect our ability to operate include the following:

healthcare Anti-Kickback Statute which prohibits, among other things, individuals and entities from knowingly and willfully soliciting,

offering, receiving or providing remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward,

or in return for, either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for

which payment might be made under a federal healthcare program such as Medicare and Medicaid;

federal civil

and criminal false claims laws, including the federal False Claims Act that can be enforced through civil whistleblower or qui tam

actions, and civil monetary penalty laws, prohibit individuals or entities from knowingly presenting, or causing to be presented,

federal healthcare Anti-Kickback Statute which prohibits, among other things, individuals and entities from knowingly and willfully

soliciting, offering, receiving or providing remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce

or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation of, any good or service,

for which payment might be made under a federal healthcare program such as Medicare and Medicaid;

civil and criminal false claims laws, including the federal False Claims Act that can be enforced through civil whistleblower or

qui tam actions, and civil monetary penalty laws, prohibit individuals or entities from knowingly presenting, or causing to be presented,

to the federal government, including the Medicare and Medicaid programs, claims for payment or approval that are false or fraudulent

or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;

the federal Health Insurance

Portability and Accountability Act of 1996 (“HIPAA”) which imposes criminal and civil liability for executing a scheme

to defraud any healthcare benefit program and also created federal criminal laws that prohibit knowingly and willfully falsifying,

concealing or covering up a material fact or making any materially false statements in connection with the delivery of or payment

for healthcare benefits, items or services, as amended by the Health Information Technology for Economic and Clinical Health Act

of 2009 (“HITECH”) which imposes obligations, including mandatory contractual terms, with respect to safeguarding the

privacy, security and transmission of individually identifiable health information on entities subject to the law, such as certain

healthcare providers, health plans, and healthcare clearinghouses, known as covered entities, and their respective business associates

that perform services for them that involve the creation, use, maintenance or disclosure of, individually identifiable health information;

the federal physician sunshine

requirements under the ACA which requires certain manufacturers of drugs, devices, biologics and medical supplies, with certain exceptions,

to report annually to HHS information related to payments and other transfers of value to physicians, other healthcare providers,

and teaching hospitals, and ownership and investment interests held by physicians and other healthcare providers and their immediate

family members and applicable group purchasing organizations;

analogous state and foreign

laws and regulations, such as state anti-kickback and false claims laws, which might apply to sales or marketing arrangements and

claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers;

state laws which require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines

and the relevant compliance guidance promulgated by the federal government and might require drug manufacturers to report information

related to payments and other transfers of value to physicians and other healthcare providers, marketing expenditures or pricing

federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) which imposes criminal and civil liability

for executing a scheme to defraud any healthcare benefit program and also created federal criminal laws that prohibit knowingly and

willfully falsifying, concealing or covering up a material fact or making any materially false statements in connection with the

delivery of or payment for healthcare benefits, items or services, as amended by the Health Information Technology for Economic and

Clinical Health Act of 2009 (“HITECH”) which imposes obligations, including mandatory contractual terms, with respect

to safeguarding the privacy, security and transmission of individually identifiable health information on entities subject to the

law, such as certain healthcare providers, health plans, and healthcare clearinghouses, known as covered entities, and their respective

business associates that perform services for them that involve the creation, use, maintenance or disclosure of, individually identifiable

health information;

federal physician sunshine requirements under the ACA which requires certain manufacturers of drugs, devices, biologics and medical

supplies, with certain exceptions, to report annually to HHS information related to payments and other transfers of value to physicians,

other healthcare providers, and teaching hospitals, and ownership and investment interests held by physicians and other healthcare

providers and their immediate family members and applicable group purchasing organizations;

state and foreign laws and regulations, such as state anti-kickback and false claims laws, which might apply to sales or marketing

arrangements and claims involving healthcare items or services reimbursed by non-governmental third party payors, including private

some state laws which require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance

guidelines and the relevant compliance guidance promulgated by the federal government and might require drug manufacturers to report

information related to payments and other transfers of value to physicians and other healthcare providers, marketing expenditures

or pricing information;

and certain state and local laws which require the registration of pharmaceutical sales representatives;

state and foreign laws

govern the privacy and security of health information in specified circumstances, many of which differ from each other in significant

ways and often are not pre-empted by HIPAA, thus complicating compliance efforts.

