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 (BDO USA, LLP; Boston, Massachusetts; PCAOB ID# 243)
F-1
Consolidated Balance Sheets as of December 31, 2021 and 2020
F-3
Consolidated Statements of Operations for the Years Ended December 31, 2021 and 2020
F-4
Consolidated Statements of Stockholders’ Equity for the Years Ended December 31, 2021 and 2020
F-5
Consolidated Statements of Cash Flows for the Years Ended December 31, 2021 and 2020
F-6
Notes to Consolidated Financial Statements
F-7
40
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, 2021 and 2020, the related consolidated statements
of operations, stockholders’ equity, and cash flows for each of the two years in the period ended December 31, 2021, and the related
notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements
present fairly, in all material respects, the financial position of the Company at December 31, 2021 and 2020, and the results of
its operations and its cash flows for each of the two years in the period ended December 31, 2021 , 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
offering
As described in Note 10 to the consolidated
financial statements, the Company completed a private placement offering in January 2021 that included the issuance of common stock
and warrants to purchase common stock. The warrants were evaluated for proper classification on the consolidated balance sheet and
it was determined that the warrants issued in this equity offering should be classified within stockholders’ equity.
We identified the accounting for warrants
issued as part of the equity offering in January 2021 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.
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 memo 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 22, 2022
243
F- 1
PHIO PHARMACEUTICALS CORP.
CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share data)
December 31,
2021
December 31,
2020
ASSETS
Current assets:
Cash
$ 24,057
$ 14,244
Restricted cash
50
50
Prepaid expenses and other current assets
620
870
Total current assets
24,727
15,164
Right of use asset, net
283
400
Property and equipment, net
133
157
Other assets
27
18
Total assets
$ 25,170
$ 15,739
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$ 283
$ 728
Accrued expenses
2,660
1,352
Lease liability
125
116
Total current liabilities
3,068
2,196
Lease liability, net of current portion
170
295
Long-term debt
–
231
Total liabilities
3,238
2,722
Commitments and contingencies (Footnote 9)
–
–
Stockholders’ equity:
Preferred stock, $ 0.0001 par value, 10,000,000 shares authorized
–
–
Common stock, $ 0.0001 par value, 100,000,000 shares authorized; 13,534,996 and 5,780,973 shares issued and outstanding at December 31, 2021 and December 31, 2020, respectively
1
1
Additional paid-in capital
138,831
116,629
Accumulated deficit
( 116,900 )
( 103,613 )
Total stockholders’ equity
21,932
13,017
Total liabilities and stockholders’ equity
$ 25,170
$ 15,739
See accompanying notes to consolidated financial
statements.
F- 2
PHIO PHARMACEUTICALS CORP.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per
share data)
Twelve Months Ended
December 31,
2021
2020
Operating expenses:
Research and development
$ 8,886
$ 3,716
General and administrative
4,625
5,077
Total operating expenses
13,511
8,793
Operating loss
( 13,511 )
( 8,793 )
Other income (expense)
Gain on extinguishment of debt
233
–
Interest (expense) income, net
( 9 )
( 1 )
Total other income (expense)
224
( 1 )
Loss before income taxes
( 13,287 )
( 8,794 )
Provision for income taxes
–
–
Net loss
$ ( 13,287 )
$ ( 8,794 )
Net loss per share:
Basic and diluted
$ ( 1.04 )
$ ( 1.92 )
Weighted average number of common shares outstanding
Basic and diluted
12,830,809
4,587,346
See accompanying notes to consolidated financial
statements.
F- 3
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, 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
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
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
Issuance of common stock, pre-funded
warrants and warrants in connection with private placement, net of offering costs
4,420,863
–
12,669
–
12,669
Issuance of common stock in registered
direct offering, net of offering costs
2,246,784
–
6,908
–
6,908
Issuance of common stock upon the
exercise of warrants
1,083,321
–
2,146
–
2,146
Issuance of common stock upon vesting
of restricted stock units
3,055
–
( 1 )
–
( 1 )
Stock-based compensation expense
–
–
480
–
480
Net loss
–
–
–
( 13,287 )
( 13,287 )
Balance at December 31,
2021
13,534,996
$ 1
$ 138,831
$ ( 116,900 )
$ 21,932
See accompanying notes to consolidated financial
statements.
