1 unchanged sentence
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: Report of Independent Registered Public Accounting Firm
+Added: Independent Registered Public Accounting Firm (BDO USA, LLP;
+Added: Boston, Massachusetts;
+Added: PCAOB ID# 243)
Consolidated Balance Sheets as of December 31, 2021 and 2020
Consolidated Statements of Operations for the Years Ended December 31, 2021 and 2020
−Removed: Consolidated Statements of Stockholders’
−Removed: Equity for the Years Ended December 31, 2020 and 2019
+Added: Consolidated Statements of Stockholders’ Equity for the Years Ended December 31, 2021 and 2020
Consolidated Statements of Cash Flows for the Years Ended December 31, 2021 and 2020
Notes to Consolidated Financial Statements
−Removed: Report of Independent Registered Public
−Removed: Accounting Firm
+Added: Report of Independent Registered Public Accounting
Stockholders and Board of Directors
2 unchanged sentences
Opinion on the Consolidated Financial Statements
−Removed: We have audited the accompanying consolidated balance sheets
−Removed: of Phio Pharmaceuticals Corp.
−Removed: (the “Company”) and subsidiary as of December 31, 2020 and 2019, the related consolidated
−Removed: statements of operations, stockholders’
−Removed: equity, and cash flows for each of the two years in the period ended December 31,
−Removed: 2020, and the related notes (collectively referred to as the “consolidated financial statements”).
−Removed: In our opinion,
−Removed: the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31,
−Removed: 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,
−Removed: 2020 , in conformity with accounting principles generally accepted in the United States of America.
+Added: We have audited the accompanying consolidated balance sheets of Phio
+Added: Pharmaceuticals Corp.
+Added: (the “Company”) and subsidiary as of December 31, 2021 and 2020, the related consolidated statements
+Added: of operations, stockholders’ equity, and cash flows for each of the two years in the period ended December 31, 2021, and the related
+Added: notes (collectively referred to as the “consolidated financial statements”).
+Added: In our opinion, the consolidated financial statements
+Added: present fairly, in all material respects, the financial position of the Company at December 31, 2021 and 2020, and the results of
+Added: its operations and its cash flows for each of the two years in the period ended December 31, 2021 , in conformity with accounting
+Added: principles generally accepted in the United States of America.
Basis for Opinion
−Removed: These consolidated financial statements are the responsibility
−Removed: of the Company’s management.
−Removed: Our responsibility is to express an opinion on the Company’s consolidated financial statements
−Removed: based on our audits.
−Removed: We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States)
−Removed: (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S.
−Removed: federal securities
−Removed: laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
−Removed: We conducted our audits in accordance with the standards of
−Removed: Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated
−Removed: financial statements are free of material misstatement, whether due to error or fraud.
−Removed: The Company is not required to have, nor
−Removed: were we engaged to perform, an audit of its internal control over financial reporting.
−Removed: As part of our audits we are required to
−Removed: obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness
−Removed: of the Company’s internal control over financial reporting.
+Added: These consolidated financial statements are the responsibility of the
+Added: Company’s management.
+Added: Our responsibility is to express an opinion on the Company’s consolidated financial statements based
+Added: on our audits.
+Added: We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”)
+Added: and are required to be independent with respect to the Company in accordance with the U.S.
+Added: federal securities laws and the applicable
+Added: rules and regulations of the Securities and Exchange Commission and the PCAOB.
+Added: We conducted our audits in accordance with the standards of the PCAOB.
+Added: Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements
+Added: are free of material misstatement, whether due to error or fraud.
+Added: The Company is not required to have, nor were we engaged to perform,
+Added: an audit of its internal control over financial reporting.
+Added: As part of our audits we are required to obtain an understanding of internal
+Added: control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal
+Added: control over financial reporting.
Accordingly, we express no such opinion.
−Removed: Our audits included performing procedures to assess the risks
−Removed: of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that
−Removed: respond to those risks.
−Removed: Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in
−Removed: the consolidated financial statements.
−Removed: Our audits also included evaluating the accounting principles used and significant estimates
−Removed: made by management, as well as evaluating the overall presentation of the consolidated financial statements.
−Removed: We believe that our
−Removed: audits provide a reasonable basis for our opinion.
−Removed: The critical audit matter communicated
−Removed: below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required
−Removed: to be communicated to the audit committee and that:
−Removed: (1) relates to accounts or disclosures that are material to the consolidated
−Removed: financial statements and (2) involved our especially challenging, subjective, or complex judgments.
−Removed: The communication of critical
−Removed: audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not,
−Removed: by communicating the critical audit matter below, providing separate opinions on the critical audit matter or on the accounts or
−Removed: disclosures to which it relates.
−Removed: Accounting for warrants issued as part
−Removed: of equity offerings
+Added: Our audits included performing procedures to assess the risks of material
+Added: misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those
+Added: Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial
+Added: Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as
+Added: evaluating the overall presentation of the consolidated financial statements.
+Added: We believe that our audits provide a reasonable basis for
+Added: Critical Audit Matter
+Added: The critical audit matter communicated below is
+Added: a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated
+Added: to the audit committee and that:
+Added: (1) relates to accounts or disclosures that are material to the consolidated financial statements and
+Added: (2) involved our especially challenging, subjective, or complex judgments.
+Added: The communication of critical audit matters does not alter
+Added: in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit
+Added: matter below, providing separate opinions on the critical audit matter or on the accounts or disclosures to which it relates.
+Added: Accounting for warrants issued as part of equity
As described in Note 10 to the consolidated
−Removed: financial statements, the Company entered into two registered direct offerings and an underwritten public offering during 2020
−Removed: that included the issuance of common stock and warrants to purchase common stock.
−Removed: The warrants were evaluated for proper classification
−Removed: on the balance sheet and it was determined that the warrants issued in these equity offerings should be classified within stockholders’
+Added: financial statements, the Company completed a private placement offering in January 2021 that included the issuance of common stock
+Added: and warrants to purchase common stock.
+Added: The warrants were evaluated for proper classification on the consolidated balance sheet and
+Added: it was determined that the warrants issued in this equity offering should be classified within stockholders’ equity.
We identified the accounting for warrants
−Removed: issued as part of equity offerings as a critical audit matter.
−Removed: Our principal considerations included the existence of accounting
−Removed: complexities related to certain provisions of the warrant agreements, including provisions of cash settlement and derivative elements.
−Removed: Auditing these elements required especially challenging auditor judgement and significant audit effort as well as the need for
−Removed: specialized knowledge and skill assessing these elements of the agreement.
−Removed: The primary procedures we performed to
−Removed: address this critical audit matter included:
−Removed: Reading the agreements related to the warrants issued along with management’s technical accounting
−Removed: memos to understand the facts and circumstances within the warrant agreements and other assumptions impacting the determination
−Removed: of warrant classification.
−Removed: Utilizing personnel with specialized knowledge
−Removed: and skill in debt and equity accounting to evaluate the appropriateness of management’s interpretation on how to apply
−Removed: the relevant accounting guidance for the classification of the warrants issued, including the evaluation of derivative characteristics
−Removed: and the terms associated with the Company’s control that could require cash settlement of the warrants.
+Added: issued as part of the equity offering in January 2021 as a critical audit matter.
+Added: Our principal considerations included the
+Added: existence of accounting complexities related to certain provisions of the warrant agreements, including provisions of cash
+Added: settlement and derivative elements.
+Added: Auditing these elements required especially challenging auditor judgement and significant audit
+Added: effort as well as the need for specialized knowledge and skill assessing these elements of the agreement.
+Added: The primary procedures we performed to address
+Added: this critical audit matter included:
+Added: Reading the agreements related to the warrants issued along with management’s technical accounting memo to understand the facts and circumstances within the warrant agreements and other assumptions impacting the determination of warrant classification.
+Added: Utilizing personnel with specialized knowledge and skill in debt and equity accounting to evaluate the appropriateness of management’s interpretation on how to apply the relevant accounting guidance for the classification of the warrants issued, including the evaluation of derivative characteristics and the terms associated with the Company’s control that could require cash settlement of the warrants.
/s/ BDO USA, LLP
−Removed: We have served as the Company’s auditor since 2011.
+Added: We have served as the Company’s auditor since 2011.
Boston, Massachusetts
3 unchanged sentences
(Amounts in thousands, except share data)
−Removed: Years Ended December 31,
Current assets:
3 unchanged sentences
Right of use asset, net
−Removed: Property and equipment, net of accumulated depreciation of $1,122 and $1,048 in 2020 and 2019, respectively
−Removed: LIABILITIES AND STOCKHOLDERS’
+Added: Property and equipment, net
+Added: LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
−Removed: Accrued expenses and other current liabilities
+Added: Accrued expenses
Lease liability
3 unchanged sentences
Total liabilities
−Removed: Commitments and contingencies (Note 8)
−Removed: Stockholders’
+Added: Commitments and contingencies (Footnote 9)
+Added: Stockholders’ equity:
Preferred stock, $ 0.0001 par value, 10,000,000 shares authorized
3 unchanged sentences
Accumulated deficit
−Removed: Total stockholders’
−Removed: Total liabilities and stockholders’
+Added: Total stockholders’ equity
+Added: Total liabilities and stockholders’ equity
See accompanying notes to consolidated financial
1 unchanged sentence
CONSOLIDATED STATEMENTS OF OPERATIONS
−Removed: (Amounts in thousands, except share and
−Removed: per share data)
−Removed: Years Ended December 31,
+Added: (Amounts in thousands, except share and per
+Added: Twelve Months Ended
Operating expenses:
3 unchanged sentences
Operating loss
−Removed: Total other (expense) income, net
+Added: Other income (expense)
+Added: Gain on extinguishment of debt
+Added: Interest (expense) income, net
+Added: Total other income (expense)
Loss before income taxes
Provision for income taxes
−Removed: Net loss per common share:
+Added: Net loss per share:
Basic and diluted
3 unchanged sentences
PHIO PHARMACEUTICALS CORP.
−Removed: CONSOLIDATED STATEMENTS OF STOCKHOLDERS’
+Added: CONSOLIDATED STATEMENTS OF STOCKHOLDERS’
(Amounts in thousands, except share data)
Balance at December 31, 2019
−Removed: Issuance of common stock upon
−Removed: the exercise of warrants
−Removed: Issuance of common stock under
−Removed: Lincoln Park Capital, LLC purchase agreement
−Removed: Issuance of restricted stock
+Added: Cash in lieu of fractional shares
+Added: reverse stock split
Issuance of common stock under
employee stock purchase plan
−Removed: Issuance of common stock in
−Removed: connection with registered direct public offering, net of offering costs of $234
−Removed: Issuance of common stock upon
−Removed: vesting of restricted stock units
+Added: Issuance of common stock and warrants
+Added: in connection with registered direct and private placement offerings, net of offering costs
+Added: Issuance of common stock, pre-funded
+Added: warrants and warrants in connection with underwritten public offering, net of offering costs
+Added: Issuance of common stock upon the
+Added: exercise of warrants
+Added: Issuance of common stock upon vesting
+Added: of restricted stock units
Stock-based compensation expense
Balance at December 31, 2020
−Removed: Cash in lieu of fractional
−Removed: shares for 1:55 reverse stock split
−Removed: Issuance of common stock under
−Removed: employee stock purchase plan
−Removed: Issuance of common stock and
−Removed: warrants in connection with registered direct and private placement offerings, net of offering costs of $746
−Removed: Issuance of common stock,
−Removed: pre-funded warrants and warrants in connection with underwritten public offering, net of offering costs of $906
−Removed: Issuance of common stock upon
−Removed: the exercise of warrants
−Removed: Issuance of common stock upon
−Removed: vesting of restricted stock units
+Added: Issuance of common stock, pre-funded
+Added: warrants and warrants in connection with private placement, net of offering costs
+Added: Issuance of common stock in registered
+Added: direct offering, net of offering costs
+Added: Issuance of common stock upon the
+Added: exercise of warrants
+Added: Issuance of common stock upon vesting
+Added: of restricted stock units
Stock-based compensation expense
Balance at December 31,
+Added: $ ( 116,900 )
See accompanying notes to consolidated financial
2 unchanged sentences
(Amounts in thousands)
−Removed: Years Ended December 31,
+Added: Twelve Months Ended
Cash flows from operating activities:
Adjustments to reconcile net loss to net cash used in operating activities:
−Removed: Depreciation and amortization expense
+Added: Depreciation and amortization
Non-cash lease expense
−Removed: Non-cash stock-based compensation expense
+Added: Non-cash stock-based compensation
+Added: Forgiveness of debt
Changes in operating assets and liabilities:
10 unchanged sentences
Net proceeds from the exercise of warrants
−Removed: Cash paid in lieu of fractional shares for 1:55 reverse stock split
−Removed: Payment of taxes for net share settled restricted stock unit issuances
Proceeds from debt
−Removed: Proceeds from the issuance of common stock in connection with the employee stock purchase plan
−Removed: Payments for capital lease obligations less than one year
+Added: Cash paid in lieu of fractional shares for 1:55 reverse stock split
+Added: Payments of taxes for net share settled restricted stock unit issuances
+Added: Payments of capital lease obligations less than one year
Net cash provided by financing activities
−Removed: Net increase (decrease) in cash and restricted cash
+Added: Net increase in cash and restricted cash
Cash and restricted cash at the beginning of period
2 unchanged sentences
Interest paid
−Removed: Supplemental disclosure of non-cash investing and financing activities:
−Removed: Right of use asset obtained in exchange for operating lease liability
−Removed: Acquisition of property and equipment included in accrued expenses and other current liabilities
See accompanying notes to consolidated financial
2 unchanged sentences
Nature of Operations
−Removed: Pharmaceuticals Corp.
