What changed in this filing

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Item 1. Financial Statements

2021-11-10 compared with 2021-08-12 · 355 added, 331 removed, 265 unchanged (72% of the section changed)

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(Amounts in thousands, except share and per

September 30,

Current assets:

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Common stock, $ 0.0001 par value, 100,000,000 shares authorized;

13,534,389 and 5,780,973 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively

13,534,692 and 5,780,973 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively

Additional paid-in capital

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Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

Operating expenses:

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Operating loss

Operating income (expense):

Other (expense) income

Gain on extinguishment of debt

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(Amounts in thousands, except share data)

For the Three and Six Months Ended June 30, 2021

For the Three and Nine Months Ended

Balance at December 31, 2020

$ ( 103,613 )

Issuance of common stock, pre-funded

warrants and warrants in connection with private placement, net of offering costs

Issuance of common stock in registered

direct offering, net of offering costs

Issuance of common stock upon

the exercise of warrants

Issuance of common stock upon

vesting of restricted stock units

Issuance of common stock, pre-funded warrants and warrants in connection with private placement, net of offering costs

Issuance of common stock

under employee stock purchase plan

Cash in lieu of fractional shares for 1:55 reverse stock

Issuance of common stock and warrants in connection

with registered direct and private placement offerings, net of offering costs

Issuance of common stock, pre-funded warrants and warrants

in connection with underwritten public offering, net of offering costs

Issuance of common stock in registered direct offering, net of offering costs

Issuance of common stock upon the exercise of warrants

Issuance of common stock upon vesting of restricted stock units

Stock-based compensation expense

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Balance at June 30, 2021

Offering costs related to the exercise of warrants

Issuance of common stock upon vesting of restricted stock units

Stock-based compensation expense

Balance at September 30, 2021

$ ( 113,449 )

For the Three and Six Months Ended June 30, 2020

the Three and Nine Months Ended

September 30, 2020

Balance at December 31, 2019

Issuance of common stock under

employee stock purchase plan

Cash in lieu of fractional shares

for 1:55 reverse stock split

Issuance of common stock and

warrants in connection with registered direct and private placement offerings, net of offering costs

Issuance of common stock, pre-funded

warrants and warrants in connection with underwritten public offering, net of offering costs

Issuance of common stock upon

the exercise of warrants

Issuance of common stock upon

vesting of restricted stock units

Issuance of common stock under employee

stock purchase plan

Cash in lieu of fractional shares for 1:55 reverse stock

Issuance of common stock and warrants in connection

with registered direct and private placement offerings, net of offering costs

Issuance of common stock, pre-funded warrants and warrants

in connection with underwritten public offering, net of offering costs

Issuance of common stock upon the exercise of warrants

Issuance of common stock upon vesting of restricted

Stock-based compensation expense

Balance at March 31, 2020

Issuance of common stock and

warrants in connection with registered direct and private placement offerings, net of offering costs

Issuance of common stock upon

the exercise of warrants

Issuance of common stock upon

vesting of restricted stock units

Issuance of common stock and warrants in connection

with registered direct and private placement offerings, net of offering costs

Issuance of common stock upon the exercise of warrants

Issuance of common stock upon vesting of restricted

Stock-based compensation expense

Balance at June 30, 2020

Offering costs related to the exercise of warrants

Issuance of common stock upon vesting of restricted

Stock-based compensation expense

Balance at September 30, 2020

The accompanying notes are an integral part of

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(Amounts in thousands)

Six Months Ended

Nine Months Ended

September 30,

Cash flows from operating activities:

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Non-cash stock-based compensation

Forgiveness of debt

Changes in operating assets and liabilities:

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Proceeds from debt

Forgiveness of debt

Cash paid in lieu of fractional shares for 1:55 reverse stock split

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The Company’s efforts are focused on silencing tumor-induced suppression of the immune system through its

proprietary INTASYL platform with utility in immune cells and the tumor micro-environment.

proprietary INTASYL platform with utility in immune cells and the tumor microenvironment.

The Company’s goal is to develop powerful

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the implementation of safety measures such as working remotely and flexible scheduling.

As a result of the coronavirus

pandemic, certain of our third-party suppliers and service providers on which we rely have seen impacts to their operations.

has undertaken efforts to mitigate potential future impacts by identifying and engaging alternative third-party service providers and

suppliers, and because of that, the Company had been able to limit the impact of delays from our third-party service providers to its

program’s anticipated timelines.

However, the continued impacts to our third-party service providers, including, for example, limited

availability in certain services and supplies, have now started to significantly affect our operations in the second quarter of 2021 resulting

in delays to certain of our clinical program timelines.

If measures to contain the pandemic are insufficient, it could further reduce

or delay the availability of supplies and services that we purchase and rely on, which may in turn further slow or delay our preclinical

and clinical activities.

a result of the coronavirus pandemic, certain of our third-party suppliers and service providers on which we rely have seen impacts to

their operations.

The Company has undertaken efforts to mitigate potential future impacts by identifying and engaging alternative third-party

service providers and suppliers, and because of that, the Company had been able to limit the impact of delays from our third-party service

providers to our program’s anticipated timelines.

However, the continued impacts to our third-party service providers, including,

for example, limited availability of certain services and supplies, began to significantly affect our operations in the second quarter

of 2021, resulting in delays to certain of our clinical program timelines.

If measures to overcome the pandemic are insufficient, it could

further reduce or delay the availability of supplies and services that we purchase and rely on, which may in turn further slow or delay

our preclinical and clinical activities.

We believe that the coronavirus pandemic has not

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Basis of Presentation

The accompanying condensed consolidated

financial statements are unaudited and have been prepared in accordance with accounting principles generally accepted in the United States

of America (“ GAAP ”).

