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, P.C.; Boston, Massachusetts; PCAOB ID# 243 )
F-1
Consolidated Balance Sheets as of December 31, 2023 and 2022
F-3
Consolidated Statements of Operations for the Years Ended December 31, 2023 and 2022
F-4
Consolidated Statements of Preferred Stock and Stockholders’ Equity for the Years Ended December 31, 2023 and 2022
F-5
Consolidated Statements of Cash Flows for the Years Ended December 31, 2023 and 2022
F-6
Notes to Consolidated Financial Statements
F-7
31
Report of Independent Registered Public Accounting
Firm
Shareholders 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”) as of December 31, 2023 and 2022,
the related consolidated statements of operations, preferred stock and stockholders’ equity, and cash flows for each of the years
then ended, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion,
the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31,
2023 and 2022, and the results of its operations and its cash flows for the years then ended , in conformity with accounting principles
generally accepted in the United States of America.
Going Concern Uncertainty
The accompanying consolidated
financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the consolidated
financial statements, the Company has suffered recurring losses from operations and negative cash flows from operations that raise substantial
doubt about its ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note
1. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
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: (i) relates to accounts or disclosures that are material to the consolidated financial statements and (ii) 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.
F- 1
Accounting for Certain Warrants Issued in 2023
As described in Note 9 to the consolidated
financial statements, the Company completed each of two registered direct offerings of common stock and concurrent private placement
offerings of warrants to purchase common stock in April and June 2023 (the “April 2023 Financing” and “June 2023
Financing”, respectively). In December 2023, the Company issued additional warrants to purchase common stock to certain
holders of existing warrants in connection with an Inducement Letter Agreement (the “December 2023 Financing”). The
Company assessed the warrants issued in the April 2023 Financing, June 2023 Financing and December 2023 Financing to determine
whether the warrants should be accounted for as either liabilities or equity instruments depending on the specific terms of the
agreements. The Company determined that the warrants issued in the April 2023 Financing, June 2023 Financing and December 2023
Financing were classified within stockholders’ equity.
We identified the assessment of the accounting for certain warrants
to purchase common stock issued in connection with the April 2023 Financing, June 2023 Financing and December 2023 Financing as a critical
audit matter. Determining whether the certain warrants issued should be accounted for as either liabilities or equity instruments requires
significant judgment due to the application of complex technical accounting guidance. Auditing this element required especially challenging
and complex auditor judgement due to the nature and extent of the audit effort required to address the matter, including the need for
specialized knowledge and skill in assessing elements of the agreements.
The primary procedures we performed to address this critical audit
matter included:
· Reading
and analyzing agreements related to the certain warrants issued to identify relevant terms
and conditions that affect whether the certain warrants issued should be accounted for as
either liabilities or equity instruments.
· Evaluating
whether the certain warrants issued should be accounted for as either liabilities or equity
instruments.
· Utilizing
personnel with specialized knowledge and skill in the relevant technical accounting guidance
to evaluate the appropriateness of the Company’s application of the relevant technical
accounting guidance in determining whether the certain warrants issued should be accounted
for as either liabilities or equity instruments.
/s/ BDO USA, P.C.
We have served as the Company's auditor since
2011.
Boston, Massachusetts
April 1, 2024
F- 2
PHIO PHARMACEUTICALS CORP.
CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share data)
December 31,
2023
December 31,
2022
ASSETS
Current assets:
Cash
$ 8,490
$ 11,781
Restricted cash
–
50
Prepaid expenses and other current assets
832
615
Total current assets
9,322
12,446
Right of use asset
33
161
Property and equipment, net
6
183
Other assets
3
24
Total assets
$ 9,364
$ 12,814
LIABILITIES, PREFERRED STOCK AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$ 657
$ 779
Accrued expenses
942
1,025
Lease liability
35
135
Total current liabilities
1,634
1,939
Lease liability, net of current portion
–
35
Total liabilities
1,634
1,974
Commitments and contingencies (Footnote 7)
–
–
Series D Preferred Stock, $ 0.0001 par value; 0 and 1 shares authorized, issued and outstanding at December 31, 2023 and December 31, 2022, respectively
–
2
Stockholders’ equity:
Common stock, $ 0.0001 par value, 100,000,000 shares authorized; 3,747,329 and 1,139,024 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively
–
–
Additional paid-in capital
146,936
139,218
Accumulated deficit
( 139,206 )
( 128,380 )
Total stockholders’ equity
7,730
10,838
Total liabilities, preferred stock and stockholders’ equity
$ 9,364
$ 12,814
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)
Year Ended
December 31,
2023
2022
Operating expenses:
Research and development
$ 6,332
$ 7,012
General and administrative
4,366
4,450
Loss on impairment of property and equipment
126
–
Total operating expenses
10,824
11,462
Operating loss
( 10,824 )
( 11,462 )
Total other expense, net
( 2 )
( 18 )
Net loss
$ ( 10,826 )
$ ( 11,480 )
Net loss per common share:
Basic and diluted
$ ( 5.20 )
$ ( 10.10 )
Weighted average number of common shares outstanding
Basic and diluted
2,083,569
1,136,566
See accompanying notes to consolidated financial
statements.
