Item 8. Financial Statements and Supplementary Data
ITEM 8.
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page
Report of Independent Registered Public Accounting Firm
F-1
Consolidated Balance Sheets as of December 31, 2020 and 2019
F-3
Consolidated Statements of Operations for the Years Ended December 31, 2020 and 2019
F-4
Consolidated Statements of Stockholders’ Equity for the Years Ended December 31, 2020 and 2019
F-5
Consolidated Statements of Cash Flows for the Years Ended December 31, 2020 and 2019
F-6
Notes to Consolidated Financial Statements
F-7
37
Report of Independent Registered Public
Accounting Firm
Stockholders and Board of Directors
Phio Pharmaceuticals Corp.
Marlborough, Massachusetts
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheets
of Phio Pharmaceuticals Corp. (the “Company”) and subsidiary as of December 31, 2020 and 2019, the related consolidated
statements of operations, stockholders’ equity, and cash flows for each of the two years in the period ended December 31,
2020, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion,
the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31,
2020 and 2019, and the results of its operations and its cash flows for each of the two years in the period ended December 31,
2020 , in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
These consolidated financial statements are the responsibility
of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements
based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States)
(“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities
laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of
the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated
financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor
were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to
obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness
of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks
of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that
respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in
the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates
made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our
audits provide a reasonable basis for our opinion.
Critical
Audit Matter
The critical audit matter communicated
below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required
to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the consolidated
financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical
audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not,
by communicating the critical audit matter below, providing separate opinions on the critical audit matter or on the accounts or
disclosures to which it relates.
Accounting for warrants issued as part
of equity offerings
As described in Note 9 to the consolidated
financial statements, the Company entered into two registered direct offerings and an underwritten public offering during 2020
that included the issuance of common stock and warrants to purchase common stock. The warrants were evaluated for proper classification
on the balance sheet and it was determined that the warrants issued in these equity offerings should be classified within stockholders’
equity.
We identified the accounting for warrants
issued as part of equity offerings as a critical audit matter. Our principal considerations included the existence of accounting
complexities related to certain provisions of the warrant agreements, including provisions of cash settlement and derivative elements.
Auditing these elements required especially challenging auditor judgement and significant audit effort as well as the need for
specialized knowledge and skill assessing these elements of the agreement.
F- 1
The primary procedures we performed to
address this critical audit matter included:
· Reading the agreements related to the warrants issued along with management’s technical accounting
memos to understand the facts and circumstances within the warrant agreements and other assumptions impacting the determination
of warrant classification.
· 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
We have served as the Company’s auditor since 2011.
Boston, Massachusetts
March 25, 2021
F- 2
PHIO PHARMACEUTICALS CORP.
CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share data)
Years Ended December 31,
2020
2019
ASSETS
Current assets:
Cash
$ 14,244
$ 6,934
Restricted cash
50
50
Prepaid expenses and other current assets
870
316
Total current assets
15,164
7,300
Right of use asset, net
400
511
Property and equipment, net of accumulated depreciation of $1,122 and $1,048 in 2020 and 2019, respectively
157
210
Other assets
18
18
Total assets
$ 15,739
$ 8,039
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$ 728
$ 809
Accrued expenses and other current liabilities
1,352
964
Lease liability
116
107
Total current liabilities
2,196
1,880
Lease liability, net of current portion
295
411
Long-term debt
231
–
Total liabilities
2,722
2,291
Commitments and contingencies (Note 8)
Stockholders’ equity:
Preferred stock, $0.0001 par value, 10,000,000 shares authorized
–
–
Common stock, $0.0001 par value, 100,000,000 shares authorized; 5,780,973 and 669,433 shares issued and outstanding at December 31, 2020 and December 31, 2019, respectively
1
1
Additional paid-in capital
116,629
100,566
Accumulated deficit
(103,613 )
(94,819 )
Total stockholders’ equity
13,017
5,748
Total liabilities and stockholders’ equity
$ 15,739
$ 8,039
See accompanying notes to consolidated financial
statements.
F- 3
PHIO PHARMACEUTICALS CORP.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and
per share data)
Years Ended December 31,
2020
2019
Revenues
$ –
$ 21
Operating expenses:
Research and development
4,431
4,300
General and administrative
4,362
4,708
Total operating expenses
8,793
9,008
Operating loss
(8,793 )
(8,987 )
Total other (expense) income, net
(1 )
79
Loss before income taxes
(8,794 )
(8,908 )
Provision for income taxes
–
–
Net loss
$ (8,794 )
$ (8,908 )
Net loss per common share:
Basic and diluted
$ (1.92 )
$ (19.33 )
Weighted average number of common shares outstanding:
Basic and diluted
4,587,346
460,809
See accompanying notes to consolidated financial
statements.
F- 4
PHIO PHARMACEUTICALS CORP.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’
EQUITY
(Amounts in thousands, except share data)
Common
Stock
Additional
Paid-in
Accumulated
Shares
Amount
Capital
Deficit
Total
Balance at December 31, 2018
342,578
$ –
$ 99,489
$ (85,911 )
$ 13,578
Issuance of common stock upon
the exercise of warrants
130,338
–
72
–
72
Issuance of common stock under
Lincoln Park Capital, LLC purchase agreement
9,090
–
(58 )
–
(58 )
Issuance of restricted stock
4,419
–
–
–
–
Issuance of common stock under
employee stock purchase plan
36
–
1
–
1
Issuance of common stock in
connection with registered direct public offering, net of offering costs of $234
181,818
1
765
–
766
Issuance of common stock upon
vesting of restricted stock units
1,154
–
(3 )
–
(3 )
Stock-based compensation expense
–
–
300
–
300
Net loss
–
–
–
(8,908 )
(8,908 )
Balance at December 31,
2019
669,433
$ 1
$ 100,566
$ (94,819 )
$ 5,748
Cash in lieu of fractional
shares for 1:55 reverse stock split
(1,364 )
–
(15 )
–
(15 )
Issuance of common stock under
employee stock purchase plan
153
–
1
–
1
Issuance of common stock and
warrants in connection with registered direct and private placement offerings, net of offering costs of $746
1,910,120
–
4,994
–
4,994
Issuance of common stock,
pre-funded warrants and warrants in connection with underwritten public offering, net of offering costs of $906
993,633
–
7,093
–
7,093
Issuance of common stock upon
the exercise of warrants
2,205,663
–
3,856
–
3,856
Issuance of common stock upon
vesting of restricted stock units
3,335
–
(2 )
–
(2 )
Stock-based compensation expense
–
–
136
–
136
Net loss
–
–
–
(8,794 )
(8,794 )
Balance at December 31,
2020
5,780,973
$ 1
$ 116,629
$ (103,613 )
$ 13,017
See accompanying notes to consolidated financial
statements.