F- 4
PHIO PHARMACEUTICALS CORP.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Amounts in thousands)
Twelve Months Ended
December 31,
2021
2020
Cash flows from operating activities:
Net loss
$ ( 13,287 )
$ ( 8,794 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
75
72
Non-cash lease expense
117
111
Non-cash stock-based compensation
480
136
Forgiveness of debt
( 233 )
–
Changes in operating assets and liabilities:
Prepaid expenses and other assets
241
( 554 )
Accounts payable
( 445 )
( 81 )
Accrued expenses and other liabilities
1,310
415
Lease liability
( 116 )
( 107 )
Net cash used in operating activities
( 11,858 )
( 8,802 )
Cash flows from investing activities:
Cash paid for purchase of property and equipment
( 51 )
( 19 )
Net cash used in investing activities
( 51 )
( 19 )
Cash flows from financing activities:
Net proceeds from the issuance of common stock and warrants
19,577
12,088
Net proceeds from the exercise of warrants
2,146
3,856
Proceeds from debt
–
231
Cash paid in lieu of fractional shares for 1:55 reverse stock split
–
( 15 )
Payments of taxes for net share settled restricted stock unit issuances
( 1 )
( 2 )
Payments of capital lease obligations less than one year
–
( 27 )
Net cash provided by financing activities
21,722
16,131
Net increase in cash and restricted cash
9,813
7,310
Cash and restricted cash at the beginning of period
14,294
6,984
Cash and restricted cash at the end of period
$ 24,107
$ 14,294
Supplemental disclosure of cash flow information:
Interest paid
$ 8
$ 6
See accompanying notes to consolidated financial
statements.
F- 5
PHIO PHARMACEUTICALS CORP.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. Nature of Operations
Phio Pharmaceuticals Corp. (“ Phio ,”
“ we ,” “ our ” or the “ Company ”) is seeking to address the biggest challenges in
immuno-oncology by creating new pathways to a cancer-free future for patients. We are developing therapeutics that leverage our INTASYL™
technology to target both tumor and immune cells by regulating genes to strengthen a patient’s immune system while weakening tumor
defense mechanisms. With our INTASYL self-delivering RNAi technology, we aim to bring the benefits of RNA therapeutics into cancer care
where other modalities may fall short.
Our operations are being conducted in accordance
with guidance provided by the World Health Organization, the Center for Disease Control and governmental authorities, including the implementation
of safety measures such as working remotely and flexible scheduling. We expect to continue following these safety measures and may take
further actions as we require, as government authorities require or recommend, or as we determine to be in the best interests of our employees.
As a result
of the coronavirus pandemic, certain of our third-party providers on which we rely have seen impacts to their operations. The Company
had and continues to undertake efforts to mitigate potential future impacts by identifying and engaging alternative third-party providers
to limit the impact of potential delays on our program’s anticipated timelines. However, the continued impacts to these third-party
providers, including, for example, limited availability of certain services and supplies, began significantly affecting our operations
in the second quarter of 2021, which resulted in delays to the start of our clinical trials. If measures to overcome the pandemic are
insufficient, it could further reduce or delay the availability of supplies and services that we purchase and rely on, which may in turn
further slow or delay our preclinical and clinical activities.
We believe
that the coronavirus pandemic has not had a significant impact on our financial condition to date; however a variety of factors such as
those described above, may further impact our operations and slow or diminish our research and development activities, which in turn may
impact our financial condition in the future. 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 prior year amounts have been reclassified for consistency with the current year presentation. The Company made an adjustment to
the consolidated statements of operations to reflect patent costs within general and administrative operating expenses in the consolidated
statements of operations. The reclassification increased general and administrative operating expenses and reduced research and development
operating expenses by $ 715,000 for the year ended December 31, 2020. This reclassification had no effect on total operating expenses,
net loss, net loss per share and had no impact on the Company’s consolidated balance sheets, statement of stockholders’ equity
and statement of cash flows for the prior year period.
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- 6
Uses of Estimates in Preparation of Financial Statements
The preparation of financial statements in accordance
with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during
the reporting period. The areas subject to significant estimates and judgement include, among others, those related to the fair value
of equity awards, accruals for research and development expenses, useful lives of property and equipment, income taxes, and our valuation
allowance on our deferred tax assets. On an ongoing basis we evaluate our estimates and base our estimates on historical experience and
other relevant assumptions that we believe are reasonable under the circumstances, including as a result of new information that may emerge
concerning the coronavirus pandemic. We have made estimates of the impact of the coronavirus pandemic within our financial statements
and there may be changes to those estimates in future periods. 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. The following table provides a reconciliation
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
cash flows (in thousands):
Schedule of Cash
December 31,
2021
2020
Cash
$
24,057
$
14,244
Restricted cash
50
50
Cash and restricted cash shown in the statement of cash flows
$
24,107
$
14,294
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 (the “ 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:
Schedule of estimated useful lives
Computer equipment
3 years
Machinery & equipment
5 years
Furniture & fixtures
5 years
Leasehold improvements
5 years
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, 2021 or 2020.