−Removed: Phio ,”
−Removed: or the “
−Removed: Company ”)
−Removed: is a biotechnology company developing the next generation of immuno-oncology therapeutics based on its self-delivering RNAi (“
−Removed: INTASYL™
−Removed: therapeutic platform.
−Removed: The Company’s efforts are focused on silencing tumor-induced suppression of the immune system through
−Removed: its proprietary INTASYL platform with utility in immune cells and the tumor micro-environment.
−Removed: The Company’s goal is to develop
−Removed: powerful INTASYL therapeutic compounds that can weaponize immune effector cells to overcome tumor immune escape, thereby potentially
−Removed: providing patients with a powerful new treatment option that goes beyond current treatment modalities.
−Removed: In December 2019, a novel strain of coronavirus
−Removed: that causes COVID-19 was reported to have surfaced in Wuhan, China and has since spread to other parts of the world, including
−Removed: the United States.
−Removed: In March 2020, the World Health Organization (the “
−Removed: WHO ”) declared the outbreak
−Removed: Our operations have continued with limited impact and are operating in accordance with federal, state, WHO and the
−Removed: Center for Disease Control’s guidelines, including the implementation of safety measures such as working remotely, staggered
−Removed: scheduling and cleaning protocols.
−Removed: While the measures to contain and prevent the spread of coronavirus may be modified
−Removed: or extended, we expect that our activities, including our internal research and development functions, will continue to remain
−Removed: largely operational.
−Removed: As a result of the coronavirus pandemic,
−Removed: certain of our third-party suppliers and service providers on which we rely have seen impacts to their operations.
−Removed: If the impact
−Removed: to their operations continue or extend, it may in turn affect our operations.
−Removed: We previously had been able to engage with
−Removed: third-party service providers in areas with limited or no impact (e.g.
−Removed: countries with limited or no restrictions), but with
−Removed: the global spread of the virus and associated restrictions, this has been no longer possible.
−Removed: The Company does not expect a material
−Removed: impact to its program’s anticipated timelines as a result of potential delays from our third-party service providers and
−Removed: believes that it has a sufficient supply of our INTASYL compounds to conduct its ongoing preclinical studies and initial clinical
−Removed: The Company has also undertaken efforts to mitigate potential future impact by identifying and engaging alternative
−Removed: third-party service providers and suppliers.
−Removed: However, the ultimate impact to these third parties on which we rely is highly uncertain
−Removed: and subject to change.
−Removed: If the measures to contain the outbreak are extended or further expanded, it could reduce or delay the
−Removed: availability of supplies and services that we purchase and outsource, which may in turn slow or delay our preclinical and clinical
−Removed: activities, and/or result in higher costs.
−Removed: We believe that the coronavirus pandemic has not had a significant impact on our operations and
−Removed: financial condition thus far, however a variety of factors, including current and future restrictions and the length
−Removed: of the pandemic, may further impact our operations and may slow or diminish our research and development activities.
−Removed: to which the coronavirus pandemic impacts our results will depend on future developments, which are highly uncertain and cannot
−Removed: be predicted.
+Added: Phio Pharmaceuticals Corp.
+Added: “ we ,” “ our ” or the “ Company ”) is seeking to address the biggest challenges in
+Added: immuno-oncology by creating new pathways to a cancer-free future for patients.
+Added: We are developing therapeutics that leverage our INTASYL™
+Added: technology to target both tumor and immune cells by regulating genes to strengthen a patient’s immune system while weakening tumor
+Added: defense mechanisms.
+Added: With our INTASYL self-delivering RNAi technology, we aim to bring the benefits of RNA therapeutics into cancer care
+Added: where other modalities may fall short.
+Added: Our operations are being conducted in accordance
+Added: with guidance provided by the World Health Organization, the Center for Disease Control and governmental authorities, including the implementation
+Added: of safety measures such as working remotely and flexible scheduling.
+Added: We expect to continue following these safety measures and may take
+Added: further actions as we require, as government authorities require or recommend, or as we determine to be in the best interests of our employees.
+Added: of the coronavirus pandemic, certain of our third-party providers on which we rely have seen impacts to their operations.
+Added: had and continues to undertake efforts to mitigate potential future impacts by identifying and engaging alternative third-party providers
+Added: to limit the impact of potential delays on our program’s anticipated timelines.
+Added: However, the continued impacts to these third-party
+Added: providers, including, for example, limited availability of certain services and supplies, began significantly affecting our operations
+Added: in the second quarter of 2021, which resulted in delays to the start of our clinical trials.
+Added: If measures to overcome the pandemic are
+Added: insufficient, it could further reduce or delay the availability of supplies and services that we purchase and rely on, which may in turn
+Added: further slow or delay our preclinical and clinical activities.
+Added: that the coronavirus pandemic has not had a significant impact on our financial condition to date;
+Added: however a variety of factors such as
+Added: those described above, may further impact our operations and slow or diminish our research and development activities, which in turn may
+Added: impact our financial condition in the future.
+Added: The extent to which the coronavirus pandemic impacts our results will depend on future developments,
+Added: which are highly uncertain and cannot be predicted.
Summary of Significant Accounting Policies
Basis of Presentation
−Removed: The accompanying financial statements have
−Removed: been prepared in accordance with accounting principles generally accepted in the United States of America (“
−Removed: GAAP ”).
−Removed: Additionally, certain reclassifications have been made to prior period financial statements to conform to the current period presentation.
−Removed: Reverse Stock Split
−Removed: Effective January 15, 2020, the Company
−Removed: completed a 1-for-55 reverse stock split of the Company’s outstanding common stock.
−Removed: All share and per share amounts in the
−Removed: financial statements have been retroactively adjusted for all periods presented to give effect to the reverse stock split, including
−Removed: reclassifying an amount equal to the reduction in par value to additional paid-in capital.
−Removed: Unless otherwise noted, shares of common
−Removed: stock issued and outstanding, shares underlying warrants and stock awards, shares reserved, conversion price of convertible securities,
−Removed: exercise prices of warrants and stock awards and loss per share have been proportionately adjusted to reflect the reverse stock
−Removed: The reverse stock split did not reduce the number of authorized shares of the Company’s common stock or preferred
+Added: The accompanying financial statements have been
+Added: prepared in accordance with accounting principles generally accepted in the United States of America (“ GAAP ”).
+Added: Additionally,
+Added: certain prior year amounts have been reclassified for consistency with the current year presentation.
+Added: The Company made an adjustment to
+Added: the consolidated statements of operations to reflect patent costs within general and administrative operating expenses in the consolidated
+Added: statements of operations.
+Added: The reclassification increased general and administrative operating expenses and reduced research and development
+Added: operating expenses by $ 715,000 for the year ended December 31, 2020.
+Added: This reclassification had no effect on total operating expenses,
+Added: net loss, net loss per share and had no impact on the Company’s consolidated balance sheets, statement of stockholders’ equity
+Added: and statement of cash flows for the prior year period.
Principles of Consolidation
−Removed: The consolidated financial statements include
−Removed: the accounts of Phio and its wholly owned subsidiary, MirImmune, LLC.
−Removed: All material intercompany accounts have been eliminated in
−Removed: consolidation.
+Added: The consolidated financial statements include the
+Added: accounts of Phio and its wholly-owned subsidiary, MirImmune, LLC.
+Added: All material intercompany accounts have been eliminated in consolidation.
Uses of Estimates in Preparation of Financial Statements
−Removed: The preparation of financial statements
−Removed: in accordance with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities
−Removed: and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues
−Removed: and expenses during the reporting period.
−Removed: The areas subject to significant estimates and judgement include, among others, those
−Removed: related to the fair value of equity awards, research and development expenses, useful lives of property and equipment, income taxes,
−Removed: and our valuation allowance on our deferred tax assets.
−Removed: On an ongoing basis we evaluate our estimates and base our estimates on
−Removed: historical experience and other relevant assumptions that we believe are reasonable under the circumstances, including as a result
−Removed: of new information that may emerge concerning the coronavirus pandemic.
−Removed: We have made estimates of the impact of the coronavirus
−Removed: pandemic within our financial statements and there may be changes to those estimates in future periods.
−Removed: Actual results could differ
−Removed: materially from these estimates.
+Added: The preparation of financial statements in accordance
+Added: with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure
+Added: of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during
+Added: the reporting period.
+Added: The areas subject to significant estimates and judgement include, among others, those related to the fair value
+Added: of equity awards, accruals for research and development expenses, useful lives of property and equipment, income taxes, and our valuation
+Added: allowance on our deferred tax assets.
+Added: On an ongoing basis we evaluate our estimates and base our estimates on historical experience and
+Added: other relevant assumptions that we believe are reasonable under the circumstances, including as a result of new information that may emerge
+Added: concerning the coronavirus pandemic.
+Added: We have made estimates of the impact of the coronavirus pandemic within our financial statements
+Added: and there may be changes to those estimates in future periods.
+Added: Actual results could differ materially from these estimates.
Restricted Cash
−Removed: Restricted cash consists of certificates
−Removed: of deposit held by financial institutions as collateral for the Company’s corporate credit cards.
+Added: Restricted cash consists of certificates of deposit
+Added: held by financial institutions as collateral for the Company’s corporate credit cards.
+Added: The following table provides a reconciliation
+Added: of cash and restricted cash reported within the balance sheet that sum to the total of the same such amounts shown in the statement of
+Added: cash flows (in thousands):
+Added: Schedule of Cash
+Added: Restricted cash
+Added: Cash and restricted cash shown in the statement of cash flows
Concentrations of Credit Risk
−Removed: Financial instruments that potentially subject
−Removed: the Company to concentrations of credit risk consist principally of cash.
−Removed: The Company maintains cash balances in several accounts
−Removed: with a financial institution that management believes is creditworthy, which at times are in excess of federally insured limits.
−Removed: These accounts are insured by the Federal Deposit Insurance Corporation (FDIC) for up to
+Added: Financial instruments that potentially
+Added: subject the Company to concentrations of credit risk consist principally of cash.
+Added: The Company maintains cash balances in several
+Added: accounts with a financial institution that management believes is creditworthy, which at times are in excess of federally insured
+Added: These accounts are insured by the Federal Deposit Insurance Corporation (the “ FDIC ”) for up to $ 250,000
per institution.
Property and Equipment
−Removed: Property and equipment are stated at cost
−Removed: and depreciated using the straight-line method based on the estimated useful lives of the related assets.
−Removed: The Company provides
−Removed: for depreciation over the assets’
−Removed: estimated useful lives as follows:
+Added: Property and equipment are stated at cost and
+Added: depreciated using the straight-line method based on the estimated useful lives of the related assets.
+Added: The Company provides for depreciation
+Added: over the assets’ estimated useful lives as follows:
+Added: Schedule of estimated useful lives
Computer equipment
2 unchanged sentences
Leasehold improvements
−Removed: Depreciation and amortization expense for
−Removed: the years ended December 31, 2020 and 2019 was $72,000 and $67,000, respectively.
Impairment of Long-Lived Assets
−Removed: The Company reviews long-lived assets for
−Removed: impairment whenever an event occurs or change in circumstances that the related carrying amounts may not be recoverable.
−Removed: An impairment
−Removed: loss would be recognized based on the difference between the carrying value of the asset and its estimated fair value, which would
−Removed: be determined based on either discounted future cash flows or other appropriate fair value methods.
−Removed: The Company believes no impairment
−Removed: existed as of December 31, 2020 or 2019.
+Added: The Company reviews long-lived assets for impairment
+Added: whenever an event occurs or change in circumstances that the related carrying amounts may not be recoverable.
+Added: An impairment loss would
+Added: be recognized based on the difference between the carrying value of the asset and its estimated fair value, which would be determined
+Added: based on either discounted future cash flows or other appropriate fair value methods.
+Added: The Company believes no impairment existed as of
+Added: December 31, 2021 or 2020.
Fair Value of Financial Instruments
−Removed: The carrying amounts reported in the balance
−Removed: sheet for restricted cash, accounts payable and accrued expenses approximate their fair values due to their short-term
−Removed: At the inception of a contract, the Company
−Removed: determines whether the contract is or contains a lease based on all relevant facts and circumstances.
−Removed: For contracts that contain
−Removed: a lease, the Company identifies the lease and non-lease components, determines the consideration in the contract and recognizes
−Removed: the classification of the lease as operating or financing.
−Removed: For leases with a term greater than one year, the Company recognizes
−Removed: a liability to make lease payments and an asset representing the right to use the underlying asset during the lease term at the
−Removed: commencement date of the lease.
−Removed: Lease liabilities and the corresponding
−Removed: right of use assets are recorded based on the present value of lease payments to be made over the lease term.
−Removed: The discount rate
−Removed: used to calculate the present value is the rate implicit in the lease, or if not readily determinable, the Company’s incremental
−Removed: borrowing rate.
−Removed: The Company’s incremental borrowing rate is the rate of interest that the Company would have to pay to borrow
−Removed: on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment.
−Removed: adjustments to the right of use asset may be required for items such as initial direct costs or incentives received.
−Removed: Lease payments
−Removed: on operating leases are recognized on a straight-line basis over the expected term of the lease.
−Removed: Lease payments on financing leases
−Removed: are recognized using the effective interest method.