F- 5
PHIO PHARMACEUTICALS CORP.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Amounts in thousands)
Years Ended December 31,
2020
2019
Cash flows from operating activities:
Net loss
$ (8,794 )
$ (8,908 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization expense
72
67
Non-cash lease expense
111
109
Non-cash stock-based compensation expense
136
300
Changes in operating assets and liabilities:
Prepaid expenses and other assets
(554 )
(113 )
Accounts payable
(81 )
259
Accrued expenses and other liabilities
415
(257 )
Lease liability
(107 )
(102 )
Net cash used in operating activities
(8,802 )
(8,645 )
Cash flows from investing activities:
Cash paid for purchase of property and equipment
(19 )
(72 )
Net cash used in investing activities
(19 )
(72 )
Cash flows from financing activities:
Net proceeds from the issuance of common stock and warrants
12,087
708
Net proceeds from the exercise of warrants
3,856
72
Cash paid in lieu of fractional shares for 1:55 reverse stock split
(15 )
–
Payment of taxes for net share settled restricted stock unit issuances
(2 )
(3 )
Proceeds from debt
231
–
Proceeds from the issuance of common stock in connection with the employee stock purchase plan
1
1
Payments for capital lease obligations less than one year
(27 )
(6 )
Net cash provided by financing activities
16,131
772
Net increase (decrease) in cash and restricted cash
7,310
(7,945 )
Cash and restricted cash at the beginning of period
6,984
14,929
Cash and restricted cash at the end of period
$ 14,294
$ 6,984
Supplemental disclosure of cash flow information:
Interest paid
$ 6
$ 5
Supplemental disclosure of non-cash investing and financing activities:
Right of use asset obtained in exchange for operating lease liability
$ –
$ 620
Acquisition of property and equipment included in accrued expenses and other current liabilities
$ –
$ 33
See accompanying notes to consolidated financial
statements.
F- 6
PHIO PHARMACEUTICALS CORP.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. Nature of Operations
Phio
Pharmaceuticals Corp. (“ Phio ,” “ we ,” “ our ” or the “ Company ”)
is a biotechnology company developing the next generation of immuno-oncology therapeutics based on its self-delivering RNAi (“ INTASYL™ ”)
therapeutic platform. The Company’s efforts are focused on silencing tumor-induced suppression of the immune system through
its proprietary INTASYL platform with utility in immune cells and the tumor micro-environment. The Company’s goal is to develop
powerful INTASYL therapeutic compounds that can weaponize immune effector cells to overcome tumor immune escape, thereby potentially
providing patients with a powerful new treatment option that goes beyond current treatment modalities.
In December 2019, a novel strain of coronavirus
that causes COVID-19 was reported to have surfaced in Wuhan, China and has since spread to other parts of the world, including
the United States. In March 2020, the World Health Organization (the “ WHO ”) declared the outbreak
a pandemic. Our operations have continued with limited impact and are operating in accordance with federal, state, WHO and the
Center for Disease Control’s guidelines, including the implementation of safety measures such as working remotely, staggered
scheduling and cleaning protocols. While the measures to contain and prevent the spread of coronavirus may be modified
or extended, we expect that our activities, including our internal research and development functions, will continue to remain
largely operational.
As a result of the coronavirus pandemic,
certain of our third-party suppliers and service providers on which we rely have seen impacts to their operations. If the impact
to their operations continue or extend, it may in turn affect our operations. We previously had been able to engage with
third-party service providers in areas with limited or no impact (e.g. countries with limited or no restrictions), but with
the global spread of the virus and associated restrictions, this has been no longer possible. The Company does not expect a material
impact to its program’s anticipated timelines as a result of potential delays from our third-party service providers and
believes that it has a sufficient supply of our INTASYL compounds to conduct its ongoing preclinical studies and initial clinical
activities. The Company has also undertaken efforts to mitigate potential future impact by identifying and engaging alternative
third-party service providers and suppliers. However, the ultimate impact to these third parties on which we rely is highly uncertain
and subject to change. If the measures to contain the outbreak are extended or further expanded, it could reduce or delay the
availability of supplies and services that we purchase and outsource, which may in turn slow or delay our preclinical and clinical
activities, and/or result in higher costs.
We believe that the coronavirus pandemic has not had a significant impact on our operations and
financial condition thus far, however a variety of factors, including current and future restrictions and the length
of the pandemic, may further impact our operations and may slow or diminish our research and development activities. The extent
to which the coronavirus pandemic impacts our results will depend on future developments, which are highly uncertain and cannot
be predicted.
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying financial statements have
been prepared in accordance with accounting principles generally accepted in the United States of America (“ GAAP ”).
Additionally, certain reclassifications have been made to prior period financial statements to conform to the current period presentation.
Reverse Stock Split
Effective January 15, 2020, the Company
completed a 1-for-55 reverse stock split of the Company’s outstanding common stock. All share and per share amounts in the
financial statements have been retroactively adjusted for all periods presented to give effect to the reverse stock split, including
reclassifying an amount equal to the reduction in par value to additional paid-in capital. Unless otherwise noted, shares of common
stock issued and outstanding, shares underlying warrants and stock awards, shares reserved, conversion price of convertible securities,
exercise prices of warrants and stock awards and loss per share have been proportionately adjusted to reflect the reverse stock
split. The reverse stock split did not reduce the number of authorized shares of the Company’s common stock or preferred
stock.
Principles of Consolidation
The consolidated financial statements include
the accounts of Phio and its wholly owned subsidiary, MirImmune, LLC. All material intercompany accounts have been eliminated in
consolidation.
F- 7
Uses of Estimates in Preparation of Financial Statements
The preparation of financial statements
in accordance with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities
and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues
and expenses during the reporting period. The areas subject to significant estimates and judgement include, among others, those
related to the fair value of equity awards, research and development expenses, useful lives of property and equipment, income taxes,
and our valuation allowance on our deferred tax assets. On an ongoing basis we evaluate our estimates and base our estimates on
historical experience and other relevant assumptions that we believe are reasonable under the circumstances, including as a result
of new information that may emerge concerning the coronavirus pandemic. We have made estimates of the impact of the coronavirus
pandemic within our financial statements and there may be changes to those estimates in future periods. Actual results could differ
materially from these estimates.
Restricted Cash
Restricted cash consists of certificates
of deposit held by financial institutions as collateral for the Company’s corporate credit cards.