Certain information and footnote disclosures included in the Company’s annual financial

statements have been condensed or omitted.

The year-end condensed balance sheet data was derived from audited financial statements, but

does not include all disclosures required by GAAP.

These statements should be read in conjunction with the consolidated financial statements

and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities

and Exchange Commission (the “ SEC ”).

In the opinion of management, all

adjustments (including normal recurring accruals) considered necessary for a fair presentation of the condensed consolidated financial

statements have been included.

The accompanying condensed

consolidated financial statements are unaudited and have been prepared in accordance with accounting principles generally accepted in

the United States of America (“ GAAP ”).

Certain information and footnote disclosures included in the Company’s

annual financial statements have been condensed or omitted.

The year-end condensed balance sheet data was derived from audited financial

statements, but does not include all disclosures required by GAAP.

These statements should be read in conjunction with the consolidated

financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020,

as filed with the Securities and Exchange Commission (the “ SEC ”).

In the opinion of management, all adjustments (including

normal recurring accruals) considered necessary for a fair presentation of the condensed consolidated financial statements have been included.

Interim results are not necessarily indicative of results for a full year.

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Uses of Estimates in Preparation of Financial Statements

The preparation of financial statements in accordance

with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure

of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during

the reporting period.

The areas subject to significant estimates and judgement include, among others, those related to the fair value

of equity awards, accruals for research and development expenses, useful lives of property and equipment, income taxes, and our valuation

allowance on our deferred tax assets.

On an ongoing basis we evaluate our estimates and base our estimates on historical experience and

other relevant assumptions that we believe are reasonable under the circumstances, including as a result of new information that may emerge

concerning the coronavirus pandemic.

We have made estimates of the impact of the coronavirus pandemic within our financial statements

and there may be changes to those estimates in future periods.

The preparation of financial

statements in accordance with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and

liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues

and expenses during the reporting period.

The areas subject to significant estimates and judgement include, among others, those related

to the fair value of equity awards, accruals for research and development expenses, useful lives of property and equipment, income taxes,

and our valuation allowance on our deferred tax assets.

On an ongoing basis we evaluate our estimates and base our estimates on historical

experience and other relevant assumptions that we believe are reasonable under the circumstances, including as a result of new information

that may emerge concerning the coronavirus pandemic.

We have made estimates of the impact of the coronavirus pandemic within our financial

statements and there may be changes to those estimates in future periods.

Actual results could differ materially from these estimates.

Restricted Cash

Restricted cash consists of certificates of deposit

held by financial institutions as collateral for the Company’s corporate credit cards.

Fair Value of Financial Instruments

The carrying amounts reported in the balance sheet

for restricted cash, accounts payable and accrued expenses approximate their fair values due to their short-term nature.

At the inception of a

contract, the Company determines whether the contract is or contains a lease based on all relevant facts and circumstances.

For contracts

that contain a lease, the Company identifies the lease and non-lease components, determines the consideration in the contract and recognizes

the classification of the lease as operating or financing.

For leases with a term greater than one year, the Company recognizes a liability

to make lease payments and an asset representing the right to use the underlying asset during the lease term at the commencement date

of the lease.

Lease liabilities and the corresponding right of

use assets are recorded based on the present value of lease payments to be made over the lease term.

The discount rate used to calculate

the present value is the rate implicit in the lease, or if not readily determinable, the Company’s incremental borrowing rate.

Company’s incremental borrowing rate is the rate of interest that the Company would have to pay to borrow on a collateralized basis

over a similar term an amount equal to the lease payments in a similar economic environment.

Certain adjustments to the right of use asset

may be required for items such as initial direct costs or incentives received.

Lease payments on operating leases are recognized on a

straight-line basis over the expected term of the lease.

Lease payments on financing leases are recognized using the effective interest

On March 27, 2020, the

United States enacted the Coronavirus Aid, Relief, and Economic Security Act (the “ CARES Act ”) in response to the coronavirus

The CARES Act is an emergency economic stimulus package passed in response to the coronavirus outbreak that includes, but is

not limited to, provisions providing aid to small businesses in the form of loans and grants and numerous tax provisions including, certain

payroll tax benefits, changes to the net operating loss rules and changes to the business interest expense deduction rules.

2020, the Company received loan proceeds pursuant to the Paycheck Protection Program (the “ PPP ”) offered under the

CARES Act, and the loan was subsequently forgiven in February 2021.

Outside of the PPP, the Company has not utilized the other loan programs

and tax provisions, such as certain payroll tax benefits.

Restricted cash consists of

certificates of deposit held by financial institutions as collateral for the Company’s corporate credit cards.

Fair Value of Financial

The carrying amounts reported

in the balance sheet for restricted cash, accounts payable and accrued expenses approximate their fair values due to their short-term

the inception of a contract, the Company determines whether the contract is or contains a lease based on all relevant facts and circumstances.

For contracts that contain a lease, the Company identifies the lease and non-lease components, determines the consideration in the contract

and recognizes the classification of the lease as operating or financing.

For leases with a term greater than one year, the Company recognizes

a liability to make lease payments and an asset representing the right to use the underlying asset during the lease term at the commencement

date of the lease.

Lease liabilities and the

corresponding right of use assets are recorded based on the present value of lease payments to be made over the lease term.

rate used to calculate the present value is the rate implicit in the lease, or if not readily determinable, the Company’s incremental

borrowing rate.

The Company’s incremental borrowing rate is the rate of interest that the Company would have to pay to borrow on

a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment.

