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Item 8. Financial Statements and Supplementary Data

2022-03-21 compared with 2021-03-02 · 267 added, 718 removed, 193 unchanged (84% of the section changed)

1 unchanged sentence

FINANCIAL STATEMENTS

INDEX TO FINANCIAL STATEMENTS FOR CELLECTAR

BIOSCIENCES, INC.

Report of Independent Registered Public Accounting Firm

Consolidated Balance Sheets at December 31, 2020 and 2019

INDEX TO FINANCIAL STATEMENTS FOR CELLECTAR BIOSCIENCES, INC.

Report of Independent Registered Public Accounting Firm (Baker Tilly US, LLP, Philadelphia, Pennsylvania, PCAOB ID No.

Consolidated Balance Sheets as of December 31, 2021 and 2020

Consolidated Statements of Operations for the Years Ended December 31, 2021 and 2020

2 unchanged sentences

Notes to Consolidated Financial Statements

REPORT OF INDEPENDENT

REGISTERED PUBLIC ACCOUNTING FIRM

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and Shareholders of

Cellectar Biosciences, Inc.

and Subsidiary

Opinion on the Consolidated Financial Statements

We have audited the accompanying consolidated balance sheets

of Cellectar Biosciences, Inc.

and Subsidiary (the "Company") as of December 31, 2020 and 2019, the related consolidated

statements of operations, stockholders' equity, and cash flows for each of the two years in the period ended December 31,

2020, and the related notes (collectively referred to as the "consolidated financial statements").

In our opinion, the

consolidated financial statements present fairly, in all material respects, the financial position of the Company at December

31, 2020 and 2019, and the results of its operations and its cash flows for each of the two years in the period ended December

31, 2020, in conformity with accounting principles generally accepted in the United States of America.

We have audited the accompanying consolidated balance sheets of Cellectar Biosciences, Inc.

and Subsidiary (the "Company") as of December 31, 2021 and 2020, the related consolidated statements of operations, stockholders' equity, and cash flows for the years then ended, and the related notes (collectively referred to as the "consolidated financial statements").

In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2021 and 2020, and the results of their operations and their cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States of America.

Basis for Opinion

These consolidated financial statements are the responsibility

of the Company's management.

Our responsibility is to express an opinion on the Company's consolidated financial statements based

on our audits.

We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States)

("PCAOB") and are required to be independent with respect to the Company in accordance with the U.S.

federal securities

laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of

Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated

financial statements are free of material misstatement, whether due to error or fraud.

The Company is not required to have, nor

were we engaged to perform, an audit of its internal control over financial reporting.

As part of our audits we are required to

obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness

of the Company's internal control over financial reporting.

These consolidated financial statements are the responsibility of the Company's management.

Our responsibility is to express an opinion on the Company's consolidated financial statements based on our audits.

We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) ("PCAOB") and are required to be independent with respect to the Company in accordance with the U.S.

federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB.

Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.

The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.

As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting.

Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks

of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that

respond to those risks.

Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in

the consolidated financial statements.

Our audits also included evaluating the accounting principles used and significant estimates

made by management, as well as evaluating the overall presentation of the consolidated financial statements.

We believe that our

audits provide a reasonable basis for our opinion.

Critical Audit Matter

The critical audit matter communicated

below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required

to be communicated to the audit committee and that:

(1) relates to accounts or disclosures that are material to the consolidated

financial statements and (2) involved our especially challenging, subjective, or complex judgments.

The communication of critical

audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not,

by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts

or disclosures to which it relates.

Complex Equity Instruments

As described in Note 6 to

the consolidated financial statements, the Company issued $20.5 million of Series D Convertible Preferred Stock (“Preferred

Stock”) in December 2020.

The Preferred Stock is redeemable and convertible upon the occurrence of certain events.

The Preferred

Stock was evaluated to determine whether or not it (i) was mandatorily redeemable or (ii) represented an unconditional obligation

of the Company to be settled in a variable number of shares of common stock.

The Company determined that the Preferred Stock was

neither mandatorily redeemable nor did it require settlement in a variable number of shares of common stock.

The embedded conversion features

were evaluated for bifurcation as an embedded derivative instrument.

This evaluation included determining whether or not the economic

characteristics and risks of the embedded conversion features were clearly and closely related to the economic characteristics

of the Preferred Stock.

Based on its terms, the Company determined that the Preferred Stock was akin to an equity-like host.

a result, the Company concluded that the embedded conversion features were clearly and closely related to the Preferred Stock.

The embedded conversion features

were further evaluated for the presence of a beneficial conversion feature and the Preferred Stock for classification as mezzanine,

or temporary, equity.

As the Preferred Stock is contingently convertible at the commitment date and requires shareholder approval,

a beneficial conversion feature was not recognized in 2020.

Mezzanine equity classification

is required when preferred stock is redeemable upon the occurrence of an event that is not solely within the control of the Company.

There is a limited exception provided to this requirement.

The Company determined that this exception was applicable based upon

the terms of the Preferred Stock.

The Company concluded that the Preferred Stock should be classified in stockholders’

Also as described in Note

6 to the consolidated financial statements, the Company issued $20.0 million of common stock, pre-funded warrants, which are exercisable

for one share of common stock, and Series H warrants to purchase additional shares of common stock in June 2020.

The Company determined

the pre-funded warrants and the Series H warrants are freestanding financial instruments because both the pre-funded warrants and

the Series H warrants are separately exercisable and legally detachable from each other and from the common stock.

evaluated the pre-funded warrants and Series H warrants pursuant to ASC 480, Distinguishing Liabilities from Equity , and

concluded they are not liabilities.

The pre-funded warrants and Series H warrants were further evaluated to determine whether or

not they were derivative financial instruments.

The Company concluded that both the pre-funded warrants and the Series H warrants

should be classified in stockholders’

equity, as they meet both the indexation guidance and the equity classification guidance

included in ASC 815-40.

The Company allocated the proceeds to the common stock, pre-funded warrants and the Series H warrants based

on their relative fair values.

The principal considerations

for our determination that the accounting for complex equity instruments constituted a critical audit matter included the significant

complexity of the relevant accounting guidance, as well as extent of management judgments involved in the application of that guidance.

In addition, the audit effort included the use of firm personnel with relevant expertise to assist in auditing these transactions.

The primary procedures we

performed to address this critical audit matter included:

We assessed the design and implementation of management’s controls

over the accounting for complex equity instruments

We read the agreements and compared the relevant terms to management’s

analysis of the transactions

With the assistance of firm personnel having expertise in the accounting

for complex equity instruments, we evaluated management’s conclusions regarding the balance sheet classification and valuation

of the complex equity instruments

We tested the Company’s determination of the fair value for

the transactions, as well as the respective relative fair value allocations.

Our testing included assessing the reasonableness

of certain assumptions used by the Company, as well as, the completeness and accuracy of the data utilized

We assessed the required financial statement disclosures

related to the transactions

/s/ Baker Tilly US, LLP (formerly known as Baker Tilly Virchow

Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks.

Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements.

Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.

We believe that our audits provide a reasonable basis for our opinion.

Critical Audit Matters

Critical audit matters are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that:

(1) relate to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgements.

We determined that there are no critical audit matters.

/s/ Baker Tilly US, LLP

We have served as the Company's auditor since 2016.

Madison, Wisconsin

Philadelphia, Pennsylvania

March 21, 2022

8 unchanged sentences

Long-term assets

LIABILITIES AND STOCKHOLDERS’

LIABILITIES AND STOCKHOLDERS’ EQUITY

CURRENT LIABILITIES:

2 unchanged sentences

Total current liabilities

LONG-TERM LIABILITIES:

Lease liability

Total long-term liabilities

Lease liability, net of current portion

TOTAL LIABILITIES

COMMITMENTS AND CONTINGENCIES (Note 10)

STOCKHOLDERS’

STOCKHOLDERS’ EQUITY:

Preferred stock, $ 0.00001 par value;

1 unchanged sentence

Series C preferred stock:

215 issued and outstanding as of both December 31, 2020 and 2019

0 and 215 shares issued and outstanding as of December 31, 2021 and 2020, respectively

Series D preferred stock:

1,519 and 0 issued and outstanding as of December 31, 2020 and 2019, respectively

111 and 1,519 shares issued and outstanding as of December 31,

2021 and 2020, respectively

Common stock, $ 0.00001 par value;

80,000,000 shares authorized;

45,442,729 and 9,386,689 shares issued and outstanding at December 31, 2020 and 2019, respectively

160,000,000 and 80,000,000 shares authorized;

61,101,263 and 45,442,729 shares issued and outstanding as of December 31, 2021 and 2020, respectively

Additional paid-in capital

2 unchanged sentences

( 126,775,427 )

Total stockholders’

TOTAL LIABILITIES AND STOCKHOLDERS’

See report of independent registered

public accounting firm and accompanying notes to the consolidated financial statements.