F- 4
PHIO PHARMACEUTICALS CORP.
CONSOLIDATED STATEMENTS OF PREFERRED STOCK AND
STOCKHOLDERS’ EQUITY
(Amounts in thousands, except share data)
Series D Preferred Stock
Common Stock
Additional
Paid-in
Accumulated
Shares
Amount
Shares
Amount
Capital
Deficit
Total
Balance at December 31, 2021
–
$ –
1,127,917
$ –
$ 138,832
$ ( 116,900 )
$ 21,932
Issuance of common stock upon vesting of restricted stock units
–
–
14,043
–
–
–
–
Shares withheld for payroll taxes
–
–
( 2,936 )
–
( 28 )
–
( 28 )
Issuance of preferred stock
1
2
–
–
–
–
–
Stock-based compensation expense
–
–
–
–
414
–
414
Net loss
–
–
–
–
–
( 11,480 )
( 11,480 )
Balance at December 31, 2022
1
$ 2
1,139,024
$ –
$ 139,218
$ ( 128,380 )
$ 10,838
Cash-in-lieu of fractional shares for reverse stock split
–
–
( 1,706 )
–
( 11 )
–
( 11 )
Redemption of preferred stock
( 1 )
( 2 )
–
–
–
–
–
Issuance of common stock and warrants, net of offering costs
–
–
1,963,511
–
7,452
–
7,452
Issuance of common stock upon exercise of warrants
–
–
628,935
–
–
–
–
Issuance of common stock upon vesting of restricted stock units
–
–
23,414
–
–
–
–
Shares withheld for payroll taxes
–
–
( 5,849 )
–
( 26 )
–
( 26 )
Stock-based compensation expense
–
–
–
–
303
–
303
Net loss
–
–
–
–
–
( 10,826 )
( 10,826 )
Balance at December 31, 2023
–
$ –
3,747,329
$ –
$ 146,936
$ ( 139,206 )
$ 7,730
See accompanying notes to consolidated financial
statements.
F- 5
PHIO PHARMACEUTICALS CORP.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Amounts in thousands)
Year Ended
December 31,
2023
2022
Cash flows from operating activities:
Net loss
$ ( 10,826 )
$ ( 11,480 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
56
71
Amortization of right of use asset
128
122
Impairment of property and equipment
126
–
Stock-based compensation
303
414
Changes in operating assets and liabilities:
Prepaid expenses and other assets
( 196 )
8
Accounts payable
( 122 )
496
Accrued expenses
( 83 )
( 1,635 )
Lease liability
( 135 )
( 125 )
Net cash used in operating activities
( 10,749 )
( 12,129 )
Cash flows from investing activities:
Cash paid for purchase of property and equipment
( 5 )
( 121 )
Net cash used in investing activities
( 5 )
( 121 )
Cash flows from financing activities:
Net proceeds from the issuance of common stock and warrants
7,452
–
Net proceeds from the issuance of preferred stock
–
2
Cash-in-lieu of fractional shares for reverse stock split
( 11 )
–
Redemption of Series D Preferred Stock
( 2 )
–
Payment of taxes on net share settlements of restricted stock units
( 26 )
( 28 )
Net cash provided by (used in) financing activities
7,413
( 26 )
Net decrease in cash and restricted cash
( 3,341 )
( 12,276 )
Cash and restricted cash at the beginning of period
11,831
24,107
Cash and restricted cash at the end of period
$ 8,490
$ 11,831
The following table provides a reconciliation of cash and restricted
cash reported within the consolidated balance sheets to the totals above:
December 31,
2023
2022
Cash
$ 8,490
$ 11,781
Restricted cash
–
50
Total cash and restricted cash
$ 8,490
$ 11,831
See accompanying notes to consolidated financial
statements.
F- 6
PHIO PHARMACEUTICALS CORP.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. Organization and Significant Accounting Policies
Nature of Operations
Phio Pharmaceuticals Corp. (“ Phio ”
or the “ Company ”) is a clinical stage biotechnology company whose proprietary INTASYL™ self-delivering RNAi technology
platform is designed to make immune cells more effective in killing tumor cells. The Company is developing therapeutics that are designed
to leverage INTASYL to precisely target specific proteins that reduce the body’s ability to fight cancer, without the need for specialized
formulations or drug delivery systems.
Phio was incorporated in the state of Delaware
in 2011 as RXi Pharmaceuticals Corporation. On November 19, 2018, the Company changed its name to Phio Pharmaceuticals Corp., to reflect
its transition from a platform company to one that is fully committed to developing groundbreaking immuno-oncology therapeutics.
Basis of Presentation
The accompanying consolidated financial statements
have been prepared in accordance with accounting principles generally accepted in the United States of America (“ GAAP ”).
Principles of Consolidation
The consolidated financial statements include
the accounts of the Company and its wholly-owned subsidiary, MirImmune, LLC. All material intercompany accounts have been eliminated
in consolidation.
Segments
The Company operates as one operating
segment and all assets are located in the United States.