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.
The Company follows the provisions of the FASB
ASC Topic 820, “Fair Value Measurements and Disclosures,” for the Company’s financial assets and liabilities that are
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
value hierarchy that is broken down into three levels. Level inputs are defined as follows:
Level 1 – quoted prices in active markets
for identical assets or liabilities.
Level 2 – other significant observable inputs for the
assets or liabilities through corroboration with market data at the measurement date.
Level 3 – significant unobservable inputs that reflect
management’s best estimate of what market participants would use to price the assets or liabilities at the measurement date.
For the years ended December 31, 2021 and 2020, the Company categorized
its restricted cash of $ 50,000 as Level 2 hierarchy. The assets classified as Level 2 have initially been valued at the applicable transaction
price and subsequently valued, at the end of each reporting period, using other market observable data. Observable market data points
include quoted prices, interest rates, reportable trades and other industry and economic events.
F- 7
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, including scheduled
increases, 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 including, certain payroll tax benefits,
changes to the net operating loss rules and changes to the business interest expense deduction rules. In May 2020, the Company received
loan proceeds pursuant to the Paycheck Protection Program (the “ PPP ”) offered under the CARES Act, and
the loan was subsequently forgiven in February 2021. Outside of the PPP, the Company has not utilized the other CARES Act
loan programs and tax provisions, such as certain payroll tax benefits.
The Company followed the guidance under the Financial
Accounting Standards Board (the “ FASB ”) Accounting Standards Codification
(“ 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 the PPP loan proceeds received and accrued interest over the term of the loan. Upon loan
forgiveness, the Company recognized the extinguishment of the liability in the consolidated statement of operations as a gain on extinguishment
of debt.
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, research activities under our research collaborations, 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.
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.
F- 8
Collaborative Arrangements
The Company
follows the provisions of the FASB ASC Topic 808, “Collaborative Arrangements,” (“ Topic 808 ”) when collaboration
agreements involve joint operating activities in which both parties are active participants and that are also both exposed to significant
risks and rewards. The Company also considers the guidance in the FASB ASC Topic 606, “Revenue from Contracts with Customers,”
(“ Topic 606 ”) in determining the appropriate treatment for activities between the Company and its collaborative partners
that are more reflective of a vendor-customer relationship and therefore, within the scope of Topic 606. Under Topic 808, the Company
determines an appropriate recognition method, either by analogy to appropriate accounting literature or by applying a reasonable accounting
policy election. Generally, the classification of transactions under the collaborative arrangements is determined based on the nature
and contractual terms of the arrangement along with the nature of the operations of the participants. Payments
or reimbursements that are the result of a collaborative relationship instead of a customer relationship, such as co-development activities,
are recorded as increases or decreases to research and development expense.
Patents and Patent Application
Costs
Although the Company believes that its patents
and underlying technology have continuing value, the amount of future benefits to be derived from the patents is uncertain. Patent
costs are, therefore, expensed as general and administrative costs as incurred.
Stock-based Compensation
The Company follows the provisions of the FASB
ASC Topic 718, “ Compensation — Stock Compensation ” (“ ASC 718 ”), which requires the measurement
and recognition of compensation expense for all stock-based payment awards. The fair value of restricted stock units is based upon the
Company’s closing stock price at the grant date. The Company uses the Black-Scholes 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. 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 award forfeitures and record stock-based compensation expense only for
those awards that are expected to vest. Our forfeiture rate estimates are based on an analysis of our actual forfeiture experience, employee
turnover behavior, and other factors. The impact of any adjustments to our forfeiture rates is recorded as a cumulative adjustment in
the period of adjustment. To the extent that actual forfeitures differ from our estimates, the difference is recorded as a cumulative
adjustment in the period the estimates are 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. Valuation
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
tax asset will not be realized. The provision for income taxes, if any, represents the tax payable for the period and the change in deferred
income tax assets and liabilities during the period.
Immaterial Revision
In 2021, the Company completed an Internal Revenue
Code Section 382 analysis of its historical net operating loss carry-forward amount. As a result, the prior year net operating loss carry-forward
was determined to be limited. See Note 13 Income Taxes , for further details.