Total stockholders’ equity

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

See report of independent registered public accounting firm and accompanying notes to the consolidated financial statements.

CELLECTAR BIOSCIENCES, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

Year Ended December 31,

COSTS AND EXPENSES:

6 unchanged sentences

OTHER INCOME:

Gain on revaluation of derivative warrants

Gain on extinguishment of debt

5 unchanged sentences

SHARES USED IN COMPUTING BASIC AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE

See report of independent registered

public accounting firm and accompanying notes to the consolidated financial statements.

See report of independent registered public accounting firm and accompanying notes to the consolidated financial statements.

CELLECTAR BIOSCIENCES, INC.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’

Additional Paid-

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

Preferred Stock

Stockholders’

AT DECEMBER 31, 2018

$ 108,323,208

Paid-In Capital

BALANCE AT DECEMBER 31, 2019

( 111,681,255 )

Issuance of common stock,

warrants and preferred stock, net of issuance costs

Issuance of common stock, preferred stock, pre-funded warrants and warrants, net of issuance costs

Stock-based compensation

1 unchanged sentence

Retired shares

Conversion of preferred shares into common

Conversion of warrants into common shares

( 15,094,172 )

2 unchanged sentences

( 126,775,427 )

Conversion of preferred into common shares

( 18,653,826 )

Issuance of common stock,

preferred stock, pre-funded warrants and warrants, net of issuance costs

Conversion of warrants into common shares

Issuance of common stock, net of issuance costs

Stock-based compensation

Vested restricted stock

Retired shares

Conversion of warrants

into common shares

( 24,122,362 )

2 unchanged sentences

( 150,897,789 )

$ (126,775,427 )

See report of independent registered

public accounting firm and accompanying notes to the consolidated financial statements.

See report of independent registered public accounting firm and accompanying notes to the consolidated financial statements.

CELLECTAR BIOSCIENCES, INC.

7 unchanged sentences

Gain on extinguishment of debt

Loss on disposal of asset

Noncash lease expense

Gain on revaluation of derivative warrants

Prepaid expenses and other current assets

8 unchanged sentences

CASH FLOWS FROM FINANCING ACTIVITIES:

Payments on capital lease obligations

Proceeds from long-term obligations

Proceeds from issuance of common stock and preferred stock, net of underwriting issuance costs

Proceeds from issuance of common stock, net of underwriting issuance costs

Proceeds from exercise of warrants

1 unchanged sentence

INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS, AND RESTRICTED CASH

( 21,461,402 )

CASH, CASH EQUIVALENTS, AND RESTRICTED CASH AT BEGINNING OF PERIOD

4 unchanged sentences

Conversion of preferred stock to common stock

See report of independent registered

public accounting firm and accompanying notes to the consolidated financial statements.

See report of independent registered public accounting firm and accompanying notes to the consolidated financial statements.

CELLECTAR BIOSCIENCES, INC.

2 unchanged sentences

Cellectar Biosciences, Inc.

(the Company)

is a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the

treatment of cancer leveraging our proprietary phospholipid drug conjugate™ (PDCs™) delivery platform that specifically

targets cancer cells, delivering improved efficacy and better safety as a result of fewer off-target effects.

The Company has incurred losses since inception in devoting

substantially all of its efforts toward research and development and has an accumulated deficit of approximately $126,775,000 at

December 31, 2020.

During the year ended December 31, 2020 the Company generated a net loss of approximately $15,094,000 and the

Company expects that it will continue to generate operating losses for the foreseeable future.

However, the Company believes that

its cash balance at December 31, 2020 is adequate to fund our basic budgeted operations for at least 12 months from the filing

of these financial statements.

The Company’s ability to execute its current operating plan depends on its ability to obtain

additional funding via the sale of equity and/or debt securities, a strategic transaction or otherwise.

The Company plans

to continue to actively pursue financing alternatives, but there can be no assurance that it will obtain the necessary funding.

(the Company, our, we) is a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer leveraging our proprietary phospholipid drug conjugate™ (PDCs™) delivery platform that specifically targets cancer cells and deliver improved efficacy and better safety as a result of fewer off-target effects.

The Company has incurred losses since inception in devoting substantially all of its efforts toward research and development and has an accumulated deficit of approximately $150,898,000 as of December 31, 2021.

During the year ended December 31, 2021, the Company generated a net loss of approximately $24,122,000 and the Company expects that it will continue to generate operating losses for the foreseeable future.

However, the Company believes that its cash balance as of December 31, 2021 is adequate to fund its basic budgeted operations for at least 12 months from the filing of these financial statements.

The Company’s ability to execute its current operating plan depends on its ability to obtain additional funding via the sale of equity and/or debt securities, a strategic transaction or otherwise.

The Company plans to continue to actively pursue financing alternatives, but there can be no assurance that it will obtain the necessary funding.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

The accompanying consolidated financial

statements reflect the application of certain accounting policies, as described in this note and elsewhere in the accompanying

notes to the consolidated financial statements.

The consolidated financial statements as of and for the twelve months ended December

31, 2020 are presented on a consolidated basis.

of Consolidation — The consolidated financial statements include the accounts of the Company and the accounts

of its wholly-owned subsidiary.

The accompanying consolidated financial statements reflect the application of certain accounting policies, as described in this note and elsewhere in the notes to the consolidated financial statements.

Principles of Consolidation — The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary.

All inter-company accounts and transactions have been eliminated in consolidation.

of Estimates — The preparation of financial statements in conformity with accounting principles generally

accepted in the U.S.

requires management to make estimates and judgments that may affect the reported amounts of assets, liabilities,

revenue and expenses and disclosure of contingent assets and liabilities.

On an on-going basis, management evaluates its estimates

including those related to unbilled vendor amounts, share-based compensation and derivative liability valuation.

Management bases

its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which

form the basis for making judgments about the carrying values of assets and liabilities.

Actual results may differ from those estimates

under different assumptions or conditions.

Changes in estimates are reflected in reported results in the period in which they become

and Cash Equivalents — All short-term investments purchased with original maturities of three months or less

are considered to be cash equivalents.

Assets — Property and equipment are stated at cost.

Depreciation on property and equipment is provided using

the straight-line method over the estimated useful lives of the assets (3 to 10 years).

Due to the significant value of leasehold

improvements purchased, leasehold improvements are depreciated over 64 months (their estimated useful life), which represents the

full term of the lease.

Use of Estimates — The preparation of financial statements in conformity with accounting principles generally accepted in the U.S.

requires management to make estimates and judgments that may affect the reported amounts of assets, liabilities, revenue and expenses and disclosure of contingent assets and liabilities.

On an on-going basis, management evaluates its estimates including those related to unbilled vendor amounts and share-based compensation.

Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities.

Actual results may differ from those estimates under different assumptions or conditions.

Changes in estimates are reflected in reported results in the period in which they become known.

Cash and Cash Equivalents — All short-term investments purchased with original maturities of three months or less are considered to be cash equivalents.

Fixed Assets — Property and equipment are stated at cost.

Depreciation on property and equipment is provided using the straight-line method over the estimated useful lives of the assets ( 3 to 10 years ).

Due to the significant value of leasehold improvements, leasehold improvements are depreciated over 64 months (their estimated useful life), which represents the full term of the lease.

Our only long-lived assets are property and equipment.

The Company periodically evaluates long-lived assets

for potential impairment.

Whenever events or circumstances change, an assessment is made as to whether there has been impairment

to the value of long-lived assets by determining whether projected undiscounted cash flows generated by the applicable asset exceed

its net book value as of the assessment date.

There were no fixed asset impairment charges recorded during the years ended December

31, 2020 or 2019.

Right-of-Us e Asset

and Lease Liabilities — In February 2016, the Financial Accounting Standard Board (“FASB”) issued

Accounting Standard Update (“ASU”) 2016-02, Leases (ASC 842), which supersedes the existing guidance for lease

accounting, Leases (Topic 840).

ASU 2016-02 requires lessees to recognize Right-Of-Use (“ROU”) Asset and Lease

Liability for virtually all of their leases (other than leases that meet the definition of a short-term lease).

On January 1,

2019, the Company adopted FASB Accounting Standards Codification (“ASC”) Topic 842 using the modified

retrospective method for all material leases that existed at or commenced after January 1, 2019.

ROU Assets are amortized

over their estimated useful life, which represents the full term of the lease.

See Leases below for additional

Compensation — The Company uses the Black-Scholes option-pricing model to calculate the grant-date fair value

of stock option awards.

The resulting compensation expense, net of expected forfeitures, for awards that are not performance-based

is recognized on a straight-line basis over the service period of the award, which for 2019 ranged from seven months to three years

and for grants issued in 2020 was over three years.

For stock options with performance-based vesting provisions, recognition of

compensation expense, net of expected forfeitures, commences if and when the achievement of the performance criteria is deemed

The compensation expense, net of expected forfeitures, for performance-based stock options is recognized over the relevant

performance period.