Reverse Stock Split
Effective January 26, 2023, the Company
completed a 1-for-12
reverse stock split of the Company’s outstanding common stock (the “ Reverse Stock Split ”). All share
and per share amounts in the consolidated 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. Additionally, the Company made adjustments to the outstanding stock option and unvested restricted stock unit
(“ RSU ”) balances, and related per share amounts, at December 31, 2022 to reflect final revisions to those
outstanding equity awards as a result of 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.
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 as of 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, and the valuation allowance
on our deferred tax assets. On an ongoing basis the Company evaluates its estimates and bases its estimates on historical experience and
other relevant assumptions that the Company believes are reasonable under the circumstances. Actual results could differ materially from
these estimates.
Liquidity
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 the Company fails to obtain additional funding when needed, the Company would be forced to scale back or terminate
its operations or seek to merge with or to be acquired by another company.
F- 7
The Company has limited cash resources, has reported
recurring losses from operations since inception, negative operating cash flows and has not yet received product revenues. These factors
raise substantial doubt regarding the Company’s ability to continue as a going concern, and the Company’s current cash resources
may not provide sufficient capital to fund operations for at least the next 12 months from the date of the release of these consolidated
financial statements. The continuation of the Company as a going concern depends upon the Company’s ability to raise additional
capital through an equity offering, debt offering and/or strategic opportunity to fund its operations. There can be no assurance that
the Company will be successful in accomplishing these plans in order to continue as a going concern. These consolidated financial statements
do not include any adjustments to the recoverability and classification of recorded asset amounts and classification of liabilities that
might be necessary should the Company be unable to continue as a going concern.
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 reputable financial institution that management believes is creditworthy, and which at times are in excess of
federally insured limits. These accounts are insured by the Federal Deposit Insurance Corporation for up to $ 250,000
per institution.
The Company
relies, and expects to continue to rely, on a small number of vendors to perform research activities and clinical trial activities that
continue to progress its product candidates for its development programs. These programs could be adversely affected by a significant
interruption in the related processes of these vendors.
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
Lesser of lease term or 5 years
Impairment of Long-Lived Assets
The Company reviews long-lived assets for impairment
annually or whenever an event or change in circumstance occurs in which 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.
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.
F- 8
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.
Collaborative Arrangements
The Company follows the provisions of the Financial
Accounting Standards Board (the “ FASB ”) Accounting Standards Codification (“ 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. The Company recognizes its share of costs arising from research and development
activities performed by collaborators in the period its collaborators incur such expense. Reimbursements that are the result
of a collaborative relationship instead of a customer relationship, such as co-development activities, are evaluated on a quarterly basis
and recorded as an offset to research and development expense incurred. Payments in excess of our collaboration expense will be recorded as
revenue.
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 RSUs 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
on a straight-line basis 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.
F- 9
Stock-based compensation expense recognized in
the consolidated 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 or to the extent that actual forfeitures differ from our estimates, 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
consolidated 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.
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 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,
RSUs and stock options.
Recent Accounting Pronouncements
In November 2023, the FASB issued Accounting Standards
Update (“ ASU ”) 2023-07, “ Segment Reporting (Topic 280) – Improvements to Reporting Segment Disclosures”
(“ ASU 2023-07 ”), which requires disclosure of incremental segment information on an annual and interim basis.
In addition, ASU 2023-07 clarifies circumstances in which an entity can disclose multiple segment measures of profit or loss, provides
new segment disclosure requirements for entities with a single reportable segment, and contains other disclosure requirements. The amendments
in ASU 2023-07 are effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after
December 15, 2024. Early adoption is permitted. The enhanced disclosures are required to be applied
retrospectively to all prior periods presented in the financial statements. The Company is currently evaluating the impact of
ASU 2023-07 on its consolidated financial statements and disclosures, but does not expect that it will have a material impact on its
consolidated financial statements.
In December 2023, the FASB issued ASU 2023-09,
“ Income Taxes (Topic 740) – Improvements to Income Tax Disclosures” (“ ASU 2023-09 ”), which
requires disclosure of specific categories in the rate reconciliation table along with additional information for reconciling items that
meet a quantitative threshold, disclosure of disaggregated income taxes paid and modifies other income tax-related disclosures. The amendments
in ASU 2023-09 are effective for annual periods beginning after December 15, 2024 and allows for adoption on a prospective basis, with
a retrospective option. Early adoption is permitted. The Company is currently evaluating the impact of ASU 2023-09, but does not expect
that it will have a material impact on its consolidated financial statements.
F- 10
2. Collaboration Agreement
AgonOx, Inc. (“ AgonOx ”)
In February 2021, the Company entered into a
clinical co-development collaboration agreement (the “ Clinical Co-Development Agreement ”) with AgonOx, a private
company developing a pipeline of novel immunotherapy drugs targeting key regulators of the immune response to cancer. Under the
Clinical Co-Development Agreement, Phio and AgonOx are working to develop a T cell-based therapy using the Company’s lead
product candidate, PH-762, and AgonOx’s “double positive” tumor infiltrating lymphocytes (“ DP
TIL ”) technology. Per the terms of the Clinical Co-Development Agreement, the Company agreed to reimburse AgonOx up to
$ 4,000,000 in expenses incurred to conduct a Phase 1 clinical trial of PH-762 treated DP TIL in patients with advanced melanoma and
other advanced solid tumors.