and foreign laws govern the privacy and security of health information in specified circumstances, many of which differ from each

other in significant ways and often are not pre-empted by HIPAA, thus complicating compliance efforts.

to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involve

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Regardless of merit or eventual outcome, liability claims might result in:

decreased demand

for any product candidates or products that we might develop;

termination of clinical

trial sites or entire clinical trial programs;

injury to our reputation

and significant negative media attention;

withdrawal of clinical

trial participants;

significant costs to defend

the related litigation;

substantial monetary awards

to trial subjects or patients;

loss of revenue;

diversion of management

and scientific resources from our business operations;

the inability to commercialize

any products that we might develop.

demand for any product candidates or products that we might develop;

of clinical trial sites or entire clinical trial programs;

to our reputation and significant negative media attention;

of clinical trial participants;

costs to defend the related litigation;

monetary awards to trial subjects or patients;

of management and scientific resources from our business operations;

inability to commercialize any products that we might develop.

to engaging in future clinical trials, we intend to obtain product liability insurance coverage at a level that we believe is customary

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business might be adversely affected by the ongoing coronavirus pandemic.

outbreak of the novel coronavirus (SARS-CoV-2) has evolved into a global pandemic.

The coronavirus has spread to many regions of the

The extent to which the coronavirus impacts our business and operating results will depend on future developments that are highly

uncertain and cannot be accurately predicted, including new information that might emerge concerning the coronavirus and the actions

to contain the coronavirus or treat its impact, among others.

a result of the continuing spread of the coronavirus and emergence of new variants, our business operations could be delayed or interrupted.

For instance, our clinical trials might be affected by the pandemic.

Site initiation, participant recruitment and enrollment, participant

dosing, distribution of clinical trial materials, study monitoring and data analysis might be paused or delayed due to changes in hospital

or university policies, federal, state or local regulations, prioritization of hospital resources toward pandemic efforts, or other reasons

related to the pandemic.

If the coronavirus continues to spread, some participants and clinical investigators might not be able to comply

with clinical trial protocols.

For example, quarantines or other travel limitations (whether voluntary or required) might impede participant

movement, affect sponsor access to study sites, or interrupt healthcare services, and we might be unable to conduct our clinical trials.

Further, if the spread of the coronavirus pandemic continues and our operations are adversely impacted, we risk a delay, default and/or

non-performance under existing agreements which might increase our costs.

These cost increases might not be fully recoverable or adequately

covered by insurance.

and deaths related to the pandemic might disrupt the United States healthcare and healthcare regulatory systems.

Such disruptions could

divert healthcare resources away from, or materially delay FDA review and/or approval with respect to, our clinical trials.

It is unknown

how long these disruptions could continue, were they to occur.

Any elongation or de-prioritization of our clinical trials or delay in

regulatory review resulting from such disruptions could materially affect the development and study of our product candidates.

currently utilize third parties to, among other things, manufacture raw materials.

If either any third-party parties in the supply chain

for materials used in the production of our product candidates are adversely impacted by restrictions resulting from the coronavirus

outbreak, our supply chain might be disrupted, limiting our ability to manufacture our product candidates for our clinical trials and

research and development operations.

a result of the shelter-in-place order and other mandated local travel restrictions, our employees conducting research and development

or manufacturing activities might not be able to access their laboratory or manufacturing space which might result in our core activities

being significantly limited or curtailed, possibly for an extended period of time.

spread of the coronavirus, which has caused a broad impact globally, including travel restrictions and quarantine policies put into place

by businesses and governments, might have a material adverse effect on our business.

While the potential economic impact brought by and

the duration of the pandemic might be difficult to assess or predict, it has already caused, and is likely to result in further, significant

disruption of global financial markets, which might reduce our ability to access capital either at all or on favorable terms.

a recession, depression or other sustained adverse market event resulting from the spread of the coronavirus could materially and adversely

affect our business and the value of our common stock.

ultimate impact of the current pandemic, or any other health epidemic, is highly uncertain and subject to change.