Non-employee stock-based compensation is accounted for in accordance with the guidance of FASB Accounting Standards

Codification (“ASC”) Topic 505, Equity.

The Company recognizes an expense based on the estimated fair value

of options granted to non-employees over their vesting period, which is generally the period during which services are rendered

and deemed completed.

and Development — Research and development costs are expensed as incurred.

To the extent that such costs are

reimbursed by the federal government on a fixed price, best efforts basis and the federal government is the sole customer for such

research and development, the funding is recognized as a reduction of research and development expenses.

Taxes — Income taxes are accounted for using the liability method of accounting.

Under this method, deferred

tax assets and liabilities are determined based on temporary differences between the financial statement basis and tax basis of

assets and liabilities and net operating loss and credit carryforwards using enacted tax rates in effect for the year in which

the differences are expected to reverse.

The effect on deferred tax assets and liabilities of a change in tax rates is recognized

in income in the period that includes the enactment date.

Valuation allowances are established when it is more likely than

not that some portion of the deferred tax assets will not be realized.

Management has provided a full valuation allowance against

the Company’s gross deferred tax asset.

Tax positions taken or expected to be taken in the course of preparing tax returns

are required to be evaluated to determine whether the tax positions are “more likely than not” to be sustained by the

applicable tax authority.

Tax positions deemed not to meet a more-likely-than-not threshold would be recorded as tax expense in

the current year.

There were no uncertain tax positions that require accrual to or disclosure in the financial statements as of

December 31, 2020 and 2019.

Value of Financial Instruments — The guidance under FASB ASC Topic 825, Financial Instruments , requires

disclosure of the fair value of certain financial instruments.

Financial instruments in the accompanying financial statements consist

of cash equivalents, prepaid expenses and other assets, accounts payable and long-term obligations.

The carrying amount of

cash equivalents and accounts payable approximate their fair value due to their short-term nature.

The carrying value of long-term

obligations, including the current portion, approximates fair value because the fixed interest rate approximates current market

rates of interest available in the market.

Instruments — The Company generally does not use derivative instruments to hedge exposures to cash flow or

market risks;

however, certain warrants to purchase common stock that do not meet the requirements for classification as equity,

in accordance with the Derivatives and Hedging Topic of the FASB ASC, are classified as liabilities.

In such instances, net-cash

settlement is assumed for financial reporting purposes, even when the terms of the underlying contracts do not provide for a net-cash

These warrants are considered derivative instruments because the agreements contain a certain type of cash settlement

feature, contain “down-round” provisions whereby the number of shares for which the warrants are exercisable, and/or

the exercise price of the warrants are subject to change in the event of certain issuances of stock at prices below the then-effective

exercise price of the warrants.

The number of shares issuable under such warrants was 49,425 at December 31, 2018.

31, 2018, these warrants represented the only outstanding derivative instruments issued or held by the Company and expired on August

Concentration

of Credit Risk — Financial instruments that subject the Company to credit risk consist of cash and equivalents

on deposit with financial institutions.

The Company’s excess cash as of December 31, 2020 and 2019 is on deposit in interest-bearing

transaction accounts with well-established financial institutions.

At times, such amounts may exceed the FDIC insurance limits.

The Company periodically, and at a minimum annually, evaluates long-lived assets for potential impairment.

Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset.

If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized for the amount by which the carrying amount of the asset exceeds the fair value of the asset.

Such analyses necessarily involve judgement.

The Company did not experience any events or changes in circumstances that indicate the carrying amount of the assets may not be recoverable as of December 31, 2021.

There were no fixed asset impairment charges recorded during the years ended December 31, 2021 or 2020.

Right-of-Use Asset and Lease Liability — The Company accounts for all material leases in accordance with FASB Accounting Standards Codification (ASC) Topic 842, Leases .

Right-of-use (ROU) assets are amortized over their estimated useful life, which represents the full term of the lease.

Stock-Based Compensation — The Company uses the Black-Scholes option-pricing model to calculate the grant-date fair value of stock option awards.

The resulting compensation expense, net of expected forfeitures, for awards that are not performance-based, is

recognized on a straight-line basis over the service period of the award, which for 2021 and 2020 ranged from twelve months to three years .

Research and Development — Research and development costs are expensed as incurred.

The Company recognizes revenue and cost reimbursements from government grants when it is probable that the Company will comply with the conditions attached to the grant arrangement and the grant proceeds will be received.

Government grants are recognized in the Consolidated Statements of Operations on a systematic basis over the periods in which the Company recognizes the related costs for which the government grant is intended to compensate.

Specifically, when government grants are related to reimbursements for cost of revenues or operating expenses, the government grants are recognized as a reduction of the related expense in the Consolidated Statements of Operations.

Income Taxes — Income taxes are accounted for using the liability method of accounting.

Under this method, deferred tax assets and liabilities are determined based on temporary differences between the financial statement basis and tax basis of assets and liabilities and net operating loss and credit carryforwards using enacted tax rates in effect for the year in which the differences are expected to reverse.

The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.

Valuation allowances are established when it is more likely than not that some portion of the deferred tax assets will not be realized.

Management has provided a full valuation allowance against the Company’s gross deferred tax asset.

Tax positions taken or expected to be taken in the course of preparing tax returns are required to be evaluated to determine whether the tax positions are “more likely than not” to be sustained by the applicable tax authority.

Tax positions deemed to not meet a more-likely-than-not threshold would be recorded as tax expense in the current year.

There were no uncertain tax positions that require accrual to or disclosure in the consolidated financial statements as of December 31, 2021 and 2020.

Fair Value of Financial Instruments — The guidance under FASB ASC Topic 825, Financial Instruments , requires disclosure of the fair value of certain financial instruments.

Financial instruments in the accompanying consolidated financial statements consist of cash equivalents, prepaid expenses and other assets, accounts payable and long-term obligations.

The carrying amount of cash equivalents, prepaid expenses and accounts payable approximate their fair value due to their short-term nature.

See Note 11 regarding long-term obligations.

Concentration of Credit Risk — Financial instruments that subject the Company to credit risk consist of cash and equivalents on deposit with financial institutions.

The Company’s excess cash as of December 31, 2021 and 2020 is on deposit in interest-bearing accounts with well-established financial institutions.

At times, such amounts may exceed the Federal Deposit Insurance Corporation (FDIC) insurance limits.

As of December 31, 2021, uninsured cash balances totaled approximately $ 35,200,000 .

— In February 2016, the FASB issued ASU 2016-02, Leases (ASC 842), which supersedes the existing guidance for lease accounting,

Leases (Topic 840).

ASU 2016-02 requires lessees to recognize Right-Of-Use Asset and Lease Liability for virtually all of their

leases (other than leases that meet the definition of a short-term lease).

Lessor accounting remains largely unchanged except for

changes in the definition and classification of leases.

ASU 2016-02 allows a modified retrospective approach for all leases existing

at, or entered into after the date of initial adoption, with an option to elect to use certain transition relief.

The FASB also

proposed a transition method to allow entities to not apply the new leases standard in the comparative periods they present in

their financial statements in the year of adoption.

Because of the immaterial financial impact, the Company will not apply ASC

842 to leases that individually have total lease payments of less than $100,000 over their life of service to the Company.

On January 1, 2019, the Company adopted

ASC 842 using the modified retrospective method for all material leases that existed at or commenced after January 1, 2019.

Note 11 for additional details.

The Company elected to apply the practical expedients in ASC 842-10-65-1 (f) and (gg) and therefore:

did not reassess expired contracts for presence of lease components therein and if it was already concluded that such contracts had lease components then the classification of the respective lease components therein was not re-assessed.

did not re-assess initial direct costs for any existing leases.

will not separate the lease and non-lease components.

will continue applying its current policy for accounting for land easements that existed as of, or expired before effective date.

Adopted Accounting Pronouncements - In July 2017, the FASB issued ASU No.

2017-11, Earnings Per Share (Topic 260),

Distinguishing Liabilities from Equity (Topic 480), Derivatives and Hedging (Topic 815).

The amendments in Part I of this update

change the classification analysis of certain equity-linked financial instruments (or embedded features) with down round features.

When determining whether certain financial instruments should be classified as liabilities or equity instruments, a down round

feature no longer precludes equity classification when assessing whether the instrument is indexed to an entity’s own stock.

The amendments also clarify existing disclosure requirements for equity-classified instruments.

As a result, a freestanding equity-linked

financial instrument (or embedded conversion option) no longer would be accounted for as a derivative liability at fair value as

a result of the existence of a down round feature.

The standard is effective for annual and interim periods beginning after December

15, 2018, with early adoption permitted upon issuance.

The Company believes that its adoption of ASU 2017-11 has not had a material

impact on its results of operations, cash flows and financial position.

For the fiscal year beginning January 1,

2021, management early adopted ASU 2020-06 using the modified retrospective method.

ASU 2020-06 simplifies entities’

for convertible instruments by eliminating the cash conversion and BCF models outlined in ASC 470-20.