The Company will recognize its share of costs arising
from research and development activities performed by AgonOx in the Company’s consolidated financial statements in the period AgonOx
incurs such expense. Phio will be entitled to certain future development milestones and low single-digit sales-based royalty payments
from AgonOx’s licensing of its DP TIL technology.
The Company recognized approximately $ 1,115,000
and $ 130,000 of expense in connection with these efforts during the years ended December 31, 2023 and 2022, respectively.
There is approximately $ 2,757,000 of remaining
costs not yet incurred under the Clinical Co-Development Agreement as of December 31, 2023.
3. Fair
Value of Financial Instruments
The Company
follows the provisions of the FASB ASC Topic 820, “ Fair Value Measurement ,” 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 annually 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.
At
December 31, 2022, the Company categorized its restricted cash of $ 50,000 as Level 2 hierarchy. Restricted cash consisted of certificates
of deposit held by financial institutions as collateral for the Company’s corporate credit cards . 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.
The carrying amounts of cash,
accounts payable and accrued expenses of the Company approximate their fair values due to their short-term nature.
F- 11
4. Property and Equipment
The following table summarizes the Company’s
major classes of property and equipment, in thousands:
Schedule of property and equipment
December 31,
2023
2022
Computer equipment
$ 62
$ 116
Machinery & equipment
964
1,077
Furniture & fixtures
70
119
Leasehold improvements
46
46
Total gross fixed assets
1,142
1,358
Less: accumulated depreciation and amortization
( 1,136 )
( 1,175 )
Property and equipment, net
$ 6
$ 183
Depreciation and amortization expense for the years
ended December 31, 2023 and 2022 was $ 56,000 and $ 71,000 , respectively.
In November 2023, the Company decided not to
renew the lease for its corporate headquarters and primary research facility in Marlborough, Massachusetts. Beginning in April of
2024, we expect to continue operations as a remote business with a small laboratory facility. Based on this evaluation, the Company
determined that long-lived assets with a carrying amount of $ 126,000
were no longer recoverable and an impairment charge of $ 126,000
was recorded to write those assets down to their fair value. The Company did no t
record any impairment charges at December 31, 2022.
5. Accrued Expenses
Accrued expenses consist of the following, in thousands:
Schedule of accrued expenses
December 31,
2023
2022
Compensation and benefits
$ 222
$ 408
Professional fees
126
97
Research and development costs
517
501
Other
77
19
Total accrued expenses
$ 942
$ 1,025
6. 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- 12
The lease for the Company’s corporate headquarters
represents all of its significant lease obligations. The amounts reported in the consolidated balance sheets for the operating lease 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,
2023
2022
Assets
Right of use asset
$ 33
$ 161
Liabilities
Lease liability, current
35
135
Lease liability, non-current
–
35
Total lease liability
$ 35
$ 170
Lease Term and Discount Rate
Weighted average remaining lease term
0.25
1.25
Weighted average discount rate
4.70 %
4.70 %
Operating lease costs included in operating expense
were $ 132,000 for the years ended December 31, 2023 and 2022, respectively.
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 the Company’s consolidated statements of cash flows was $ 139,000 and $ 135,000 for the years ended
December 31, 2023 and 2022, respectively.
Future lease payments for our non-cancellable operating
lease and a reconciliation to the carrying amount of the operating lease liability presented in the consolidated balance sheet as of December
31, 2023 is as follows, in thousands:
Schedule of future minimum lease payments
2024
$ 35
Total lease payments
35
Less: Imputed interest
–
Total operating lease liability
$ 35
7. Commitments and Contingencies
Commitments
In February 2021, the
Company entered into the Clinical Co-Development Agreement with AgonOx to develop a T cell-based therapy using the Company’s
lead product candidate, PH-762, and AgonOx’s DP TIL technology. Per the terms of the Clinical Co-Development Agreement, the
Company agreed to reimburse AgonOx up to $ 4,000,000
in expenses incurred to conduct a Phase 1 clinical trial of PH-762 treated DP TIL in patients with advanced melanoma
and other advanced solid tumors. Refer to Note 2 for further details on the Clinical Co-Development Agreement with AgonOx.
Refer to Note 6 for more information about the
Company’s obligations under its non-cancellable lease for its corporate headquarters.
F- 13
In September 2011, the Company entered into
an agreement with Advanced RNA Technologies, LLC (“ Advirna ”), pursuant to which Advirna assigned to the Company
its existing patent and technology rights related to the INTASYL technology in exchange for an annual maintenance fee of $ 100,000 ,
a one-time milestone payment upon the future issuance of the first patent with valid claims covering the assigned patent and
technology rights and the issuance of shares of common stock of the Company equal to 5 %
of the Company’s fully-diluted shares outstanding at the time of issuance. The one-time milestone payment and the issuance of
shares of common stock of the Company were completed in 2014 and 2012, respectively. Additionally, the Company is required to pay
low single-digit royalties to Advirna on any licensing revenue received by the Company with respect to future licensing of the
assigned Advirna patent and technology rights. To date, any royalties owed to Advirna under the Advirna agreement have been
minimal.
The Company’s 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 Advirna agreement. Further, the Company also granted back to Advirna a license under the assigned patent and
technology rights for fields of use outside human therapeutics.