We do not yet know

the full extent of potential delays or impacts on our business, our clinical trials, our research programs, healthcare systems or the

global economy as a whole.

However, these effects could have a material impact on our operations, and we will continue to monitor the

situation closely.

disruptions of information technology systems, computer system failures or breaches of information security could adversely affect our

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

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

Although the Covid-19 outbreak has subsided,

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

efforts in the future is uncertain and cannot be predicted.

disruptions of information technology systems, computer system failures or breaches of information and cyber security could adversely

affect our business.

rely to a large extent upon sophisticated information technology systems to operate our business.

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Future growth would impose significant added responsibilities on members of management, including:

clinical trials effectively;

identifying, recruiting,

maintaining, motivating and integrating additional employees;

managing our internal development

efforts effectively while complying with our contractual obligations to licensors, licensees, contractors and other third parties;

improving our managerial,

development, operational, information technology, and finance systems;

expanding our facilities.

our clinical trials effectively;

recruiting, maintaining, motivating and integrating additional employees;

our internal development efforts effectively while complying with our contractual obligations to licensors, licensees, contractors

and other third parties;

our managerial, development, operational, information technology, and finance systems;

our facilities.

our operations expand, we will likely also need to manage additional relationships with various strategic partners, suppliers and other

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The financial markets and the global economy may also be adversely

affected by the current or anticipated impact of military conflict, including the conflict between Russia and Ukraine, terrorism or other

geopolitical events.

Sanctions imposed by the United States and other countries in response to such conflicts, including the one in Ukraine,

may also adversely impact the financial markets and the global economy, and any economic countermeasures by the affected countries or

others could exacerbate market and economic instability.

More recently, the closures of Silicon Valley Bank and Signature Bank and their

placement into receivership with the Federal Deposit Insurance Corporation (FDIC) created bank-specific and broader financial institution

liquidity risk and concerns.

Although the Department of the Treasury, the Federal Reserve, and the FDIC jointly released a statement

that depositors at Silicon Valley Bank and Signature Bank would have access to their funds, even those in excess of the standard FDIC

insurance limits, under a systemic risk exception, future adverse developments with respect to specific financial institutions or the

broader financial services industry may lead to market-wide liquidity shortages, impair the ability of companies to access near-term

working capital needs, and create additional market and economic uncertainty.

There can be no assurance that future credit and financial

market instability and a deterioration in confidence in economic conditions will not occur.

Our general business strategy may be adversely

affected by any such economic downturn, liquidity shortages, volatile business environment or continued unpredictable and unstable market

If the equity markets deteriorate, or if adverse developments are experienced by financial institutions, it may cause short-term

liquidity risk and also make any necessary equity financing more difficult, more costly and more dilutive.

Failure to secure any necessary

financing in a timely manner and on favorable terms could have a material adverse effect on our business plans and stock price and could

require us to delay or abandon clinical development plans.

In addition, there is a risk that one or more of our current service providers,

financial institutions, manufacturers and other partners may be adversely affected by the foregoing risks, which could directly affect

our ability to conduct our business plans on schedule and on budget.

affected by the current or anticipated impact of military conflict, including the conflict between Russia and Ukraine, between Israel

and Gaza, terrorism or other geopolitical events.

Sanctions imposed by the United States and other countries in response to such conflicts,

including the one in Ukraine, may also adversely impact the financial markets and the global economy, and any economic countermeasures

by the affected countries or others could exacerbate market and economic instability.

Future adverse developments with respect to financial

institutions or the broader financial services industry may lead to market-wide liquidity shortages, impair the ability of companies

to access near-term working capital needs, and create additional market and economic uncertainty.

There can be no assurance that future

credit and financial market instability and a deterioration in confidence in economic conditions will not occur.

Our general business

strategy may be adversely affected by any such economic downturn, liquidity shortages, volatile business environment or continued unpredictable

and unstable market conditions.

If the equity markets deteriorate, or if adverse developments are experienced by financial institutions,

it may cause short-term liquidity risk and also make any necessary equity financing more difficult, more costly and more dilutive.

to secure any necessary financing in a timely manner and on favorable terms could have a material adverse effect on our business plans

and stock price and could require us to delay or abandon clinical development plans.