Under ASU 2020-06, convertible

instruments that would have previously been subject to the BCF or cash conversion guidance no longer require separate accounting

for the conversion feature.

Recently Adopted Accounting Pronouncements — For the fiscal year beginning January 1, 2021, management adopted ASU 2020-06 using the modified retrospective method.

ASU 2020-06 simplifies entities’ accounting for convertible instruments by eliminating the cash conversion and beneficial conversion feature (BCF) models outlined in ASC 470-20.

Under ASU 2020-06, convertible instruments that would have previously been subject to the BCF or cash conversion guidance no longer require separate accounting for the conversion feature.

Entities may elect to early adopt ASU 2020-06 for fiscal years beginning after December 15, 2020.

the Company early adopted ASU 2020-06 beginning January 1, 2021, the Company would no longer be required to recognize a BCF even

when shareholder approval is received.

In December 2020, the Company completed a private placement where we issued Series D

convertible preferred stock.

The preferred shares are convertible into shares of common stock upon receipt of stockholder approval

of the issuance of the underlying shares of common stock as required by Nasdaq Marketplace Rule 5635(d) at a special

stockholder meeting.

As such, management will continue to account for the Series D Preferred Stock in equity without any separate

accounting for the conversion options.

In accordance with Fair Value Measurements

and Disclosures Topic of the FASB ASC 820, the Company groups its financial assets and financial liabilities generally measured

at fair value in three levels, based on the markets in which the assets and liabilities are traded and the reliability of the assumptions

used to determine fair value.

New Accounting Pronouncements – Issued but Not Yet Adopted — In December 2021, the FASB issued ASU No.

2021-10, Government Assistance (Topic 832), which aims to provide increased transparency by requiring business entities to disclose information about certain type of government assistance they receive in the notes to the financial statements.

The Company does not expect the adoption of this standard to have a material impact on its consolidated financial statements.

In accordance with Fair Value Measurements and Disclosures Topic of the FASB ASC 820, the Company groups its financial assets and financial liabilities generally measured at fair value in three levels, based on the markets in which the assets and liabilities are traded and the reliability of the assumptions used to determine fair value.

Input prices quoted in an active market for identical financial assets or liabilities.

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Input prices quoted that are significant to the fair value of the financial assets or liabilities which are not observable or supported by an active market.

To the extent that the valuation is based

on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment.

Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized

A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input

that is significant to the fair value measurement.

In August 2014, as part of an underwritten

public offering, the Company issued warrants to purchase 49,425 shares of common stock (the “August 2014 Warrants”).

The August 2014 Warrants were listed on the NASDAQ Capital Market under the symbol “CLRBW,” however, there are certain

periods where trading volume is low;

therefore, they were classified as Level 2 within the hierarchy.

On August 20, 2019, these

warrants expired.

To estimate the fair value of the August

2014 Warrants, the Company calculated the weighted average closing price for the trailing 10-day period with trades that ended

on the balance sheet date.

Fixed assets consisted of the following

at December 31:

To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment.

Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3.

A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.

Fixed assets consisted of the following as of December 31:

Office and laboratory equipment

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Total fixed assets

accumulated depreciation and amortization

Less– accumulated depreciation and amortization

Fixed assets, net

For the years ended December 31, 2020 and

2019, the Company incurred approximately $141,000 and $133,000 of depreciation and amortization expense, respectively.

ACCRUED EXPENSES

For the years ended December 31, 2021 and 2020, the Company recorded approximately $150,000 and $141,000 of depreciation and amortization expense, respectively.

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES

approximately consist of the following:

Accounts payable and accrued liabilities approximately consist of the following:

Incentive compensation

Accounts payable

Clinical study costs

Clinical project costs

Professional fees

STOCKHOLDERS’ EQUITY

2020 Public Offering and Private Placement

On December 23, 2020, the Company

issued and sold 18,148,136 shares of common stock, par value $0.00001 per share, of the at a public offering price of $1.35 per

share of common stock, prior to deducting underwriting discounts and commissions and estimated offering expenses.

In a concurrent private placement, we issued

and sold 1,518.5180 shares of Series D convertible preferred stock.

The preferred shares are convertible into a number of

shares of common stock equal to $13,500 divided by $1.35 (or 10,000 shares of common stock for each share of Series D preferred

stock converted) and were issued at a price of $13,500 per share of Series D preferred stock.

The preferred shares will only

be convertible into common stock upon receipt of stockholder approval of the issuance of the underlying shares of common stock

as required by Nasdaq Marketplace Rule 5635(d) at a special stockholder meeting to be called for that purpose.

In accordance with the concept of ASC 820

regarding the December 2020 public offering, the Company allocated value of the proceeds to the common stock and preferred stock

utilizing a relative fair value basis.

Using the Nasdaq closing trading price for our stock on December 28, 2020, the Company computed

the fair value of the shares sold.

Authorized Share Increase

At a special meeting held on February 25, 2021, the Company’s stockholders approved the amendment of the Company’s Second Amended and Restated Certificate of Incorporation, as amended, to increase the authorized common stock from 80,000,000 shares to 160,000,000 shares.

Equity Distribution Agreement

On August 11, 2020, the Company entered into an equity distribution agreement (the Sales Agreement) with Oppenheimer & Co.

(the Sales Agent).

Pursuant to the Sales Agreement, the Company may offer and sell from time-to-time through the Sales Agent, up to $ 14.5 million of shares of the Company’s common stock, par value $ 0.00001 per share (the ATM Shares).

The Sales Agent will receive from the Company a commission of 3.0 % of the gross proceeds from the sales of the ATM Shares pursuant to the terms of the Sales Agreement.

The offering of the ATM Shares pursuant to the Sales Agreement will terminate upon the earliest of (i) the sale of all ATM Shares subject to the Sales Agreement, and (ii) the termination of the Sales Agreement by the Company or the Sales Agent.

Net proceeds from the sale of the ATM Shares will be used for general corporate purposes, including working capital.

The ATM Shares issued under the Sales Agreement are offered pursuant to a registration statement on Form S-3, which was declared effective by the U.S.

Securities and Exchange Commission (SEC) on August 20, 2020.

In June 2021, the Company issued and sold an aggregate of 41,692 ATM Shares pursuant to the Sales Agreement and received gross proceeds of approximately $ 69,000 and net proceeds of $ 35,000 after deducting commissions to the Sales Agent and other offering expenses.

December 2020 Public Offering and Private Placement

On December 23, 2020, the Company issued and sold 18,148,136 shares of common stock, par value $ 0.00001 per share, of the at a public offering price of $ 1.35 per share of common stock, prior to deducting underwriting discounts and commissions and estimated offering expenses.

In a concurrent private placement, the Company issued and sold 1,518.5180 shares of Series D convertible preferred stock.

The preferred shares are convertible into a number of shares of common stock equal to $ 13,500 divided by $ 1.35 (or 10,000 shares of common stock for each share of Series D preferred stock converted) and were issued at a price of $ 13,500 per share of Series D preferred stock.

The preferred shares would only be convertible into common stock upon receipt of stockholder approval of the issuance of the underlying shares of common stock as required by Nasdaq Marketplace Rule 5635(d) at a special stockholder meeting to be called for that purpose.

At a special meeting of stockholders held on February 25, 2021, the stockholders approved, in accordance with Nasdaq Listing Rule 5635(d), the issuance of shares of the Company’s common stock upon the conversion of the Series D preferred stock.

During the twelve months ended December 31, 2021, the total Series D convertible preferred stock converted into 14,074,069 Common Stock at a rate of 1 to 10,000 shares.

The net proceeds of the offerings to the Company, after deducting the underwriting discounts and commissions, placement agency fees and estimated offering expenses payable by the Company, were approximately $ 41.4 million.

The common stock issued in the public offering was offered by the Company pursuant to a registration statement on Form S-3, which was declared effective by the SEC on August 20, 2020.

The common stock issuable upon conversion of the Series D preferred stock in the private placement was offered by the Company pursuant to a registration statement on Form S-3, which was declared effective by the SEC on February 1, 2021.

In accordance with the concept of ASC 820 regarding the December 2020 public offering, the Company allocated the value of the proceeds to the common stock and preferred stock utilizing a relative fair value basis.

Using the Nasdaq closing trading price for our stock on December 23, 2020, the Company computed the fair value of the shares sold.

The fair value of the preferred stock was estimated on a relative fair value basis.

This valuation

did not impact total Stockholders’ Equity of $45.0 million, but is an internal proportionate calculation allocating the gross

proceeds of approximately $24.5 million to common stock and $20.5 million to preferred stock.

The net proceeds of the offerings to the

Company, after deducting the underwriting discounts and commissions, placement agency fees and estimated offering expenses payable

by the Company were approximately $41.4 million.

The common stock were offered by the Company

pursuant to a registration statement on Form S-3, which was declared effective by the Securities and Exchange Commission on February

1, 2021.The preferred shares are only convertible upon stockholder approval.