As part of its business, the Company may enter
into licensing agreements with third parties that require milestone and royalty payments based on the progress of the asset through development
stages. Milestone payments may be required, for example, upon progress through clinical trials, upon approval of the product by a regulatory
agency and/or upon a percentage of sales of the product pursuant to such agreements. The expenditures required under these arrangements
may be material individually in relation to any product candidates covered by the intellectual property licensed under any such arrangement,
and material in the aggregate in the unlikely event that milestones for multiple products covered by these arrangements were reached in
the same period. Due to the contingent nature of these payments, they are not included in the table of contractual obligations shown below.
During the years ended December 31, 2023 and 2022,
the Company did no t trigger any milestone payments.
The Company’s contractual license obligations
that will require future cash payments as of December 31, 2023, which result from payments expected in connection with annual license
fees, are as follows, in thousands:
Schedule of future cash payments for contractual license obligations
Year Ending December 31,
2024
$ 100
2025
100
2026
100
2027
100
2028
100
Thereafter
100
Total
$ 600
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.
F- 14
Litigation
From time to time, the Company may become a party
to various legal proceedings and complaints arising in the ordinary course of business. To the Company’s knowledge, it is not currently
a party to any actual or threatened material legal proceedings. Accordingly, there were no contingent liabilities recorded as of the year
ended December 31, 2023.
8. Preferred Stock
The Company has authorized up to 10,000,000 shares
of preferred stock, $ 0.0001 par value per share, for issuance. The Company’s Board of Directors (the “ Board ”)
is authorized under the Company’s Amended and Restated Certificate of Incorporation (as may be amended and/or restated from time to
time, the “ Amended Certificate ”), to designate the authorized preferred stock into one or more series and to fix and
determine such rights, preferences, privileges and restrictions of any series of preferred stock, including voting rights, dividend rights,
conversion rights, redemption privileges and liquidation preferences, as shall be determined by the Board upon its issuance.
In November 2022, the Company sold one
share of Series D Preferred Stock, par value $ 0.0001
per share (the “ Series D Preferred Stock ”) to Robert Bitterman, then its interim Executive Chairman and current
Chief Executive Officer, for $ 1,750 .
The Series D Preferred Stock was not convertible into, or exchangeable for, shares of any other class or series of stock or other
securities of the Company; had no rights with respect to any distribution of assets of the Company, including upon a liquidation,
bankruptcy, reorganization, merger, acquisition, sale, dissolution or winding up of the Company, whether voluntarily or
involuntarily; and was not entitled to receive dividends of any kind.
The Series D Preferred Stock was entitled to 17,500,000
votes per share exclusively with respect to any proposal to amend the Company’s Amended Certificate to effect a reverse stock split
of the Company’s common stock. The terms provided that it would be voted, without action by the holder, on any such proposal in
the same proportion as shares of the Company’s common stock were voted. The Series D Preferred Stock otherwise had no voting rights
except as otherwise required by the General Corporation Law of the State of Delaware.
Under its terms, the outstanding share of Series
D Preferred Stock was to be redeemed in whole, but not in part, at any time: (i) if such redemption was approved by the Board in its sole
discretion or (ii) automatically and effective upon the approval by the Company's stockholders of an amendment to the Amended Certificate
to effect a reverse stock split of the Company’s common stock. The Series D Preferred Stock was redeemed in whole on January 4,
2023, upon the approval by the Company’s stockholders of the Reverse Stock Split. Upon such redemption, the holder of the Series
D Preferred Stock received consideration of $ 1,750 in cash.
At December 31, 2023, there were no shares of preferred
stock issued or outstanding.
9. Stockholders’ Equity
April
2023 Financing — In April 2023, the Company completed a registered direct offering and a concurrent private placement of
a total of: 353,983 registered shares of the Company’s common stock at a purchase price per share of $ 5.65 , unregistered
five and one-half year term Series A warrants to purchase up to 353,983 shares of common stock at an exercise price of $ 5.40 per
share and unregistered eighteen month term Series B warrants to purchase up to 353,983 shares of common stock at an exercise
price of $ 5.40 per share (collectively, the “ April 2023 Financing ”). In addition, the Company issued unregistered
warrants to the placement agent, H.C. Wainwright & Co., LLC (“ HCW ”), in the April 2023 Financing to purchase a
total of 26,549 shares of common stock at an exercise price of $ 7.0625 per share. Net proceeds to the Company from the
April 2023 Financing were $ 1,538,000 after deducting placement agent fees and offering expenses.
F- 15
In
connection with the April 2023 Financing, the Company entered into warrant amendment agreements (the “ Warrant Amendment
Agreements ”) with the participating investors to amend the exercise price of certain existing warrants to purchase up to
an aggregate of 191,619 shares
of common stock that were previously issued in April 2018 through January 2021, such that each of the amended warrants have an
exercise price of $ 5.40 per
share. The Company received $ 24,000
as consideration in connection with the Warrant Amendment Agreements. The Company assessed the amendments to the exercise price of
the warrants under the FASB ASC Topic 815, “ Derivatives and Hedging ” (“ ASC 815 ”) and
determined that the amendment to the exercise price was completed in connection with and contingent on the close of the April 2023
Financing. The increase in fair value of $ 293,000
related to the Warrant Amendment Agreements was recognized as an equity issuance cost and recorded in additional paid in capital per
ASC 815.