−Removed: On March 27, 2020, the United States enacted
−Removed: the Coronavirus Aid, Relief, and Economic Security Act (the “
−Removed: CARES Act ”) in response to the coronavirus pandemic.
−Removed: The CARES Act is an emergency economic stimulus package passed in response to the coronavirus outbreak that includes, but is not
−Removed: limited to, provisions providing aid to small businesses in the form of loans and grants and numerous tax provisions such as certain
−Removed: payroll tax benefits, changes to the net operating loss rules, and the business interest expense deduction rules.
−Removed: Outside of the
−Removed: Paycheck Protection Program (the “
−Removed: PPP ”) offered under the CARES Act, the Company has not utilized the other
+Added: The carrying amounts reported in the balance sheet
+Added: for restricted cash, accounts payable and accrued expenses approximate their fair values due to their short-term nature.
+Added: The Company follows the provisions of the FASB
+Added: ASC Topic 820, “Fair Value Measurements and Disclosures,” for the Company’s financial assets and liabilities that are
+Added: re-measured and reported at fair value each reporting period and are re-measured and reported at fair value at least annual using a fair
+Added: value hierarchy that is broken down into three levels.
+Added: Level inputs are defined as follows:
+Added: Level 1 – quoted prices in active markets
+Added: for identical assets or liabilities.
+Added: Level 2 – other significant observable inputs for the
+Added: assets or liabilities through corroboration with market data at the measurement date.
+Added: Level 3 – significant unobservable inputs that reflect
+Added: management’s best estimate of what market participants would use to price the assets or liabilities at the measurement date.
+Added: For the years ended December 31, 2021 and 2020, the Company categorized
+Added: its restricted cash of $ 50,000 as Level 2 hierarchy.
+Added: The assets classified as Level 2 have initially been valued at the applicable transaction
+Added: price and subsequently valued, at the end of each reporting period, using other market observable data.
+Added: Observable market data points
+Added: include quoted prices, interest rates, reportable trades and other industry and economic events.
+Added: At the inception of a contract, the Company determines
+Added: whether the contract is or contains a lease based on all relevant facts and circumstances.
+Added: For contracts that contain a lease, the Company
+Added: identifies the lease and non-lease components, determines the consideration in the contract and recognizes the classification of the lease
+Added: as operating or financing.
+Added: For leases with a term greater than one year, the Company recognizes a liability to make lease payments and
+Added: an asset representing the right to use the underlying asset during the lease term at the commencement date of the lease.
+Added: Lease liabilities and the corresponding right of
+Added: use assets are recorded based on the present value of lease payments to be made over the lease term.
+Added: The discount rate used to calculate
+Added: the present value is the rate implicit in the lease, or if not readily determinable, the Company’s incremental borrowing rate.
+Added: Company’s incremental borrowing rate is the rate of interest that the Company would have to pay to borrow on a collateralized basis
+Added: over a similar term an amount equal to the lease payments in a similar economic environment.
+Added: Certain adjustments to the right of use asset
+Added: may be required for items such as initial direct costs or incentives received.
+Added: Lease payments on operating leases, including scheduled
+Added: increases, are recognized on a straight-line basis over the expected term of the lease.
+Added: Lease payments on financing leases are recognized
+Added: using the effective interest method.
+Added: On March 27, 2020, the United States enacted the
+Added: Coronavirus Aid, Relief, and Economic Security Act (the “ CARES Act ”) in response to the coronavirus pandemic.
+Added: Act is an emergency economic stimulus package passed in response to the coronavirus outbreak that includes, but is not limited to, provisions
+Added: providing aid to small businesses in the form of loans and grants and numerous tax provisions including, certain payroll tax benefits,
+Added: changes to the net operating loss rules and changes to the business interest expense deduction rules.
+Added: In May 2020, the Company received
+Added: loan proceeds pursuant to the Paycheck Protection Program (the “ PPP ”) offered under the CARES Act, and
+Added: the loan was subsequently forgiven in February 2021.
+Added: Outside of the PPP, the Company has not utilized the other CARES Act
loan programs and tax provisions, such as certain payroll tax benefits.
−Removed: On May 11, 2020, the Company received loan proceeds pursuant
−Removed: The Company followed the guidance under the FASB ASC Topic 470, “
−Removed: ASC 470 ”)
+Added: The Company followed the guidance under the Financial
+Added: Accounting Standards Board (the “ FASB ”) Accounting Standards Codification
+Added: (“ ASC ”) Topic 470, “ Debt ” (“ ASC 470 ”)
in assessing the accounting for the PPP loan proceeds.
−Removed: Per ASC 470, the Company recorded a liability on the balance sheet for the
−Removed: full amount of PPP loan proceeds received and is accruing interest over the term of the loan.
−Removed: For additional information regarding
−Removed: the Company’s accounting for the PPP loan proceeds, refer to Note 7.
−Removed: As there continues to be updates to the provisions under
−Removed: the CARES Act, the Company will continue to assess the potential impacts on its business, results of operations and financial statements.
+Added: Per ASC 470, the Company recorded a liability on the balance sheet for the full
+Added: amount of the PPP loan proceeds received and accrued interest over the term of the loan.
+Added: forgiveness, the Company recognized the extinguishment of the liability in the consolidated statement of operations as a gain on extinguishment
Derivative Financial Instruments
Financial instruments that meet the definition
−Removed: of a derivative are classified as an asset or liability and measured at fair value on the issuance date and are revalued on each
−Removed: subsequent balance sheet date.
+Added: 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
+Added: balance sheet date.
The changes in fair value are recognized as current period income or loss.
−Removed: Financial instruments
−Removed: that do not meet the definition of a derivative are classified as equity and measured at fair value and recorded as additional
−Removed: paid in capital in stockholders’
+Added: Financial instruments that do not meet
+Added: 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.
1 unchanged sentence
Research and Development Expenses
−Removed: and development expenses relate to compensation and benefits for research and development personnel, facility-related expenses,
−Removed: supplies, external services, costs to acquire technology licenses, expenses associated with preclinical and clinical development
−Removed: activities and other operating costs.
−Removed: Research and development expenses are charged to expense as incurred.
−Removed: Payments made by the
−Removed: Company in advance for research and development services not yet provided and/or for materials not yet received are recorded as
−Removed: prepaid expenses and expensed when the service has been performed or when the goods have been received.
−Removed: liabilities are recorded related to those expenses for which vendors have not yet billed the Company with respect to services provided
−Removed: and/or materials that it has received.
−Removed: Accrued liabilities for the services provided by contract research organizations are recorded
−Removed: during the period incurred based on such estimates and assumptions as expected cost, passage of time, the achievement of milestones
−Removed: and other information available to us and are assessed on a quarterly basis.
−Removed: Actual results may differ from these estimates and
−Removed: could have a material impact on the Company’s reported results.
−Removed: The Company’s historical accrual estimates have not
−Removed: been materially different from its actual costs.
+Added: and development expenses relate to compensation and benefits for research and development personnel, facility-related expenses, supplies,
+Added: external services, costs to acquire technology licenses, research activities under our research collaborations, expenses
+Added: associated with preclinical and clinical development activities and other operating costs.
+Added: Research and development expenses are charged
+Added: to expense as incurred.
+Added: Payments made by the Company in advance for research and development services not yet provided and/or for materials
+Added: not yet received are recorded as prepaid expenses and expensed when the service has been performed or when the goods have been received.
+Added: Accrued liabilities
+Added: are recorded related to those expenses for which vendors have not yet billed the Company with respect to services provided and/or materials
+Added: that it has received.
+Added: Accrued liabilities for the services provided by contract research organizations are recorded during the period
+Added: incurred based on such estimates and assumptions as expected cost, passage of time, the achievement of milestones and other information
+Added: available to us and are assessed on a quarterly basis.
+Added: Actual results may differ from these estimates and could have a material impact
+Added: on the Company’s reported results.
+Added: The Company’s historical accrual estimates have not been materially different from its
+Added: actual costs.
+Added: Collaborative Arrangements
+Added: follows the provisions of the FASB ASC Topic 808, “Collaborative Arrangements,” (“ Topic 808 ”) when collaboration
+Added: agreements involve joint operating activities in which both parties are active participants and that are also both exposed to significant
+Added: risks and rewards.
+Added: The Company also considers the guidance in the FASB ASC Topic 606, “Revenue from Contracts with Customers,”
+Added: (“ Topic 606 ”) in determining the appropriate treatment for activities between the Company and its collaborative partners
+Added: that are more reflective of a vendor-customer relationship and therefore, within the scope of Topic 606.
+Added: Under Topic 808, the Company
+Added: determines an appropriate recognition method, either by analogy to appropriate accounting literature or by applying a reasonable accounting
+Added: policy election.
+Added: Generally, the classification of transactions under the collaborative arrangements is determined based on the nature
+Added: and contractual terms of the arrangement along with the nature of the operations of the participants.
+Added: or reimbursements that are the result of a collaborative relationship instead of a customer relationship, such as co-development activities,
+Added: are recorded as increases or decreases to research and development expense.
+Added: Patents and Patent Application
+Added: Although the Company believes that its patents
+Added: and underlying technology have continuing value, the amount of future benefits to be derived from the patents is uncertain.
+Added: costs are, therefore, expensed as general and administrative costs as incurred.
Stock-based Compensation
−Removed: The Company follows the provisions of the
−Removed: Financial Accounting Standards Board (the “
−Removed: FASB ”) Accounting Standards Codification (“
−Removed: Topic 718, “
−Removed: Compensation —
−Removed: Stock Compensation ”
−Removed: ASC 718 ”), which requires the
−Removed: measurement and recognition of compensation expense for all stock-based payment awards.
−Removed: The Company uses the Black-Scholes option-pricing
−Removed: model to estimate the fair value of stock options at the grant date.
−Removed: The Black-Scholes valuation model requires the input of valuation
−Removed: assumptions to calculate the value of stock options, including expected volatility, expected term, risk-free interest rate and
−Removed: expected dividends.
−Removed: The fair value of restricted stock units is based upon the Company’s closing stock price at the grant
−Removed: Stock-based compensation expense is recognized over the requisite service period, which generally represents the vesting
−Removed: period, and commences at the date of grant based on the fair value of the award.
+Added: The Company follows the provisions of the FASB
+Added: ASC Topic 718, “ Compensation — Stock Compensation ” (“ ASC 718 ”), which requires the measurement
+Added: and recognition of compensation expense for all stock-based payment awards.
+Added: The fair value of restricted stock units is based upon the
+Added: Company’s closing stock price at the grant date.
+Added: The Company uses the Black-Scholes option-pricing model to estimate the fair value
+Added: of stock options at the grant date.
+Added: The Black-Scholes valuation model requires the input of valuation assumptions to calculate the value
+Added: of stock options, including expected volatility, expected term, risk-free interest rate and expected dividends.
+Added: Stock-based compensation
+Added: expense is recognized over the requisite service period, which generally represents the vesting period, and commences at the date of grant
+Added: 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.
−Removed: we are also required to estimate forfeitures at the time of grant, and to revise those estimates in subsequent periods if actual
−Removed: forfeitures differ from estimates.
−Removed: We use historical data to estimate pre-vesting option forfeitures and record stock-based compensation
−Removed: expense only for those awards that are expected to vest.
−Removed: Our forfeiture rate estimates are based on an analysis of our actual forfeiture
−Removed: experience, employee turnover behavior, and other factors.
−Removed: The impact of any adjustments to our forfeiture rates would be recorded
−Removed: as a cumulative adjustment in the period of adjustment.
−Removed: To the extent that actual forfeitures differ from our estimates, the difference
−Removed: is recorded as a cumulative adjustment in the period the estimates were revised.
−Removed: The Company recognizes assets or liabilities
−Removed: for the deferred tax consequences of temporary differences between the tax basis of assets or liabilities and their reported amounts
−Removed: in the financial statements in accordance with the FASB ASC Topic 740, “Accounting for Income Taxes”
−Removed: 740 ”) .
−Removed: These temporary differences will result in taxable or deductible amounts in future years when the reported
−Removed: amounts of the assets or liabilities are recovered or settled.
−Removed: Those temporary differences referred to as deferred tax assets and
−Removed: liabilities are determined at the end of each period using the tax rate expected to be in effect when taxes are actually paid or
−Removed: ASC 740 requires that a valuation allowance
−Removed: be established when management determines that it is more likely than not that all or a portion of a deferred asset will not be
−Removed: The Company evaluates the realizability of its net deferred income tax assets and valuation allowances as necessary,
−Removed: at least on an annual basis.
−Removed: During this evaluation, the Company reviews its forecasts of income in conjunction with other positive
−Removed: and negative evidence surrounding the realizability of its deferred income tax assets to determine if a valuation allowance is
−Removed: Adjustments to the valuation allowance will increase or decrease the Company’s income tax provision or benefit.
−Removed: The recognition and measurement of benefits
−Removed: related to the Company’s tax positions requires significant judgment, as uncertainties often exist with respect to new laws,
−Removed: new interpretations of existing laws, and rulings by taxing authorities.
−Removed: The Company follows a more-likely-than not threshold for
−Removed: financial statement recognition and measurement of a tax position taken, or expected to be taken in a tax return.
−Removed: relates to, amongst other things, classification, accounting for interest and penalties associated with tax positions, and disclosure
−Removed: requirements.
−Removed: Any interest and penalties accrued related to uncertain tax positions are recorded as tax expense.