This valuation did not impact total Stockholders’ Equity but is an internal proportionate calculation allocating gross proceeds of approximately $ 24.5 million to common stock and $ 20.5 million to preferred stock.

June 2020 Public Offering

On June 5, 2020, the Company issued and

sold 14,601,628 shares of common stock, 2,789,700 pre-funded warrants exercisable for one share of our common stock at an exercise

price of $0.00001 per share and 8,695,664 Series H warrants to purchase 8,695,664 shares of common stock.

The public offering price

of a share of common stock together with one-half of a Series H warrant to purchase one share of common stock was $1.15.

offering price of a pre-funded warrant together with one-half of a Series H Warrant was $1.1499.

The Series H warrants have an

exercise price of $1.2075 per share and are exercisable for five years from the date of issuance.

As of December 31, 2020, all

2,789,700 pre-funded warrants and 482,375 Series H warrants have been exercised.

In accordance with the concept of ASC 820

regarding the June 2020 public offering, the Company allocated value of the proceeds to the common stock and warrants utilizing

a relative fair value basis.

Using the Nasdaq closing trading price for our stock on June 5, 2020, the Company computed the fair

value of the shares sold.

The fair value of the warrants was estimated using the Black-Scholes option-pricing model at that same

This valuation did not impact total Stockholders’ Equity of $20.0 million, but is an internal proportionate calculation

allocating the gross proceeds of approximately $12.1 million to common stock and $7.9 million to warrants.

Gross offering proceeds to the Company

were $20.0 million, with net proceeds to the Company of approximately $18.3 million after deducting placement agent fees and related

offering expenses.

The Company intends to use the net proceeds from the offering for research and development, funding clinical

studies, working capital and general corporate purposes.

The common stock, pre-funded warrants and

Series H warrants were offered by the Company pursuant to a registration statement on Form S-1 filed on May 8, 2020 with the SEC

under the Act and an additional registration statement filed on June 2, 2020 pursuant to Rule 462(b) under the Act.

May 2019 Public Offering

On May 20, 2019, the Company issued and

sold 1,982,000 shares of common stock at an offering price of $2.50 per share.

In a concurrent private placement, we issued to

the purchasers of our common stock, Series F warrants to purchase an aggregate of 1,982,000 shares of common stock.

F warrants were immediately exercisable, expire five years after the date of issuance, and have an exercise price of $2.40.

of December 31, 2020, 25,000 Series F warrants have been exercised.

In a separate concurrent private placement

transaction, the Company sold 2,018,000 shares of common stock together with Series G warrants to purchase an aggregate of up to

2,018,000 shares of common stock.

The shares of common stock and Series G warrants were priced at $2.50 per fixed combination.

The warrants sold in the private placement were immediately exercisable, expire five years after the date of issuance, and have

an exercise price of $2.40.

In accordance with the concept of ASC 820

regarding the May 2019 public offering, the Company allocated value to the proceeds to the common stock and warrants utilizing

a relative fair value basis.

Using the Nasdaq closing trading price for our stock on May 20, 2019, we computed the fair value of

the shares sold.

On June 5, 2020, the Company issued and sold 14,601,628 shares of common stock, 2,789,700 pre-funded warrants exercisable for one share of our common stock at an exercise price of $ 0.00001 per share and 8,695,664 Series H warrants to purchase 8,695,664 shares of common stock.

The public offering price of a share of common stock, together with one -half of a Series H warrant to purchase one share of common stock, was $ 1.15 .

The public offering price of a pre-funded warrant together with one -half of a Series H Warrant was $ 1.1499 .

The Series H warrants have an exercise price of $ 1.2075 per share and are exercisable for five years from the date of issuance.

During the year ended December 31, 2020, all 2,789,700 pre-funded warrants and 482,375 Series H warrants were exercised.

During the year ended December 31, 2021, 1,005,320 Series H warrants were exercised.

In accordance with the concept of ASC 820 regarding the June 2020 public offering, the Company allocated value of the proceeds to the common stock and warrants utilizing a relative fair value basis.

Using the Nasdaq closing trading price for our stock on June 5, 2020, the Company computed the fair value of the shares sold.

The fair value of the warrants was estimated using the Black-Scholes option-pricing model at that same date.

valuation did not impact total Stockholders’ Equity of $10.0 million, but is an internal proportionate calculation allocating

the gross proceeds of approximately $6 million to common stock and $4.0 million to warrants.

Gross offering proceeds to the Company

were $10.0 million, with net proceeds to the Company of approximately $9.0 million after deducting placement agent fees and related

offering expenses.

The Company intends to use the net proceeds from the offering for research and development, funding clinical

studies, working capital and general corporate purposes.

The registered direct offering described

above was made pursuant to a registration statement on Form S-3 previously filed with and subsequently declared effective by the

The unregistered common shares and warrants were offered pursuant to the exemption from registration afforded by Section 4(a)(2)

under the Act, and Regulation D promulgated thereunder.

The offerings’ unregistered common shares and warrants were ultimately

registered through our May 31, 2019 filing of Form S-1 and acceptance of this Registration Statement by the SEC.

This valuation did not impact total Stockholders’ Equity but is an internal proportionate calculation allocating the gross proceeds of approximately $ 12.1 million to common stock and $ 7.9 million to warrants.

Gross offering proceeds to the Company were $ 20.0 million, with net proceeds to the Company of approximately $ 18.3 million after deducting placement agent fees and related offering expenses.

The Company intends to use the net proceeds from the offering for research and development, funding clinical studies, working capital and general corporate purposes.

The common stock, pre-funded warrants and Series H warrants were offered by the Company pursuant to a registration statement on Form S-1 filed on May 8, 2020 with the SEC under the Securities Act of 1933 (the Act) and an additional registration statement filed on June 2, 2020 pursuant to Rule 462(b) under the Act.

Common Stock Warrants

The following table summarizes information

with regard to outstanding warrants to purchase common stock as of December 31, 2020:

The following table summarizes information with regard to outstanding warrants to purchase common stock as of December 31, 2021:

Number of Shares

Issuable Upon

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October 14, 2024

November 2016 Public Offering Series C

November 29, 2021

April 2016 Underwritten Registered Series A

April 20,2021

October 2015 Incremental Series A

October 20,2021

October 2015 Private Placement Series A

April 1, 2021

STOCK-BASED COMPENSATION

Accounting for Stock-Based Compensation

in 2015 Stock Incentive Plan .

At the 2020 annual meeting of stockholders held on June 24, 2020, the Company’s

stockholders approved an increase in the number of shares of common stock available for issuance under our 2015 Stock Incentive

Plan by 700,000 shares.

2021 Stock Incentive Plan

The 2015 Stock Incentive Plan was adopted on June 9, 2015 authorizing an aggregate of 42,000 shares

for issuance (after taking into account the 2018 and 2016 10:1 reverse stock splits).

On May 31, 2017, our stockholders approved

the Amended and Restated 2015 Stock Incentive Plan (the “2015 Plan”) to increase the authorized shares by 120,000 shares.

On May 31, 2018, our stockholders approved the Amended and Restated 2015 Stock Incentive Plan to increase the authorized shares

On June 13, 2019, the Company’s stockholders approved an increase in the number of shares of common stock available

for issuance under our 2015 Stock Incentive Plan by 700,000 shares.

On June 24, 2020, the Company’s stockholders approved

an increase in the number of shares of common stock available for issuance under our 2015 Stock Incentive Plan by 700,000 shares.

A total of 1,682,000 shares of common stock are authorized for issuance under the 2015 Plan for grants of incentive or nonqualified

stock options, rights to purchase restricted and unrestricted shares of common stock, stock appreciation rights and performance

share grants.

A committee of the board of directors determines exercise prices, vesting periods and any performance requirements

on the date of grant, subject to the provisions of the Plan.

Options are granted at or above the fair market value of the

common stock at the grant date and expire on the tenth anniversary of the grant date.

Vesting periods are generally between

one and four years.

Options granted pursuant to the Plan generally will become fully vested upon a termination event occurring

within one year following a change in control, as defined.

A termination event is defined as either termination of employment

or services other than for cause or constructive termination of employees or consultants resulting from a significant reduction

in either the nature or scope of duties and responsibilities, a reduction in compensation or a required relocation.

Upon adoption

of the 2015 Plan, shares were no longer available for grant under our 2006 Stock Incentive Plan (the “2006 Plan”).

All outstanding awards under the 2006 Plan remained in effect according to the terms of the 2006 Plan and the respective agreements

relating to such awards.

In addition, any shares that are currently available under the 2006 Plan and any shares underlying awards

under the 2006 Plan which are forfeited, cancelled, reacquired by the Company or otherwise terminated will be added to the number

of shares available for grant under the 2015 Plan.

As of December 31, 2020, there are an aggregate of 675,685 shares available

for future grants under the 2015 Plan.

Stock Option Plan.