Certain adjustments

to the right of use asset may be required for items such as initial direct costs or incentives received.

Lease payments on operating leases

are recognized on a straight-line basis over the expected term of the lease.

Lease payments on financing leases are recognized using the

effective interest method.

March 27, 2020, the United States enacted the Coronavirus Aid, Relief, and Economic Security Act (the “ CARES Act ”)

in response to the coronavirus pandemic.

The CARES Act is an emergency economic stimulus package passed in response to the coronavirus

outbreak that includes, but is not limited to, provisions providing aid to small businesses in the form of loans and grants and numerous

tax provisions including, certain payroll tax benefits, changes to the net operating loss rules and changes to the business interest

expense deduction rules.

On May 11, 2020, the Company received loan proceeds pursuant to the Paycheck Protection Program (the “ PPP ”)

offered under the CARES Act, and the loan was subsequently forgiven in February 2021.

Outside of the PPP, the Company has not utilized

the other CARES Act loan programs and tax provisions, such as certain payroll tax benefits.

The Company followed the

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Derivative Financial Instruments

Financial instruments that meet the definition

of a derivative are classified as an asset or liability and measured at fair value on the issuance date and are revalued on each subsequent

balance sheet date.

Financial instruments that

meet the definition of a derivative are classified as an asset or liability and measured at fair value on the issuance date and are revalued

on each subsequent balance sheet date.

The changes in fair value are recognized as current period income or loss.

Financial instruments that do not meet

the definition of a derivative are classified as equity and measured at fair value and recorded as additional paid-in capital in stockholders’

equity at the date of issuance.

Financial instruments

that do not meet the definition of a derivative are classified as equity and measured at fair value and recorded as additional paid-in

capital in stockholders’ equity at the date of issuance.

No further adjustments to their valuation are made.

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when the service has been performed or when the goods have been received.

Accrued liabilities

are recorded related to those expenses for which vendors have not yet billed the Company with respect to services provided and/or materials

that it has received.

Accrued liabilities for the services provided by contract research organizations (“ CROs ”) are

recorded during the period incurred based on such estimates and assumptions as expected cost, passage of time, the achievement of milestones

and other information available to us and are assessed on a quarterly basis.

Actual results may differ from these estimates and could

have a material impact on the Company’s reported results.

The Company’s historical accrual estimates have not been materially

different from its actual costs.

liabilities are recorded related to those expenses for which vendors have not yet billed the Company with respect to services provided

and/or materials that it has received.

Accrued liabilities for the services provided by contract research organizations (“ CROs ”)

are recorded during the period incurred based on such estimates and assumptions as expected cost, passage of time, the achievement of

milestones and other information available to us and are assessed on a quarterly basis.

Actual results may differ from these estimates

and could have a material impact on the Company’s reported results.

The Company’s historical accrual estimates have not been

materially different from its actual costs.

Stock-based Compensation

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718 ”), which requires the measurement and recognition of compensation expense for all stock-based payment awards.

value of restricted stock units is based upon the Company’s closing stock price at the grant date.

The fair value

of restricted stock units is based upon the Company’s closing stock price at the grant date.

The Company uses the Black-Scholes

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and expected dividends.

Stock-based compensation expense is recognized over the requisite service period, which generally represents

the vesting period, and commences at the date of grant based on the fair value of the award.

Stock-based compensation expense is recognized over the requisite service period, which generally represents the

vesting period, and commences at the date of grant based on the fair value of the award.

compensation expense recognized in the financial statements is based on awards that are ultimately expected to vest.

Accordingly, we

are also required to estimate forfeitures at the time of grant and to revise those estimates in subsequent periods if actual forfeitures

differ from estimates.

We use historical data to estimate pre-vesting option forfeitures and record stock-based compensation expense

only for those awards that are expected to vest.

Our forfeiture rate estimates are based on an analysis of our actual forfeiture experience,

employee turnover behavior, and other factors.

The impact of any adjustments to our forfeiture rates is recorded as a cumulative adjustment

in the period of adjustment.

Accordingly, we are

also required to estimate forfeitures at the time of grant and to revise those estimates in subsequent periods if actual forfeitures differ

from estimates.

We use historical data to estimate pre-vesting award forfeitures and record stock-based compensation expense only for

those awards that are expected to vest.

Our forfeiture rate estimates are based on an analysis of our actual forfeiture experience, employee

turnover behavior, and other factors.

The impact of any adjustments to our forfeiture rates is recorded as a cumulative adjustment in

the period of adjustment.

To the extent that actual forfeitures differ from our estimates, the difference is recorded as a cumulative

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Comprehensive Loss

The Company’s comprehensive loss is equal

to its net loss for all periods presented.

The Company’s comprehensive

loss is equal to its net loss for all periods presented.

Net Loss per Share

loss per share is computed by dividing net loss by the weighted average number of common shares outstanding.

Diluted net loss per share

is computed by dividing the Company’s net loss by the weighted average number of common shares outstanding and the impact of all

dilutive potential common shares outstanding, except where such dilutive potential common shares would be anti-dilutive.

Dilutive potential

common shares primarily consist of warrants, restricted stock units and stock options.

net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding.

Diluted net loss per

share is computed by dividing the Company’s net loss by the weighted average number of common shares outstanding and the impact

of all dilutive potential common shares outstanding, except where such dilutive potential common shares would be anti-dilutive.

potential common shares primarily consist of warrants, restricted stock units and stock options.

Liquidity and Going Concern

The Company has reported

recurring losses from operations since its inception and expects to continue to have negative cash flows from operations for the foreseeable

Company has reported recurring losses from operations since its inception and expects to continue to have negative cash flows from operations

for the foreseeable future.