−Removed: Differences between
−Removed: actual results and the Company’s assumptions or changes in the Company’s assumptions in future periods are recorded
−Removed: in the period they become known.
+Added: Accordingly, we are
+Added: also required to estimate forfeitures at the time of grant and to revise those estimates in subsequent periods if actual forfeitures differ
+Added: from estimates.
+Added: We use historical data to estimate pre-vesting award forfeitures and record stock-based compensation expense only for
+Added: those awards that are expected to vest.
+Added: Our forfeiture rate estimates are based on an analysis of our actual forfeiture experience, employee
+Added: turnover behavior, and other factors.
+Added: The impact of any adjustments to our forfeiture rates is recorded as a cumulative adjustment in
+Added: the period of adjustment.
+Added: To the extent that actual forfeitures differ from our estimates, the difference is recorded as a cumulative
+Added: adjustment in the period the estimates are revised.
+Added: The Company recognizes assets or liabilities for
+Added: the deferred tax consequences of temporary differences between the tax basis of assets or liabilities and their reported amounts in the
+Added: financial statements in accordance with the FASB ASC Topic 740, “Accounting for Income Taxes” (“ ASC 740 ”) .
+Added: These temporary differences will result in taxable or deductible amounts in future years when the reported amounts of the assets or liabilities
+Added: are recovered or settled.
+Added: Those temporary differences referred to as deferred tax assets and liabilities are determined at the end of
+Added: each period using the tax rate expected to be in effect when taxes are actually paid or recovered.
+Added: allowances are established if, based on the weight of available evidence, it is more likely than not that all or a portion of a deferred
+Added: tax asset will not be realized.
+Added: The provision for income taxes, if any, represents the tax payable for the period and the change in deferred
+Added: income tax assets and liabilities during the period.
+Added: Immaterial Revision
+Added: In 2021, the Company completed an Internal Revenue
+Added: Code Section 382 analysis of its historical net operating loss carry-forward amount.
+Added: As a result, the prior year net operating loss carry-forward
+Added: was determined to be limited.
+Added: See Note 13 Income Taxes , for further details.
Comprehensive Loss
−Removed: The Company’s comprehensive loss is
−Removed: equal to its net loss for all periods presented.
+Added: The Company’s comprehensive loss is equal
+Added: to its net loss for all periods presented.
Net Loss per Share
−Removed: Basic net loss per share is computed by
−Removed: dividing net loss by the weighted average number of common shares outstanding.
−Removed: Diluted net loss per share is computed by dividing
−Removed: the Company’s net less by the weighted average number of common shares outstanding and the impact of all dilutive potential
−Removed: common shares outstanding, except where such dilutive potential common shares would be anti-dilutive.
−Removed: Dilutive potential common
−Removed: shares primarily consist of warrants, restricted stock units and stock options.
−Removed: Liquidity and Going
−Removed: The Company has reported recurring losses
−Removed: from operations since inception and expects that the Company will continue to have negative cash flows from operations for the
−Removed: foreseeable future.
−Removed: Historically, the Company’s primary source of funding has been the sale of its securities.
−Removed: The Company’s
−Removed: ability to continue to fund its operations is dependent on obtaining funding from third parties, such as proceeds from the issuance
−Removed: of debt, sale of equity, or strategic opportunities, in order to maintain its operations.
−Removed: This is dependent on a number of factors,
−Removed: including the market demand or liquidity of the Company’s common stock.
−Removed: There is no guarantee that debt, additional equity
−Removed: or other funding will be available to us on acceptable terms, or at all.
−Removed: If we fail to obtain additional funding when needed, we
−Removed: would be forced to scale back or terminate our operations or seek to merge with or to be acquired by another company.
+Added: Basic net loss per share is computed by dividing
+Added: net loss by the weighted average number of common shares outstanding.
+Added: Diluted net loss per share is computed by dividing the Company’s
+Added: net loss by the weighted average number of common shares outstanding and the impact of all dilutive potential common shares outstanding,
+Added: except where such dilutive potential common shares would be anti-dilutive.
+Added: Dilutive potential common shares primarily consist of warrants,
+Added: restricted stock units and stock options.
+Added: Liquidity and Going Concern
+Added: The Company has reported recurring losses from
+Added: operations since its inception and expects to continue to have negative cash flows from operations for the foreseeable future.
+Added: Historically,
+Added: the Company’s primary source of funding has been from sales of its securities.
+Added: The Company’s ability to continue to fund
+Added: its operations is dependent on obtaining funding from third parties, such as proceeds from the issuance of debt, sale of equity, or strategic
+Added: opportunities, in order to maintain its operations.
+Added: This is dependent on a number of factors, including the market demand or liquidity
+Added: of the Company’s common stock.
+Added: There is no guarantee that debt, additional equity or other funding will be available to us on acceptable
+Added: terms, or at all.
+Added: If we fail to obtain additional funding when needed, we would be forced to scale back or terminate our operations or
+Added: seek to merge with or to be acquired by another company.
While we believe that the coronavirus pandemic
−Removed: has not had a significant impact on our financial condition and results of operations at this time, the potential economic impact
−Removed: brought by, and the duration of, the coronavirus pandemic is difficult to assess or predict.
−Removed: There may be developments outside
−Removed: of our control that require us to adjust our operating plans and given the nature of the situation, we cannot reasonably estimate
−Removed: the impact of the coronavirus pandemic on our financial conditions, results of operations or cash flows in the future.
−Removed: The Company believes that its existing cash
−Removed: and the net proceeds received from the Company’s financing activities subsequent to the balance sheet date, discussed further
−Removed: in Note 14, should be sufficient to fund operations for at least the next 12 months from
−Removed: the date of the release of these financial statements .
+Added: has not had a significant impact on our financial condition and results of operations at this time, the potential economic impact brought
+Added: by, and the duration of, the coronavirus pandemic is difficult to assess or predict.
+Added: There may be developments outside of our control
+Added: that require us to adjust our operating plans and given the nature of the situation, we cannot reasonably estimate the impact of the coronavirus
+Added: pandemic on our financial conditions, results of operations or cash flows in the future.
+Added: believes that its existing cash should be sufficient to fund operations for at least the next 12 months from the date of the release
+Added: of these financial statements.
Recent Accounting Pronouncements
−Removed: In November 2018, the FASB issued Accounting
−Removed: Standards Update (“
−Removed: ASU ”) 2018-18, “
−Removed: Collaborative Arrangements (Topic 808) ”
−Removed: 808 ”), which clarifies the interaction between Topic 808 and ASC Topic 606, “
−Removed: Revenue from Customers ”
−Removed: Topic 606 ”).
−Removed: The update provides guidance on whether certain transactions between collaborative arrangement
−Removed: participants should be accounted for with revenue under Topic 606 and provides more comparability in the presentation of revenue
−Removed: for certain transactions between collaborative arrangement participants.
−Removed: This ASU is effective for annual reporting periods beginning
−Removed: after December 15, 2019, including interim periods within that reporting period.
−Removed: This guidance is required to be applied retrospectively
−Removed: to the date of adoption of Topic 606.
−Removed: The Company adopted Topic 606 in the first quarter of 2018 and adopted
−Removed: ASU 2018-18 in the first quarter of 2020.
−Removed: The Company also elected to apply ASU 2018-18 only to contracts that were not completed
−Removed: at the date of initial application of Topic 606.
−Removed: Since the Company has no significant revenue, this ASU has no immediate impact
−Removed: on the Company’s consolidated financial statements.
−Removed: In December 2019, the FASB issued ASU 2019-12,
−Removed: Income Taxes (Topic 740):
−Removed: Simplifying the Accounting for Income Taxes .”
−Removed: The amendments in the update simplify
−Removed: the accounting for income taxes by eliminating the exceptions related to the incremental approach for intraperiod tax allocation,
−Removed: the recognition of a deferred tax liability for equity method investments, not recognizing a deferred tax liability for a foreign
−Removed: subsidiary and the general methodology for calculating income taxes in an interim period.
−Removed: amendments also clarify and simplify other aspects of the accounting for income taxes.
−Removed: The amendments in ASU 2019-12 are effective
−Removed: for public entities for fiscal years, and the interim periods within those fiscal years, beginning after December 20, 2020.
−Removed: adoption is permitted.
−Removed: The Company does not expect the adoption of ASU 2019-12 to have a material impact on its consolidated
−Removed: financial statements.
−Removed: August 2020, the FASB issued ASU 2020-06, “
−Removed: Debt with Conversion and Other Options (Subtopic 470-20) and
−Removed: Derivatives and Hedging –
−Removed: Contracts in Entity’s Own Equity (Subtopic 815 –
−Removed: 2020-06 ”), which simplifies the accounting for certain financial instruments with characteristics of liabilities and
−Removed: equity, including convertible instruments and contracts in an entity’s own equity.
−Removed: The ASU is part of the FASB’s simplification
−Removed: initiative, which aims to reduce unnecessary complexity in U.S.
−Removed: For convertible instruments, the accounting models
−Removed: for instruments issued with beneficial conversion features or cash conversion features are removed.
−Removed: contracts in an entity’s own equity, ASU 2020-06 simplifies the settlement assessment by removing the requirements to (1)
−Removed: to consider whether the contract would be settled in registered shares, (2) to consider whether collateral is required to be posted,
−Removed: and (3) to assess shareholder rights.
−Removed: ASU 2020-06 is effective for fiscal years beginning after December 15, 2023, and interim
−Removed: periods within those fiscal years.
−Removed: Early adoption is permitted, but no earlier than fiscal years beginning after December 15,
−Removed: 2020, and interim periods within those fiscal years.
−Removed: The Company does not expect the adoption of ASU 2020-06 to have a material
−Removed: impact on its consolidated financial statements.
−Removed: Accrued Expenses and Other Current Liabilities
−Removed: Accrued expenses and other current liabilities
−Removed: consist of the following, in thousands:
+Added: In December 2019, the FASB issued Accounting Standards
+Added: Update (“ ASU ”) 2019-12, “ Income Taxes (Topic 740):
+Added: Simplifying the Accounting for Income Taxes ”
+Added: (“ ASU 2019-12 ”).
+Added: The amendments in the update simplify the accounting for income taxes by eliminating the exceptions
+Added: related to the incremental approach for intraperiod tax allocation, the recognition of a deferred tax liability for equity method investments,
+Added: not recognizing a deferred tax liability for a foreign subsidiary and the general methodology for calculating income taxes in an interim
+Added: The amendments also clarify and simplify other aspects of the accounting for income taxes.
+Added: The amendments in ASU 2019-12 are effective for public entities for fiscal years, and the interim periods within those fiscal years, beginning
+Added: after December 20, 2020.
+Added: The Company adopted ASU 2019-12 on January 1, 2021.
+Added: The adoption of this standard did not have a material
+Added: impact on the Company’s consolidated financial statements.
+Added: 2020, the FASB issued ASU 2020-06, “ Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and
+Added: Hedging – Contracts in Entity’s Own Equity (Subtopic 815 – 40)” (“ ASU 2020-06 ”), which
+Added: simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments
+Added: and contracts in an entity’s own equity.
+Added: ASU 2020-06 is part of the FASB’s simplification initiative, which aims to reduce
+Added: unnecessary complexity in U.S.
+Added: For convertible instruments, the accounting models for instruments issued with beneficial
+Added: conversion features or cash conversion features are removed.
+Added: For contracts in an entity’s
+Added: own equity, ASU 2020-06 simplifies the settlement assessment by removing the requirements to (1) consider whether the contract would be
+Added: settled in registered shares, (2) consider whether collateral is required to be posted, and (3) assess shareholder rights.
+Added: is effective for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years.
+Added: Early adoption is permitted,
+Added: but no earlier than fiscal years beginning after December 15, 2020, and interim periods within those fiscal years.
+Added: The Company early adopted
+Added: ASU 2020-06 on January 1, 2021.
+Added: The adoption of this standard did not have an impact on the Company’s consolidated financial statements.
+Added: May 2021, the FASB issued ASU 2021-04, “ Earnings per Share (Topic 260), Debt – Modifications and Extinguishments
+Added: (Subtopic 470-50), Compensation – Stock Compensation (Topic 718), and Derivatives and Hedging – Contracts in Entity’s
+Added: Own Equity (Subtopic 815-40) ” (“ ASU 2021-04 ”).
+Added: The amendments in the updates are intended to clarify and reduce diversity in an issuer’s accounting for modifications or exchanges
+Added: of freestanding equity-classified written call options that remain equity classified after modification or exchange.
+Added: The amendments in
+Added: ASU 2021-04 are effective for all entities for fiscal years beginning after December 15, 2021, including interim periods within those
+Added: fiscal years.
+Added: An entity should apply the amendments prospectively to modifications or exchanges occurring on or after the effective date
+Added: of the amendments.
+Added: Early adoption is permitted for all entities, including within an interim period.
+Added: The Company does not expect the adoption
+Added: of ASU 2021-04 to have a material impact on its consolidated financial statements.
+Added: Property and Equipment
+Added: The following table summarizes the Company’s
+Added: major classes of property and equipment:
+Added: Schedule of property and equipment
+Added: Computer equipment
+Added: Machinery & equipment
+Added: Furniture & fixtures
+Added: Leasehold improvements
+Added: Total gross fixed assets
+Added: accumulated depreciation and amortization
+Added: Property and equipment, net
+Added: Depreciation and amortization expense for the years
+Added: ended December 31, 2021 and 2020 was $ 75,000 and $ 72,000 , respectively.