Prior to the approval of the 2015 Stock Incentive Plan, option grants to directors and employees

were made under the 2006 Plan.

A total of 7,000 shares of common stock were authorized for issuance under the 2006 Plan for

grants of incentive or nonqualified stock options, rights to purchase restricted and unrestricted shares of common stock, stock

appreciation rights and performance share grants.

A committee of the board of directors determined exercise prices, vesting

periods and any performance requirements on the date of grant, subject to the provisions of the 2006 Plan.

Options were granted

at or above the fair market value of the common stock at the grant date and expire on the tenth anniversary of the grant date.

periods were generally between one and four years.

During the twelve-months ended December

31, 2020 and 2019, stock options granted were 653,750 and 411,930, respectfully.

The following table summarizes amounts charged

to expense for stock-based compensation related to employee and director stock option grants:

The 2021 Stock Incentive Plan (the “2021 Plan”) was adopted on June 23, 2021, authorizing an aggregate of 6,000,000 shares of common stock for grants of incentive or nonqualified stock options, rights to purchase restricted and unrestricted shares of common stock, stock appreciation rights and performance share grants.

The Compensation Committee determines exercise prices, vesting periods and any performance requirements on the date of grant, subject to the provisions of the 2021 Plan.

Options are granted at or above the fair market value of the common stock at the grant date and expire on the tenth anniversary of the grant date.

Vesting periods are generally between one and three years .

Options granted pursuant to the 2021 Plan generally will become fully vested upon a termination event occurring within one year following a change in control, as defined.

A termination event is defined as either termination of employment or services other than for cause or constructive termination of employees or consultants resulting from a significant reduction in either the nature or scope of duties and responsibilities, a reduction in compensation or a required relocation.

All outstanding awards under the 2015 Stock Incentive Plan (the “2015 Plan”) remained in effect according to the terms of the 2015 Plan and the respective agreements relating to such awards.

In addition, any shares that are currently available under the 2015 Plan and any shares underlying awards under the 2015 Plan which are forfeited, cancelled, reacquired by the Company or otherwise terminated will be added to the number of shares available for grant under the 2021 Plan.

As of December 31, 2021, there are an aggregate of 3,521,949 shares available for future grants under the 2021 Plan.

During the twelve-months ended December 31, 2021 and 2020, stock options granted were 3,537,500 and 653,750 , respectively.

The following table summarizes amounts charged to expense for stock-based compensation related to employee and director stock option grants:

Twelve Months Ended

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Total stock-based compensation

On October 12, 2018, the Company granted

167,430 contingent non-statutory stock options, net of forfeitures, at an exercise price of $2.61 per share to current non-employee

directors and employees, and on January 17, 2019, the Company granted 118,750 contingent non-statutory stock options, net of forfeitures,

at an exercise price of $1.99 per share to employees.

Each of these grants was contingent on approval by the Company’s stockholders

of the amendment to the 2015 Stock Incentive Plan at the 2019 Annual Meeting of Stockholders, and stockholders approved the amendment

on June 13, 2019 .

In accordance with the timing of the stockholder approval, all related expenses were recognized by the

Company in June 2019, including the catch-up for compensation expenses for recognition of contingent non-statutory stock options

from October 2018.

On March 4, 2021, we granted 2,810,000 contingent non-statutory stock option awards at an exercise price of $ 1.74 per share to our employees.

Each of these grants was contingent on approval of the 2021 Plan that was voted on and approved by the stockholders

at the Annual Meeting of Stockholders held on June 23, 2021.

In accordance with the timing of the stockholder approval, the Company recognized the compensation expense of the contingent non-statutory stock option awards issued in March 2021 beginning in June 2021 and continuing through the vesting period.

Assumptions Used in Determining Fair Value

and amortization method .

The fair value of each stock award is estimated on the grant date using the Black-Scholes option-pricing

The estimated fair value of employee stock options is amortized to expense using the straight-line method over the required

service period which is generally the vesting period.

The estimated fair value of the non-employee options is amortized to expense

over the period during which a non-employee is required to provide services for the award (usually the vesting period).

Valuation and amortization method .

The fair value of each stock award is estimated on the grant date using the Black-Scholes option-pricing model.

The estimated fair value of employee stock options is amortized to expense using the straight-line method over the required service period which is generally the vesting period.

The estimated fair value of the non-employee options is amortized to expense over the period during which a non-employee is required to provide services for the award (usually the vesting period).

The Company estimates volatility based on the Company’s historical volatility since its common stock has been publicly traded.

interest rate .

Risk-free interest rate .

The risk-free interest rate is based on the U.S.

Treasury yield curve in effect at the time of grant

commensurate with the expected term assumption.

Treasury yield curve in effect at the time of grant commensurate with the expected term assumption.

Expected term .

The expected term of stock options granted is based on an estimate of when options will be exercised in the future.

The Company applied the simplified method of estimating the expected term of the options, as described in the SEC’s Staff

Accounting Bulletins 107 and 110, as the historical experience is not indicative of the expected behavior in the future.

term, calculated under the simplified method, is applied to groups of stock options that have similar contractual terms.

this method, the expected term is determined using the average of the vesting period and the contractual life of the stock options

The Company applied the simplified method to non-employees who have a truncation of term based on termination of service

and utilizes the contractual life of the stock options granted for those non-employee grants which do not have a truncation of

The Company applied the simplified method of estimating the expected term of the options, as described in the SEC’s Staff Accounting Bulletins 107 and 110, as the historical experience is not indicative of the expected behavior in the future.

The expected term, calculated under the simplified method, is applied to groups of stock options that have similar contractual terms.

Using this method, the expected term is determined using the average of the vesting period and the contractual life of the stock options granted.

The Company applied the simplified method to non-employees who have a truncation of term based on termination of service and utilizes the contractual life of the stock options granted for those non-employee grants which do not have a truncation of service.

The Company records stock-based compensation expense only for those awards that are expected to vest.

A forfeiture rate is estimated

at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from initial estimates.

forfeiture rate of 2% was applied to all unvested options for employees and no forfeiture rate to directors for the twelve months

ended December 31, 2020 and 2019.

Ultimately, the actual expense recognized over the vesting period will be for only those shares

The Company accounts for forfeitures as they occur.

The Company has not historically recorded dividends related to stock options.

The following table summarizes the weighted-average values and assumptions used for stock options granted to employees and directors

in the periods indicated:

The following table summarizes the weighted-average values and assumptions used for stock options granted to employees and directors in the periods indicated:

Year Ended December 31,

102.19 - 104.73

Risk-free interest rate

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Weighted-average grant-date fair value

Exercise prices for all grants made during

the twelve months ended December 31, 2020 and 2019 were equal to the market value of the Company’s common stock on the date

There were 653,750 stock option grants during the twelve months ended December 31, 2020.

Exercise prices for all grants made during the twelve months ended December 31, 2021 and 2020 were equal to the market value of the Company’s common stock on the date of grant.

There were 3,537,500 stock options granted during the twelve months ended December 31, 2021.

Stock Option Activity

A summary of stock option activity is as

Outstanding at December 31, 2018

Outstanding at December 31, 2019

Outstanding at December 31, 2020

Exercisable, December 31, 2020

Unvested, December 31, 2020

The aggregate intrinsic value of options

outstanding is calculated based on the positive difference between the estimated per-share fair value of common stock at the end

of the respective period and the exercise price of the underlying options.

Shares of common stock issued upon the exercise of options

are from authorized but unissued shares.

The weighted-average grant-date fair value

of options granted during the years ended December 31, 2020 and 2019 was $1.42 and $1.76, respectively.

The total fair

value of shares vested during the years ended December 31, 2020 and 2019 was $389,398 and $715,587, respectively.

weighted-average grant-date fair value of vested and unvested options outstanding at December 31, 2020 was $6.62 and $1.44,

respectively.

The weighted-average grant-date fair value of vested and unvested options outstanding at December 31, 2019 was

$10.62 and $1.82, respectively.

The weighted average grant date fair value

of options forfeited during the years ended December 31, 2020 and 2019 was $1.90 and $3.80 respectively.

The number of options

vested during the years ended December 31, 2020 and December 31, 2019 was 209,354 and 203,523, respectively.

of options unvested at January 1, 2020 and January 1, 2019 was 361,743 and 186,895, respectively.

The weighted average

grant date fair value of options unvested at January 1, 2020 and January 1, 2019 was $1.82 and $4.14, respectively.

As of December 31, 2020, there was approximately

$790,035 of total unrecognized compensation cost related to unvested stock-based compensation arrangements.

Of this total amount,

the Company expects to recognize approximately $424,673, $292,129 and $73,233 during 2021, 2022 and 2023, respectively.

The Company’s

expense estimates are based upon the expectation that all unvested options will vest in the future, less the forfeiture rate discussed

The weighted-average grant-date fair value of vested and unvested options outstanding at December 31, 2020 was $6.62 and

$1.44, respectively.

