What changed in this filing

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Item 7. Management’s Discussion and Analysis

2023-03-29 compared with 2022-03-21 · 524 added, 393 removed, 393 unchanged (70% of the section changed)

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

should read the following discussion and analysis of our financial condition and results of operations together with and our consolidated

financial statements and the related notes appearing elsewhere in this Annual Report on Form 10-K.

In addition to historical information,

this discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions.

Our actual results

may differ materially from those discussed below.

Factors that could cause or contribute to such differences include, but are not limited

to, those identified below, and those discussed in the section titled “Risk Factors” included elsewhere in this Annual Report

on Form 10-K.

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

and then designs novel compounds to attack those targets.

The Company’s product pipeline is primarily focused on inhibitors of

protein phosphatases, used alone and in combination with cytotoxic agents and/or x-ray and immune checkpoint blockers, and encompasses

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

The Company’s corporate office is located in Pasadena, California.

Company’s product pipeline is primarily focused on inhibitors of protein phosphatases, used alone and in combination with cytotoxic

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

The Company believes that inhibitors of protein phosphatases have broad therapeutic

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

The Company has developed 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.

The Company is directing its efforts on

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

activity at doses that produce little or no toxicity.

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

has not yet commenced any revenue-generating operations, relies on stock-based compensation for a substantial portion of employee and

consultant compensation, does not have positive cash flows from operations, and is dependent on periodic infusions of equity capital

to fund its operating requirements.

following is a summary of recent developments, including information contained in recent news releases issued by the Company:

12, 2022 - The Company reported that its recent collaboration with the Netherlands Cancer Institute (NKI), Amsterdam, one of the world’s

leading comprehensive cancer centers, and Stichting Oncode Institute (Oncode Institute), Utrecht, a major independent cancer research

center, has led to an initial joint patent application covering LB-100 combination therapy with one of several other investigational

The Company, NKI and Oncode Institute believe that the combination therapy would provide unexpectedly strong synergistic anti-cancer

effects in cancer patients.

The Company previously announced its entry into a collaboration with the NKI and the Oncode Institute to

identify the most promising drugs to be used in combination with the Company’s LB-100 or with one of the Company’s LB-100

analogues to treat a range of cancers, as well as to identify the specific molecular mechanisms underlying the identified combinations.

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

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

operating requirements.

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

of February 7, 2023 News Release

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

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

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

Most surprisingly,

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

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

drug resistance.

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

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

following are comments by Dr.

Kovach that were included in the news release:

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

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

Matheus Henrique

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

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

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

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

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

colorectal, pancreatic, and bile duct carcinomas.

The Bernards’

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

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

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

signaling much better than cancer cells.

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

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

Intriguingly,

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

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

This “tumor suppressive drug resistance” still

needs to be demonstrated in patients.

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

this hypothesis should be readily testable in the clinic.

of February 14, 2023 News Release

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

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

unappreciated mechanism.

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

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

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

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

axis can sensitize tumors to immunotherapy.”

following are comments by Dr.

Kovach that were included in the news release:

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

Ho, Assistant

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

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

Studies in animals show that

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

Nature Comm 2021).

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

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

maintenance phase of treatment (NCT04560972).

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

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

Notification of Failure to Satisfy a Continued Listing Rule

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

per share for a period of 30 consecutive business days.

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

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

As we did not regain compliance with

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

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

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

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

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

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

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

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

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

then be delisted.

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

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

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

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

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

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

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

Moreover, if the Company is delisted from

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

experience potentially more price volatility than experienced on Nasdaq.

Stockholders may not be able to sell their shares of common

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

on a more liquid trading market.

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

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

A delisting of the Company’s

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

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

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

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Even if the Company is able to generate revenues through licensing

its technologies or through product sales, there can be no assurance that the Company will be able to achieve positive earnings and operating

its technology, product sales or other commercial activities, there can be no assurance that the Company will be able to achieve and

maintain positive earnings and operating cash flows.

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

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and has experienced negative operating cash flows since inception.

The Company has financed its working capital requirements primarily

through the recurring sale of its equity securities.

The Company has financed its working capital requirements through

the recurring sale of its equity securities.

a result, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern.

The Company’s independent registered public accounting firm, in its report on the Company’s consolidated financial statements

for the year ended December 31, 2021, has also expressed substantial doubt about the Company’s ability to continue as a going concern.

The Company’s consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Company’s ability to continue as a going concern is dependent upon its ability to raise additional equity capital to fund its research

and development activities and to ultimately achieve sustainable operating revenues and profitability.