Concentrations of Credit Risk
Financial instruments that potentially subject
the Company to concentrations of credit risk consist principally of cash. The Company maintains cash balances in several accounts
with a financial institution that management believes is creditworthy, which at times are in excess of federally insured limits.
These accounts are insured by the Federal Deposit Insurance Corporation (FDIC) for up to
$250,000 per institution.
Property and Equipment
Property and equipment are stated at cost
and depreciated using the straight-line method based on the estimated useful lives of the related assets. The Company provides
for depreciation over the assets’ estimated useful lives as follows:
Computer equipment
3 years
Machinery & equipment
5 years
Furniture & fixtures
5 years
Leasehold improvements
5 years
Depreciation and amortization expense for
the years ended December 31, 2020 and 2019 was $72,000 and $67,000, respectively.
Impairment of Long-Lived Assets
The Company reviews long-lived assets for
impairment whenever an event occurs or change in circumstances that the related carrying amounts may not be recoverable. An impairment
loss would be recognized based on the difference between the carrying value of the asset and its estimated fair value, which would
be determined based on either discounted future cash flows or other appropriate fair value methods. The Company believes no impairment
existed as of December 31, 2020 or 2019.
Fair Value of Financial Instruments
The carrying amounts reported in the balance
sheet for restricted cash, accounts payable and accrued expenses approximate their fair values due to their short-term
nature.
F- 8
Leases
At the inception of a contract, the Company
determines whether the contract is or contains a lease based on all relevant facts and circumstances. For contracts that contain
a lease, the Company identifies the lease and non-lease components, determines the consideration in the contract and recognizes
the classification of the lease as operating or financing. For leases with a term greater than one year, the Company recognizes
a liability to make lease payments and an asset representing the right to use the underlying asset during the lease term at the
commencement date of the lease.
Lease liabilities and the corresponding
right of use assets are recorded based on the present value of lease payments to be made over the lease term. The discount rate
used to calculate the present value is the rate implicit in the lease, or if not readily determinable, the Company’s incremental
borrowing rate. The Company’s incremental borrowing rate is the rate of interest that the Company would have to pay to borrow
on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. Certain
adjustments to the right of use asset may be required for items such as initial direct costs or incentives received. Lease payments
on operating leases are recognized on a straight-line basis over the expected term of the lease. Lease payments on financing leases
are recognized using the effective interest method.
Debt
On March 27, 2020, the United States enacted
the Coronavirus Aid, Relief, and Economic Security Act (the “ CARES Act ”) in response to the coronavirus pandemic.
The CARES Act is an emergency economic stimulus package passed in response to the coronavirus outbreak that includes, but is not
limited to, provisions providing aid to small businesses in the form of loans and grants and numerous tax provisions such as certain
payroll tax benefits, changes to the net operating loss rules, and the business interest expense deduction rules. Outside of the
Paycheck Protection Program (the “ PPP ”) offered under the CARES Act, the Company has not utilized the other
loan programs and tax provisions, such as certain payroll tax benefits. On May 11, 2020, the Company received loan proceeds pursuant
to the PPP. The Company followed the guidance under the FASB ASC Topic 470, “ Debt ” (“ ASC 470 ”)
in assessing the accounting for the PPP loan proceeds. Per ASC 470, the Company recorded a liability on the balance sheet for the
full amount of PPP loan proceeds received and is accruing interest over the term of the loan. For additional information regarding
the Company’s accounting for the PPP loan proceeds, refer to Note 7. As there continues to be updates to the provisions under
the CARES Act, the Company will continue to assess the potential impacts on its business, results of operations and financial statements.
Derivative Financial Instruments
Financial instruments that meet the definition
of a derivative are classified as an asset or liability and measured at fair value on the issuance date and are revalued on each
subsequent balance sheet date. The changes in fair value are recognized as current period income or loss. Financial instruments
that do not meet the definition of a derivative are classified as equity and measured at fair value and recorded as additional
paid in capital in stockholders’ equity at the date of issuance. No further adjustments to their valuation are made.
Research and Development Expenses
Research
and development expenses relate to compensation and benefits for research and development personnel, facility-related expenses,
supplies, external services, costs to acquire technology licenses, expenses associated with preclinical and clinical development
activities and other operating costs. Research and development expenses are charged to expense as incurred. Payments made by the
Company in advance for research and development services not yet provided and/or for materials not yet received are recorded as
prepaid expenses and expensed when the service has been performed or when the goods have been received.
F- 9
Accrued
liabilities are recorded related to those expenses for which vendors have not yet billed the Company with respect to services provided
and/or materials that it has received. Accrued liabilities for the services provided by contract research organizations are recorded
during the period incurred based on such estimates and assumptions as expected cost, passage of time, the achievement of milestones
and other information available to us and are assessed on a quarterly basis. Actual results may differ from these estimates and
could have a material impact on the Company’s reported results. The Company’s historical accrual estimates have not
been materially different from its actual costs.
Stock-based Compensation
The Company follows the provisions of the
Financial Accounting Standards Board (the “ FASB ”) Accounting Standards Codification (“ ASC ”)
Topic 718, “ Compensation — Stock Compensation ” (“ ASC 718 ”), which requires the
measurement and recognition of compensation expense for all stock-based payment awards. The Company uses the Black-Scholes option-pricing
model to estimate the fair value of stock options at the grant date. The Black-Scholes valuation model requires the input of valuation
assumptions to calculate the value of stock options, including expected volatility, expected term, risk-free interest rate and
expected dividends. The fair value of restricted stock units is based upon the Company’s closing stock price at the grant
date. Stock-based compensation expense is recognized over the requisite service period, which generally represents the vesting
period, and commences at the date of grant based on the fair value of the award.
Stock-based
compensation expense recognized in the financial statements is based on awards that are ultimately expected to vest. Accordingly,
we are also required to estimate forfeitures at the time of grant, and to revise those estimates in subsequent periods if actual
forfeitures differ from estimates. We use historical data to estimate pre-vesting option forfeitures and record stock-based compensation
expense only for those awards that are expected to vest. Our forfeiture rate estimates are based on an analysis of our actual forfeiture
experience, employee turnover behavior, and other factors. The impact of any adjustments to our forfeiture rates would be recorded
as a cumulative adjustment in the period of adjustment. To the extent that actual forfeitures differ from our estimates, the difference
is recorded as a cumulative adjustment in the period the estimates were revised.