In addition, there is a risk that one or more of

our current service providers, financial institutions, manufacturers and other partners may be adversely affected by the foregoing risks,

which could directly affect our ability to conduct our business plans on schedule and on budget.

Related to Owning our Securities

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Specifically,

holders of the Warrants may exercise their right to acquire the common stock and pay an exercise price of $5.70 per share.

each Warrant will expire five (5) years from the original issuance date.

In the event our common stock price does not exceed the exercise

price of the Warrants during the period when the Warrants are exercisable, the Warrants might not have any value.

holders of the Warrants may exercise their right to acquire the common stock and pay an effective exercise price of $57.00 per share,

which is substantially in excess of the current market price of the Company’s common stock.

Furthermore, each Warrant will expire

five (5) years from the original issuance date.

In the event our common stock price does not exceed the exercise price of the Warrants

during the period when the Warrants are exercisable, the Warrants may not have any value.

of the Warrants will have no rights as a common stockholder until they acquire our common stock.

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even where the acquisition could be beneficial to you.

20, 2023 sale of common stock and warrants.

July 2023, we sold common stock and warrants to an institutional investor and raised gross proceeds of approximately $3,500,000.

of this financing, the Company sold warrants to the institutional investor to purchase 583,334 shares of common stock.

Each common warrant

had an initial exercise price of $6.00 per share, was immediately exercisable upon issuance, and expires five years thereafter on July

The Company also issued warrants to the placement agent to purchase 35,000 shares of common stock at an exercise price of $6.60

per share and expiring on July 20, 2028.

exercise prices of the warrants issued to the institutional investor and to the placement agent are subject to customary adjustments

for stock splits, stock dividends, stock combinations, reclassifications, reorganizations, or similar events affecting the Company’s

common stock.

In addition, the warrants issued to the institutional investor contain a “fundamental transaction” provision

whereby in the event of a fundamental transaction (a sale or transfer of assets or ownership of the Company as defined in the warrant

agreement) within the Company’s control, the holder of the unexercised common stock warrants would be entitled to receive, in exchange

for extinguishment of the warrants, cash consideration equal to a Black-Scholes valuation, as defined in the warrant agreement.

fundamental transaction is not within the Company’s control, the warrant holder would only be entitled to receive the same form

of consideration (and in the same proportion) as the holders of the Company’s common stock.

in the event of a change in control of the Company or a sale or transfer of all or substantially all of the Company’s assets, to

the extent that the warrants issued to the institutional investor are outstanding at the effective date that such a transaction is closed,

this “fundamental transaction” provision would entitle the institutional investor to substantial cash consideration, thus

reducing the amounts to be retained by the Company or potentially distributable to the Company’s stockholders.

price of our common stock or Warrants might fluctuate substantially.

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stock or Warrants to fluctuate, in addition to the other risks mentioned in this “Risk Factors,” are:

common stock by our stockholders, executives, and directors and our stockholders;

volatility and limitations

in trading volumes of our shares of common stock;

our ability to obtain financings

to conduct and complete research and development activities including, but not limited to, our clinical trials, and other business

and success of introductions of new products by us or our competitors or any other change in the competitive dynamics of our industry,

including consolidation among competitors, customers or strategic partners;

network outages or security

our ability to secure resources

and the necessary personnel to conduct clinical trials on our desired schedule;

commencement, enrollment

or results of our clinical trials for our lead product candidate or any future clinical trials we might conduct;

changes in the development

status of our lead product candidate;

any delays or adverse developments

or perceived adverse developments with respect to the FDA’s review of our planned preclinical and clinical trials;

any delay in our submission

for studies or product approvals or adverse regulatory decisions, including failure to receive regulatory approval for our lead product

unanticipated safety concerns

related to the use of our lead product candidate;

failures to meet external

expectations or management guidance;

changes in our capital

structure or dividend policy, future issuances of securities, sales of large blocks of common stock by our stockholders;

our cash position;

announcements and events

surrounding financing efforts, including debt and equity securities;

our inability to enter

into new markets or develop new products;