The amount and timing of future

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

availability of operating capital to fund such activities.

on current operating plans, the Company estimates that existing cash resources will provide sufficient working capital to fund the current

clinical trial program with respect to the development of the Company’s lead anti-cancer clinical compound LB-100 through approximately

December 31, 2023.

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

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

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

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

In addition, the Company’s operating plans may change as a result

of many factors that are currently unknown and/or outside of the control of the Company, and additional funds may be needed sooner than

market conditions present uncertainty as to the Company’s ability to secure additional funds, there can be no assurance that the

Company will be able to secure additional financing on acceptable terms, as and when necessary, to continue to conduct operations.

cash resources are insufficient to satisfy the Company’s ongoing cash requirements, the Company would be required to scale back

or discontinue its clinical trial program, as well as its licensing and patent prosecution efforts and its technology and product development

efforts, or obtain funds, if available, through strategic alliances or joint ventures that could require the Company to relinquish rights

to and/or control of LB-100, or to discontinue operations entirely.

Accounting Pronouncements

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on or after the effective date.

Early adoption is permitted for all entities, including adoption in an interim period.

If an entity elects

to early adopt ASU 2021-04 in an interim period, the guidance should be applied as of the beginning of the fiscal year that includes

that interim period.

The adoption of ASU 2021-04 is not expected to have any impact on the Company’s consolidated financial statement

presentation or disclosures.

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

The adoption of ASU 2021-04 did not have any

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

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

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and 2021 are described as follows.

and administrative costs for the years ended December 31, 2021 and 2020 include combined charges from two legal firms for general licensing

and patent prosecution costs relating to the Company’s intellectual properties representing 14.6% and 27.1%, respectively, of total

general and administrative costs.

General and administrative costs for the years ended December 31, 2021 and 2020 also included charges

for the fair value of stock options granted to directors and corporate officers representing 44.2% and 23.5%, respectively, of total

general and administrative costs for those periods.

and development costs for the year ended December 31, 2021 include charges from three vendors and consultants representing 30.3%, 21.8%,

and 14.4%, respectively, of total research and development costs for that period.

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

licensing and patent prosecution costs relating to the Company’s intellectual properties representing 26.5% and 14.6% of total

general and administrative costs, respectively.

General and administrative costs for the years ended December 31, 2022 and 2021 also

included charges for the fair value of stock options granted to directors and corporate officers representing 30.3% and 44.2%, respectively,

of total general and administrative costs.

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

15.1% and 12.1%, respectively, of total research and development costs.

Research and development costs for the year ended December 31,

31, 2020 include charges from a consultant, and the value associated with extending stock options previously granted to that consultant,

representing 65.6% of total research and development costs, and charges from a vendor representing 13.7% of total research and development

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

Accounting Policies and Estimates

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Actual results could differ from those estimates.

Significant estimates include those related to assumptions used in accruals for potential

liabilities, valuing equity instruments issued for services, and the realization of deferred tax assets.

Significant estimates include those related to assumptions used in the calculation

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

of deferred tax assets.

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

consolidated financial statements.

is held in a cash bank deposit program maintained by Morgan Stanley Wealth Management, a division of Morgan Stanley Smith Barney LLC

(“Morgan Stanley”).

Morgan Stanley is a FINRA-regulated broker-dealer.

The Company’s policy is to maintain its cash

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

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

The Company periodically has cash

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

Morgan Stanley

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

The Company has not experienced

any losses to date resulting from this policy.

Company operates and reports in one segment, which focuses on the utilization of biomarker technology to identify enzyme targets associated

with serious common diseases and then designing novel compounds to attack those targets.

The Company’s operating segment is reported

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

Chief Executive Officer and Chief Scientific Officer.

and Development

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

design, development and clinical trials with respect to the Company’s compounds and product candidates.

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

Research and development

costs also include the costs to produce the compounds used in research and clinical trials, which are charged to operations as incurred.

costs also include the costs to manufacture the compounds used in research and clinical trials, which are charged to operations as incurred.

The Company’s inventory of LB-100 for clinical use has been manufactured separately in the United States and in the European Union

in accordance with the laws and regulations of such jurisdictions.

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

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charged to operations as incurred.

incurred with respect to mandatory scheduled payments under research agreements with milestone provisions are recognized as charges to

research and development costs in the Company’s consolidated statement of operations based on the achievement of such milestones,

as specified in the agreement.

Obligations incurred with respect to mandatory scheduled payments under research agreements without milestone

provisions are accounted for when due, are recognized ratably over the appropriate period, as specified in the agreement, and are recorded

incurred with respect to mandatory scheduled payments under agreements with milestone provisions are recognized as charges to research

and development costs in the Company’s consolidated statement of operations based on the achievement of such milestones, as specified

in the respective agreement.