Income Taxes
The Company recognizes assets or liabilities
for the deferred tax consequences of temporary differences between the tax basis of assets or liabilities and their reported amounts
in the financial statements in accordance with the FASB ASC Topic 740, “Accounting for Income Taxes” (“ ASC
740 ”) . These temporary differences will result in taxable or deductible amounts in future years when the reported
amounts of the assets or liabilities are recovered or settled. Those temporary differences referred to as deferred tax assets and
liabilities are determined at the end of each period using the tax rate expected to be in effect when taxes are actually paid or
recovered.
ASC 740 requires that a valuation allowance
be established when management determines that it is more likely than not that all or a portion of a deferred asset will not be
realized. The Company evaluates the realizability of its net deferred income tax assets and valuation allowances as necessary,
at least on an annual basis. During this evaluation, the Company reviews its forecasts of income in conjunction with other positive
and negative evidence surrounding the realizability of its deferred income tax assets to determine if a valuation allowance is
required. Adjustments to the valuation allowance will increase or decrease the Company’s income tax provision or benefit.
The recognition and measurement of benefits
related to the Company’s tax positions requires significant judgment, as uncertainties often exist with respect to new laws,
new interpretations of existing laws, and rulings by taxing authorities. The Company follows a more-likely-than not threshold for
financial statement recognition and measurement of a tax position taken, or expected to be taken in a tax return. The guidance
relates to, amongst other things, classification, accounting for interest and penalties associated with tax positions, and disclosure
requirements. Any interest and penalties accrued related to uncertain tax positions are recorded as tax expense. Differences between
actual results and the Company’s assumptions or changes in the Company’s assumptions in future periods are recorded
in the period they become known.
Comprehensive Loss
The Company’s comprehensive loss is
equal to its net loss for all periods presented.
Net Loss per Share
Basic net loss per share is computed by
dividing net loss by the weighted average number of common shares outstanding. Diluted net loss per share is computed by dividing
the Company’s net less by the weighted average number of common shares outstanding and the impact of all dilutive potential
common shares outstanding, except where such dilutive potential common shares would be anti-dilutive. Dilutive potential common
shares primarily consist of warrants, restricted stock units and stock options.
F- 10
3. Liquidity and Going
Concern
The Company has reported recurring losses
from operations since inception and expects that the Company will continue to have negative cash flows from operations for the
foreseeable future. Historically, the Company’s primary source of funding has been the sale of its securities. The Company’s
ability to continue to fund its operations is dependent on obtaining funding from third parties, such as proceeds from the issuance
of debt, sale of equity, or strategic opportunities, in order to maintain its operations. This is dependent on a number of factors,
including the market demand or liquidity of the Company’s common stock. There is no guarantee that debt, additional equity
or other funding will be available to us on acceptable terms, or at all. If we fail to obtain additional funding when needed, we
would be forced to scale back or terminate our operations or seek to merge with or to be acquired by another company.
While we believe that the coronavirus pandemic
has not had a significant impact on our financial condition and results of operations at this time, the potential economic impact
brought by, and the duration of, the coronavirus pandemic is difficult to assess or predict. There may be developments outside
of our control that require us to adjust our operating plans and given the nature of the situation, we cannot reasonably estimate
the impact of the coronavirus pandemic on our financial conditions, results of operations or cash flows in the future.
The Company believes that its existing cash
and the net proceeds received from the Company’s financing activities subsequent to the balance sheet date, discussed further
in Note 14, should be sufficient to fund operations for at least the next 12 months from
the date of the release of these financial statements .
4. Recent Accounting Pronouncements
In November 2018, the FASB issued Accounting
Standards Update (“ ASU ”) 2018-18, “ Collaborative Arrangements (Topic 808) ” (“ Topic
808 ”), which clarifies the interaction between Topic 808 and ASC Topic 606, “ Revenue from Customers ”
(“ Topic 606 ”). The update provides guidance on whether certain transactions between collaborative arrangement
participants should be accounted for with revenue under Topic 606 and provides more comparability in the presentation of revenue
for certain transactions between collaborative arrangement participants. This ASU is effective for annual reporting periods beginning
after December 15, 2019, including interim periods within that reporting period. This guidance is required to be applied retrospectively
to the date of adoption of Topic 606. The Company adopted Topic 606 in the first quarter of 2018 and adopted
ASU 2018-18 in the first quarter of 2020. The Company also elected to apply ASU 2018-18 only to contracts that were not completed
at the date of initial application of Topic 606. Since the Company has no significant revenue, this ASU has no immediate impact
on the Company’s consolidated financial statements.
In December 2019, the FASB issued ASU 2019-12,
“ Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes .” The amendments in the update simplify
the accounting for income taxes by eliminating the exceptions related to the incremental approach for intraperiod tax allocation,
the recognition of a deferred tax liability for equity method investments, not recognizing a deferred tax liability for a foreign
subsidiary and the general methodology for calculating income taxes in an interim period. The
amendments also clarify and simplify other aspects of the accounting for income taxes. The amendments in ASU 2019-12 are effective
for public entities for fiscal years, and the interim periods within those fiscal years, beginning after December 20, 2020. Early
adoption is permitted. The Company does not expect the adoption of ASU 2019-12 to have a material impact on its consolidated
financial statements.
In
August 2020, the FASB issued ASU 2020-06, “ Debt – Debt with Conversion and Other Options (Subtopic 470-20) and
Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815 – 40)” (“ ASU
2020-06 ”), which simplifies the accounting for certain financial instruments with characteristics of liabilities and
equity, including convertible instruments and contracts in an entity’s own equity. The ASU is part of the FASB’s simplification
initiative, which aims to reduce unnecessary complexity in U.S. GAAP. For convertible instruments, the accounting models
for instruments issued with beneficial conversion features or cash conversion features are removed. For
contracts in an entity’s own equity, ASU 2020-06 simplifies the settlement assessment by removing the requirements to (1)
to consider whether the contract would be settled in registered shares, (2) to consider whether collateral is required to be posted,
and (3) to assess shareholder rights. ASU 2020-06 is effective for fiscal years beginning after December 15, 2023, and interim
periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15,
2020, and interim periods within those fiscal years. The Company does not expect the adoption of ASU 2020-06 to have a material
impact on its consolidated financial statements.
F- 11
5. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities
consist of the following, in thousands:
December 31,
2020
2019
Compensation and benefits
$ 618
$ 524
Professional fees
81
171
Research and development costs
549
242
Other
104
27
Total accrued expenses and other current liabilities
$ 1,352
$ 964
6. Leases
On January 22, 2019, the Company amended
the lease for its corporate headquarters and primary research facility in Marlborough, Massachusetts. The Company leases 7,581
square feet of office and laboratory space, which will expire on March 31, 2024. The lease contains an option to terminate the
lease after two years or three years by providing advance written notice of termination pursuant to the terms of the agreement.