F- 9
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 loss by the weighted average number of common shares outstanding and the impact of all dilutive potential common shares outstanding,
except where such dilutive potential common shares would be anti-dilutive. Dilutive potential common shares primarily consist of warrants,
restricted stock units and stock options.
3. Liquidity and Going Concern
The Company has reported recurring losses from
operations since its inception and expects to continue to have negative cash flows from operations for the foreseeable future. Historically,
the Company’s primary source of funding has been from sales of its securities. The Company’s ability to continue to fund
its operations is dependent on obtaining funding from third parties, such as proceeds from the issuance of debt, sale of equity, or strategic
opportunities, in order to maintain its operations. This is dependent on a number of factors, including the market demand or liquidity
of the Company’s common stock. There is no guarantee that debt, additional equity or other funding will be available to us on acceptable
terms, or at all. If we fail to obtain additional funding when needed, we would be forced to scale back or terminate our operations or
seek to merge with or to be acquired by another company.
While we believe that the coronavirus pandemic
has not had a significant impact on our financial condition and results of operations at this time, the potential economic impact brought
by, and the duration of, the coronavirus pandemic is difficult to assess or predict. There may be developments outside of our control
that require us to adjust our operating plans and given the nature of the situation, we cannot reasonably estimate the impact of the coronavirus
pandemic on our financial conditions, results of operations or cash flows in the future.
The Company
believes that its existing cash should be sufficient to fund operations for at least the next 12 months from the date of the release
of these financial statements.
4. Recent Accounting Pronouncements
In December 2019, the FASB issued Accounting Standards
Update (“ ASU ”) 2019-12, “ Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes ”
(“ ASU 2019-12 ”). The amendments in the update simplify the accounting for income taxes by eliminating the exceptions
related to the incremental approach for intraperiod tax allocation, the recognition of a deferred tax liability for equity method investments,
not recognizing a deferred tax liability for a foreign subsidiary and the general methodology for calculating income taxes in an interim
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. The Company adopted ASU 2019-12 on January 1, 2021. The adoption of this standard did not have a material
impact on the Company’s consolidated financial statements.
In August
2020, the FASB issued ASU 2020-06, “ Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and
Hedging – Contracts in Entity’s Own Equity (Subtopic 815 – 40)” (“ ASU 2020-06 ”), which
simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments
and contracts in an entity’s own equity. ASU 2020-06 is part of the FASB’s simplification initiative, which aims to reduce
unnecessary complexity 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) consider whether the contract would be
settled in registered shares, (2) consider whether collateral is required to be posted, and (3) 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 early adopted
ASU 2020-06 on January 1, 2021. The adoption of this standard did not have an impact on the Company’s consolidated financial statements.
F- 10
In
May 2021, the FASB issued ASU 2021-04, “ Earnings per Share (Topic 260), Debt – Modifications and Extinguishments
(Subtopic 470-50), Compensation – Stock Compensation (Topic 718), and Derivatives and Hedging – Contracts in Entity’s
Own Equity (Subtopic 815-40) ” (“ ASU 2021-04 ”).
The amendments in the updates are intended to clarify and reduce diversity in an issuer’s accounting for modifications or exchanges
of freestanding equity-classified written call options that remain equity classified after modification or exchange. The amendments in
ASU 2021-04 are effective for all entities for fiscal years beginning after December 15, 2021, including interim periods within those
fiscal years. An entity should apply the amendments prospectively to modifications or exchanges occurring on or after the effective date
of the amendments. Early adoption is permitted for all entities, including within an interim period. The Company does not expect the adoption
of ASU 2021-04 to have a material impact on its consolidated financial statements.
5. Property and Equipment
The following table summarizes the Company’s
major classes of property and equipment:
Schedule of property and equipment
December 31,
2021
2020
Computer equipment
$ 108
$ 195
Machinery & equipment
1,035
992
Furniture & fixtures
49
46
Leasehold improvements
46
46
Total gross fixed assets
1,238
1,279
Less: accumulated depreciation and amortization
( 1,105 )
( 1,122 )
Property and equipment, net
$ 133
$ 157
Depreciation and amortization expense for the years
ended December 31, 2021 and 2020 was $ 75,000 and $ 72,000 , respectively.