Obligations incurred with respect to mandatory scheduled payments under agreements without milestone provisions

are accounted for when due, are recognized ratably over the appropriate period, as specified in the respective agreement, and are recorded

as liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs in the

Company’s consolidated statement of operations.

made pursuant to research and development contracts are initially recorded as advances on research and development contract services

in the Company’s consolidated balance sheet and are then charged to research and development costs in the Company’s consolidated

statement of operations as those contract services are performed.

Expenses incurred under research and development contracts in excess

of amounts advanced are recorded as research and development contract liabilities in the Company’s consolidated balance sheet,

with a corresponding charge to research and development costs in the Company’s consolidated statement of operations.

reviews the status of its research and development contracts on a quarterly basis.

made pursuant to contracts are initially recorded as advances on research and development contract services in the Company’s consolidated

balance sheet and are then charged to research and development costs in the Company’s consolidated statement of operations as those

contract services are performed.

Expenses incurred under contracts in excess of amounts advanced are recorded as research and development

contract liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs

in the Company’s consolidated statement of operations.

The Company reviews the status of its various clinical trial and research

and development contracts on a quarterly basis.

and Licensing Legal and Filing Fees and Costs

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the years ended December 31, 2022 and 2021, patent and licensing legal and filing fees and costs related to the development and protection

of its intellectual property were $729,171 and $553,173, respectively, an increase of $175,998 (31.8%) in 2021 as compared to 2020.

late 2021, the Company engaged a new patent law firm, highly regarded for its expertise in biotechnology, and requested a comprehensive

analysis of the Company’s extensive patent portfolio in order to maximize intellectual property protection, both domestically and

internationally.

In addition, several patents were filed recently, reflecting potentially new uses of the Company’s unique lead

clinical compound LB-100 in cancer therapy.

These activities resulted in the increase in patent and licensing legal and filing fees and

costs in 2021 as compared to 2020.

The Company expects that patent and licensing legal and filing fees and costs will remain relatively

stable in 2022, as the Company expects to focus primarily on obtaining clinical data validating its novel approach to cancer treatment.

of the Company’s intellectual property were $1,268,308 and $729,171, respectively, an increase of $539,137, or 73.9%, in 2022 as

compared to 2021.

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

This firm conducted

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

protection, both domestically and internationally.

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

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

These activities resulted in an increase in patent and licensing

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

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

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

and expand its patent portfolio related to the clinical development of LB-100.

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

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

Company has developed two series of pharmacologically active drugs, the LB-100 series and the LB-200 series.

The Company believes 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.

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 animal models.

The enhancement

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

It is therefore hoped that, when combined with standard anti-cancer regimens against many tumor types, the Company’s compounds

will improve therapeutic benefit without enhancing toxicity in humans.

Company is focusing its development activities on its LB-100 series of drugs.

The Company believes 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.

Lead compounds from

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

In addition, compounds

from both series have anti-cancer activity in animal models of glioblastoma multiforme, neuroblastoma, and medulloblastoma, all cancers

of neural tissue.

Lead compounds of the LB-100 series also have activity against melanoma, breast cancer and sarcoma in animal models

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

The enhancement of anti-cancer activity of these

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

It is therefore hoped that, when

combined with standard anti-cancer regimens against many tumor types, the Company’s compounds will improve therapeutic benefit

without enhancing toxicity in humans.

The Company is not currently planning to allocate resources to further develop its LB-200 series

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

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

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

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

At this time, the Company intend to only maintain composition

of matter patents for LB-200.

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

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

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

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

Collaborations

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with pharmaceutical companies with major programs in cancer.

of the Novel Coronavirus (Covid-19) on the Company’s Business Activities

global outbreak of the novel coronavirus (Covid-19) has led to disruptions in general economic activities worldwide, as businesses and

governments have taken broad actions to mitigate this public health crisis.

light of the uncertain and continually evolving situation relating to the spread of Covid-19, this pandemic could pose a risk to the

The extent to which the coronavirus may impact the Company’s business activities will depend on future developments, which

are highly uncertain and cannot be predicted at this time.

The Company intends to continue to monitor the situation and may adjust its

current business plans as more information and guidance become available.

coronavirus pandemic presents a challenge to medical facilities worldwide.

As the Company’s clinical trials are conducted on an

outpatient basis, it is not currently possible to predict the full impact of this developing health crisis on such clinical trials, which

could include delays in and increased costs of such clinical trials.