The exercise of this option was not determined to be reasonably certain and thus is not included in the lease liability on the
Company’s balance sheet. Additionally, the lease agreement did not contain information to determine the rate implicit in
the lease. As such, the Company calculated its incremental borrowing rate based on what the Company would have to pay to borrow
on a collateralized basis over the lease term for an amount equal to the remaining lease payments taking into consideration such
assumptions as, but not limited to, the U.S. treasury yield rate and borrowing rates from a creditworthy financial institution
using the above lease factors.
The lease for our corporate headquarters
represents substantially all of our significant lease obligations. The amounts reported in the consolidated balance sheets for
operating leases in which the Company is the lessee and other supplemental balance sheet information is set forth as follows, in
thousands, except lease term and discount rate:
December 31, 2020
December 31, 2019
Assets
Right of use asset
$ 400
$ 511
Liabilities
Lease liability, current
116
107
Lease liability, non-current
295
411
Total lease liability
$ 411
$ 518
Lease Term and Discount Rate
Weighted average remaining lease term
3.71
4.43
Weighted average discount rate
4.70%
4.64%
Operating lease cost included in operating
expense was $132,000 and $127,000 for the years ended December 31, 2020 and 2019, respectively. Short-term lease costs were not
material for the years ended December 31, 2020 and 2019.
Cash paid for the amounts included in the
measurement of the operating lease liability on the Company’s consolidated balance sheets and included within changes in
the lease liability in the operating activities of our consolidated statement of cash flows was $127,800 and $121,000 for the years
ended December 31, 2020 and 2019, respectively.
F- 12
Future lease payments for our non-cancellable
operating leases and a reconciliation to the carrying amount of the operating lease liability presented in the consolidated
balance sheet as of December 31, 2020 is as follows, in thousands:
2021
$ 132
2022
135
2023
140
2024
35
Total lease payments
442
Less: Imputed interest
(31 )
Total operating lease liabilities (includes current portion)
$ 411
7. Debt
On May 11, 2020, the Company received loan
proceeds in the amount of $231,252 from Bank of America, N.A., as lender, pursuant to the PPP under the CARES Act. The PPP loan
matures on May 11, 2022, bears interest at a rate of 1% per year and monthly principal and interest payments are deferred to the
date that the Small Business Administration remits the borrower’s loan forgiveness amount to the lender. The loan may be
forgiven if used for eligible purposes, including payroll, benefits, rent and utilities. The Company believes it has used the loan
proceeds for the eligible purposes allowed and applied for full loan forgiveness. On February 18, 2021, the Small Business Administration
determined that the Company’s application for full loan forgiveness was fully approved and the full amount of the PPP loan
was remitted to the lender for forgiveness.
When applying for the PPP loan, the Company
carefully assessed the requirements for application under the program and believed that the loan was necessary to support its
operations. As loan forgiveness had not yet been determined at December 31, 2020, the Company followed the guidance under ASC
470 in assessing the accounting for the PPP loan proceeds. Per ASC 470, the Company recorded a liability on the balance sheet
for the full amount of PPP loan proceeds received and is accruing interest over the term of the loan. As of December 31, 2020,
the PPP loan proceeds have been classified as long-term debt on the balance sheet.
8. Commitments and Contingencies
License Commitments
The Company acquires assets under development
and enters into research and development arrangements with third parties that often require milestone and royalty payments based
on the progress of the asset through development stages. Milestone payments may be required, for example, upon approval of the
product for marketing by a regulatory agency. In certain agreements, the Company is required to make royalty payments based upon
a percentage of the sales of the products licensed pursuant to such agreements. Because of the contingent nature of these payments,
they are not included in the table of contractual obligations shown below. During the years
ended December 31, 2020 and 2019, the Company did not trigger any milestone payments.
F- 13
The Company’s contractual license
obligations that will require future cash payments as of December 31, 2020 are as follows, in thousands:
Year Ending December 31,
2021
165
2022
100
2023
100
2024
100
2025
100
Thereafter
400
Total
$ 965
The Company applies the disclosure provisions
of the FASB ASC Topic 460, “ Guarantor’s Accounting and Disclosure Requirements for Guarantees, Including Indirect
Guarantees of Indebtedness of Others ” (“ ASC 460 ”), to its agreements that contain guarantee or
indemnification clauses. The Company provides: (i) indemnifications of varying scope and size to certain investors and other
parties for certain losses suffered or incurred by the indemnified party in connection with various types of third-party claims;
and (ii) indemnifications of varying scope and size to officers and directors against third-party claims arising from the
services they provide to us. These indemnifications give rise only to the disclosure provisions of ASC 460. To date, the Company
has not incurred costs as a result of these obligations and does not expect to incur material costs in the future. Accordingly,
the Company has not accrued any liabilities in its consolidated financial statements related to these indemnifications.
Litigation
From time to time, the Company is party
to legal proceedings. There are none deemed to be material at this time. Accordingly, the Company has not accrued any liabilities
in its consolidated financial statements related to proceedings.
9. Stockholders’ Equity
November 2019 Registered Public Offering— On
November 19, 2019, the Company closed a registered public offering of 181,818 shares of the Company’s common stock at an
offering price of $5.50 per share (the “ November 2019 Offering ”). Net proceeds from the November 2019 Offering
were $766,000, after deducting fees and expenses. In connection with the November 2019 Offering, the Company issued warrants to
purchase a total of 13,636 shares of common stock with an exercise price of $6.875 per share (the “ November 2019 Placement
Agent Warrants ”) to the placement agent, H.C. Wainwright & Co., LLC (“ HCW ”).
Concurrent with the close of the November
2019 Offering, the Company unilaterally reduced the per share exercise price of all of the outstanding common stock warrants issued
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
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
Company’s common stock on November 15, 2019. The modification resulted in an increase in fair value of approximately $800,000.
This amount was recorded as a cost of capital of the November 2019 Offering and recorded in additional paid-in capital as the modification
was required to complete the capital raise.
February 2020 Registered Direct Offering
and Private Placement — On February 6, 2020, the Company completed a registered direct offering (the “ February
2020 Registered Offering ”) of 197,056 shares of the Company’s common stock at a purchase price of $8.705 per share
and in a concurrent private placement, sold warrants to purchase an aggregate of 197,056 shares of the Company’s common stock
at a purchase price of $0.125 per underlying warrant share and with an exercise price of $8.71 per share (the “ February
2020 Registered Direct Warrants ”). Net proceeds to the Company from the February 2020 Registered Offering were $1,467,000
after deducting placement agent fees and offering expenses paid by the Company. In connection with the February 2020 Registered
Offering, the Company also issued warrants to purchase a total of 14,779 shares of the Company’s common stock with an exercise
price of $11.0375 per share (the “ February 2020 Placement Agent Warrants ”) to the placement agent, HCW.