6. Accrued Expenses
Accrued expenses consist of the following, in
thousands:
Schedule of accrued expenses and other current liabilities
December 31,
2021
2020
Compensation and benefits
$ 572
$ 618
Professional fees
102
81
Research and development costs
1,986
549
Other
–
104
Total accrued expenses and other current liabilities
$ 2,660
$ 1,352
7. Leases
In January 2019, the Company amended the
lease for its corporate headquarters and primary research facility in Marlborough, Massachusetts. The lease is for a total of 7,581
square feet of office and laboratory space and will expire on March
31, 2024 . The lease contains an option to terminate after two or three years by providing advance written notice of
termination pursuant to the terms of the agreement. The exercise of this option was not determined to be reasonably certain and thus
was not included in the lease liability on the Company’s balance sheet. The Company did not exercise its option to terminate
in either the second or third year of the lease, and the option to terminate has expired. Additionally, the lease agreement did not
contain information to determine the borrowing rate implicit in the lease. As such, the Company calculated its incremental borrowing
rate based on what the Company would have to pay to borrow on a collateralized basis over the lease term for an amount equal to the
remaining lease payments, taking into consideration such assumptions as, but not limited to, the U.S. treasury yield rate and
borrowing rates from a creditworthy financial institution using the above lease factors.
F- 11
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 the lease term (number of
years) and discount rate:
Schedule of lease amounts recorded in balance sheet
December 31, 2021
December 31, 2020
Assets
Right of use asset
$ 283
$ 400
Liabilities
Lease liability, current
125
116
Lease liability, non-current
170
295
Total lease liability
$ 295
$ 411
Lease Term and Discount Rate
Weighted average remaining lease term
2.25
3.25
Weighted average discount rate
4.70 %
4.70 %
Operating lease costs included in operating
expense were $ 132,000 and $ 132,000 for
the years ended December 31, 2021 and 2020, respectively. Short-term lease costs were not material for the years ended December 31,
2021 and 2020.
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 $ 131,600 and $ 127,800 for the years ended December 31, 2021
and 2020, respectively.
Future lease payments for our non-cancellable
operating leases and a reconciliation to the carrying amount of the operating lease liability presented in the consolidated balance sheet
as of December 31, 2021 is as follows, in thousands:
Aggregate future minimum lease payments
2022
$ 135
2023
140
2024
35
Total lease payments
310
Less: Imputed interest
( 15 )
Total operating lease liabilities (includes current portion)
$ 295
8. Debt
In
May 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 had a maturity date of May
11, 2022 , interest at a rate of 1 %
per year and monthly principal and interest payments that were deferred to the date that the Small Business Administration (the
“ SBA ”) remitted the borrower’s loan forgiveness amount to the lender. 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. The loans under the PPP may be forgiven if used for eligible purposes, including payroll, benefits, rent and
utilities.
The
Company followed the guidance under ASC 470 in assessing the accounting for the PPP loan proceeds. Per ASC 470, the Company recorded
a liability on the balance sheet for the full amount of PPP loan proceeds received and accrued interest over the term of the loan.
The Company believed it used the loan proceeds for eligible purposes and applied for full loan forgiveness. In February 2021, the
SBA approved the Company’s application for full loan forgiveness, and the full amount of the PPP loan was remitted to the
lender for forgiveness. Upon loan forgiveness, the Company recognized a gain on the extinguishment of debt of $ 233 ,000
for the loan proceeds received and interest accrued in the consolidated statements of operations for the year ended December
31, 2021.
F- 12
9. 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, 2021 and 2020, the Company
did not trigger any milestone payments.
The Company’s contractual license obligations
that will require future cash payments as of December 31, 2021 are as follows, in thousands:
Schedule of future cash payments for contractual
license obligations
Year Ending December 31,
2022
$ 100
2023
100
2024
100
2025
100
2026
100
Thereafter
300
Total
$ 800
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.
10. Stockholders’ Equity
January
2021 Private Placement — On January 25, 2021, the Company completed a private placement of 4,420,863 shares
of the Company’s common stock at a purchase price per share of $ 3.07 ,
pre-funded warrants to purchase an aggregate of 140,065
shares of the Company’s common stock (the “ January 2021 Pre-Funded Warrants ”) at a purchase price per
pre-funded warrant share of $ 3.069
and warrants to purchase an aggregate of 3,420,696 shares
of the Company’s common stock with an exercise price of $ 3.00 per
warrant share (the “ January 2021 Warrants ”) (the “ Private Placement ”). In connection with the
Private Placement, the Company issued warrants to the placement agent, H.C. Wainwright & Co., LLC (“ HCW ”), to
purchase a total of 342,070 shares
of the Company’s common stock at an exercise price of $ 3.8375 (the
“ January 2021 Placement Agent Warrants ”). Net proceeds to the Company from the Private Placement were $ 12,669,000 after
deducting placement agent fees and offering expenses.