Current indications from the clinical research organizations conducting

the clinical trials for the Company are that such clinical trials are being delayed or extended for several months or more as a result

of the coronavirus pandemic.

the near term, there is also significant and continuing uncertainty as to the effect that the coronavirus may have on the capital markets

in general and on the amount and type of financing available to the Company in particular.

Company is continuing to monitor the situation and will adjust its current business and financing plans as more information and guidance

Risks Associated with the Company’s Business Activities

The 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.

The extent to which the coronavirus

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

uncertain and cannot be predicted.

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

the extent additional information and guidance become available.

The coronavirus pandemic has also presented a challenge to medical facilities

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

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

The Company does not believe that inflation has had a material effect on its operations to date, other than its impact on the

general economy.

However, there is a risk that the Company’s operating costs could become subject to inflationary and interest

rate pressures in the future, which would have the effect of increasing the Company’s operating costs (including, specifically,

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

Chain Issues.

The Company does not currently expect that supply chain issues will have a significant impact on its business activities,

including its ongoing clinical trials.

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

Although unclear at

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

affect the Company.

Company is continuing to monitor these matters and will adjust its current business and financing plans as more information and guidance

become available.

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

Ended December 31,

and expenses:

and administrative costs:

to related parties

and licensing legal and filing fees and costs

and development costs

Years Ended December 31,

Costs and expenses:

from operations

currency gain (loss)

General and administrative costs:

Compensation to related parties

Patent and licensing legal and filing fees and costs

Research and development costs

Total costs and expenses

Loss from operations

Interest income

Interest expense

Foreign currency gain (loss)

$ (6,312,535 )

$ (6,728,396 )

loss per common share – basic and diluted

average common shares outstanding – basic and diluted

Net loss per common share – basic and diluted

Weighted average common shares outstanding – basic and diluted

Ended December 31, 2022 and 2021

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of the fair value of vested stock options issued to directors and officers of $1,502,776, patent and licensing legal and filing fees

and costs of $729,171, other consulting and professional fees of $610,846, insurance expense of $385,312, officer’s salary and

related costs of $781,254, cash-based director and committee fees of $92,833, licensing fees of $24,999, shareholder reporting costs

of $42,792, listing fees of $58,000, filing fees of $18,114, taxes and licenses of $16,200, and other operating costs of $22,868.

and costs of $1,268,308, other consulting and professional fees of $450,243, insurance expense of $453,417, officer salaries and related

costs of $831,890, cash-based director and board committee fees of $266,020, licensing fees of $25,000, shareholder reporting costs of

$40,790, listing fees of $59,500, filing fees of $12,183, taxes and licenses of $15,071, investor relations of $17,293, and other operating

costs of $19,721.

the year ended December 31, 2021, general and administrative costs were $4,983,669, which consisted of the fair value of vested stock

options issued to directors and officers of $2,201,280, patent and licensing legal and filing fees and costs of $729,171, other consulting

and professional fees of $503,983, insurance expense of $142,575, officer’s salary and related costs of $268,457, licensing fees

of $25,001, shareholder reporting costs of $11,801, listing fees of $12,000, filing fees of $10,616, taxes and licenses of $19,032, and

other operating costs of $15,492.

and administrative costs increased by $2,940,905, or 144.0%, in 2021 as compared to 2020, primarily as a result of an increase in the

fair value of vested stock options issued to directors and officers of $1,720,646, an increase in patent and licensing legal and filing

fees and costs of $175,998, an increase in other consulting and professional fees of $106,863, an increase in insurance expense of $242,737,

an increase in officer’s salary and related costs of $512,797, and an increase in cash-based director and committee fees $92,833.

and professional fees of $610,846, insurance expense of $385,312, officer salaries and related costs of $781,254, cash-based director

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

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

and administrative costs decreased by $21,457, or 0.4%, in 2022 as compared to 2021, primarily as a result of a decrease in the fair

value of vested stock options issued to directors and officers of $698,504, a decrease in other consulting and professional fees of $160,603,

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

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

and Development Costs .