reputational issues;

competition from existing

technologies and products or new technologies and products that might emerge;

announcements of acquisitions,

partnerships, collaborations, joint ventures, new products, capital commitments, or other events by us or our competitors;

general economic, political and market conditions in or any of the regions in which we conduct our business;

changes in industry conditions

or perceptions;

changes in valuations of

similar companies or groups of companies;

analyst research reports,

recommendation and changes in recommendations, price targets, and withdrawals of coverage;

departures and additions

of key personnel;

disputes and litigations

related to intellectual properties, proprietary rights, and contractual obligations;

changes in applicable laws,

rules, regulations, or accounting practices and other dynamics;

other events or factors,

many of which might be out of our control.

of our common stock by our stockholders, executives, and directors and our stockholders;

and limitations in trading volumes of our shares of common stock;

ability to obtain financings to conduct and complete research and development activities including, but not limited to, our clinical

trials, and other business activities;

timing and success of introductions of new products by us or our competitors or any other change in the competitive dynamics of our

industry, including consolidation among competitors, customers or strategic partners;

outages or security breaches;

ability to secure resources and the necessary personnel to conduct clinical trials on our desired schedule;

commencement,

enrollment or results of our clinical trials for our lead product candidate or any future clinical trials we might conduct;

in the development status of our lead product candidate;

delays or adverse developments or perceived adverse developments with respect to the FDA’s review of our planned preclinical

and clinical trials;

delay in our submission for studies or product approvals or adverse regulatory decisions, including failure to receive regulatory

approval for our lead product candidate;

unanticipated

safety concerns related to the use of our lead product candidate;

to meet external expectations or management guidance;

in our capital structure or dividend policy, future issuances of securities, sales of large blocks of common stock by our stockholders;

cash position;

announcements

and events surrounding financing efforts, including debt and equity securities;

inability to enter into new markets or develop new products;

from existing technologies and products or new technologies and products that might emerge;

announcements

of acquisitions, partnerships, collaborations, joint ventures, new products, capital commitments, or other events by us or our competitors;

in general economic, political and market conditions in or any of the regions in which we conduct our business;

in industry conditions or perceptions;

in valuations of similar companies or groups of companies;

research reports, recommendation and changes in recommendations, price targets, and withdrawals of coverage;

and additions of key personnel;

and litigations related to intellectual properties, proprietary rights, and contractual obligations;

in applicable laws, rules, regulations, or accounting practices and other dynamics;

events or factors, many of which might be out of our control.

addition, if the market for stocks in our industry or industries related to our industry, or the stock market in general, experiences

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Related to the Company’s Common Stock

Company received a written notice from Nasdaq that it has failed to comply with certain listing requirements of The Nasdaq Stock Market,

which could result in the Company being delisted from The Nasdaq Stock Market.

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

per share for a period of 30 consecutive business days.

The Nasdaq Listing Rules provided the Company a compliance period of 180 calendar

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

As the Company did not regain

compliance with the minimum bid price requirement, the Company was afforded a second 180 calendar day compliance period to regain compliance

by letter dated December 22, 2022.

If at any time from the date of this second notice until June 19, 2023, the closing bid price of the

Company’s common stock is at least $1.00 per share for a minimum of ten consecutive business days, Nasdaq will provide the Company

with written confirmation of compliance and the matter will be closed.

If the Company does not regain compliance with the minimum bid

price requirement by the end of the second compliance period, the Company’s common stock and warrants will become subject to delisting.

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

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

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

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

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

then be delisted.

there can be no assurance that the market price per new share of the Company’s common stock after the reverse stock split will

remain unchanged or increase in proportion to the reduction in the number of old shares of the Company’s common stock outstanding

before the reverse stock split.

Even if the reverse stock split is approved by the Company’s stockholders, there can be no assurance

that the Company will be able to maintain compliance with the minimum bid price requirement in the future or will otherwise be able to

maintain compliance with other Nasdaq listing rules.

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

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

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

Moreover, if the Company is delisted from

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

experience potentially more price volatility than experienced on Nasdaq.

Stockholders may not be able to sell their shares of common

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

on a more liquid trading market.