February
2021 Registered Direct Offering — On February 17, 2021, the Company completed a registered direct offering
of 2,246,784 shares
of the Company’s common stock at a purchase price of $ 3.42 per
share (the “ Offering ”). In connection with the Offering, the Company issued warrants to the placement agent, HCW,
to purchase a total of 168,509 shares
of the Company’s common stock at an exercise price of $ 4.275 (the
“ February 2021 Placement Agent Warrants ”). Net proceeds to the Company from the Offering were $ 6,908,000
after deducting placement agent fees and offering expenses.
F- 13
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 ”). 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. 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.
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 share (the “ February 2020 Underwritten Offering ”). The 2020 Pre-Funded Warrants were immediately
exercisable at an exercise price per share of $ 0.001 and
each share of Company common stock or 2020 Pre-Funded Warrant, as applicable, was sold with a February 2020 Warrant. In connection
with the February 2020 Underwritten Offering, the Company issued warrants to purchase up to 150,000
shares of Company common stock, immediately exercisable at an exercise price of $ 5.00 per
share (the “ February 2020 Underwriter Warrants ”) to HCW, as underwriter.
In connection with the February
2020 Underwritten Offering, the Company also granted to the underwriter, HCW, a 30-day option to purchase up to an additional 300,000
shares of the Company’s common stock at a purchase price of $ 3.999 per
such share and/or warrants to purchase up to 300,000
shares of the Company’s common stock at a purchase price of $ 0.001
per such warrant. Such warrants have the same terms as the February 2020 Warrants. On February 12, 2020, HCW exercised its option
to purchase warrants to purchase an aggregate of 300,000
shares of the Company’s common stock.
Net proceeds from the
February 2020 Underwritten Offering were $ 7,093,000
after deducting underwriting discounts and commissions and offering expenses paid by the Company.
April 2020 Registered
Direct Offering and Private Placement — On April 2, 2020, the Company completed a registered direct offering (the
“ April 2020 Offering ”) of 1,713,064 shares
of the Company’s common stock at a purchase price of $ 2.21 per
share and in a concurrent private placement, sold warrants to purchase an aggregate of 1,713,064 shares
of the Company’s common stock at a purchase price of $ 0.125 per
underlying warrant share and with an exercise price of $ 2.21 per
share (the “ April 2020 Warrants ”). In connection with the April 2020 Offering, the Company also issued warrants
to purchase a total of 128,480 shares
of the Company’s common stock with an exercise price of $ 2.9188 per
share (the “ April 2020 Placement Agent Warrants ”) to the placement agent, HCW. Net proceeds to the Company from
the April 2020 Offering were $ 3,527,000
after deducting placement agent fees and offering expenses paid by the Company.
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 were no instances outside of the Company’s control
that could require cash settlement of the warrants issued in the Private Placement and Offering, as well as warrants issued in the Company’s
prior financing transactions, the 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 warrants issued in the Private Placement and the Offering
do not meet the definition of a derivative instrument as they are indexed to the Company’s common stock and classified within stockholders’
equity, as are the warrants issued in the Company’s prior financing transactions. Based on this determination, the Company’s
warrants are classified within stockholders’ equity.
F- 14
The following
table summarizes the Company’s outstanding equity-classified warrants at December 31, 2021:
Summary of outstanding warrants
Exercise
Expiration
Balance December 31,
Warrants
Warrants
Warrants
Balance
December
30,
Description
Price
Date
2020
Issued
Exercised
Expired
2021
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 Warrants
$ 4.00
2/13/2025
1,326,500
–
–
–
1,326,500
February 2020 Underwriter Warrants
$ 5.00
2/11/2025
150,000
–
–
–
150,000
April 2020 Warrants
$ 2.21
10/2/2025
1,284,798
–
( 856,532 )
–
428,266
April 2020 Placement Agent Warrants
$ 2.9188
3/31/2025
128,480
–
( 86,724 )
–
41,756
January 2021 Pre-Funded Warrants
$ 0.001
No expiration
–
140,065
( 140,065 )
–
–
January 2021 Warrants
$ 3.00
7/27/2026
–
3,420,696
–
–
3,420,696
January 2021 Placement Agent Warrants
$ 3.8375
7/27/2026
–
342,070
–
–
342,070
February 2021
Placement Agent Warrants
$ 4.275
2/12/2026
–
168,509
–
–
168,509
3,579,284
4,071,340
( 1,083,321 )
( 23,233 )
6,544,070
F- 15
The Company received net proceeds of $ 2,146,000 and
$ 3,856,000
from the exercise of warrants during the years ended December 31, 2021 and 2020, respectively.