+Added: Accrued Expenses
+Added: Accrued expenses consist of the following, in
+Added: Schedule of accrued expenses and other current liabilities
Compensation and benefits
2 unchanged sentences
Total accrued expenses and other current liabilities
−Removed: On January 22, 2019, the Company amended
−Removed: the lease for its corporate headquarters and primary research facility in Marlborough, Massachusetts.
−Removed: The Company leases 7,581
−Removed: square feet of office and laboratory space, which will expire on March 31, 2024.
−Removed: The lease contains an option to terminate the
−Removed: lease after two years or three years by providing advance written notice of termination pursuant to the terms of the agreement.
−Removed: The exercise of this option was not determined to be reasonably certain and thus is not included in the lease liability on the
−Removed: Company’s balance sheet.
−Removed: Additionally, the lease agreement did not contain information to determine the rate implicit in
−Removed: As such, the Company calculated its incremental borrowing rate based on what the Company would have to pay to borrow
−Removed: on a collateralized basis over the lease term for an amount equal to the remaining lease payments taking into consideration such
−Removed: assumptions as, but not limited to, the U.S.
−Removed: treasury yield rate and borrowing rates from a creditworthy financial institution
−Removed: using the above lease factors.
−Removed: The lease for our corporate headquarters
−Removed: represents substantially all of our significant lease obligations.
−Removed: The amounts reported in the consolidated balance sheets for
−Removed: operating leases in which the Company is the lessee and other supplemental balance sheet information is set forth as follows, in
−Removed: thousands, except lease term and discount rate:
+Added: In January 2019, the Company amended the
+Added: lease for its corporate headquarters and primary research facility in Marlborough, Massachusetts.
+Added: The lease is for a total of 7,581
+Added: square feet of office and laboratory space and will expire on March
+Added: The lease contains an option to terminate after two or three years by providing advance written notice of
+Added: termination pursuant to the terms of the agreement.
+Added: The exercise of this option was not determined to be reasonably certain and thus
+Added: was not included in the lease liability on the Company’s balance sheet.
+Added: The Company did not exercise its option to terminate
+Added: in either the second or third year of the lease, and the option to terminate has expired.
+Added: Additionally, the lease agreement did not
+Added: contain information to determine the borrowing rate implicit in the lease.
+Added: As such, the Company calculated its incremental borrowing
+Added: 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
+Added: remaining lease payments, taking into consideration such assumptions as, but not limited to, the U.S.
+Added: treasury yield rate and
+Added: borrowing rates from a creditworthy financial institution using the above lease factors.
+Added: The lease for our corporate headquarters represents substantially all
+Added: of our significant lease obligations.
+Added: The amounts reported in the consolidated balance sheets for operating leases in which the Company
+Added: is the lessee and other supplemental balance sheet information is set forth as follows, in thousands, except the lease term (number of
+Added: years) and discount rate:
+Added: Schedule of lease amounts recorded in balance sheet
December 31, 2021
7 unchanged sentences
Weighted average discount rate
−Removed: Operating lease cost included in operating
−Removed: expense was $132,000 and $127,000 for the years ended December 31, 2020 and 2019, respectively.
−Removed: Short-term lease costs were not
−Removed: material for the years ended December 31, 2020 and 2019.
−Removed: Cash paid for the amounts included in the
−Removed: measurement of the operating lease liability on the Company’s consolidated balance sheets and included within changes in
−Removed: the lease liability in the operating activities of our consolidated statement of cash flows was $127,800 and $121,000 for the years
−Removed: ended December 31, 2020 and 2019, respectively.
+Added: Operating lease costs included in operating
+Added: expense were $ 132,000 and $ 132,000 for
+Added: the years ended December 31, 2021 and 2020, respectively.
+Added: Short-term lease costs were not material for the years ended December 31,
+Added: 2021 and 2020.
+Added: Cash paid for the amounts included in the measurement
+Added: of the operating lease liability on the Company’s consolidated balance sheets and included within changes in the lease liability
+Added: in the operating activities of our consolidated statement of cash flows was $ 131,600 and $ 127,800 for the years ended December 31, 2021
+Added: and 2020, respectively.
Future lease payments for our non-cancellable
−Removed: operating leases and a reconciliation to the carrying amount of the operating lease liability presented in the consolidated
−Removed: balance sheet as of December 31, 2020 is as follows, in thousands:
+Added: operating leases and a reconciliation to the carrying amount of the operating lease liability presented in the consolidated balance sheet
+Added: as of December 31, 2021 is as follows, in thousands:
+Added: Aggregate future minimum lease payments
Total lease payments
1 unchanged sentence
Total operating lease liabilities (includes current portion)
−Removed: On May 11, 2020, the Company received loan
−Removed: proceeds in the amount of $231,252 from Bank of America, N.A., as lender, pursuant to the PPP under the CARES Act.
−Removed: matures on May 11, 2022, bears interest at a rate of 1% per year and monthly principal and interest payments are deferred to the
−Removed: date that the Small Business Administration remits the borrower’s loan forgiveness amount to the lender.
−Removed: The loan may be
−Removed: forgiven if used for eligible purposes, including payroll, benefits, rent and utilities.
−Removed: The Company believes it has used the loan
−Removed: proceeds for the eligible purposes allowed and applied for full loan forgiveness.
−Removed: On February 18, 2021, the Small Business Administration
−Removed: determined that the Company’s application for full loan forgiveness was fully approved and the full amount of the PPP loan
−Removed: was remitted to the lender for forgiveness.
−Removed: When applying for the PPP loan, the Company
−Removed: carefully assessed the requirements for application under the program and believed that the loan was necessary to support its
−Removed: As loan forgiveness had not yet been determined at December 31, 2020, the Company followed the guidance under ASC
−Removed: 470 in assessing the accounting for the PPP loan proceeds.
−Removed: Per ASC 470, the Company recorded a liability on the balance sheet
−Removed: for the full amount of PPP loan proceeds received and is accruing interest over the term of the loan.
−Removed: As of December 31, 2020,
−Removed: the PPP loan proceeds have been classified as long-term debt on the balance sheet.
+Added: May 2020, the Company received loan proceeds in the amount of $ 231,252
+Added: from Bank of America, N.A., as lender, pursuant to the PPP under the CARES Act.
+Added: The PPP loan had a maturity date of May
+Added: 11, 2022 , interest at a rate of 1 %
+Added: per year and monthly principal and interest payments that were deferred to the date that the Small Business Administration (the
+Added: “ SBA ”) remitted the borrower’s loan forgiveness amount to the lender.
+Added: When applying for the PPP loan, the
+Added: Company carefully assessed the requirements for application under the program and believed that the loan was necessary to support
+Added: its operations.
+Added: The loans under the PPP may be forgiven if used for eligible purposes, including payroll, benefits, rent and
+Added: Company followed the guidance under ASC 470 in assessing the accounting for the PPP loan proceeds.
+Added: Per ASC 470, the Company recorded
+Added: a liability on the balance sheet for the full amount of PPP loan proceeds received and accrued interest over the term of the loan.
+Added: The Company believed it used the loan proceeds for eligible purposes and applied for full loan forgiveness.
+Added: In February 2021, the
+Added: SBA approved the Company’s application for full loan forgiveness, and the full amount of the PPP loan was remitted to the
+Added: lender for forgiveness.
+Added: Upon loan forgiveness, the Company recognized a gain on the extinguishment of debt of $ 233 ,000
+Added: for the loan proceeds received and interest accrued in the consolidated statements of operations for the year ended December
Commitments and Contingencies
License Commitments
−Removed: The Company acquires assets under development
−Removed: and enters into research and development arrangements with third parties that often require milestone and royalty payments based
−Removed: on the progress of the asset through development stages.
−Removed: Milestone payments may be required, for example, upon approval of the
−Removed: product for marketing by a regulatory agency.
−Removed: In certain agreements, the Company is required to make royalty payments based upon
−Removed: a percentage of the sales of the products licensed pursuant to such agreements.
−Removed: Because of the contingent nature of these payments,
−Removed: they are not included in the table of contractual obligations shown below.
−Removed: During the years
−Removed: ended December 31, 2020 and 2019, the Company did not trigger any milestone payments.
−Removed: The Company’s contractual license
−Removed: obligations that will require future cash payments as of December 31, 2020 are as follows, in thousands:
+Added: The Company acquires assets under development and
+Added: enters into research and development arrangements with third parties that often require milestone and royalty payments based on the progress
+Added: of the asset through development stages.
+Added: Milestone payments may be required, for example, upon approval of the product for marketing by
+Added: a regulatory agency.
+Added: In certain agreements, the Company is required to make royalty payments based upon a percentage of the sales of the
+Added: products licensed pursuant to such agreements.
+Added: Because of the contingent nature of these payments, they are not included in the table
+Added: of contractual obligations shown below.
+Added: During the years ended December 31, 2021 and 2020, the Company
+Added: did not trigger any milestone payments.
+Added: The Company’s contractual license obligations
+Added: that will require future cash payments as of December 31, 2021 are as follows, in thousands:
+Added: Schedule of future cash payments for contractual
+Added: license obligations
Year Ending December 31,
−Removed: The Company applies the disclosure provisions
−Removed: of the FASB ASC Topic 460, “
−Removed: Guarantor’s Accounting and Disclosure Requirements for Guarantees, Including Indirect
−Removed: Guarantees of Indebtedness of Others ”
−Removed: ASC 460 ”), to its agreements that contain guarantee or
−Removed: indemnification clauses.
+Added: The Company applies the disclosure provisions of
+Added: the FASB ASC Topic 460, “ Guarantor’s Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees
+Added: of Indebtedness of Others ” (“ ASC 460 ”), to its agreements that contain guarantee or indemnification
The Company provides:
−Removed: (i) indemnifications of varying scope and size to certain investors and other
−Removed: parties for certain losses suffered or incurred by the indemnified party in connection with various types of third-party claims;
−Removed: and (ii) indemnifications of varying scope and size to officers and directors against third-party claims arising from the
−Removed: services they provide to us.
−Removed: These indemnifications give rise only to the disclosure provisions of ASC 460.
−Removed: To date, the Company
−Removed: has not incurred costs as a result of these obligations and does not expect to incur material costs in the future.
−Removed: the Company has not accrued any liabilities in its consolidated financial statements related to these indemnifications.
−Removed: From time to time, the Company is party
−Removed: to legal proceedings.
+Added: (i) indemnifications of varying scope and size to certain investors and other parties for certain
+Added: losses suffered or incurred by the indemnified party in connection with various types of third-party claims;
+Added: and (ii) indemnifications
+Added: of varying scope and size to officers and directors against third-party claims arising from the services they provide to us.
+Added: These indemnifications
+Added: give rise only to the disclosure provisions of ASC 460.
+Added: To date, the Company has not incurred costs as a result of these obligations and
+Added: does not expect to incur material costs in the future.
+Added: Accordingly, the Company has not accrued any liabilities in its consolidated financial
+Added: statements related to these indemnifications.
+Added: From time to time, the Company is party to legal
There are none deemed to be material at this time.
−Removed: Accordingly, the Company has not accrued any liabilities
−Removed: in its consolidated financial statements related to proceedings.
−Removed: Stockholders’
−Removed: November 2019 Registered Public Offering—
−Removed: November 19, 2019, the Company closed a registered public offering of 181,818 shares of the Company’s common stock at an
−Removed: offering price of $5.50 per share (the “
−Removed: November 2019 Offering ”).
−Removed: Net proceeds from the November 2019 Offering
−Removed: were $766,000, after deducting fees and expenses.
−Removed: In connection with the November 2019 Offering, the Company issued warrants to
−Removed: purchase a total of 13,636 shares of common stock with an exercise price of $6.875 per share (the “
−Removed: November 2019 Placement
−Removed: Agent Warrants ”) to the placement agent, H.C.
−Removed: Wainwright & Co., LLC (“
−Removed: HCW ”).
−Removed: Concurrent with the close of the November
−Removed: 2019 Offering, the Company unilaterally reduced the per share exercise price of all of the outstanding common stock warrants issued
−Removed: in October 2018 to an exercise price of $10.45 per share, which was equal to the closing price of the Company’s common stock
−Removed: on November 15, 2019, and to $13.06 per share for the warrants issued to HCW, which was equal to 125% of the closing price of the
−Removed: Company’s common stock on November 15, 2019.
−Removed: The modification resulted in an increase in fair value of approximately $800,000.
−Removed: This amount was recorded as a cost of capital of the November 2019 Offering and recorded in additional paid-in capital as the modification
−Removed: was required to complete the capital raise.
−Removed: February 2020 Registered Direct Offering
−Removed: and Private Placement —
−Removed: On February 6, 2020, the Company completed a registered direct offering (the “
−Removed: 2020 Registered Offering ”) of 197,056 shares of the Company’s common stock at a purchase price of $8.705 per share
−Removed: and in a concurrent private placement, sold warrants to purchase an aggregate of 197,056 shares of the Company’s common stock
−Removed: at a purchase price of $0.125 per underlying warrant share and with an exercise price of $8.71 per share (the “
−Removed: 2020 Registered Direct Warrants ”).
−Removed: Net proceeds to the Company from the February 2020 Registered Offering were $1,467,000
−Removed: after deducting placement agent fees and offering expenses paid by the Company.
+Added: Accordingly, the Company has not accrued any liabilities in its consolidated
+Added: financial statements related to proceedings.