For the year ended December 31, 2022, research and development costs were $1,349,269, which consisted of the

fair value of vested stock options issued to a consultant of $397,642, contractor costs incurred in connection with the synthesis work

done to develop a new supply of LB-100 of $624,187, clinical and related oversight costs of $456,921, and pre-clinical research focused

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

fair value of vested stock options issued to consultant of $43,264, contractor costs incurred in connection with the synthesis work done

to develop a new supply of LB-100 for the Spanish clinical trial of $352,862, clinical and related oversight costs of $363,829, and pre-clinical

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

the year ended December 31, 2021, research and development costs were $1,736,776, which consisted of the fair value of vested stock options

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

of $167,120, clinical and related oversight costs of $115,941, and pre-clinical research focused on development of additional novel anti-cancer

compounds to add to the Company’s clinical pipeline of $269,900.

and development costs increased by $513,100, or 41.9% in 2021 as compared to 2020, primarily as a result of an increase in contractor

costs incurred in connection with the synthesis work done to develop a new supply of LB-100 of $457,067, an increase in clinical and

related oversight costs of $340,980, which included an upfront payment to City of Hope of $240,508 upon execution of the Clinical Research

Support Agreement in January 2021, offset by a decrease in the fair value of vested stock options issued to a consultant of $273,073.

The absence of costs associated with ongoing clinical trials during the years ended December 31, 2021 and 2020 reflects the slow accrual

of patients into such clinical trials.

For the year ended December 31, 2021, the Company had interest income of $626, as compared to interest income of $4,342 for

the year ended December 31, 2020, as a result of a reduction in the Company’s cash resources previously invested in short-term

federally insured certificates of deposit.

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

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

and development costs decreased by $387,507, or 22.3%, in 2022 as compared to 2021, primarily as a result of a decrease in the fair value

of vested stock options issued to consultant of $354,378, a decrease in contractor costs incurred in connection with the synthesis work

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

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

For the year ended December 31, 2022, the Company had interest income of $11,195, as compared to interest income of $626

for the year ended December 31, 2021, related to the investment of funds generated by the Company’s financing activities.

For the year ended December 31, 2022, the Company had interest expense of $8,875, as compared to interest expense of $7,414

for the year ended December 31, 2020, related to the financing of its directors and officers liability insurance policy premium.

for the year ended December 31, 2021, related to the financing of the premium for the Company’s directors and officers liability

insurance policy.

Currency Loss .

For the year ended December 31, 2021, the Company had a loss from foreign currency transactions of $1,163 as compared

to a gain of $890 for the year ended December 31, 2020.

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

currency loss of $1,163 for the year ended December 31, 2021, from foreign currency transactions.

For the year ended December 31, 2022, the Company incurred a net loss of $6,312,535, as compared to a net loss of $6,728,396

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and Capital Resources – December 31, 2022

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

Ended December 31,

cash used in operating activities

Company’s consolidated statements of cash flows as discussed herein are as follows:

Years Ended December 31,

Net cash used in operating activities

$ (4,611,737 )

$ (4,142,915 )

cash provided by (used in) investing activities

cash provided by financing activities

increase (decrease) in cash

Net cash provided by (used in) investing activities

Net cash provided by financing activities

Net increase (decrease) in cash

December 31, 2022, the Company had working capital of $5,165,227, as compared to working capital of $4,790,338 at December 31, 2021,

reflecting a decrease in working capital of $221,613 for the year ended December 31, 2021.

The decrease in working capital during the

year ended December 31, 2021 was the result of the net cash proceeds of $3,689,761 from the Company’s March 2021 direct equity

offering, proceeds of $17,100 from the exercise of warrants, and proceeds of $201,000 from the exercise of stock options that were utilized

to pay offering costs of $10,467 and to fund the Company’s research and development activities and ongoing operating expenses,

including the Company’s clinical trial program and maintaining and developing its patent portfolio.

At December 31, 2021, the Company

had cash of $4,823,745 available to fund its operations.

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

The increase in working capital during the

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

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

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

its patent portfolio.

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

Company’s ability to continue as a going concern is dependent upon its ability to raise additional equity capital to fund its research

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The amount and timing of future

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

of operating capital to fund such activities.

November 30, 2020, the Company listed on The Nasdaq Capital Market in conjunction with the completion of its public offering of units

of common stock and warrants that generated net cash proceeds of $4,591,349.

Subsequently, effective March 2, 2021, the Company completed

a sale of common stock under a registered direct equity offering that generated net cash proceeds of $3,689,761.

on current operating plans, the Company estimates that it will need to raise additional capital to fund its operations, including its

various clinical trial commitments, during the quarter ending September 30, 2022.