Historically, the Company’s primary source of funding has been from the sales of its securities.

The Company’s ability

to continue to fund its operations is dependent on obtaining funding from third parties, such as proceeds from the issuance of debt, sale

of equity, or strategic opportunities, in order to maintain its operations.

This is dependent on a number of factors, including the market

demand or liquidity of the Company’s common stock.

There is no guarantee that debt, additional equity or other funding will be available

to us on acceptable terms, or at all.

If we fail to obtain additional funding when needed, we would be forced to scale back or terminate

our operations or seek to merge with or to be acquired by another company.

While we believe that

the coronavirus pandemic has not had a significant impact on our financial condition and results of operations at this time, the potential

economic impact brought by, and the duration of, the coronavirus pandemic is difficult to assess or predict.

There may be developments

outside of our control that require us to adjust our operating plans and given the nature of the situation, we cannot reasonably estimate

the impact of the coronavirus pandemic on our financial condition, results of operations or cash flows in the future.

The Company believes that

its existing cash should be sufficient to fund operations for at least the next 12 months from

Company’s ability to continue to fund its operations is dependent on obtaining funding from third parties, such as proceeds from

the issuance of debt, sale of equity, or strategic opportunities, in order to maintain its operations.

This is dependent on a number of

factors, including the market demand or liquidity of the Company’s common stock.

There is no guarantee that debt, additional equity

or other funding will be available to us on acceptable terms, or at all.

If we fail to obtain additional funding when needed, we would

be forced to scale back or terminate our operations or seek to merge with or to be acquired by another company.

we believe that the coronavirus pandemic has not had a significant impact on our financial condition and results of operations at this

time, the potential economic impact brought by, and the duration of, the coronavirus pandemic is difficult to assess or predict.

may be developments outside of our control that require us to adjust our operating plans and given the nature of the situation, we cannot

reasonably estimate the impact of the coronavirus pandemic on our financial conditions, results of operations or cash flows in the future.

Company believes that its existing cash should be sufficient to fund operations for at least the next 12 months from

the date of the release of these financial statements .

Recent Accounting Pronouncements

In December 2019, the FASB issued Accounting Standards

Update (“ ASU ”) 2019-12, “ Income Taxes (Topic 740):

Simplifying the Accounting for Income Taxes ”

(“ ASU 2019-12 ”).

The amendments in the update simplify the accounting for income taxes by eliminating the exceptions

related to the incremental approach for intraperiod tax allocation, the recognition of a deferred tax liability for equity method investments,

not recognizing a deferred tax liability for a foreign subsidiary and the general methodology for calculating income taxes in an interim

In December 2019, the FASB

issued Accounting Standards Update (“ ASU ”) 2019-12, “ Income Taxes (Topic 740):

Simplifying the Accounting

for Income Taxes ” (“ ASU 2019-12 ”).

The amendments in the update simplify the accounting for income taxes

by eliminating the exceptions related to the incremental approach for intraperiod tax allocation, the recognition of a deferred tax liability

for equity method investments, not recognizing a deferred tax liability for a foreign subsidiary and the general methodology for calculating

income taxes in an interim period.

The amendments also clarify and simplify other aspects of the accounting for income taxes.

The amendments in ASU 2019-12

are effective for public entities for fiscal years, and the interim periods within those fiscal years, beginning after December 20, 2020.

amendments in ASU 2019-12 are effective for public entities for fiscal years, and the interim periods within those fiscal years, beginning

after December 20, 2020.

The Company adopted ASU 2019-12 on January 1, 2021.

The adoption of this standard did not have a material impact on the Company’s

consolidated financial statements.

In August 2020, the FASB issued

ASU 2020-06, “ Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts

in Entity’s Own Equity (Subtopic 815 – 40)” (“ ASU 2020-06 ”), which simplifies the accounting

for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts in an

entity’s own equity.

ASU 2020-06 is part of the FASB’s simplification initiative, which aims to reduce unnecessary complexity

For convertible instruments, the accounting models for instruments issued with beneficial conversion features or cash

conversion features are removed.

The adoption of this standard did not have a material

impact on the Company’s consolidated financial statements.

In August 2020, the FASB

issued ASU 2020-06, “ Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging –

Contracts in Entity’s Own Equity (Subtopic 815 – 40) ” (“ ASU 2020-06 ”), which simplifies the

accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts

in an entity’s own equity.

ASU 2020-06 is part of the FASB’s simplification initiative, which aims to reduce unnecessary

complexity in U.S.

For convertible instruments, the accounting models for instruments issued with beneficial conversion features

or cash conversion features are removed.

For contracts in an entity’s own equity, ASU 2020-06 simplifies the settlement assessment

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The Company is evaluating the potential impact of this guidance on its consolidated financial statements and related disclosures.

In January 2019, the Company amended the lease for its corporate headquarters and primary research facility in Marlborough, Massachusetts.

The lease is for a total of 7,581 square feet of office and laboratory space and will expire on March 31, 2024 .

The lease contains an option to terminate after two or three years by providing advance written notice of termination pursuant to the terms of the agreement.

The exercise of this option is not determined to be reasonably certain and thus is not included in the lease liability on the Company’s balance sheet.

Additionally, the lease agreement did not contain information to determine the borrowing rate implicit in the lease.

As such, the Company calculated its incremental borrowing rate based on what the Company would have to pay to borrow on a collateralized basis over the lease term for an amount equal to the remaining lease payments, taking into consideration such assumptions as, but not limited to, the U.S.

In January 2019, the

Company amended the lease for its corporate headquarters and primary research facility in

Marlborough, Massachusetts.