+Added: Stockholders’ Equity
+Added: 2021 Private Placement — On January 25, 2021, the Company completed a private placement of 4,420,863 shares
+Added: of the Company’s common stock at a purchase price per share of $ 3.07 ,
+Added: pre-funded warrants to purchase an aggregate of 140,065
+Added: shares of the Company’s common stock (the “ January 2021 Pre-Funded Warrants ”) at a purchase price per
+Added: pre-funded warrant share of $ 3.069
+Added: and warrants to purchase an aggregate of 3,420,696 shares
+Added: of the Company’s common stock with an exercise price of $ 3.00 per
+Added: warrant share (the “ January 2021 Warrants ”) (the “ Private Placement ”).
+Added: In connection with the
+Added: Private Placement, the Company issued warrants to the placement agent, H.C.
+Added: Wainwright & Co., LLC (“ HCW ”), to
+Added: purchase a total of 342,070 shares
+Added: of the Company’s common stock at an exercise price of $ 3.8375 (the
+Added: “ January 2021 Placement Agent Warrants ”).
+Added: Net proceeds to the Company from the Private Placement were $ 12,669,000 after
+Added: deducting placement agent fees and offering expenses.
+Added: 2021 Registered Direct Offering — On February 17, 2021, the Company completed a registered direct offering
+Added: of 2,246,784 shares
+Added: of the Company’s common stock at a purchase price of $ 3.42 per
+Added: share (the “ Offering ”).
+Added: In connection with the Offering, the Company issued warrants to the placement agent, HCW,
+Added: to purchase a total of 168,509 shares
+Added: of the Company’s common stock at an exercise price of $ 4.275 (the
+Added: “ February 2021 Placement Agent Warrants ”).
+Added: Net proceeds to the Company from the Offering were $ 6,908,000
+Added: after deducting placement agent fees and offering expenses.
+Added: February 2020 Registered
+Added: Direct Offering and Private Placement — On February 6, 2020, the Company completed a registered direct offering (the
+Added: “ February 2020 Registered Offering ”) of 197,056 shares
+Added: of the Company’s common stock at a purchase price of $ 8.705
+Added: per share and in a concurrent private placement, sold warrants to purchase an aggregate of 197,056
+Added: shares of the Company’s common stock at a purchase price of $ 0.125
+Added: per underlying warrant share and with an exercise price of $ 8.71
+Added: per share (the “ February 2020 Registered Direct Warrants ”).
In connection with the February 2020 Registered
−Removed: Offering, the Company also issued warrants to purchase a total of 14,779 shares of the Company’s common stock with an exercise
−Removed: price of $11.0375 per share (the “
−Removed: February 2020 Placement Agent Warrants ”) to the placement agent, HCW.
−Removed: February 2020 Underwritten Public Offering —
−Removed: On February 13, 2020, the Company completed an underwritten public offering of 993,633 shares of the Company’s common stock
−Removed: at a purchase price per share of $4.00, pre-funded warrants (the “
−Removed: 2020 Pre-Funded Warrants ”) to purchase an
−Removed: 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
−Removed: warrants (the “
−Removed: February 2020 Warrants ”) to purchase an aggregate of 2,000,000 shares of the Company’s
−Removed: common stock with an exercise price of $4.00 per warrant shares (the “
−Removed: February 2020 Underwritten Offering ”).
−Removed: The 2020 Pre-Funded Warrants were immediately exercisable at an exercise price per share of $0.001 and each share of Company common
−Removed: stock or 2020 Pre-Funded Warrant, as applicable, was sold with a February 2020 Warrant.
+Added: Offering, the Company also issued warrants to purchase a total of 14,779
+Added: shares of the Company’s common stock with an exercise price of $ 11.0375
+Added: per share (the “ February 2020 Placement Agent Warrants ”) to the placement agent, HCW.
+Added: Net proceeds to the Company
+Added: from the February 2020 Registered Offering were $ 1,467,000
+Added: after deducting placement agent fees and offering expenses paid by the Company.
+Added: February 2020
+Added: Underwritten Public Offering — On February 13, 2020, the Company completed an underwritten public offering
+Added: of 993,633 shares
+Added: of the Company’s common stock at a purchase price per share of $ 4.00 ,
+Added: pre-funded warrants (the “ 2020 Pre-Funded Warrants ”) to purchase an aggregate of 1,006,367 shares
+Added: of the Company’s common stock at a purchase price per pre-funded warrant share of $ 3.999 and
+Added: warrants (the “ February 2020 Warrants ”) to purchase an aggregate of 2,000,000
+Added: shares of the Company’s common stock with an exercise price of $ 4.00 per
+Added: warrant share (the “ February 2020 Underwritten Offering ”).
+Added: The 2020 Pre-Funded Warrants were immediately
+Added: exercisable at an exercise price per share of $ 0.001 and
+Added: each share of Company common stock or 2020 Pre-Funded Warrant, as applicable, was sold with a February 2020 Warrant.
+Added: In connection
+Added: with the February 2020 Underwritten Offering, the Company issued warrants to purchase up to 150,000
+Added: shares of Company common stock, immediately exercisable at an exercise price of $ 5.00 per
+Added: share (the “ February 2020 Underwriter Warrants ”) to HCW, as underwriter.
In connection with the February
−Removed: Underwritten Offering, the Company also granted to the underwriter, HCW, a 30-day
−Removed: option to purchase up to an additional 300,000 shares of the Company’s common stock at a purchase price of $3.999 per
−Removed: 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
+Added: 2020 Underwritten Offering, the Company also granted to the underwriter, HCW, a 30-day option to purchase up to an additional 300,000
+Added: shares of the Company’s common stock at a purchase price of $ 3.999 per
+Added: such share and/or warrants to purchase up to 300,000
+Added: 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.
−Removed: On February 12, 2020, HCW exercised its
−Removed: option to purchase warrants to purchase an aggregate of 300,000 shares of the Company’s common stock.
−Removed: Additionally, pursuant to the February 2020 Underwritten Offering, the Company issued warrants to purchase up to 150,000
−Removed: shares of Company common stock, immediately exercisable at an exercise price of $5.00 per share (the “
−Removed: February 2020
−Removed: Underwriter Warrants ”) to HCW, as underwriter.
−Removed: Net proceeds from the February 2020 Underwritten
−Removed: Offering were $7,093,000 after deducting underwriting discounts and commissions and offering expenses paid by the Company.
−Removed: April 2020 Registered Direct Offering
−Removed: and Private Placement —
−Removed: On April 2, 2020, the Company completed a registered direct offering (the “
−Removed: 2020 Offering ”) of 1,713,064 shares of the Company’s common stock at a purchase price of $2.21 per share and in
−Removed: a concurrent private placement, sold warrants to purchase an aggregate of 1,713,064 shares of the Company’s common stock
−Removed: at a purchase price of $0.125 per underlying warrant share and with an exercise price of $2.21 per share (the “
−Removed: Warrants ”).
−Removed: Net proceeds to the Company from the April 2020 Offering were $3,527,000 after deducting placement agent
−Removed: fees and offering expenses paid by the Company.
−Removed: In connection with the April 2020 Offering, the Company also issued warrants to
−Removed: purchase a total of 128,480 shares of the Company’s common stock with an exercise price of $2.9188 per share (the “
−Removed: 2020 Placement Agent Warrants ”) to the placement agent, HCW.
−Removed: Company first assesses the warrants it issues under the FASB ASC Topic 480, “
−Removed: Distinguishing Liabilities from Equity ”
−Removed: ASC 480 ”) to determine whether they are within the scope of ASC 480.
−Removed: As there are no instances outside of
−Removed: the Company’s control that could require cash settlement of the warrants, the Company’s outstanding warrants are outside
−Removed: the scope of ASC 480.
−Removed: Company then applies and follows the applicable accounting guidance in ASC 815.
−Removed: Financial instruments are accounted for as either
−Removed: derivative liabilities or as equity instruments depending on the specific terms of the agreement.
−Removed: The Company’s outstanding
−Removed: warrants do not meet the definition of a derivative instrument as they are indexed to the Company’s common stock and classified
−Removed: within stockholders’
−Removed: Based on this determination, all of the Company’s outstanding warrants issued are classified
−Removed: within stockholders’
−Removed: The following table summarizes warrant
−Removed: activity and the shares of common stock underlying the Company’s outstanding equity-classified warrants for the year ended
−Removed: December 31, 2020:
−Removed: Balance December 31,
+Added: On February 12, 2020, HCW exercised its option
+Added: to purchase warrants to purchase an aggregate of 300,000
+Added: shares of the Company’s common stock.
+Added: Net proceeds from the
+Added: February 2020 Underwritten Offering were $ 7,093,000
+Added: after deducting underwriting discounts and commissions and offering expenses paid by the Company.
+Added: April 2020 Registered
+Added: Direct Offering and Private Placement — On April 2, 2020, the Company completed a registered direct offering (the
+Added: “ April 2020 Offering ”) of 1,713,064 shares
+Added: of the Company’s common stock at a purchase price of $ 2.21 per
+Added: share and in a concurrent private placement, sold warrants to purchase an aggregate of 1,713,064 shares
+Added: of the Company’s common stock at a purchase price of $ 0.125 per
+Added: underlying warrant share and with an exercise price of $ 2.21 per
+Added: share (the “ April 2020 Warrants ”).
+Added: In connection with the April 2020 Offering, the Company also issued warrants
+Added: to purchase a total of 128,480 shares
+Added: of the Company’s common stock with an exercise price of $ 2.9188 per
+Added: share (the “ April 2020 Placement Agent Warrants ”) to the placement agent, HCW.
+Added: Net proceeds to the Company from
+Added: the April 2020 Offering were $ 3,527,000
+Added: after deducting placement agent fees and offering expenses paid by the Company.
+Added: first assesses the warrants it issues under the FASB ASC Topic 480, “ Distinguishing Liabilities from Equity ” (“ ASC
+Added: 480 ”) to determine whether they are within the scope of ASC 480.
+Added: As there were no instances outside of the Company’s control
+Added: that could require cash settlement of the warrants issued in the Private Placement and Offering, as well as warrants issued in the Company’s
+Added: prior financing transactions, the Company’s outstanding warrants are outside the scope of ASC 480.
+Added: then applies and follows the applicable accounting guidance in ASC 815.
+Added: Financial instruments are accounted for as either derivative liabilities
+Added: or as equity instruments depending on the specific terms of the agreement.
+Added: The warrants issued in the Private Placement and the Offering
+Added: do not meet the definition of a derivative instrument as they are indexed to the Company’s common stock and classified within stockholders’
+Added: equity, as are the warrants issued in the Company’s prior financing transactions.
+Added: Based on this determination, the Company’s
+Added: warrants are classified within stockholders’ equity.
+Added: The following
+Added: table summarizes the Company’s outstanding equity-classified warrants at December 31, 2021:
+Added: Summary of outstanding warrants
Balance December 31,
−Removed: June 2015 Warrants
December 2016 Warrants
6 unchanged sentences
February 2020 Placement Agent Warrants
−Removed: February 2020 Underwritten Offering Warrants
−Removed: February 2020 Pre-funded Warrants
−Removed: No expiration
+Added: February 2020 Warrants
February 2020 Underwriter Warrants
1 unchanged sentence
April 2020 Placement Agent Warrants
−Removed: During the year ended December 31, 2020,
−Removed: the Company received net proceeds of $3,856,000 from the exercise of warrants.
−Removed: During the year ended December 31, 2019, the Company
−Removed: received net proceeds of $72,000 from the exercise warrants.
−Removed: Of the warrants exercised during the year
−Removed: ended December 31, 2020, 428,266 of the Company’s April 2020 Warrants were exercised via a cashless exercise transaction
−Removed: and as a result a total of 225,796 shares of common stock were issued.
−Removed: There were no cashless exercises of warrants during the
−Removed: year ended December 31, 2019.
+Added: January 2021 Pre-Funded Warrants
+Added: No expiration
+Added: January 2021 Warrants
+Added: January 2021 Placement Agent Warrants
+Added: February 2021
+Added: Placement Agent Warrants
+Added: ( 1,083,321 )
+Added: The Company received net proceeds of $ 2,146,000 and
+Added: from the exercise of warrants during the years ended December 31, 2021 and 2020, respectively.
+Added: Of the warrants exercised during the year ended
+Added: December 31, 2020, 428,266 of the Company’s April 2020 Warrants were exercised via a cashless exercise transaction and as a result
+Added: a total of 225,796 shares of common stock were issued.
+Added: There were no such cashless exercises of warrants during the year ended December
Net Loss per Share
−Removed: The following table sets forth the potential
−Removed: common shares excluded from the calculation of net loss per share because their inclusion would be anti-dilutive:
+Added: The following table sets forth the potential common
+Added: shares excluded from the calculation of net loss per share because their inclusion would be anti-dilutive:
+Added: Schedule of antidilutive stock
Options to purchase common stock
−Removed: Nonvested restricted stock units
+Added: Unvested restricted stock units
Warrants to purchase common stock
Stock-based Compensation
−Removed: The Company’s approved equity plans
−Removed: include the Phio Pharmaceuticals Corp.
−Removed: 2020 Long Term Incentive Plan (the “
−Removed: 2020 Plan ”) and the Phio Pharmaceuticals
−Removed: 2012 Long Term Incentive Plan (the “
−Removed: 2012 Plan ”).
−Removed: These plans are administered by our board of directors
−Removed: and provide for the grant of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock
−Removed: awards, restricted stock unit awards, performance stock awards, and performance cash awards.