In addition, the Company’s operating plans may

change as a result of many factors which are currently unknown to the Company, including possible additional clinical trials, and the

Company may need additional funds sooner than currently planned.

market conditions present uncertainty as to the Company’s ability to secure additional funds, there can be no assurances that the

Company will be able to secure additional financing on acceptable terms, as and when necessary, to continue to conduct operations.

is also significant uncertainty as to the effect that the coronavirus pandemic may have on the Company’s clinical trial schedule

and the amount and type of financing available to the Company in the future.

cash resources are insufficient to satisfy the Company’s ongoing cash requirements, the Company would be required to scale back

or discontinue its clinical trial program, as well as its licensing and patent prosecution efforts and its technology and product development

efforts, or obtain funds, if available, through strategic alliances or joint ventures that could require the Company to relinquish rights

to and/or control of LB-100, or to discontinue operations

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

availability of operating capital to fund such activities.

on current operating plans, the Company estimates that existing cash resources will provide sufficient working capital to fund the current

clinical trial program with respect to the development of the Company’s lead anti-cancer clinical compound LB-100 through approximately

December 31, 2023.

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

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

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

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

In addition, the Company’s operating plans may change as a

result of many factors that are currently unknown and/or outside of the control of the Company, and additional funds may be needed sooner

than planned.

December 31, 2022, the Company did not have any transactions, obligations or relationships that could be considered off-balance sheet

arrangements.

For the year ended December 31, 2022, operating activities utilized cash of $4,611,737, as compared to utilizing cash

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For the years ended December 31, 2022 and 2021, the Company had no investing activities.

For the year ended December 31, 2021, financing activities consisted of the gross proceeds from the sales of common stock

in the Company’s direct equity offering of $4,192,478, reduced by offering costs of $502,717, $17,100 from the exercise of common

stock warrants, and $201,000 from the exercise of common stock options.

The Company also paid offering costs of $10,467 during the year

ended December 31, 2021.

For the year December 31, 2020, financing activities consisted of the gross proceeds from the sales of units

and warrants in the Company’s public offering of $5,701,800, offset by the payment of offering costs of $1,099,984.

December 31, 2021, the Company’s contractual commitments pursuant to clinical trial agreements, clinical trial monitoring agreements,

and agreements for the production of LB-100 for clinical use, as described below, aggregated $8,646,000, which are currently scheduled

to be incurred through December 31, 2025.

The Company’s ability to conduct and fund these contractual commitments is subject to

the timely availability of sufficient capital to fund such expenditures, as well as any changes in the allocation or reallocation of

such funds to the Company’s current or future clinical trial programs.

The Company expects that the full amount of these expenditures

will be incurred only if such clinical trial programs are conducted as originally designed and their respective enrollments and duration

are not modified or reduced.

Clinical trial programs, such as the types that the Company is engaged in, can be highly variable and can

frequently involve a series of changes and modifications over time as clinical data is obtained and analyzed, and are frequently modified,

suspended or terminated before the clinical trial endpoint.

Accordingly, such contractual commitments as discussed herein should be considered

as estimates only based on current clinical assumptions and conditions, and are typically subject to significant revisions over time.

Additional information with respect to the conduct of the Company’s clinical trial programs is provide at “ITEM 1A.

FACTORS - Risks Related to the Development and Regulatory Approval of Our Product Candidates”.

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

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

For the year ended December 31, 2021,

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

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

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

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

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

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

The Company’s ability to conduct and fund these contractual commitments is subject to the timely availability of sufficient capital

to fund such expenditures, as well as any changes in the allocation or reallocation of such funds to the Company’s current or future

clinical trial programs.

The Company expects that the full amount of these expenditures will be incurred only if such clinical trial

programs are conducted as originally designed and their respective enrollments and duration are not modified or reduced.

Clinical trial

programs, such as the types that the Company is engaged in, can be highly variable and can frequently involve a series of changes and

modifications over time as clinical data is obtained and analyzed, and are frequently modified, suspended or terminated before the clinical

trial endpoint.

Accordingly, such contractual commitments as discussed herein should be considered as estimates only based on current

clinical assumptions and conditions, and are typically subject to significant revisions over time.

information with respect to the conduct of the Company’s clinical trial programs is provide at “ITEM 1A.

RISK FACTORS - Risks

Related to the Development and Regulatory Approval of Our Product Candidates”.

Trial Agreements

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well as to provide funding for the clinical trial.

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

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

of two years.

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standards 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 engaged a number of vendors to carry out

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

These tasks included

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

steps involved by an independent auditor.

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

GMP conditions documented by an independent auditor.

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

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

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

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

of December 31, 2022, this program to provide new inventory of the clinical drug product for the Spanish Sarcoma Group study, and potentially

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

While the production of new inventory has been completed,

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

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

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

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

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

by December 31, 2025.

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

The Phase 1b section of the protocol is expected to

be completed by June 30, 2024, at which time the Company expects to have data on both response and toxicity from this portion of the

clinical trial.

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

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

A positive study

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

of doxorubicin alone.