Stock Grant s.

During 2017, the Company issued 46,000 shares under the 2015 Plan of restricted common stock with a weighted

average grant date fair value of $20.96.

In 2017, 8,000 shares were forfeited.

The shares vest annually over a three-year period.

The following table summarizes the restricted stock grants:

Outstanding at December 31, 2018

Outstanding at December 31, 2019

Outstanding at December 31, 2020

A summary of stock option activity is as follows:

Issuable Upon

Outstanding as of December 31, 2019

Outstanding as of December 31, 2020

Outstanding as of December 31, 2021

Exercisable as of December 31, 2021

Unvested as of December 31, 2021

The aggregate intrinsic value of options outstanding is calculated based on the positive difference between the estimated per-share fair value of common stock at the end of the respective period and the exercise price of the underlying options.

Shares of common stock issued upon the exercise of options are from authorized but unissued shares.

The weighted-average grant-date fair value of options granted during the years ended December 31, 2021 and 2020 was $ 0.94 and $ 1.42 , respectively.

The total fair value of shares vested during the years ended December 31, 2021 and 2020 was $ 537,453 and $ 389,398 , respectively.

The weighted-average grant-date fair value of vested and unvested options outstanding at December 31, 2021 was $ 1.39 and $ 0.98 , respectively.

The weighted-average grant-date fair value of vested and unvested options outstanding at December 31, 2020 was $ 6.62 and $ 1.44 , respectively.

The weighted average grant date fair value of options forfeited during the years ended December 31, 2021 and 2020 was $ 1.02 and $ 1.90 , respectively.

The number of options vested during the years ended December 31, 2021 and December 31, 2020 was 381,010 and 209,354 , respectively.

The number of options unvested at January 1, 2021 and January 1, 2020 was 726,139 and 361,743 , respectively.

The weighted average grant date fair value of options unvested at January 1, 2021 and January 1, 2020 was $ 1.44 and $ 1.82 , respectively.

As of December 31, 2021, there was approximately $ 2,536,428 of total unrecognized compensation cost related to unvested stock-based compensation arrangements.

Of this total amount, the Company expects to recognize approximately $ 1,359,075 , $ 1,001,776 , and $ 175,577 during 2022, 2023 and 2024, respectively.

The Company’s expense estimates are based upon the expectation that all unvested options will vest in the future.

Tax provision (benefit)

Total current

( 7,102,248 )

( 3,481,764 )

( 1,071,157 )

( 1,416,877 )

Total deferred

( 8,173,405 )

( 4,898,641 )

Change in valuation allowance

Deferred tax assets consisted of the following

at December 31:

Deferred tax assets consisted of the following as of December 31:

Deferred tax assets

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Less- valuation allowance

( 62,489,869 )

( 5,416,463 )

Total deferred tax assets

A reconciliation of income taxes computed

using the U.S.

A reconciliation of income taxes computed using the U.S.

federal statutory rate to that reflected in operations is as follows:

Year ended December 31,

Income tax benefit using U.S.

1 unchanged sentence

State income taxes

Permanent items

Permanent nondeductible items

Federal tax credits

Change in valuation allowance

As of December 31, 2020, the Company had

federal net operating loss carryforwards of approximately $143,722,000.

Federal net operating loss generated as of December

31, 2017 will expire in 2021 through 2037, net operating loss generated during 2018 and later will be carried forward indefinitely

until utilized.

As of December 31, 2020,the Company also had state net operating loss carryforwards of approximately $54,283,000.

State net operating loss will expire in 2028 through 2040.

As of December 31, 2020, the Company had

federal research and development and orphan drug credit carryforwards of approximately $7,064,000 which will expire in 2021 through

As of December 31, 2020, the Company also had state credit carryforwards of approximately $850,000which will expire in 2024

through 2035.

As of December 31, 2020, the company had

federal NOLs and research and development credit carryforwards of $1,690,848 and $65,675, respectively, that expired in 2020.

The amount of NOLs and tax credit carryforwards

which may be utilized annually in future periods will be limited pursuant to Section 382 and 383 of the Internal Revenue Code as

a result of substantial changes in the Company’s ownership that have occurred or that may occur in the future.

has not quantified the amount of such limitations.

During 2019, the Company changed its state

tax rate applied to the deferred tax assets and liabilities based on the expected reversal of the deferred tax assets and liabilities.

This state deferred tax benefit is offset by a corresponding increase valuation allowance.

Because of the Company’s continuing

losses and uncertainty associated with the utilization of the deferred tax assets in the future, management has provided a full

allowance against the net deferred tax asset.

The CARES Act lifts certain deduction limitations

originally imposed by the Tax Cuts and Jobs Act of 2017 (the “Tax Act”).

Under the Tax Act, federal net operating losses

generated after 2017 could not be carried back and utilization was limited to 80% of taxable income.

The CARES Act allows for a

five-year carryback of federal net operating losses generated in 2018 through 2020 and eliminates the 80% taxable income limitation

by allowing entities to fully utilize net operating loss carryforwards to offset taxable income in 2018 through 2020.

the CARES Act generally allows taxpayers to deduct interest up to 50% of adjusted taxable income (30% limit under the Tax Act)

for tax years 2019 and 2020.

The enactment of the CARES Act did not

result in any material adjustments to the Company’s income tax provision for the year ended December 31, 2020, or to its

deferred taxes and related allowance as of December 31, 2020.

Effective January 1, 2019, the Company

adopted ASU 2016-02, which resulted in the recognition of lease liabilities and right-of-use assets.

The Company’s deferred

tax balances have been adjusted to reflect the adoption of ASU2016-02.

The Company did not have unrecognized

tax benefits or accrued interest and penalties at any time during the years ended December 31, 2020 or 2019 and does not anticipate

having unrecognized tax benefits over the next twelve months.

The Company is subject to audit by the IRS and state taxing

authorities for tax periods commencing January 1, 2017.

Additionally, the Company may be subject to examination by the IRS for

years beginning prior to January 1, 2017 as a result of its NOLs.

However, any adjustment related to these periods would be limited

to the amount of the NOL generated in the year(s) under examination.

As of December 31, 2021, the Company had federal net operating loss (NOL) carryforwards of approximately $ 155,697,000 .

Federal NOLs generated as of December 31, 2017 will expire in 2021 through 2037 , while NOLs generated during

2018 and later will be carried forward indefinitely until utilized.

As of December 31, 2021, the Company had state NOL carryforwards of approximately $ 66,743,000 .

State NOL carryforwards will expire in 2028 through 2040 .

As of December 31, 2021, the Company had federal research and development (R&D) and orphan drug credit carryforwards of approximately $ 9,600,000 which will expire in 2022 through 2041 .

As of December 31, 2021, the Company also had state credit carryforwards of approximately $ 883,000 which will expire in 2024 through 2035 .

As of December 31, 2021, the Company had federal NOLs and R&D credit carryforwards of $ 1,300,575 and $ 42,355 , respectively, that expired in 2021 .

The NOL and R&D credit carryforwards may be, or may become subject to, an annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders over a three-year period in excess of 50%, as defined under Section 382 and 383 of the Internal Revenue Code of 1986, as amended, as well as similar state tax provisions.

This could limit the amount of NOLs that the Company can utilize annually to offset future taxable income or tax liabilities.

The amount of the annual limitation, if any, will be determined based on the value of the Company immediately prior to an ownership change.

Subsequent ownership changes may further affect the limitation in future years.

If and when the Company utilizes the NOL carryforwards in a future period, it will perform an analysis to determine the effect, if any, of these loss limitation rules on the NOL carryforward balances.

The Company has evaluated the available evidence supporting the realization of its deferred tax assets, including the amount and timing of future taxable income, and has determined that it is more likely than not that its net deferred tax assets will not be realized.

Due to uncertainties surrounding the realization of the deferred tax assets, the Company maintains a full valuation allowance against all of its net deferred tax assets.

When the Company determines that it will be able to realize some portion or all of its deferred tax assets, an adjustment to its valuation allowance on its deferred tax assets would have the effect of increasing net income in the period such determination is made.

The Company did not have unrecognized tax benefits or accrued interest and penalties at any time during the years ended December 31, 2021 or 2020 and does not anticipate having unrecognized tax benefits over the next twelve months.

The Company is subject to audit by the Internal Revenue Service and state taxing authorities for tax periods commencing January 1, 2017 as a result of its NOLs.

However, any adjustment related to these periods would be limited to the amount of the NOL generated in the year(s) under examination.

NET LOSS PER SHARE

Basic net loss per share is computed by

dividing net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding during

Diluted net loss attributable to common stockholders per share is computed by dividing net loss attributable to common

stockholders, as adjusted, by the sum of the weighted average number of shares of common stock and the dilutive potential common

stock equivalents then outstanding.

Potential common stock equivalents consist of stock options and warrants.

is a net loss attributable to common stockholders for the years ended December 31, 2020 and 2019, the inclusion of common stock

equivalents in the computation for those periods would be antidilutive.