−Removed: Upon adoption of the 2020 Plan, shares
−Removed: that remained available for grant under the 2012 Plan and shares that were subject to outstanding awards under the 2012 Plan were
−Removed: included in the authorized shares available for grant under the 2020 Plan.
−Removed: Further, upon adoption of the 2020 Plan, the Company
−Removed: no longer grants new equity awards under the 2012 Plan.
−Removed: As of December 31, 2020, there were
−Removed: an aggregate of 1,267,675 shares of common stock reserved under the 2020 Plan, including 2,570 shares subject to outstanding stock
−Removed: options and 9,699 shares subject to unvested restricted stock units (“
−Removed: RSUs ”) and 1,254,906 shares available
−Removed: for future grants.
−Removed: Stock options and RSUs granted by the Company to employees generally vest annually over 4 years after the grant
−Removed: date and, in the instance of stock options, expire within ten years of issuance.
+Added: The Company’s approved equity plans include
+Added: the Phio Pharmaceuticals Corp.
+Added: 2020 Long Term Incentive Plan (the “ 2020 Plan ”) and the Phio Pharmaceuticals Corp.
+Added: Long Term Incentive Plan (the “ 2012 Plan ”).
+Added: These plans are administered by our board of directors and provide for
+Added: the grant of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock awards, restricted stock
+Added: unit awards, performance stock awards, and performance cash awards.
+Added: Upon adoption of the 2020 Plan, shares that remained available for
+Added: grant under the 2012 Plan and shares that were subject to outstanding awards under the 2012 Plan were included in the authorized shares
+Added: available for grant under the 2020 Plan.
+Added: Further, upon adoption of the 2020 Plan, the Company no longer grants new equity awards under
+Added: the 2012 Plan.
+Added: As of December 31, 2021, there were an aggregate
+Added: shares of common stock reserved under the 2020 Plan, including 2,499 shares subject to outstanding stock options and 367,101 shares
+Added: subject to unvested restricted stock units (“ RSUs ”) and 894,227
+Added: shares available for future grants.
+Added: RSUs granted by the Company to employees vest annually over 3 years after the grant date,
+Added: stock options granted by the Company to employees generally vest annually over 4 years after the grant date and, in the instance of stock
+Added: options, expire within ten years of issuance.
Restricted Stock Units
−Removed: RSUs are issued under the 2020 Plan or as
−Removed: inducement grants issued outside of the plan to new employees.
−Removed: RSUs are generally subject to graded vesting and the satisfaction
−Removed: of service requirements.
−Removed: Upon vesting, each outstanding RSU will be exchanged for one share of the Company’s common stock.
−Removed: Employee RSU recipients may elect to net share settle upon vesting, in which case the Company pays the employee’s income
−Removed: taxes due upon vesting and withholds a number of shares of equal value.
−Removed: The fair value of the RSUs awarded are based upon the Company’s
−Removed: closing stock price at the grant date and are expensed over the requisite service period.
−Removed: The following table summarizes the activity
−Removed: of the Company’s RSUs for the year ended December 31, 2020:
+Added: RSUs are issued under the 2020 Plan or as inducement
+Added: grants issued outside of the plan to new employees.
+Added: RSUs are generally subject to graded vesting and the satisfaction of service requirements.
+Added: Upon vesting, each outstanding RSU will be exchanged for one share of the Company’s common stock.
+Added: Employee RSU recipients may elect
+Added: to net share settle upon vesting, in which case the Company pays the employee’s income taxes due upon vesting and withholds a number
+Added: of shares of equal value.
+Added: The fair value of the RSUs awarded are based upon the Company’s closing stock price at the grant date
+Added: and are expensed over the requisite service period.
+Added: The following table summarizes the activity of
+Added: the Company’s RSUs for the year ended December 31, 2021:
+Added: Summary of RSU activity
Grant Date Fair Value
1 unchanged sentence
Unvested units at December 31, 2021
−Removed: Stock-based compensation expense related
−Removed: to RSUs was $85,000 and $125,000 for the years ended December 31, 2020 and 2019, respectively.
+Added: Stock-based compensation expense related to RSUs
+Added: was $ 443,000 and $ 85,000 for the years ended December 31, 2021 and 2020, respectively.
+Added: The aggregate fair value of awards that
+Added: vested during the year ended December 31, 2021 was $ 9,400 ,
+Added: which represents the market value of the Company’s common stock on the date that the RSUs vested.
As of December 31, 2021, the compensation
−Removed: expense for all unvested RSUs in the amount of approximately $151,000 will be recognized in the Company’s results of operations
+Added: expense for all unvested RSUs in the amount of approximately $ 770,000 will be recognized in the Company’s results of operations
over a weighted average period of 2.03 years.
Stock Options
−Removed: Stock options are issued under the 2020
−Removed: Plan or as inducement grants issued outside of the plan to new employees.
−Removed: Stock options are generally subject to graded vesting
−Removed: and the satisfaction of service requirements.
−Removed: Upon the exercise of a stock option, the Company
−Removed: issues new shares and delivers them to the recipient.
−Removed: The Company does not expect to repurchase shares to satisfy stock option
−Removed: The Company uses the Black-Scholes option-pricing model to determine the fair value of all its option grants.
−Removed: The Company did not grant stock options during the year ended December 31, 2020.
−Removed: For valuing options granted during the year ended
−Removed: December 31, 2019, the following assumptions were used:
−Removed: December 31, 2019
−Removed: Risk-free interest rate
−Removed: Expected volatility
−Removed: 97.67 –
−Removed: Expected lives (in years)
−Removed: Expected dividend yield
−Removed: The weighted-average fair value of
−Removed: options granted during the year ended December 31, 2019 was $16.50 per share.
+Added: Stock options are issued under the 2020 Plan or
+Added: as inducement grants issued outside of the plan to new employees.
+Added: Stock options are generally subject to graded vesting and the satisfaction
+Added: of service requirements.
+Added: Upon the exercise of a stock option, the Company issues new shares and
+Added: delivers them to the recipient.
+Added: The Company does not expect to repurchase shares to satisfy stock option exercises.
The Company uses the Black-Scholes option-pricing
model to determine the fair value of all its option grants.
−Removed: The risk-free interest rate used for each grant was based upon the
−Removed: yield on zero-coupon U.S.
+Added: The risk-free interest rate used for each grant was based upon the yield on
+Added: zero-coupon U.S.
Treasury securities with a term similar to the expected life of the related option.
−Removed: The Company’s
−Removed: expected stock price volatility assumption is based upon the Company’s own implied volatility.
−Removed: As the Company has limited
−Removed: stock option exercise information, the expected life assumption used for option grants is based upon the simplified method provided
−Removed: for under ASC 718.
−Removed: The dividend yield assumption is based upon the fact that the Company has never paid cash dividends and presently
−Removed: has no intention of paying cash dividends.
−Removed: The following table summarizes the activity
−Removed: of the Company’s stock option plan for the year ended December 31, 2020:
+Added: The Company’s expected stock
+Added: price volatility assumption is based upon the Company’s own implied volatility.
+Added: As the Company has limited stock option exercise
+Added: information, the expected life assumption used for option grants is based upon the simplified method provided for under ASC 718.
+Added: yield assumption is based upon the fact that the Company has never paid cash dividends and presently has no intention of paying cash dividends.
+Added: The Company did not grant stock options during
+Added: the years ended December 31, 2021 and December 31, 2020.
+Added: The following table summarizes the activity of the Company’s stock option
+Added: plan for the year ended December 31, 2021:
+Added: Summary of Stock Option Activity
Balance at December 31, 2020
1 unchanged sentence
Exercisable at December 31, 2021
−Removed: Stock-based compensation expense related
−Removed: to stock options for the years ended December 31, 2020 and 2019 was $51,000 and $69,000, respectively.
+Added: Stock-based compensation expense related to stock
+Added: options for the years ended December 31, 2021 and 2020 was $ 37,000 and $ 51,000 , respectively.
As of December 31, 2021, the compensation
−Removed: expense for all unvested stock options in the amount of approximately $58,000 will be recognized in the Company’s results
−Removed: of operations over a weighted average period of 1.47 years.
−Removed: There is no income tax benefit as the Company
−Removed: is currently operating at a loss and an actual income tax benefit may not be realized.
−Removed: Restricted Stock
−Removed: During the period of from September 15,
−Removed: 2018 to February 28, 2019, the Company’s former Chief Executive Officer elected the right to receive, in lieu cash, up to
−Removed: 50% of his base salary and cash bonuses, if any, (collectively, the “
−Removed: Compensation ”) payable in the form of unvested,
−Removed: restricted shares of the Company’s common stock.
−Removed: Such restricted shares were received in the form of a series of grants made
−Removed: on each Company payroll date in lieu of cash payment of the Compensation.
−Removed: All shares issued in lieu of Compensation vested in full
−Removed: on June 1, 2019.
−Removed: The fair value of the restricted stock was based on the Company’s closing stock price on the date of grant
−Removed: and was expensed over the vesting period.
−Removed: During the year ended December 31, 2019, the Company granted 4,419 shares of restricted
−Removed: stock in lieu of Compensation and recorded $106,000 in stock-based compensation expense.
+Added: expense for all unvested stock options in the amount of approximately $ 21,000 will be recognized in the Company’s results of operations
+Added: over a weighted average period of 0.58 years.
+Added: There is no income tax benefit as the Company is
+Added: currently operating at a loss and an actual income tax benefit may not be realized.
Compensation Expense Related to Equity Awards
1 unchanged sentence
compensation expense for the years ended December 31, 2021 and 2020, in thousands:
+Added: Details of Stock-based Compensation Expense
Research and development
1 unchanged sentence
Total stock-based compensation
−Removed: For the years ended December 31, 2020
−Removed: and 2019, all of the Company’s loss before income taxes was generated in the United States.
−Removed: The components of federal and state income
−Removed: tax expense (benefit) are as follows, in thousands:
+Added: The provisions for income taxes for the years ended
+Added: December 31, 2021 and 2020 are as follows, in thousands:
+Added: Components of Federal and State Income Tax Expense
Years Ended December 31,
2 unchanged sentences
Valuation allowance
−Removed: Total income tax expense (benefit)
−Removed: Reconciliation of the effective income tax
−Removed: rate to the U.S.
+Added: Total provision for income taxes
+Added: Reconciliation of the effective income tax rate
statutory rate is as follows:
+Added: Schedule of effective income tax reconciliation
Years Ended December 31,
5 unchanged sentences
Effective tax rate
−Removed: The components of the Company’s deferred
+Added: The Company recognizes deferred tax assets and
+Added: liabilities to reflect the tax effects of temporary differences between the tax basis of assets or liabilities and their reported amounts
+Added: in the financial statements in accordance with ASC 740.
+Added: These temporary differences will result in taxable or deductible amounts in future
+Added: years when the reported amounts of the assets or liabilities are recovered or settled.
+Added: ASC 740 requires that a valuation allowance be
+Added: established when management determines that it is more likely than not that all or a portion of a deferred asset will not be realized.
+Added: The Company evaluates the realizability of its net deferred income tax assets and valuation allowances as necessary, at least on an annual
+Added: During this evaluation, the Company reviews its forecasts of income in conjunction with other positive and negative evidence surrounding
+Added: the realizability of its deferred income tax assets to determine if a valuation allowance is required.
+Added: Adjustments to the valuation allowance
+Added: will increase or decrease the Company’s income tax provision or benefit.
+Added: The components of the Company’s deferred
tax assets are as follows, in thousands:
+Added: Schedule of deferred
Years Ending December 31,
4 unchanged sentences
Licensing deduction deferral
−Removed: Other timing differences
Lease liability
+Added: Other timing differences
Deferred tax assets
4 unchanged sentences
Net deferred tax asset
−Removed: The Company’s deferred tax assets
−Removed: at December 31, 2020 and 2019 consisted primarily of its net operating loss carryforwards, tax credit carryforwards, deferred
−Removed: compensation and intangible assets capitalized for federal income tax purposes.
−Removed: The valuation allowance increased $2,641,000 and
−Removed: $2,532,000 for the years ended December 31, 2020 and 2019, respectively, and is primarily attributable to an increase in net
−Removed: operating losses and tax credits.
−Removed: The Company has incurred net operating losses since inception.
−Removed: At December 31,
−Removed: 2020, the Company had federal and state net operating loss carryforwards of approximately $83,600,000 and $75,300,000, respectively,
−Removed: which will begin to expire in 2031.
−Removed: Approximately, $55,300,000 of the federal net operating
−Removed: loss carryforwards will begin to expire in 2031, unless previously utilized, and approximately $28,300,000 of the federal net
−Removed: operating loss carryforwards will carryforward indefinitely.
−Removed: The Company’s state tax loss carryforwards will begin to expire
−Removed: in 2031, unless previously utilized.
−Removed: In addition, the Company has federal and state research credits of $1,430,000
−Removed: and $742,000, respectively, which begin to expire in 2031.
−Removed: Based on an assessment of all available evidence including, but not
−Removed: limited to the Company’s limited operating history in its core business and lack of profitability, uncertainties of the
−Removed: commercial viability of its technology, the impact of government regulation and healthcare reform initiatives, and other risks
−Removed: normally associated with biotechnology companies, the Company has concluded that it is more likely than not that these net operating
−Removed: loss carryforwards and credits will not be realized and, as a result, a full deferred income tax valuation allowance has been
−Removed: recorded against these assets.