F- 14
February 2020 Underwritten Public Offering —
On February 13, 2020, the Company completed an underwritten public offering of 993,633 shares of the Company’s common stock
at a purchase price per share of $4.00, pre-funded warrants (the “ 2020 Pre-Funded Warrants ”) to purchase an
aggregate of 1,006,367 shares of the Company’s common stock at a purchase price per pre-funded warrant share of $3.999, and
warrants (the “ February 2020 Warrants ”) to purchase an aggregate of 2,000,000 shares of the Company’s
common stock with an exercise price of $4.00 per warrant shares (the “ February 2020 Underwritten Offering ”).
The 2020 Pre-Funded Warrants were immediately exercisable at an exercise price per share of $0.001 and each share of Company common
stock or 2020 Pre-Funded Warrant, as applicable, was sold with a February 2020 Warrant.
In connection with the February 2020
Underwritten Offering, the Company also granted to the underwriter, HCW, a 30-day
option to purchase up to an additional 300,000 shares of the Company’s common stock at a purchase price of $3.999 per
such share and/or warrants to purchase up to 300,000 shares of the Company’s common stock at a purchase price of $0.001
per such warrant. Such warrants have the same terms as the February 2020 Warrants. On February 12, 2020, HCW exercised its
option to purchase warrants to purchase an aggregate of 300,000 shares of the Company’s common stock.
Additionally, pursuant to the February 2020 Underwritten Offering, the Company issued warrants to purchase up to 150,000
shares of Company common stock, immediately exercisable at an exercise price of $5.00 per share (the “ February 2020
Underwriter Warrants ”) to HCW, as underwriter.
Net proceeds from the February 2020 Underwritten
Offering were $7,093,000 after deducting underwriting discounts and commissions and offering expenses paid by the Company.
April 2020 Registered Direct Offering
and Private Placement — On April 2, 2020, the Company completed a registered direct offering (the “ April
2020 Offering ”) of 1,713,064 shares of the Company’s common stock at a purchase price of $2.21 per share and in
a concurrent private placement, sold warrants to purchase an aggregate of 1,713,064 shares of the Company’s common stock
at a purchase price of $0.125 per underlying warrant share and with an exercise price of $2.21 per share (the “ April 2020
Warrants ”). Net proceeds to the Company from the April 2020 Offering were $3,527,000 after deducting placement agent
fees and offering expenses paid by the Company. In connection with the April 2020 Offering, the Company also issued warrants to
purchase a total of 128,480 shares of the Company’s common stock with an exercise price of $2.9188 per share (the “ April
2020 Placement Agent Warrants ”) to the placement agent, HCW.
Warrants
The
Company first assesses the warrants it issues under the FASB ASC Topic 480, “ Distinguishing Liabilities from Equity ”
(“ ASC 480 ”) to determine whether they are within the scope of ASC 480. As there are no instances outside of
the Company’s control that could require cash settlement of the warrants, the Company’s outstanding warrants are outside
the scope of ASC 480.
The
Company then applies and follows the applicable accounting guidance in ASC 815. Financial instruments are accounted for as either
derivative liabilities or as equity instruments depending on the specific terms of the agreement. The Company’s outstanding
warrants do not meet the definition of a derivative instrument as they are indexed to the Company’s common stock and classified
within stockholders’ equity. Based on this determination, all of the Company’s outstanding warrants issued are classified
within stockholders’ equity.
F- 15
The following table summarizes warrant
activity and the shares of common stock underlying the Company’s outstanding equity-classified warrants for the year ended
December 31, 2020:
Exercise
Expiration
Balance December 31,
Warrants
Warrants
Warrants
Balance December 31,
Description
Price
Date
2019
Issued
Exercised
Expired
2020
June 2015 Warrants
$ 2,860.00
6/2/2020
2,364
–
–
(2,364 )
–
December 2016 Warrants
$ 495.00
12/21/2021
23,233
–
–
–
23,233
April 2018 Warrants
$ 173.25
5/31/2023
20,599
–
–
–
20,599
April 2018 Placement Agent Warrants
$ 223.00
4/9/2023
1,373
–
–
–
1,373
October 2018 Warrants
$ 10.45
10/3/2025
389,610
–
–
–
389,610
October 2018 Underwriter Warrants
$ 13.06
10/1/2023
29,220
–
–
–
29,220
November 2019 Placement Agent Warrants
$ 6.875
11/18/2024
13,636
–
–
–
13,636
February 2020 Registered Direct Warrants
$ 8.71
8/6/2025
–
197,056
–
–
197,056
February 2020 Placement Agent Warrants
$ 11.0375
2/4/2025
–
14,779
–
–
14,779
February 2020 Underwritten Offering Warrants
$ 4.00
2/13/2025
–
2,300,000
(973,500 )
–
1,326,500
February 2020 Pre-funded Warrants
$ 0.001
No expiration
–
1,006,367
(1,006,367 )
–
–
February 2020 Underwriter Warrants
$ 5.00
2/11/2025
–
150,000
–
–
150,000
April 2020 Warrants
$ 2.21
10/2/2025
–
1,713,064
(428,266 )
–
1,284,798
April 2020 Placement Agent Warrants
$ 2.9188
3/31/2025
–
128,480
–
–
128,480
480,035
5,509,746
(2,408,133 )
(2,364 )
3,579,284
During the year ended December 31, 2020,
the Company received net proceeds of $3,856,000 from the exercise of warrants. During the year ended December 31, 2019, the Company
received net proceeds of $72,000 from the exercise warrants.
Of the warrants exercised during the year
ended December 31, 2020, 428,266 of the Company’s April 2020 Warrants were exercised via a cashless exercise transaction
and as a result a total of 225,796 shares of common stock were issued. There were no cashless exercises of warrants during the
year ended December 31, 2019.