June
2023 Financing — In June 2023, the Company completed a registered direct offering and a concurrent private placement
of a total of: 233,646 registered
shares and 72,000 unregistered
shares of the Company’s common stock each at a purchase price per share of $ 4.28 ,
unregistered pre-funded warrants to purchase up to an aggregate of 628,935 shares
of common stock at a purchase price per share of $ 4.279
and with an exercise price of $ 0.001
per share, unregistered five and one-half year term Series A warrants to purchase up to an aggregate of 934,581
shares of common stock at an exercise price of $ 4.03 per
share and unregistered eighteen month term Series B warrants to purchase up to an aggregate of 934,581
shares of common stock at an exercise price of $ 4.03 per
share (collectively, the “ June 2023 Financing ”). In addition, the Company issued unregistered warrants to the
placement agent, HCW, in the June 2023 Financing to purchase a total of 70,094
shares of common stock at an exercise price of $ 5.35 per
share. Net proceeds to the Company from the June 2023 Financing were $ 3,510,000 after
deducting placement agent fees and offering expenses.
December
2023 Financing – In December 2023, the Company entered into an inducement letter agreement (the “ Inducement Letter
Agreement ”) with certain holders of the Company’s existing warrants to purchase up to an aggregate of 2,130,252 shares
of the Company’s common stock. The existing warrants were originally issued on dates between October 2018 and June 2023 with an
exercise price of $ 5.40 or $ 4.03 per share. Pursuant to the Inducement Letter Agreement, these warrants were exercised for cash at a reduced
exercise price of $ 1.33 per share in consideration of the Company’s agreement to issue new five and one-half year term Series A
warrants to purchase up to 2,270,320 shares of common stock at an exercise price of $ 1.08 per share and new eighteen month term Series
B warrants to purchase up to 1,990,184 shares of common stock at an exercise price of $ 1.08 per share (collectively, the “ December
2023 Financing ”). In addition, the Company issued warrants to the placement agent, HCW, in the December 2023 Financing to purchase
a total of 159,769 shares of common stock at an exercise price of $ 1.66 per share.
Pursuant to the terms of the Inducement Letter
Agreement, in the event that the exercise of the existing warrants in the December 2023 Financing would have otherwise caused a holder
to exceed the beneficial ownership limitations set forth in the existing warrant, the Company issued the number of shares that would
not cause a holder to exceed such beneficial ownership limitation and agreed to hold such balance of shares of common stock in abeyance.
Accordingly, at December 31, 2023, an aggregate of 826,370
shares of common stock were held in abeyance (the “ Abeyance Shares ”) with such Abeyance Shares evidenced through
the holder’s existing warrants and which are deemed to be prepaid. The Abeyance Shares will be held until notice is received by
the holder that the balance of the shares of common stock may be issued in compliance with such beneficial ownership limitations and
may be exercised pursuant to a notice of exercise from the holder. Until such time, the Abeyance Shares are evidenced through the holder’s
existing warrants and have been included in the Company’s table of outstanding warrants below.
Net
proceeds to the Company from the December 2023 financing were $ 2,404,000 after deducting placement agent fees and offering expenses. The
Company assessed the amendments to the exercise price of the warrants under the ASC 815 and determined that the amendment to the exercise
price was completed in connection with and contingent on the close of the December 2023 Financing. The increase in fair value of $ 412,000
related to the modification of the terms of the warrants to induce exercise was recognized as an equity issuance cost and recorded in
additional paid in capital per ASC 815.
Warrants
The Company first assessed the warrants in the
April 2023 Financing, June 2023 Financing and December 2023 Financing under the FASB ASC Topic 480, “ Distinguishing Liabilities
from Equity ” (“ ASC 480 ”) to determine whether they were within the scope of ASC 480. As there were no instances
outside of the Company’s control that could require cash settlement, the Company’s warrants issued in the April 2023 Financing,
June 2023 Financing and December 2023 Financing were determined to be outside the scope of ASC 480.
F- 16
The Company then applied and followed the applicable
accounting guidance in ASC 815. Financial instruments are accounted for as either derivative liabilities or equity instruments depending
on the specific terms of the agreement. The warrants issued in the April 2023 Financing, June 2023 Financing and December 2023 Financing
did 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, the warrants issued in the April 2023 Financing, June 2023 Financing and December 2023 Financing
were classified within stockholders’ equity.
In addition to the December 2023 Financing, the
Company issued 628,935 shares of common stock related to exercises from the pre-funded warrants issued in the June 2023 Financing for
proceeds of $ 630 . There were no warrants exercised during the year ended December 31, 2022.
The following table summarizes the Company’s
outstanding warrants, all of which are classified as equity instruments, at December 31, 2023:
Schedule of outstanding warrants
Number
of Shares
Weighted-
Average
Exercise Price
Per Share
Outstanding at December 31, 2022
545,401
$ 54.53
Issued
7,722,979
2.17
Exercised
( 1,932,817 )
0.90
Expired
( 4,275 )
624.62
Outstanding at December 31, 2023
6,331,288
$ 3.68
10. 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 and provide for the grant of
incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock awards, RSU 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. In July 2023,
the Company’s stockholders approved an amendment to the 2020 Plan to increase the number of shares authorized for issuance thereunder
to 231,140 shares of common stock.