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 such cashless exercises of warrants during the year ended December
31, 2021.
11. 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:
Schedule of antidilutive stock
December 31,
2021
2020
Options to purchase common stock
2,499
2,570
Unvested restricted stock units
367,101
9,699
Warrants to purchase common stock
6,544,070
3,579,284
Total
6,913,670
3,591,553
12. 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, 2021, there were an aggregate
of 1,267,675
shares of common stock reserved under the 2020 Plan, including 2,499 shares subject to outstanding stock options and 367,101 shares
subject to unvested restricted stock units (“ RSUs ”) and 894,227
shares available for future grants. RSUs granted by the Company to employees vest annually over 3 years after the grant date,
stock options 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.
F- 16
The following table summarizes the activity of
the Company’s RSUs for the year ended December 31, 2021:
Summary of RSU activity
Number
of Shares
Weighted-
Average
Grant Date Fair Value
Per Share
Unvested units at December 31, 2020
9,699
$ 19.97
Granted
360,750
2.94
Vested
( 3,348 )
22.67
Forfeited
–
–
Unvested units at December 31, 2021
367,101
$ 3.21
Stock-based compensation expense related to RSUs
was $ 443,000 and $ 85,000 for the years ended December 31, 2021 and 2020, respectively.
The aggregate fair value of awards that
vested during the year ended December 31, 2021 was $ 9,400 ,
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
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
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 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.
The Company did not grant stock options during
the years ended December 31, 2021 and December 31, 2020. The following table summarizes the activity of the Company’s stock option
plan for the year ended December 31, 2021:
Summary of Stock Option Activity
Total Number
of Shares
Weighted-
Average
Exercise
Price
Per Share
Weighted-
Average
Remaining
Contractual
Term
Aggregate
Intrinsic
Value
Balance at December 31, 2020
2,570
$ 3,334.06
Granted
–
–
Exercised
–
–
Cancelled
( 71 )
946.27
Balance at December 31, 2021
2,499
$ 3,401.90
5.39 years
$ –
Exercisable at December 31, 2021
2,153
$ 3,932.78
5.20 years
$ –
F- 17
Stock-based compensation expense related to stock
options for the years ended December 31, 2021 and 2020 was $ 37,000 and $ 51,000 , respectively.
As of December 31, 2021, the compensation
expense for all unvested stock options in the amount of approximately $ 21,000 will be recognized in the Company’s results of operations
over a weighted average period of 0.58 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.
Compensation Expense Related to Equity Awards
The following table sets forth total stock-based
compensation expense for the years ended December 31, 2021 and 2020, in thousands:
Details of Stock-based Compensation Expense
December 31,
2021
2020
Research and development
$ 117
$ 22
General and administrative
363
114
Total stock-based compensation
$ 480
$ 136
13. Income Taxes
The provisions for income taxes for the years ended
December 31, 2021 and 2020 are as follows, in thousands:
Components of Federal and State Income Tax Expense
Years Ended December 31,
2021
2020
Current
Federal
$ –
$ –
State
–
–
Total current
–
–
Deferred
Federal
( 3,016 )
9,780
State
( 1,329 )
5,548
Total deferred
( 4,345 )
15,328
Valuation allowance
4,345
( 15,328 )
Total provision for income taxes
$ –
$ –
Reconciliation of the effective income tax rate
to the U.S. statutory rate is as follows:
Schedule of effective income tax reconciliation
Years Ended December 31,
2021
2020
Federal statutory rate
21.0 %
21.0 %
State income taxes, net of federal benefit
8.5
6.7
Non-deductible expenses
0.2
( 0.5 )
Income tax credits
4.3
2.1
Valuation allowance
( 34.0 )
( 29.3 )
Effective tax rate
0.0 %
0.0 %
F- 18
The Company recognizes deferred tax assets and
liabilities to reflect the tax effects of temporary differences between the tax basis of assets or liabilities and their reported amounts
in the financial statements in accordance with 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.