10. Net Loss per Share
The following table sets forth the potential
common shares excluded from the calculation of net loss per share because their inclusion would be anti-dilutive:
December 31,
2020
2019
Options to purchase common stock
2,570
2,659
Nonvested restricted stock units
9,699
14,945
Warrants to purchase common stock
3,579,284
480,035
Total
3,591,553
497,639
F- 16
11. Stock-based Compensation
Stock Plans
The Company’s approved equity plans
include the Phio Pharmaceuticals Corp. 2020 Long Term Incentive Plan (the “ 2020 Plan ”) and the Phio Pharmaceuticals
Corp. 2012 Long Term Incentive Plan (the “ 2012 Plan ”). These plans are administered by our board of directors
and provide for the grant of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock
awards, restricted stock unit awards, performance stock awards, and performance cash awards. Upon adoption of the 2020 Plan, shares
that remained available for grant under the 2012 Plan and shares that were subject to outstanding awards under the 2012 Plan were
included in the authorized shares available for grant under the 2020 Plan. Further, upon adoption of the 2020 Plan, the Company
no longer grants new equity awards under the 2012 Plan.
As of December 31, 2020, there were
an aggregate of 1,267,675 shares of common stock reserved under the 2020 Plan, including 2,570 shares subject to outstanding stock
options and 9,699 shares subject to unvested restricted stock units (“ RSUs ”) and 1,254,906 shares available
for future grants. Stock options and RSUs granted by the Company to employees generally vest annually over 4 years after the grant
date and, in the instance of stock options, expire within ten years of issuance.
Restricted Stock Units
RSUs are issued under the 2020 Plan or as
inducement grants issued outside of the plan to new employees. RSUs are generally subject to graded vesting and the satisfaction
of service requirements. Upon vesting, each outstanding RSU will be exchanged for one share of the Company’s common stock.
Employee RSU recipients may elect to net share settle upon vesting, in which case the Company pays the employee’s income
taxes due upon vesting and withholds a number of shares of equal value. The fair value of the RSUs awarded are based upon the Company’s
closing stock price at the grant date and are expensed over the requisite service period.
The following table summarizes the activity
of the Company’s RSUs for the year ended December 31, 2020:
Number
of Shares
Weighted-
Average
Grant Date Fair Value
Per Share
Unvested units at December 31, 2019
14,945
$ 20.50
Granted
–
–
Vested
(4,282 )
22.18
Forfeited
(964 )
18.33
Unvested units at December 31, 2020
9,699
$ 19.97
Stock-based compensation expense related
to RSUs was $85,000 and $125,000 for the years ended December 31, 2020 and 2019, respectively.
F- 17
As of December 31, 2020, the compensation
expense for all unvested RSUs in the amount of approximately $151,000 will be recognized in the Company’s results of operations
over a weighted average period of 2.35 years.
Stock Options
Stock options are issued under the 2020
Plan or as inducement grants issued outside of the plan to new employees. Stock options are generally subject to graded vesting
and the satisfaction of service requirements. Upon the exercise of a stock option, the Company
issues new shares and delivers them to the recipient. 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.
The Company did not grant stock options during the year ended December 31, 2020. For valuing options granted during the year ended
December 31, 2019, the following assumptions were used:
December 31, 2019
Risk-free interest rate
1.85 – 2.58%
Expected volatility
97.67 – 98.87%
Expected lives (in years)
5.31
Expected dividend yield
0.00%
The weighted-average fair value of
options granted during the year ended December 31, 2019 was $16.50 per share.
The Company uses the Black-Scholes option-pricing
model to determine the fair value of all its option grants. The risk-free interest rate used for each grant was based upon the
yield on zero-coupon U.S. Treasury securities with a term similar to the expected life of the related option. The Company’s
expected stock price volatility assumption is based upon the Company’s own implied volatility. As the Company has limited
stock option exercise information, the expected life assumption used for option grants is based upon the simplified method provided
for under ASC 718. The dividend yield assumption is based upon the fact that the Company has never paid cash dividends and presently
has no intention of paying cash dividends.
F- 18
The following table summarizes the activity
of the Company’s stock option plan for the year ended December 31, 2020:
Total Number
of Shares
Weighted-
Average
Exercise
Price
Per Share
Weighted-
Average
Remaining
Contractual
Term
Aggregate
Intrinsic
Value
Balance at December 31, 2019
2,659
$ 3,298.90
Granted
–
–
Exercised
–
–
Cancelled
(89 )
2,671.45
Balance at December 31, 2020
2,570
$ 3,334.06
6.22 years
$ –
Exercisable at December 31, 2020
1,855
$ 4,578.01
5.70 years
$ –
Stock-based compensation expense related
to stock options for the years ended December 31, 2020 and 2019 was $51,000 and $69,000, respectively.
As of December 31, 2020, the compensation
expense for all unvested stock options in the amount of approximately $58,000 will be recognized in the Company’s results
of operations over a weighted average period of 1.47 years.
There is no income tax benefit as the Company
is currently operating at a loss and an actual income tax benefit may not be realized.
Restricted Stock
During the period of from September 15,
2018 to February 28, 2019, the Company’s former Chief Executive Officer elected the right to receive, in lieu cash, up to
50% of his base salary and cash bonuses, if any, (collectively, the “ Compensation ”) payable in the form of unvested,
restricted shares of the Company’s common stock. Such restricted shares were received in the form of a series of grants made
on each Company payroll date in lieu of cash payment of the Compensation. All shares issued in lieu of Compensation vested in full
on June 1, 2019. The fair value of the restricted stock was based on the Company’s closing stock price on the date of grant
and was expensed over the vesting period. During the year ended December 31, 2019, the Company granted 4,419 shares of restricted
stock in lieu of Compensation and recorded $106,000 in stock-based compensation expense.
F- 19
Compensation Expense Related to Equity Awards
The following table sets forth total stock-based
compensation expense for the years ended December 31, 2020 and 2019, in thousands:
December 31,
2020
2019
Research and development
$ 22
$ 21
General and administrative
114
279
Total stock-based compensation
$ 136
$ 300
12. Income Taxes
For the years ended December 31, 2020
and 2019, all of the Company’s loss before income taxes was generated in the United States.