The lease is for a total of 7,581

square feet of office and laboratory space and will expire on March 31, 2024 .

The lease contains an option to terminate after two or

three years by providing advance written notice of termination pursuant to the terms of the agreement.

The exercise of this option

was not determined to be reasonably certain and thus was not included in the lease liability on the Company’s balance sheet.

The Company did not exercise its option to terminate in either the

second or third year of the lease, and the option to terminate has expired.

Additionally,

the lease agreement did not contain information to determine the borrowing rate implicit in the lease.

As such, the Company

calculated its incremental borrowing rate based on what the Company would have to pay to borrow on a collateralized basis over the

lease term for an amount equal to the remaining lease payments, taking into consideration such assumptions as, but not limited to,

treasury yield rate and borrowing rates from a creditworthy financial institution using the above lease factors.

lease for our corporate headquarters represents substantially all of our significant lease obligations.

The amounts reported in the condensed

consolidated balance sheets for operating leases in which the Company is the lessee and other supplemental balance sheet information

is set forth as follows, in thousands, except the lease term (number of years) and discount rate:

The lease for our corporate

headquarters represents substantially all of our significant lease obligations.

The amounts reported in the condensed consolidated balance

sheets for operating leases in which the Company is the lessee and other supplemental balance sheet information is set forth as follows,

in thousands, except the lease term (number of years) and discount rate:

Schedule of lease and supplemental balance sheet information

June 30, 2021

September 30, 2021

December 31, 2020

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Weighted average discount rate

Operating lease costs included in operating expense were $ 33,000 for the three months ended June 30, 2021 and 2020.

Operating lease costs included in operating expense were $ 66,000 for the six months ended June 30, 2021 and 2020.

Short-term lease costs were not material for the three and six months ended June 30, 2021 and 2020.

Cash paid for the amounts included in the measurement

of the operating lease liability on the Company’s condensed consolidated balance sheets and included within changes in the lease

liability in the operating activities of our condensed consolidated statements of cash flows was $ 33,100 and $ 32,200 for the three months

June 30, 2021 and 2020, respectively.

Cash paid for the six months ended June 30, 2021 and 2020 was $ 65,300 and $ 63,400 , respectively.

Operating lease costs included in operating expense

were $ 33,000 for the three months ended September 30, 2021 and 2020.

Operating lease costs included in operating expense were $ 99,000

for the nine months ended September 30, 2021 and 2020.

Short-term lease costs were not material for the three and nine months ended September

30, 2021 and 2020.

Cash paid for the

amounts included in the measurement of the operating lease liability on the Company’s condensed consolidated balance sheets

and included within changes in the lease liability in the operating activities of our condensed consolidated statements of cash

flows was $ 44,200

and $ 32,200 for the three months

ended September 30, 2021 and 2020, respectively.

Cash paid for the nine months ended September 30, 2021 and 2020 was $ 109,500

and $ 95,600 , respectively.

Future lease payments for

our non-cancellable operating leases and a reconciliation to the carrying amount of the operating lease liability presented in the condensed

consolidated balance sheet as of June 30, 2021 is as follows, in thousands:

consolidated balance sheet as of September 30, 2021 is as follows, in thousands:

Schedule of future minimum lease payments

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Imputed interest

Total operating lease liabilities (includes current portion)

Total operating lease liability (includes current portion)

2020, the Company received loan proceeds in the amount of $ 231,252 from Bank of America, N.A., as lender, pursuant to the PPP under the

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purposes, including payroll, benefits, rent and utilities.

The Company followed the guidance under ASC 470 in assessing the accounting for the PPP loan proceeds.

Per ASC 470, the Company recorded a liability on the balance sheet for the full amount of PPP loan proceeds received and accrued interest over the term of the loan.

The Company believed it used the loan proceeds for eligible purposes and applied for full loan forgiveness.

On February 18, 2021, the SBA approved the Company’s application for full loan forgiveness, and the full amount of the PPP loan was remitted to the lender for forgiveness.

Upon loan forgiveness, the Company recognized a gain on the extinguishment of debt of $ 233,000 for the loan proceeds received and interest accrued in the condensed consolidated statements of operations for the six months ended June 30, 2021.

Company followed the guidance under ASC 470 in assessing the accounting for the PPP loan proceeds.

Per ASC 470, the Company recorded a

liability on the balance sheet for the full amount of PPP loan proceeds received and accrued interest over the term of the loan.

believed it used the loan proceeds for eligible purposes and applied for full loan forgiveness.

On February 18, 2021, the SBA approved

the Company’s application for full loan forgiveness, and the full amount of the PPP loan was remitted to the lender for forgiveness.

Upon loan forgiveness, the Company recognized a gain on the extinguishment of debt of $ 233,000 for the loan proceeds received and

interest accrued in the condensed consolidated statements of operations for the nine months ended September 30, 2021.

Stockholders’ Equity

2021 Private Placement — On January 25, 2021, the Company completed a private placement of 4,420,863

shares of the Company’s common stock at a purchase price per share of $ 3.07 ,

pre-funded warrants to purchase an aggregate of 140,065

shares of the Company’s common stock (the “ January 2021 Pre-Funded Warrants ”) at a purchase price per

pre-funded warrant share of $ 3.069

and warrants to purchase an aggregate of 3,420,696

shares of the Company’s common stock with an exercise price of $ 3.00

2021 Private Placement — On January 25, 2021, the Company completed a private placement of 4,420,863 shares

of the Company’s common stock at a purchase price per share of $ 3.07 , pre-funded warrants to purchase an aggregate of 140,065 shares

of the Company’s common stock (the “ January 2021 Pre-Funded Warrants ”) at a purchase price per pre-funded warrant

share of $ 3.069 and warrants to purchase an aggregate of 3,420,696 shares of the Company’s common stock with an exercise price of

$ 3.00 per warrant share (the “ January 2021 Warrants ”) (the “ Private Placement ”).