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

Through December 31, 2021, the Company has paid GEIS an aggregate of $67,582 towards the second milestone payment for current work being

done under this agreement.

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

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

5 unchanged sentences

be incurred through December 31, 2025.

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 (“Famar”) to

prepare a new batch of clinical LB-100 for use in clinical trials to be conducted in the European Union.

During the year ended December

31, 2021, the Company incurred costs of $119,860, pursuant to this agreement, which has been included in research and development costs

in the Company’s consolidated statements of operations.

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

amounts previously paid to date, totaled approximately $180,000 as of December 31, 2021, which is expected to be incurred through June

of December 31, 2021, the Company estimates that this program to provide new inventory of the clinical drug product for the Spanish sarcoma

study, and potentially for subsequent multiple trials within the European Union, including the costs incurred and to be incurred with

Famar as described above, will cost approximately $1,076,000.

The Company’s aggregate commitments under this program, less amounts

previously paid to date, totaled approximately $318,000 as of December 31, 2021, which are expected to be incurred through December 31,

As the production of the new inventory of the clinical drug product is being conducted in Europe and is paid for in Euros, final

costs are subject to foreign currency fluctuations between the United States Dollar and the Euro.

As the work is being conducted in Europe and is paid for in Euros, final costs are subject to

foreign currency fluctuations between the United States Dollar and the Euro.

Such fluctuations are recorded in the consolidated statements

of operations as foreign currency gain or loss, as appropriate.

Effective January 18, 2021, the Company executed a Clinical Research Support Agreement with the City of Hope National Medical

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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.

the year ended December 31, 2021, the Company incurred costs, and total costs, of $378,511, pursuant to this agreement.

The Company’s

aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $2,433,000 as of December

31, 2021, which is expected to be incurred through December 31, 2024, based upon a target of 42 enrollees.

If a significant number of

patients fail during the dose-escalation process, an increase of up to 12 patients would likely be necessary, at an estimated additional

cost of approximately $800,000.

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.

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

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

With the additional sites, the Company expects that this

clinical trial will be completed by December 31, 2024.

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

be completed no sooner than December 31, 2025.

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

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

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

SCRI, one of the largest community-based cancer trial

centers in the United States, is expected to expedite and expand the accrual of patients to this clinical trial, thus reducing the time

required to demonstrate the feasibility, tolerability and efficacy of adding LB-100 to the current standard treatment regimen.

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

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

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

If a significant

number of patients fail during the dose-escalation process, an increase of up to 12 patients would likely be necessary, at an estimated

additional cost of approximately $800,000.

Company currently expects that enrollment in this clinical trial will range from approximately 18 to 30 enrollees, with 24 enrollees

as the most likely number.

Should fewer than 42 enrollees be required, the Company has agreed to compensate City of Hope on a per enrollee

If a significant improvement in outcome is seen with the addition of LB-100, this would be an important advance in the treatment

of a very aggressive disease.

Cancer Institute Pharmacologic Clinical Trial.

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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.

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.

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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.

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.

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

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

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

If there is evidence in at least two of the patients

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

The results of this study are expected during 2023.

Trial Monitoring Agreements

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

under this work order agreement are estimated to be approximately $954,000, with such payments expected to be divided approximately 94%

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

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

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

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

years ended December 31, 2021 and 2020, the Company incurred costs of $9,750 and $18,663, respectively, pursuant to this work order.

As of December 31, 2021, total costs of $91,885 have been incurred pursuant to this work order agreement.

The Company’s aggregate

commitment pursuant to this clinical trial monitoring agreement, less amounts previously paid to date, totaled approximately $868,000

as of December 31, 2021, which is expected to be incurred through June 30, 2025.

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

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

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

total costs of $127,288 have been incurred.

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

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

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.

During the year ended

December 31, 2021, the Company incurred costs of $24,626, pursuant to this work order.

As of December 31, 2021, total costs of $24,626

have been incurred pursuant to this work order agreement.

The Company’s aggregate commitment pursuant to this clinical trial monitoring

agreement, less amounts previously paid to date, totaled approximately $314,000 as of December 31, 2021, which is expected to be incurred

through June 30, 2025.

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

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

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

The Company’s

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

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

and License Agreements

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.

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

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 year 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.

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

Pursuant to the License Agreement,

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

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

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

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

the Licensed Patents.

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

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

The clinical trial began at a single site in April

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

The Company is also obligated to pay Moffitt an annual license

maintenance fee of $25,000 commencing on the first anniversary of the Effective Date and every anniversary thereafter until the Company

commences payment of minimum royalty payments.