−Removed: In general, an ownership change, as
−Removed: defined by Section 382 of the Internal Revenue Code, results from transactions increasing the ownership of certain
−Removed: shareholders or public groups in the stock of a corporation by more than 50% over a three-year period.
−Removed: The Company has not
−Removed: conducted a study to assess whether a change of control has occurred or whether there have been multiple changes of control
−Removed: since inception due to their history of losses.
−Removed: If the Company has experienced a change of control, as defined by
−Removed: Section 382, at any time since inception, utilization of the net operating loss carryforwards or research and
−Removed: development tax credit carryforwards would be subject to an annual limitation under Section 382 and 383.
−Removed: Any limitation may
−Removed: result in expiration of a portion of the net operating loss carryforwards or research and development tax credit
−Removed: carryforwards before utilization.
−Removed: Further, until a study is completed and any limitation is known, no adjustments have been
−Removed: reflected in the deferred tax asset for net operating loss carryforwards.
−Removed: The Company files income tax returns in
−Removed: the United States, Massachusetts and New Jersey.
−Removed: The Company is subject to tax examinations for federal and state purposes for
−Removed: tax years 2012 through 2020.
−Removed: The Company has not recorded any uncertain tax positions as of December 31, 2020 or 2019.
−Removed: Company does not believe there will be any material changes in its unrecognized tax positions over the next 12 months.
−Removed: has not incurred any interest or penalties.
−Removed: In the event that the Company is assessed interest or penalties at some point in the
−Removed: future, they will be classified in the financial statements as general and administrative expenses.
−Removed: License Agreements
−Removed: As part of its business, the Company enters
−Removed: into licensing agreements with third parties that often require milestone and royalty payments based on the progress of the asset
−Removed: through development stages.
−Removed: Milestone payments may be required, for example, upon approval of the product for marketing by a regulatory
−Removed: In certain agreements, the Company is required to make royalty payments based upon a percentage of the sales of the products
−Removed: licensed pursuant to such agreements.
+Added: The Company evaluated the realizability of its
+Added: net deferred tax assets and concluded that, in accordance with the applicable accounting standards, that it is more likely than not that
+Added: the Company may not realize the benefit of all of its deferred tax assets.
+Added: Accordingly, a valuation allowance against 100% of its deferred
+Added: tax assets has been recorded.
+Added: Significant judgment is required in the evaluation of deferred tax benefits and differences in future results
+Added: from our estimates could result in material differences in the realization of these assets.
+Added: As of December 31, 2021, the Company had
+Added: federal net operating loss carryforwards of approximately $ 42,900,000
+Added: and state net operating loss carryforwards of approximately $ 18,100,000
+Added: to reduce future taxable income.
+Added: The utilization of the federal carryforwards as an available offset to future taxable
+Added: income is subject to limitations under federal income tax laws.
+Added: Under current federal income tax law, federal net operating losses
+Added: incurred in tax years beginning after December 31, 2017 may be carried forward indefinitely, but are limited to 80% of taxable
+Added: As of December
+Added: 31, 2021, approximately $ 42,579,000
+Added: of our federal net operating loss carryforwards will carryforward indefinitely, while the remaining federal net operating loss of
+Added: will begin to expire in 2031 , unless previously utilized.
+Added: The Company’s state tax loss carryforwards will begin to expire in
+Added: 2038 , unless previously utilized.
+Added: In addition, the Company had federal and state research and development credits of approximately
+Added: and $ 472,000 ,
+Added: respectively, which will begin to expire in 2042 .
+Added: Based on an assessment of all available evidence, the Company has concluded that
+Added: it is more likely than not that these net operating loss carryforwards and credits will not be realized and, as a result, a full
+Added: deferred income tax valuation allowance has been recorded against these assets.
+Added: Ownership changes may limit the amount of net operating
+Added: loss carryforwards or research and development tax credit carryforwards that can be utilized to offset future taxable income or tax liability.
+Added: In general, an ownership change, as defined by Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (the “ Code ”),
+Added: results from transactions increasing the ownership of certain shareholders or public groups in the stock of a corporation by more than
+Added: 50% over a three-year period.
+Added: If the Company has experienced a change of control, utilization of the net operating loss carryforwards
+Added: or research and development tax credit carryforwards would be subject to an annual limitation under Section 382 and 383 of the Code.
+Added: Any limitation may result in expiration of a portion of the net operating loss carryforwards or research and development tax credit carryforwards
+Added: before utilization.
+Added: During 2021, the Company completed an
+Added: assessment of the available net operating loss and tax credit carryforwards under Section 382 and 383 and determined that the
+Added: Company underwent six ownership changes during the period from 2012 to 2021.
+Added: As a result, net operating loss and tax credit
+Added: carryforwards attributable to the pre-ownership changes are subject to substantial annual limitations under Section 382 and 383 of
+Added: Code due to the ownership changes.
+Added: The Company has adjusted its net operating loss and tax credit carryforwards to address the
+Added: impact of the ownership changes.
+Added: This resulted in a reduction of available federal and state net operating loss carryforwards of
+Added: approximately $ 55,000,000 and $ 70,000,000 , respectively, which related to the years ended December 31, 2020 and prior.
+Added: resulted in a reduction of federal and state tax credit carryforwards of approximately $ 1,400,000 and $ 700,000 , respectively,
+Added: related to the years ended December 31, 2020 and prior.
+Added: Accordingly, the net operating loss and tax credit carryforwards presented
+Added: above for the year ending December 31, 2020 were reduced by $ 15,952,000 and $ 2,017,000 , respectively, with a corresponding reduction
+Added: to the valuation allowance of $ 17,969,000 .
+Added: The recognition and measurement of benefits related
+Added: to the Company’s tax positions requires significant judgment, as uncertainties often exist with respect to new laws, new interpretations
+Added: of existing laws, and rulings by taxing authorities.
+Added: The Company follows a more-likely-than not threshold for financial statement recognition
+Added: and measurement of a tax position taken, or expected to be taken in a tax return.
+Added: The guidance relates to, amongst other things, classification,
+Added: accounting for interest and penalties associated with tax positions, and disclosure requirements.
+Added: Any interest and penalties accrued related
+Added: to uncertain tax positions are recorded as tax expense.
+Added: Differences between actual results and the Company’s assumptions or changes
+Added: in the Company’s assumptions in future periods are recorded in the period they become known.
+Added: The Company has not recorded any uncertain
+Added: tax positions as of December 31, 2021 or 2020.
+Added: The Company does not believe there will be any material changes in its unrecognized
+Added: tax positions over the next 12 months.
+Added: The Company has not incurred any interest or penalties.
+Added: In the event that the Company is assessed
+Added: interest or penalties at some point in the future, they will be classified in the financial statements as general and administrative expenses.
+Added: The Company files income tax returns in the United
+Added: States, Massachusetts and New Jersey.
+Added: The Company is subject to tax examinations for federal and state purposes for tax years 2013 through
+Added: Collaboration
+Added: and License Agreements
+Added: In March 2021, the Company entered into a clinical
+Added: development collaboration with AgonOx, Inc.
+Added: (“ AgonOx ”), a private company developing a pipeline of novel immunotherapy
+Added: drugs targeting key regulators of the immune response to cancer.
+Added: Under the collaboration, the companies will develop a T cell-based therapy
+Added: using PH-762 and AgonOx’s “double positive” TIL (“ DP TIL ”) technology.
+Added: Per the terms of the clinical
+Added: development agreement, AgonOx will receive financial support from Phio to conduct a clinical trial with AgonOx’s DP TIL technology
+Added: Phio will be entitled to certain future development milestones and sales-based royalty payments from AgonOx’s DP TIL
+Added: The Company did not provide financial support to AgonOx, nor has Phio received milestone or sales-based royalty payments from
+Added: AgonOx under this agreement in 2021.
+Added: As part of its business, the Company enters into
+Added: licensing agreements with third parties that often require milestone and royalty payments based on the progress of the asset through development
+Added: Milestone payments may be required, for example, upon approval of the product for marketing by a regulatory agency.
+Added: agreements, the Company is required to make royalty payments based upon a percentage of the sales of the products licensed pursuant to
+Added: such agreements.
The expenditures required under these arrangements
−Removed: may be material individually in the event that the Company develops product candidates covered by the intellectual property licensed
−Removed: under any such arrangement, and in the unlikely event that milestones for multiple products covered by these arrangements were
−Removed: reached in the same period, the aggregate charge to expense could be material to the results of operations.
−Removed: In addition, these
−Removed: arrangements often give the Company discretion to unilaterally terminate development of the product, which would allow the Company
−Removed: to avoid making the contingent payments;
−Removed: however, the Company is unlikely to cease development if the compound successfully achieves
−Removed: clinical testing objectives.
−Removed: We have entered into
−Removed: an agreement with Advirna LLC (“
−Removed: Advirna ”), pursuant to which Advirna assigned to us its existing patent and
−Removed: technology rights related to the INTASYL™
−Removed: Under the terms of the agreement, in April 2012, the Company issued
−Removed: to Advirna shares of common stock equal to 5% of the Company’s fully-diluted shares outstanding at the time of issuance.
−Removed: In exchange, the Company is also obligated to pay Advirna an annual maintenance fee and a milestone payment upon the issuance of
−Removed: the first patent with valid claims covering the assigned technology, which was paid in 2014.
−Removed: Additionally, we will be required
−Removed: to pay low single-digit royalties to Advirna on any licensing revenue received by us with respect to future licensing of the assigned
−Removed: Advirna patent and technology rights.
−Removed: To date, royalties owed to Advirna under the agreement have been minimal.
−Removed: We also granted
−Removed: back to Advirna a license under the assigned patent and technology rights for fields of use outside human therapeutics.
−Removed: Our rights under the Advirna agreement will
−Removed: expire upon the later of:
−Removed: (i) the expiration of the last-to-expire of the “patent rights”
−Removed: (as defined therein)
−Removed: included in the Advirna agreement;
−Removed: or (ii) the abandonment of the last-to-be abandoned of such patents, unless earlier terminated
−Removed: in accordance with the provisions of the agreement.
−Removed: Subsequent Events
−Removed: 2021 Private Placement —
−Removed: On January 25, 2021, the Company closed on its private placement of 4,420,863
−Removed: shares of the Company’s common stock at a purchase price per share of $3.07, pre-funded warrants to purchase an aggregate
−Removed: of 140,065 shares of the Company’s common stock at a purchase price per pre-funded warrant share of $3.069, and warrants
−Removed: to purchase an aggregate of 3,420,696 shares of the Company’s common stock with an exercise price of $3.00 per warrant
−Removed: In connection with the private placement, the Company issued warrants to the placement agent, HCW, to purchase a total
−Removed: of 342,070 shares of the Company’s common stock at an exercise price of $3.8375.
−Removed: Net proceeds to the Company are estimated
−Removed: to be $12.7 million after deducting placement agent fees and offering expenses.
−Removed: The Company is currently reviewing the accounting
−Removed: for the pre-funded warrants and warrants issued in the January 2021 private placement.
−Removed: February 2021 Registered Direct Offering
−Removed: On February 12, 2021, the Company closed on a registered direct offering of 2,246,784 shares of the Company’s
−Removed: common stock at a purchase price of $3.42 per share.
−Removed: In connection with the registered direct offering, the Company issued warrants
−Removed: to the placement agent, HCW, to purchase a total of 168,509 shares of the Company’s common stock at an exercise price of
−Removed: Net proceeds to the Company are estimated to be $6.9 million after deducting placement agent fees and offering expenses.
−Removed: Warrant Exercises —
−Removed: to the balance sheet date, the Company received net proceeds of $2,146,000 from the exercise of warrants for a total of 1,083,321
−Removed: shares of common stock.
+Added: may be material individually in the event that the Company develops product candidates covered by the intellectual property licensed under
+Added: any such arrangement, and in the unlikely event that milestones for multiple products covered by these arrangements were reached in the
+Added: same period, the aggregate charge to expense could be material to the results of operations.
+Added: In addition, these arrangements often give
+Added: the Company discretion to unilaterally terminate development of the product, which would allow the Company to avoid making the contingent
+Added: however, the Company is unlikely to cease development if the compound successfully achieves clinical testing objectives.
+Added: We have entered into an agreement
+Added: with Advirna LLC (“ Advirna ”), pursuant to which Advirna assigned to us its existing patent and technology rights related
+Added: to the INTASYL™ technology.
+Added: Under the terms of the agreement, in April 2012, the Company issued to Advirna shares of common stock
+Added: equal to 5% of the Company’s fully-diluted shares outstanding at the time of issuance.
+Added: In exchange, the Company is also obligated
+Added: to pay Advirna an annual maintenance fee and a milestone payment upon the issuance of the first patent with valid claims covering the
+Added: assigned technology, which was paid in 2014.
+Added: Additionally, we will be required to pay low single-digit royalties to Advirna on any licensing
+Added: revenue received by us with respect to future licensing of the assigned Advirna patent and technology rights.
+Added: To date, royalties owed
+Added: to Advirna under the agreement have been minimal.
+Added: We also granted back to Advirna a license under the assigned patent and technology rights
+Added: for fields of use outside human therapeutics.
+Added: Our rights under the Advirna agreement will expire
+Added: upon the later of:
+Added: (i) the expiration of the last-to-expire of the “patent rights” (as defined therein) included in
+Added: the Advirna agreement;
+Added: or (ii) the abandonment of the last-to-be abandoned of such patents, unless earlier terminated in accordance
+Added: with the provisions of the agreement.
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.