As of December 31, 2023, there were 10,084
shares subject to outstanding stock options, 49,683 shares subject to unvested RSUs and 133,574 shares available for future grants.
Restricted Stock Units
RSUs are issued under the Company’s
2020 Plan or as inducement grants issued outside of the 2020 Plan to new employees. RSUs are generally subject to graded vesting and
the satisfaction of certain service requirements. RSUs granted by the Company to employees generally vest annually over 3
years after the grant date and over 1
year after the grant date for directors of the Board of Directors. Upon vesting, each outstanding RSU will be settled 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 Company does not expect to
repurchase shares to satisfy RSU vests. 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- 17
The following table summarizes the activity of
the Company’s RSUs for the year ended December 31, 2023:
Summary of RSU activity
Number
of Shares
Weighted-
Average
Grant Date Fair Value
Per Share
Unvested units at December 31, 2022
47,335
$ 15.03
Granted
43,500
5.24
Vested
( 23,414 )
14.99
Forfeited
( 17,738 )
9.88
Unvested units at December 31, 2023
49,683
$ 8.32
The weighted-average fair value of RSUs granted
during the years ended December 31, 2023 and 2022 was $ 5.24 and $ 10.08 , respectively.
Stock-based compensation expense related to RSUs
was $ 298,000 and $ 401,000 for the years ended December 31, 2023 and 2022, respectively.
The aggregate fair value of awards that vested
during the years ended December 31, 2023 and 2022 was $ 105,000 and $ 138,000 , which represents the market value of the Company’s
common stock on the date that the RSUs vested.
As of December 31, 2023, the compensation
expense for all unvested RSUs in the amount of approximately $ 212,000 will be recognized in the Company’s results of operations
over a weighted average period of 1.30 years.
Stock Options
Stock options are available for issuance under
the 2020 Plan or as inducement grants issued outside of the 2020 Plan to new employees. Stock options are generally subject to graded
vesting and the satisfaction of service requirements. Stock options granted by the Company to employees generally vest annually over 4
years after the grant date and generally vest over 1 year after the grant date for members of
the Board of Directors and expire within ten years of grant. 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 year ended December 31, 2022. For valuing options granted during the year ended December 31, 2023, the following assumptions were
used:
Schedule of assumptions
December 31,
2023
Risk-free interest rate
4.72 %
Expected volatility
113.74 %
Expected lives (in years)
5.25
Expected dividend yield
0 %
The weighted average grant date fair value of options
granted during the year ended December 31, 2023 was $ 1.14 per share.
F- 18
The following table summarizes the Company’s
stock option activity for the year ended December 31, 2023:
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, 2022
177
$ 35,231.40
Granted
10,000
1.37
Exercised
–
–
Forfeited
–
–
Expired
( 93 )
52,577.53
Balance at December 31, 2023
10,084
$ 134.86
9.74 years
$ –
Exercisable at December 31, 2023
84
$ 16,026.76
2.78 years
$ –
Stock-based compensation expense related to stock
options for the years ended December 31, 2023 and 2022 was $ 5,000 and $ 13,000 , respectively.
As of December 31, 2023, the compensation expense
for all unvested stock options in the amount of $ 6,000 will be recognized in the Company’s results of operations over a weighted
average period of 0.25 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.
Employee Stock Purchase Plan
The Company has 684 shares authorized for issuance under the 2013 Employee Stock Purchase
Plan (“ ESPP ”). The ESPP allows employees to contribute a percentage of their cash earnings, subject to certain maximum
amounts, to be used to purchase shares of the Company’s common stock on each of two semi-annual purchase dates at a purchase price
equal to 90% of the market value per share on either (a) the date of grant of a purchase right under the ESPP or (b) the date on which
such purchase right is deemed exercised, whichever is lower. As of December 31, 2023, 661 shares were reserved for future issuance under
the ESPP. There was no activity under the ESPP for the years ended December 31, 2023 and 2022.
Compensation Expense Related to Equity Awards
The following table sets forth total stock-based
compensation expense for the years ended December 31, 2023 and 2022, in thousands:
Schedule of stock-based compensation expense
December 31,
2023
2022
Research and development
$ 132
$ 154
General and administrative
171
260
Total stock-based compensation
$ 303
$ 414
11. Income Taxes
The provision for income taxes for the years ended
December 31, 2023 and 2022 are as follows, in thousands:
Schedule of provision for income taxes
Years Ended December 31,
2023
2022
Current
Federal
$ –
$ –
State
–
–
Total current
–
–
Deferred
Federal
( 1,831 )
( 1,733 )
State
( 718 )
( 553 )
Total deferred
( 2,549 )
( 2,286 )
Valuation allowance
2,549
2,286
Total provision for income taxes
$ –
$ –
F- 19
The following table presents a reconciliation of
the U.S. statutory tax rate to the Company’s actual effective income tax rate:
Schedule of effective income tax reconciliation
Years Ended December 31,
2023
2022
Federal statutory rate
21.0 %
21.0 %
State income taxes, net of federal benefit
5.9
7.4
Non-deductible expenses
( 0.5 )
( 0.8 )
Income tax credits
2.1
3.2
Valuation allowance
( 28.5 )
( 30.8 )
Effective tax rate
0.0 %
0.0 %
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 consolidated 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. As a result of this evaluation,
the Company has recorded a full valuation allowance against its deferred tax assets as the Company believes it is more likely than not
that the benefit of all of its deferred tax assets will not be realized.