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 components of the Company’s deferred
tax assets are as follows, in thousands:
Schedule of deferred
tax assets
Years Ending December 31,
2021
2020
Deferred tax assets:
Net operating loss carryforwards
$ 10,150
$ 6,355
Tax credit carryforwards
946
–
Stock-based compensation
1,363
1,374
Licensing deduction deferral
2,018
2,376
Lease liability
79
111
Other timing differences
169
196
Deferred tax assets
14,725
10,412
Deferred tax liabilities:
Right of use asset
( 76 )
( 108 )
Deferred tax liability
( 76 )
( 108 )
Valuation allowance
( 14,649 )
( 10,304 )
Net deferred tax asset
$ –
$ –
The Company evaluated the realizability of its
net deferred tax assets and concluded that, in accordance with the applicable accounting standards, that it is more likely than not that
the Company may not realize the benefit of all of its deferred tax assets. Accordingly, a valuation allowance against 100% of its deferred
tax assets has been recorded. Significant judgment is required in the evaluation of deferred tax benefits and differences in future results
from our estimates could result in material differences in the realization of these assets.
As of December 31, 2021, the Company had
federal net operating loss carryforwards of approximately $ 42,900,000
and state net operating loss carryforwards of approximately $ 18,100,000
to reduce future taxable income. The utilization of the federal carryforwards as an available offset to future taxable
income is subject to limitations under federal income tax laws. Under current federal income tax law, federal net operating losses
incurred in tax years beginning after December 31, 2017 may be carried forward indefinitely, but are limited to 80% of taxable
income. As of December
31, 2021, approximately $ 42,579,000
of our federal net operating loss carryforwards will carryforward indefinitely, while the remaining federal net operating loss of
$ 321,000
will begin to expire in 2031 , unless previously utilized. The Company’s state tax loss carryforwards will begin to expire in
2038 , unless previously utilized. In addition, the Company had federal and state research and development credits of approximately
$ 573,000
and $ 472,000 ,
respectively, which will begin to expire in 2042 . Based on an assessment of all available evidence, 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.
Ownership changes may limit the amount of net operating
loss carryforwards or research and development tax credit carryforwards that can be utilized to offset future taxable income or tax liability.
In general, an ownership change, as defined by Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (the “ 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. If the Company has experienced a change of control, 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 of the Code.
Any limitation may result in expiration of a portion of the net operating loss carryforwards or research and development tax credit carryforwards
before utilization.
During 2021, the Company completed an
assessment of the available net operating loss and tax credit carryforwards under Section 382 and 383 and determined that the
Company underwent six ownership changes during the period from 2012 to 2021. As a result, net operating loss and tax credit
carryforwards attributable to the pre-ownership changes are subject to substantial annual limitations under Section 382 and 383 of
Code due to the ownership changes. The Company has adjusted its net operating loss and tax credit carryforwards to address the
impact of the ownership changes. This resulted in a reduction of available federal and state net operating loss carryforwards of
approximately $ 55,000,000 and $ 70,000,000 , respectively, which related to the years ended December 31, 2020 and prior. This also
resulted in a reduction of federal and state tax credit carryforwards of approximately $ 1,400,000 and $ 700,000 , respectively,
related to the years ended December 31, 2020 and prior. Accordingly, the net operating loss and tax credit carryforwards presented
above for the year ending December 31, 2020 were reduced by $ 15,952,000 and $ 2,017,000 , respectively, with a corresponding reduction
to the valuation allowance of $ 17,969,000 .
F- 19
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. The Company has not recorded any uncertain
tax positions as of December 31, 2021 or 2020. 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.
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 2013 through
2021.
14. Collaboration
and License Agreements
In March 2021, the Company entered into a clinical
development collaboration with AgonOx, Inc. (“ AgonOx ”), a private company developing a pipeline of novel immunotherapy
drugs targeting key regulators of the immune response to cancer. Under the collaboration, the companies will develop a T cell-based therapy
using PH-762 and AgonOx’s “double positive” TIL (“ DP TIL ”) technology. Per the terms of the clinical
development agreement, AgonOx will receive financial support from Phio to conduct a clinical trial with AgonOx’s DP TIL technology
and PH-762. Phio will be entitled to certain future development milestones and sales-based royalty payments from AgonOx’s DP TIL
technology. The Company did not provide financial support to AgonOx, nor has Phio received milestone or sales-based royalty payments from
AgonOx under this agreement in 2021.
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.
F- 20
ITEM 9.
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
None.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.