In connection

with the Private Placement, the Company issued warrants to the placement agent, H.C.

In connection with

the Private Placement, the Company issued warrants to the placement agent, H.C.

Wainwright & Co., LLC (“ HCW ”),

to purchase a total of 342,070

shares of the Company’s common stock at an exercise price of $ 3.8375

(the “ January 2021 Placement Agent Warrants ”).

Net proceeds to the Company from the Private Placement were

after deducting placement agent fees and offering expenses.

to purchase a total of 342,070 shares of the Company’s common stock at an exercise price of $ 3.8375 (the “ January 2021

Placement Agent Warrants ”).

Net proceeds to the Company from the Private Placement were $ 12,669,000 after deducting placement

agent fees and offering expenses.

2021 Registered Direct Offering — On February 17, 2021, the Company completed a registered direct offering of 2,246,784

shares of the Company’s common stock at a purchase price of $ 3.42 per share (the “ Offering ”).

In connection with

the Offering, the Company issued warrants to the placement agent, HCW, to purchase a total of 168,509 shares of the Company’s common

stock at an exercise price of $ 4.275 (the “ February 2021 Placement Agent Warrants ”).

Net proceeds to the Company from

the Offering were $ 6,908,000 after deducting placement agent fees and offering expenses.

February 2020 Registered

Direct Offering — On February 17, 2021, the Company completed a registered direct offering of 2,246,784 shares of the Company’s

common stock at a purchase price of $ 3.42 per share (the “ Offering ”).

In connection with the Offering, the Company

issued warrants to the placement agent, HCW, to purchase a total of 168,509 shares of the Company’s common stock at an exercise

price of $ 4.275 (the “ February 2021 Placement Agent Warrants ”).

Net proceeds to the Company from the Offering were

$ 6,908,000 after deducting placement agent fees and offering expenses.

February 2020 Registered Direct Offering and

Private Placement — On February 6, 2020, the Company completed a registered direct offering (the “ February 2020

Registered Offering ”) of 197,056 shares of the Company’s common stock at a purchase price of $ 8.705 per share and in a

concurrent private placement, sold warrants to purchase an aggregate of 197,056 shares of the Company’s common stock at a purchase

Direct Offering and Private Placement — On February 6, 2020, the Company completed a registered direct offering (the “ February

2020 Registered Offering ”) of 197,056 shares of the Company’s common stock at a purchase price of $ 8.705 per share and

in a concurrent private placement, sold warrants to purchase an aggregate of 197,056 shares of the Company’s common stock at a purchase

price of $ 0.125 per underlying warrant share and with an exercise price of $ 8.71 per share (the “ February 2020 Registered Direct

5 unchanged sentences

February 2020 Underwritten

Public Offering — On February 13, 2020, the Company completed an underwritten public offering of 993,633

shares of the Company’s common stock at a purchase price per share of $ 4.00 ,

pre-funded warrants (the “ 2020 Pre-Funded Warrants ”) to purchase an aggregate of 1,006,367

shares of the Company’s common stock at a purchase price per pre-funded warrant share of $ 3.999

and warrants (the “ February 2020 Warrants ”) to purchase an aggregate of 2,000,000

shares of the Company’s common stock with an exercise price of $ 4.00

per warrant shares (the “ February 2020 Underwritten Offering ”).

The 2020 Pre-Funded Warrants were immediately

exercisable at an exercise price per share of $ 0.001

and each share of Company common stock or 2020 Pre-Funded Warrant, as applicable, was sold with a February 2020 Warrant.

In connection

with the February 2020 Underwritten Offering, the Company issued warrants to purchase up to 150,000

shares of Company common stock, immediately exercisable at an exercise price of $ 5.00

per share (the “ February 2020 Underwriter Warrants ”) to HCW, as underwriter.

In connection with the February 2020 Underwritten

Offering, the Company also granted to the underwriter, HCW, a 30-day option to purchase up to an additional 300,000 shares of the

Company’s common stock at a purchase price of $ 3.999 per such share and/or warrants to purchase up to 300,000 shares of the Company’s

common stock at a purchase price of $ 0.001 per such warrant.

Such warrants have the same terms as the February 2020 Warrants.

12, 2020, HCW exercised its option to purchase warrants to purchase an aggregate of 300,000 shares of the Company’s common stock.

Net proceeds from the February 2020 Underwritten

Offering were $ 7,093,000 after deducting underwriting discounts and commissions and offering expenses paid by the Company.

April 2020 Registered

Direct Offering and Private Placement — On April 2, 2020, the Company completed a registered direct offering (the

“ April 2020 Offering ”) of 1,713,064 shares

of the Company’s common stock at a purchase price of $ 2.21 per

share and in a concurrent private placement, sold warrants to purchase an aggregate of 1,713,064 shares

of the Company’s common stock at a purchase price of $ 0.125 per

underlying warrant share and with an exercise price of $ 2.21 per

share (the “ April 2020 Warrants ”).

In connection with the April 2020 Offering, the Company also issued warrants

to purchase a total of 128,480

shares of the Company’s common stock with an exercise price of $ 2.9188

per share (the “ April 2020 Placement Agent Warrants ”) to the placement agent, HCW.