The components of federal and state income
tax expense (benefit) are as follows, in thousands:
Years Ended December 31,
2020
2019
Current
Federal
$ –
$ –
State
–
–
Total current
–
–
Deferred
Federal
(1,873 )
(1,773 )
State
(768 )
(759 )
Total deferred
(2,641 )
(2,532 )
Valuation allowance
2,641
2,532
Total income tax expense (benefit)
$ –
$ –
Reconciliation of the effective income tax
rate to the U.S. statutory rate is as follows:
Years Ended December 31,
2020
2019
Federal statutory rate
21.0 %
21.0 %
State income taxes, net of federal benefit
6.7
6.7
Non-deductible expenses
(0.5 )
(0.2 )
Income tax credits
2.1
1.5
Valuation allowance
(29.3 )
(29.0 )
Effective tax rate
–
–
F- 20
The components of the Company’s deferred
tax assets are as follows, in thousands:
Years Ending December 31,
2020
2019
Deferred tax assets:
Net operating loss carryforwards
$ 22,307
$ 19,647
Tax credit carryforwards
2,017
1,710
Stock-based compensation
1,374
1,391
Licensing deduction deferral
2,376
2,717
Other timing differences
196
165
Lease liability
111
140
Deferred tax assets
28,381
25,770
Deferred tax liabilities:
Right of use asset
(108 )
(138 )
Deferred tax liability
(108 )
(138 )
Valuation allowance
(28,273 )
(25,632 )
Net deferred tax asset
$ –
$ –
The Company’s deferred tax assets
at December 31, 2020 and 2019 consisted primarily of its net operating loss carryforwards, tax credit carryforwards, deferred
compensation and intangible assets capitalized for federal income tax purposes. The valuation allowance increased $2,641,000 and
$2,532,000 for the years ended December 31, 2020 and 2019, respectively, and is primarily attributable to an increase in net
operating losses and tax credits.
The Company has incurred net operating losses since inception. At December 31,
2020, the Company had federal and state net operating loss carryforwards of approximately $83,600,000 and $75,300,000, respectively,
which will begin to expire in 2031. Approximately, $55,300,000 of the federal net operating
loss carryforwards will begin to expire in 2031, unless previously utilized, and approximately $28,300,000 of the federal net
operating loss carryforwards will carryforward indefinitely. The Company’s state tax loss carryforwards will begin to expire
in 2031, unless previously utilized. In addition, the Company has federal and state research credits of $1,430,000
and $742,000, respectively, which begin to expire in 2031. Based on an assessment of all available evidence including, but not
limited to the Company’s limited operating history in its core business and lack of profitability, uncertainties of the
commercial viability of its technology, the impact of government regulation and healthcare reform initiatives, and other risks
normally associated with biotechnology companies, the Company has concluded that it is more likely than not that these net operating
loss carryforwards and credits will not be realized and, as a result, a full deferred income tax valuation allowance has been
recorded against these assets.
In general, an ownership change, as
defined by Section 382 of the Internal Revenue Code, results from transactions increasing the ownership of certain
shareholders or public groups in the stock of a corporation by more than 50% over a three-year period. The Company has not
conducted a study to assess whether a change of control has occurred or whether there have been multiple changes of control
since inception due to their history of losses. If the Company has experienced a change of control, as defined by
Section 382, at any time since inception, utilization of the net operating loss carryforwards or research and
development tax credit carryforwards would be subject to an annual limitation under Section 382 and 383. Any limitation may
result in expiration of a portion of the net operating loss carryforwards or research and development tax credit
carryforwards before utilization. Further, until a study is completed and any limitation is known, no adjustments have been
reflected in the deferred tax asset for net operating loss carryforwards.
The Company files income tax returns in
the United States, Massachusetts and New Jersey. The Company is subject to tax examinations for federal and state purposes for
tax years 2012 through 2020. The Company has not recorded any uncertain tax positions as of December 31, 2020 or 2019. The
Company does not believe there will be any material changes in its unrecognized tax positions over the next 12 months. The Company
has not incurred any interest or penalties. In the event that the Company is assessed interest or penalties at some point in the
future, they will be classified in the financial statements as general and administrative expenses.
F- 21
13. License Agreements
As part of its business, the Company enters
into licensing agreements with third parties that often require milestone and royalty payments based on the progress of the asset
through development stages. Milestone payments may be required, for example, upon approval of the product for marketing by a regulatory
agency. In certain agreements, the Company is required to make royalty payments based upon a percentage of the sales of the products
licensed pursuant to such agreements.
The expenditures required under these arrangements
may be material individually in the event that the Company develops product candidates covered by the intellectual property licensed
under any such arrangement, and in the unlikely event that milestones for multiple products covered by these arrangements were
reached in the same period, the aggregate charge to expense could be material to the results of operations. In addition, these
arrangements often give the Company discretion to unilaterally terminate development of the product, which would allow the Company
to avoid making the contingent payments; however, the Company is unlikely to cease development if the compound successfully achieves
clinical testing objectives.
Advirna LLC. We have entered into
an agreement with Advirna LLC (“ Advirna ”), pursuant to which Advirna assigned to us its existing patent and
technology rights related to the INTASYL™ technology. Under the terms of the agreement, in April 2012, the Company issued
to Advirna shares of common stock equal to 5% of the Company’s fully-diluted shares outstanding at the time of issuance.
In exchange, the Company is also obligated to pay Advirna an annual maintenance fee and a milestone payment upon the issuance of
the first patent with valid claims covering the assigned technology, which was paid in 2014. Additionally, we will be required
to pay low single-digit royalties to Advirna on any licensing revenue received by us with respect to future licensing of the assigned
Advirna patent and technology rights. To date, royalties owed to Advirna under the agreement have been minimal. We also granted
back to Advirna a license under the assigned patent and technology rights for fields of use outside human therapeutics.
Our rights under the Advirna agreement will
expire upon the later of: (i) the expiration of the last-to-expire of the “patent rights” (as defined therein)
included in the Advirna agreement; or (ii) the abandonment of the last-to-be abandoned of such patents, unless earlier terminated
in accordance with the provisions of the agreement.
14. Subsequent Events
January
2021 Private Placement — On January 25, 2021, the Company closed on its private placement of 4,420,863
shares of the Company’s common stock at a purchase price per share of $3.07, pre-funded warrants to purchase an aggregate
of 140,065 shares of the Company’s common stock at a purchase price per pre-funded warrant share of $3.069, and warrants
to purchase an aggregate of 3,420,696 shares of the Company’s common stock with an exercise price of $3.00 per warrant
share. In connection with the private placement, the Company issued warrants to the placement agent, HCW, to purchase a total
of 342,070 shares of the Company’s common stock at an exercise price of $3.8375. Net proceeds to the Company are estimated
to be $12.7 million after deducting placement agent fees and offering expenses.
The Company is currently reviewing the accounting
for the pre-funded warrants and warrants issued in the January 2021 private placement.
February 2021 Registered Direct Offering
— On February 12, 2021, the Company closed on a registered direct offering of 2,246,784 shares of the Company’s
common stock at a purchase price of $3.42 per share. In connection with the registered direct offering, the Company issued warrants
to the placement agent, HCW, to purchase a total of 168,509 shares of the Company’s common stock at an exercise price of
$4.275. Net proceeds to the Company are estimated to be $6.9 million after deducting placement agent fees and offering expenses.
Warrant Exercises — Subsequent
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
shares of common stock.
F- 22
ITEM 9.
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
N/A.
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