Accordingly, basic and diluted net loss per share is the

same for all periods presented.

The following potentially dilutive securities

have been excluded from the computation of diluted net loss per share since their inclusion would be antidilutive:

Basic net loss per share is computed by dividing net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding during the period.

Diluted net loss attributable to common stockholders per share is computed by dividing net loss attributable to common stockholders, as adjusted, by the sum of the weighted average number of shares of common stock and the dilutive potential common stock equivalents then outstanding.

Potential common stock equivalents consist of stock options, warrants, preferred shares convertible into common stock, and pre-funded warrants.

Since there is a net loss attributable to common stockholders for the years ended December 31, 2021 and 2020, the inclusion of common stock equivalents in the computation for those periods would be antidilutive.

Accordingly, basic and diluted net loss per share is the same for all periods presented.

The following potentially dilutive securities have been excluded from the computation of diluted net loss per share since their inclusion would be antidilutive:

Year Ended December 31,

Stock options

Non-vested restricted stock

Preferred shares convertible to common

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COMMITMENTS AND CONTINGENCIES

The Company may be involved in legal matters

and disputes in the ordinary course of business.

We do not anticipate that the outcome of such matters and disputes will materially

affect the Company’s financial statements.

The Company may be involved in legal matters and disputes in the ordinary course of business.

We do not anticipate that the outcome of such matters and disputes will materially affect the Company’s financial statements.

Operating Lease Liability

June 2018, the Company executed an agreement for office space in the Borough of Florham Park, Morris County, New Jersey to be used

as its headquarters (“HQ Lease”).

The HQ Lease commenced upon completion of certain improvements in October 2018 and

terminates in February 2024 with an option to extend the term of the lease for one additional 60-month period.

the landlord made certain improvements to the facility.

As of December 31, 2018, the Company recorded a deferred lease liability

of approximately $176,000 for the improvements funded by the landlord in deferred rent ,

current and deferred rent, long-term on the consolidated balance sheet for which we amortized the deferred liability as a reduction

to rent expense in the consolidated statement of operations over the term of the lease.

the HQ Lease, the Company will pay monthly fixed rent based on approximate rate per rentable square foot which ranges between approximately

$12,400 to $13,600 over the lease period.

In addition, the Company received certain rent abatements and lease incentives subject

to the limitations in the HQ Lease.

The HQ Lease’s net ROU asset and ROU lease liability are approximately $282,000 and ($422,000),

respectively, as of December 31, 2020 and rental expense for the twelve months ended December 31, 2020 was approximately

In June 2018, the Company executed an agreement for office space in the Borough of Florham Park, Morris County, New Jersey to be used as its headquarters (HQ Lease).

The HQ Lease commenced upon completion of certain improvements in October 2018 and terminates in February 2024 with an option to extend the term of the lease for one additional 60 -month period.

During 2018, the landlord made certain improvements to the facility.

As of December 31, 2018, the Company recorded a deferred lease liability of approximately $ 176,000 for the improvements funded by the landlord in the consolidated balance sheet which is being amortized as a reduction to rent expense in the consolidated statement of operations over the term of the lease.

Under the HQ Lease, the Company will pay monthly fixed rent based on approximate rate per rentable square foot which ranges between approximately $ 12,400 to $ 13,600 over the lease period.

In addition, the Company received certain rent abatements and lease incentives subject to the limitations in the HQ Lease.

The HQ Lease’s net ROU asset and lease liability are approximately $205,000 and ($ 302,000 ), respectively, as of December 31, 2021 and rental expense for the twelve months ended December 31, 2021 was approximately $ 113,000 .

The Company has not entered into any leases with related parties.

On January 1, 2019, the

Company adopted ASC 842 using the modified retrospective method for all material leases that existed at or commenced after January

1, 2019 and elected to apply the practical expedients in ASC 842-10-65-1 (f) and (gg) to the HQ Lease.

The Company accounts for

short-term leases (i.e., lease term of 12 months or less) by making the short-term lease policy election and will not apply the

recognition and measurement requirements of ASC 842.

As a result of the immaterial financial impact, the Company will not apply

ASC 842’s extensive calculation and reporting requirement against the leases that individually have total lease payments

of less than $100,000 over their life of service to the Company.

The adoption of ASC 842 did not have a material net impact on

the Company’s Condensed Consolidated Statements of Operations as of the effective date.

See Note 1 for additional

Discount Rate

The Company has determined the interest

rate implicit in the lease considering factors such as the Company’s

credit rating, borrowing terms offered by the U.S.

Small Business Administration, amount of lease payments, quality of collateral

and alignment of the borrowing term and lease term.

The Company considers 10% per annum as reasonable to use as the incremental

borrowing rate for purposes of the calculation of lease liabilities.

Maturity Analysis of Short-Term and Operating

following table approximates the dollar maturity of the Company’s undiscounted payments

for its short-term leases and operating lease liabilities as of December 31, 2020:

The Company has determined the interest rate implicit in the lease considering factors such as the Company’s credit rating, borrowing terms offered by the U.S.

Small Business Administration, amount of lease payments, quality of collateral and alignment of the borrowing term and lease term.

The Company considers 10 % per annum as reasonable to use as the incremental borrowing rate for purposes of the calculation of lease liabilities.

Maturity Analysis of Short-Term and Operating Leases

The following table approximates the dollar maturity of the Company’s undiscounted payments for its short-term leases and operating lease liabilities as of December 31, 2021:

Years ending December 31,

3 unchanged sentences

EMPLOYEE RETIREMENT PLAN

The Company has a defined contribution

plan under Section 401(k) of the Internal Revenue Code that allows eligible employees who meet minimum age requirements to contribute

a portion of their annual compensation on a pre-tax basis.

The Company has not made any matching contributions under this

On April 21, 2020, the Company received

loan proceeds in the amount of approximately $184,000 under the Paycheck Protection Program (“PPP”).

established as part of the Coronavirus Aid, Relief and Economic Security Act (“CARES Act”), provides for loans to qualifying

businesses for amounts up to 2.5 times of the average monthly payroll expenses of the qualifying business.

The loans and accrued

interest are forgivable after 24 weeks as long as the borrower uses the loan proceeds for eligible purposes, including payroll,

benefits, rent and utilities, and maintains its payroll levels.

The amount of loan forgiveness will be reduced if the borrower

terminates employees or reduces salaries during the 24-week period.

The unforgiven portion of the PPP loan is payable over two years

at an interest rate of 1%, with a deferral of payments for the first six months.

The Company intends to use the proceeds for

purposes consistent with the PPP requirements.

On December 30, 2020, the principal loan amount of $184,000 and accrued interest

of $1,280 were forgiven.

SUBSEQUENT EVENTS

In January and February 2021, the Company

received proceeds of $1,213,924 upon the exercise of 1,005,320 Series H warrants.

In February 2021, a holder

of 215 shares of our Series C Preferred Stock converted them into 537,500 shares of Common Stock at a conversion rate of 1 to 2,500

Special Meeting of Stockholders

At a special meeting of stockholders held on February 25, 2021,

the Company’s stockholders approved the amendment of the Company’s Second Amended and Restated Certificate of Incorporation,

as amended, to increase the authorized common stock from 80,000,000 shares to 160,000,000 shares.

In addition, the stockholders

approved, in accordance with Nasdaq Listing Rule 5635(d), the issuance of shares of the Company’s common stock upon the conversion

of the Series D Preferred Stock issued in a private placement on December 28, 2020.

In February 2021, 351.8515 shares of our Series

D Preferred Stock were converted into 3,518,515 shares of Common Stock at a conversion rate of 1 to 10,000 shares.

The Company has a defined contribution plan under Section 401(k) of the Internal Revenue Code that allows eligible employees who meet minimum age requirements to contribute a portion of their annual compensation on a pre-tax basis.

The Company has not made any matching contributions under this plan.

On April 21, 2020, the Company received loan proceeds in the amount of approximately $ 184,000 under the Paycheck Protection Program (PPP).

The PPP, established as part of the Coronavirus Aid, Relief and Economic Security Act (CARES Act), provides for loans to qualifying businesses for amounts up to 2.5 times of the average monthly payroll expenses of the qualifying business.

The loans and accrued interest are forgivable after 24 weeks as long as the borrower uses the loan proceeds for eligible purposes, including payroll, benefits, rent and utilities, and maintains its payroll levels.

The amount of loan forgiveness will be reduced if the borrower terminates employees or reduces salaries during the 24-week period.

The unforgiven portion of the PPP loan is payable over two years at an interest rate of 1 %, with a deferral of payments for the first six months.

The Company used the proceeds for purposes consistent with the PPP requirements.

On December 30, 2020, the principal loan amount of $ 184,000 and accrued interest of $ 1,280 were forgiven and recognized as a gain on extinguishment of debt in the fourth quarter of 2020.

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.

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 8. Financial Statements and Supplementary Data