Net proceeds to the Company

from the April 2020 Offering were $ 3,527,000 after

deducting placement agent fees and offering expenses paid by the Company.

first assesses the warrants it issues under the FASB ASC Topic 480, “ Distinguishing Liabilities from Equity ” (“ ASC

480 ”) to determine whether they are within the scope of ASC 480.

As there were no instances outside of the Company’s control

that could require cash settlement of the warrants issued in the Private Placement and Offering, as well as warrants issued in the Company’s

prior financing transactions, the warrants are outside the scope of ASC 480.

then applies and follows the applicable accounting guidance in ASC 815.

Financial instruments are accounted for as either derivative liabilities

or as equity instruments depending on the specific terms of the agreement.

The warrants issued in the Private Placement and the Offering

do not meet the definition of a derivative instrument as they are indexed to the Company’s common stock and classified within stockholders’

equity, as are the warrants issued in the Company’s prior financing transactions.

Based on this determination, the Company’s

warrants are classified within stockholders’ equity.

The following table summarizes

the Company’s outstanding equity-classified warrants at June 30, 2021:

Summary of outstanding warrants

Public Offering — On February 13, 2020, the Company completed an underwritten public offering of 993,633 shares of the Company’s

common stock at a purchase price per share of $ 4.00 , pre-funded warrants (the “ 2020 Pre-Funded Warrants ”) to purchase

an aggregate of 1,006,367 shares of the Company’s common stock at a purchase price per pre-funded warrant share of $ 3.999 and warrants

(the “ February 2020 Warrants ”) to purchase an aggregate of 2,000,000 shares of the Company’s common stock with

an exercise price of $ 4.00 per warrant share (the “ February 2020 Underwritten Offering ”).

The 2020 Pre-Funded Warrants

were immediately exercisable at an exercise price per share of $ 0.001 and each share of Company common stock or 2020 Pre-Funded Warrant,

as applicable, was sold with a February 2020 Warrant.

In connection with the February 2020 Underwritten Offering, the Company issued warrants

to purchase up to 150,000 shares of Company common stock, immediately exercisable at an exercise price of $ 5.00 per share (the “ February

2020 Underwriter Warrants ”) to HCW, as underwriter.

In connection with the February

2020 Underwritten Offering, the Company also granted to the underwriter, HCW, a 30-day option to purchase up to an additional 300,000

shares of the Company’s common stock at a purchase price of $ 3.999 per such share and/or warrants to purchase up to 300,000 shares

of the Company’s common stock at a purchase price of $ 0.001 per such warrant.

Such warrants have the same terms as the February

2020 Warrants.

On February 12, 2020, HCW exercised its option to purchase warrants to purchase an aggregate of 300,000 shares of the Company’s

common stock.

Net proceeds from the February

2020 Underwritten Offering were $ 7,093,000 after deducting underwriting discounts and commissions and offering expenses paid by the Company.

April 2020 Registered Direct

Offering and Private Placement — On April 2, 2020, the Company completed a registered direct offering (the “ April 2020

Offering ”) of 1,713,064 shares of the Company’s common stock at a purchase price of $ 2.21 per share and in a concurrent

private placement, sold warrants to purchase an aggregate of 1,713,064 shares of the Company’s common stock at a purchase price

of $ 0.125 per underlying warrant share and with an exercise price of $ 2.21 per share (the “ April 2020 Warrants ”).

connection with the April 2020 Offering, the Company also issued warrants to purchase a total of 128,480 shares of the Company’s

common stock with an exercise price of $ 2.9188 per share (the “ April 2020 Placement Agent Warrants ”) to the placement

Net proceeds to the Company from the April 2020 Offering were $ 3,527,000 after deducting placement agent fees and offering

expenses paid by the Company.

Company first assesses the warrants it issues under the FASB ASC Topic 480, “ Distinguishing Liabilities from Equity ”

(“ ASC 480 ”) to determine whether they are within the scope of ASC 480.

As there were no instances outside of the Company’s

control that could require cash settlement of the warrants issued in the Private Placement and Offering, as well as warrants issued in

the Company’s prior financing transactions, the warrants are outside the scope of ASC 480.

Company then applies and follows the applicable accounting guidance in ASC 815.

Financial instruments are accounted for as either derivative

liabilities or as equity instruments depending on the specific terms of the agreement.

The warrants issued in the Private Placement and

the Offering do not meet the definition of a derivative instrument as they are indexed to the Company’s common stock and classified

within stockholders’ equity, as are the warrants issued in the Company’s prior financing transactions.

Based on this determination,

the Company’s warrants are classified within stockholders’ equity.

The following table summarizes the Company’s

outstanding equity-classified warrants at September 30, 2021:

Schedule of outstanding warrants

Balance December

December 2016 Warrants

3 unchanged sentences

October 2018 Underwriter Warrants

November 2019 Placement Agent Warrants

February 2020 Registered Direct Warrants

February 2020 Placement Agent Warrants

February 2020 Underwritten Offering Warrants

November 2019 Placement Agent

February 2020 Registered Direct

February 2020 Placement Agent

February 2020

February 2020 Underwriter Warrants

4 unchanged sentences

January 2021 Warrants

January 2021 Placement Agent Warrants

February 2021 Placement Agent Warrants

No warrants were exercised during the three months

ended June 30, 2021.

During the three months ended June 30, 2020, the Company received net proceeds of $ 3,863,000 from the exercise of

The Company received net proceeds of $ 2,146,000 and $ 3,864,000 from the exercise of warrants during the six months ended June

30, 2021 and 2020, respectively.

Of the warrants

exercised during the three and six months ended June 30, 2020, 428,266 of the Company’s April 2020 Warrants were exercised via

a cashless exercise transaction and as a result a total of 225,796 shares of common stock were issued.