The significant components of the Company’s
deferred tax assets and liabilities are as follows, in thousands:
Schedule of deferred tax assets and liabilities
Years Ending December 31,
2023
2022
Deferred tax assets:
Net operating loss carryforwards
$ 774
$ 11,808
Tax credit carryforwards
295
1,227
Stock-based compensation
80
435
Capitalized research and development expenses
1,384
1,662
License fees
3
1,680
Lease liability
9
46
Other timing differences
13
120
Deferred tax assets
2,558
16,978
Deferred tax liabilities:
Right of use asset
( 9 )
( 43 )
Deferred tax liability
( 9 )
( 43 )
Valuation allowance
( 2,549 )
( 16,935 )
Net deferred tax asset
$ –
$ –
Ownership changes may limit the amount of net operating
loss (“ NOL ”) carryforwards or tax credit carryforwards that can be utilized to offset future taxable income or tax
liability. Pursuant to Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (the “ Code ”), NOL
and tax credit carryforwards may be subject to annual limitations in the event a cumulative change in ownership of more than 50% occurs
within a three-year period. Any limitation may result in expiration of a portion of the NOL carryforwards or tax credit carryforwards
before utilization.
F- 20
During 2023, the Company completed an assessment
of the available NOL and tax credit carryforwards under Sections 382 and 383 of the Code since the last assessment completed in 2021 and
concluded that the Company underwent an ownership change in 2023. As a result, NOL and tax credit carryforwards attributable to the pre-ownership
change are subject to substantial annual limitations under Sections 382 and 383 of the Code. The Company adjusted its NOL and tax credit
carryforwards to address the impact of the ownership change. For the year ended December 31, 2023, federal and state NOLs were reduced
by $ 52,400,000 and $ 25,900,000 , respectively, and federal and state research and development tax credit carryforwards were reduced by
$ 918,000 and $ 517,000 , respectively, as a result of the ownership change in 2023. The Company may experience ownership changes in the
future as a result of subsequent shifts in stock ownership, some of which may be outside of the Company’s control.
At December 31, 2023, the Company had federal
and state NOL carryforwards of approximately $ 2,900,000 and
$ 2,475,000 ,
respectively, 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 NOLs generated in tax years
beginning after 2017 may be carried forward indefinitely, but are limited to offset up to 80% of future taxable income. As of December
31, 2023, all of our federal NOL carryforwards will carryforward indefinitely. The Company’s available state NOL carryforwards
will begin to expire in 2044,
unless previously utilized.
At December 31, 2023, the Company also had federal
and state research and development credits of approximately $ 227,000
and $ 87,000 ,
respectively. The federal tax credit carryforwards will begin to expire in 2044
and the state tax credit carryforwards will begin to expire in 2039.
The Company has not recorded any uncertain tax
positions as of December 31, 2023 or 2022. The Company does no t believe there will be any material changes in its unrecognized tax
positions over the next 12 months.
The Company has no t 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 consolidated
financial statements as general and administrative expenses.
The Company files income tax returns in the United
States and in multiple state jurisdictions. The Company is subject to tax examinations for federal and state purposes for tax years 2015
through 2023.
12. 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 the dilutive effect of potential common stock equivalents,
except when the inclusion of such potential common stock equivalents would be anti-dilutive. Dilutive potential common stock equivalents
primarily consist of stock options, RSUs and warrants. Therefore, basic and diluted net loss per share applicable to common stockholders
were the same for all periods presented because the impact of these items is generally anti-dilutive during periods of net loss.
The following table sets forth the potential common
shares excluded from the calculation of net loss per common share because their inclusion would be anti-dilutive:
Schedule of anti dilutive stock
December 31,
2023
2022
Stock options
10,084
177
Unvested restricted stock units
49,683
47,335
Warrants 1
5,504,918
545,401
Total
5,564,685
592,913
1
The weighted average number of common shares outstanding as of December 31, 2023 includes the Abeyance Shares from the December 2023
Financing, the exercise of which was prepaid and requires no further consideration for the delivery of the shares of common stock. Therefore,
these Abeyance Shares are not included in the table above.
F- 21
13. Subsequent Events
In connection with the Inducement Letter Agreement,
shares were held in abeyance in the event that the exercise of the existing warrants in the December 2023 Financing would have otherwise
caused a holder to exceed the beneficial ownership limitations set forth in the existing warrant. These Abeyance Shares will be held until
notice is received by the holder that the balance, or portion thereof, may be issued in compliance with the beneficial ownership limitations.
Subsequent to the balance sheet date, 826,370 Abeyance Shares were released and issued.
F- 22
ITEM 9.
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
None.