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

cannot be credited against earned royalties payable by the Company, based on reaching various clinical and commercial milestones aggregating

$1,897,000, subject to reduction by 40% under certain circumstances relating to the status of Valid Claims, as such term is defined in

the License Agreement.

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

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

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

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These employment

agreements were automatically renewed for an additional one-year period in July and August 2021.

agreements were automatically renewed for additional one-year periods in July and August 2021 and 2022.

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

Forman, the Company’s Chief Administrative Officer,

Miser, the Company’s Chief Medical Officer, and Robert N.

Weingarten, the Company’s Chief Financial Officer,

Miser, and Robert N.

under the employment agreements, such that the total aggregate annual compensation of all officers increased to $775,000, effective May

November 6, 2022, Mr.

Forman was promoted to Vice President and Chief Operating Officer, with an annual salary of $200,000.

effective October 1, 2022, Mr.

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

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

Significant Agreements and Contracts

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

for consultation and advice in the field of oncology

research and drug development.

Consulting Corp.

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

for consultation and advice

in the field of oncology research and drug development.

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

Von Hoff, M.D., to become

a member of the Company’s Scientific Advisory Committee.

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

cash fee of $4,000.

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

and advisory fees charged to operations pursuant to this agreement were $16,000 and $16,000 for the years ended December 31, 2021 and

2020, respectively, which were included in research and development costs in the consolidated statements of operations.

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.

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

The term of the agreement was for one year

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

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

date since 2014.

Consulting and advisory fees charged to operations pursuant to this agreement were $16,000 and $16,000 for the years

ended December 31, 2022 and 2021, respectively, which were included in research and development costs in the consolidated statements

of operations.

BioPharmaWorks .

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

BioPharmaWorks to perform certain services for the Company.

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

its products and strengthen its patent portfolio;

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

product pipeline;

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

consultation in drug discovery

and development;

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

BioPharmaWorks

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

5 unchanged sentences

The Company recorded charges to

operations pursuant to this Collaboration Agreement of $120,000 and $120,000 for the years ended December 31, 2021 and 2020, respectively,

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

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 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.

the year ended December 31, 2021, the Company incurred charges in the amount of $55,248, with respect to this agreement, which amount

is included in research and development0 costs in the Company’s consolidated statements of operations.

Sheet Arrangements

December 31, 2021, the Company did not have any transactions, obligations or relationships that could be considered off-balance sheet

arrangements.

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

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

for Angelman Syndrome Therapy .

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

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

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

The pre-clinical

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

David Segal, an internationally recognized

leader in AS research.

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

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

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

The genetic cause

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

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

Company’s investigational compound, LB-100.

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

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

Conditioned on FAST’s completion of this

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

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

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

in a mouse model of AS.

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

not confirmed in the US model.

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

studies of LB 100.

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

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

Cancer Institute.

On October 8, 2021, the Company entered into a Development Collaboration Agreement with the Netherlands Cancer

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

cancer research center, to identify the most promising drugs to be combined with LB-100, and potentially LB-100 analogues, to be used

to treat a range of cancers, as well as to identify the specific molecular mechanisms underlying the identified combinations.

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

The study is expected to take approximately

two years to conduct.

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

respectively, with respect to this agreement, which amounts are included in research and development costs in the Company’s consolidated

statements of operations.

As of December 31, 2022, total costs of $259,406 have been incurred pursuant to this agreement.

The Company’s

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

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

As the work is being conducted in Europe and is paid for in Euros,

final costs are subject to foreign currency fluctuations between the United States Dollar and the Euro.

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

in the United States.

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

date of April 30, 2023.

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

pursuant to this agreement.

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

The Company’s

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

Events and Uncertainties

3 unchanged sentences

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

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

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

sustainable revenues sufficient to support our operations.

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

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

There can be no assurances that we will be able

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

If cash resources are insufficient to satisfy

our ongoing cash requirements, we would be required to reduce or discontinue our research and development programs, or attempt to obtain

funds, if available (although there can be no assurances), through strategic alliances that may require us to relinquish rights to certain

of our pharmaceutical compounds, or to curtail or discontinue our operations entirely.

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

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

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

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

If cash resources are insufficient to satisfy our ongoing

cash requirements, we would be required to reduce or discontinue our research and development programs, or attempt to obtain funds, if

available, through strategic alliances that may require us to relinquish rights to certain of our pharmaceutical compounds, or to curtail

or discontinue our operations entirely.

than as discussed above, we are not currently aware of any trends, events or uncertainties that are likely to have a material effect

7 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 7. Management’s Discussion and Analysis