January 2021 Placement Agent

2021 Placement Agent Warrants

( 1,083,321 )

No warrants were exercised

during the three months ended September 30, 2021 and 2020.

The Company received net proceeds of $ 2,146,000 and $ 3,856,000 from the exercise

of warrants during the nine months ended September 30, 2021 and 2020, respectively.

the warrants exercised during the nine months ended September 30, 2020, 428,266 of the Company’s April 2020 Warrants were exercised

via a cashless exercise transaction and as a result a total of 225,796 shares of common stock were issued.

There were no cashless exercises

of warrants for the same periods in the current year.

of warrants for the nine months ended September 30, 2021.

Net Loss per Share

2 unchanged sentences

Schedule of antidilutive stock

September 30,

Options to purchase common stock

Nonvested restricted stock units

Unvested restricted stock units

Warrants to purchase common stock

11 unchanged sentences

and are expensed over the requisite service period.

The following table summarizes

the activity of the Company’s RSUs for the six months ended June 30, 2021:

Summary of RSU activity

The following table summarizes the activity of

the Company’s RSUs for the nine months ended September 30, 2021:

Schedule of RSU activity

Unvested units at December 31, 2020

Unvested units at June 30, 2021

compensation expense related to RSUs was $ 124,000 and $ 19,000 for the three months ended June 30, 2021 and 2020, respectively.

compensation expense related to RSUs was $ 181,000 and $ 48,000 for the six months ended June 30, 2021 and 2020, respectively.

Stock Options

Unvested units at September 30, 2021

compensation expense related to RSUs was $ 132,000 and $ 21,000 for the three months ended September 30, 2021 and 2020, respectively.

compensation expense related to RSUs was $ 313,000 and $ 69,000 for the nine months ended September 30, 2021 and 2020, respectively.

Stock Options

are issued under the 2020 Plan or as inducement grants issued outside of the plan to new employees.

Stock options are generally subject

to graded vesting and the satisfaction of service requirements.

Upon the exercise of a stock option, the Company issues new shares

and delivers them to the recipient.

options are issued under the 2020 Plan or as inducement grants issued outside of the plan to new employees.

Stock options are generally

subject to graded vesting and the satisfaction of service requirements.

Upon the exercise of a stock option, the Company issues new

shares and delivers them to the recipient.

The Company does not expect to repurchase shares to satisfy stock option exercises.

uses the Black-Scholes option-pricing model to determine the fair value of all its option grants.

The risk-free interest rate used for

each grant was based upon the yield on zero-coupon U.S.

Treasury securities with a term similar to the expected life of the related option.

Company uses the Black-Scholes option-pricing model to determine the fair value of all its option grants.

The risk-free interest rate

used for each grant was based upon the yield on zero-coupon U.S.

Treasury securities with a term similar to the expected life of the related

The Company’s expected stock price volatility assumption is based upon the Company’s own implied volatility.

As the Company

has limited stock option exercise information, the expected life assumption used for option grants is based upon the simplified method

provided for under ASC 718.

The dividend yield assumption is based upon the fact that the Company has never paid cash dividends and presently

has no intention of paying cash dividends.

did not grant stock options during the three and six months ended June 30, 2021 and 2020.

The following table summarizes

the activity of the Company’s stock options for the six months ended June 30, 2021:

Summary of Stock Option Activity

Company has limited stock option exercise information, the expected life assumption used for option grants is based upon the simplified

method provided for under ASC 718.

The dividend yield assumption is based upon the fact that the Company has never paid cash dividends

and presently has no intention of paying cash dividends.

Company did not grant stock options during the three and nine months ended September 30, 2021 and 2020.

The following table summarizes the activity of

the Company’s stock options for the nine months ended September 30, 2021:

Schedule of Stock Option Activity

Balance at December 31, 2020

Balance at June 30, 2021

Exercisable at June 30, 2021

Stock-based compensation expense related to stock

options for the three months ended June 30, 2021 and 2020 was $ 8,000 and $ 11,000 , respectively.

Stock-based compensation expense related

to stock options for the six months ended June 30, 2021 and 2020 was $ 18,000 and $ 25,000 , respectively.

Balance at September 30, 2021

Exercisable at September 30, 2021

Stock-based compensation expense

related to stock options for the three months ended September 30, 2021 and 2020 was $ 11,000 and $ 16,000 , respectively.

Stock-based compensation

expense related to stock options for the nine months ended September 30, 2021 and 2020 was $ 29,000 and $ 41,000 , respectively.

Compensation Expense Related to Equity Awards

The following table sets

forth total stock-based compensation expense for the three and six months ended June 30, 2021 and 2020, in thousands:

Details of Stock-based Compensation Expense Recorded

forth total stock-based compensation expense for the three and nine months ended September 30, 2021 and 2020, in thousands:

Schedule of Details of Stock-based Compensation Expense

Three Months Ended

Six Months Ended

Nine Months Ended

September 30,

Research and development

1 unchanged sentence

Total stock-based compensation

Company has incurred net operating losses since inception and based on an assessment of all available evidence, has concluded that it

is more likely than not that the net operating loss carryforwards generated as result will not be realized and a full deferred income

tax valuation allowance has been recorded against these assets.

If the Company has experienced a change of control, as defined by Section

382 of the Internal Revenue Code as transactions increasing the ownership of certain shareholders or public groups in the stock of a corporation

by more than 50% over a three-year period, utilization of the net operating loss carryforwards would be subject to an annual limitation.

The Company is in the process of conducting a study to assess the utilization of its net operating loss carryforwards and may be subject

to substantial annual limitations.

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-Q

Item 1. Financial Statements