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

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

A delisting of the Company’s

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

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

the Company implements a reverse stock split, liquidity of its common stock may be adversely effected.

indicated above, the Company intends to seek approval from its stockholders to effect a reverse stock split of the issued and outstanding

shares of its common stock in order to regain compliance with the Nasdaq $1.00 minimum bid price requirement.

The liquidity of the shares

of the Company’s common stock may be affected adversely by any reverse stock split given the reduced number of shares of the Company’s

common stock that will be outstanding following the reverse stock split, particularly if the market price of the Company’s common

stock does not increase as a result of the reverse stock split.

any reverse stock split, the resulting market price of the Company’s common stock may not attract new investors and may not satisfy

the investing requirements of those investors.

Although the Company believes that a higher market price of the Company’s common

stock may help generate greater or broader investor interest, there can be no assurance that the reverse stock split will result in a

share price that will attract new investors, including institutional investors.

In addition, there can be no assurance that the market

price of the Company’s common stock will satisfy the investing requirements of those investors.

As a result, the trading liquidity

of the Company’s common stock may not necessarily improve, or could decrease.

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

respectively.

order to achieve compliance with the $1.00 minimum closing bid price requirement of the Nasdaq Capital Market, the Company held a special

meeting of stockholders on May 26, 2023 to seek approval for an amendment to the Company’s Certificate of Incorporation to effect

a reverse stock split of its issued and outstanding shares of common stock.

As a result of the approval of this amendment, the Company

effected a 1-for-10 reverse stock split of its issued and outstanding common stock effective on Friday, June 2, 2023.

Commencing with

the opening of trading on the Nasdaq Capital Market on Monday, June 5, 2023, the Company’s common stock began trading on a post-split

basis under the same symbol LIXT.

The Company subsequently received confirmation from Nasdaq that it had regained compliance with the

minimum bid price requirement of $1.00 per share under Nasdaq Listing Rule 5550(a)(2) and currently meets all other applicable criteria

for continued listing.

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

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

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

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

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

Moreover, if the Company is

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

and therefore experience potentially more price volatility than experienced on Nasdaq.

Stockholders may not be able to sell their shares

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

available on a more liquid trading market.

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

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

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

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

sale or perceived sale of a substantial number of shares of our common stock might cause the price of our common stock to decline.

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We might sell common stock

convertible securities or other equity securities in one or more transactions at prices and in a manner we determine from time to time.

If we sell common stock, convertible securities or other equity securities in more than one transaction, investors might be materially

diluted by subsequent sales.

Such sales might also result in material dilution to our existing stockholders, and new investors could

gain rights superior to our existing stockholders.

(with or without warrants), convertible securities or other equity securities in one or more transactions at prices and in a manner we

determine from time to time.

If we sell common stock, convertible securities or other equity securities in more than one transaction,

investors might be materially diluted by subsequent sales.

Such sales might also result in material dilution to our existing stockholders,

and new investors could gain rights superior to our existing stockholders.

do not intend to pay cash dividends on our shares of common stock so any returns will be limited to the value of our shares.

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the certificate of incorporation and bylaws and Delaware law, as applicable, among other things:

Board of Directors with the ability to alter the bylaws without stockholder approval;

place limitations on the

removal of directors;

establishing advance notice

requirements for nominations for election to the Board of Directors or for proposing matters that can be acted upon at stockholder

provide that vacancies

on the Board of Directors might be filled by a majority of directors in office, although less than a quorum.

the Board of Directors with the ability to alter the bylaws without stockholder approval;

limitations on the removal of directors;

advance notice requirements for nominations for election to the Board of Directors or for proposing matters that can be acted upon

at stockholder meetings;

that vacancies on the Board of Directors might be filled by a majority of directors in office, although less than a quorum.

reporting obligations of being a public company in the United States are expensive and time-consuming, and our management will be required

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confidence in our reported financial information, and the trading price of our common stock could drop significantly.

UNRESOLVED STAFF COMMENTS

LEGAL PROCEEDINGS

Company is not a party to any threatened or pending legal proceedings.

MINE SAFETY DISCLOSURES

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 1A. Risk Factors