Phio Pharmaceuticals Corp. 10-Q
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
☒ QUARTERLY REPORT PURSUANT TO SECTION
13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2025
OR
☐ TRANSITION REPORT PURSUANT TO SECTION
13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from
to
Commission File Number: 001-36304
Phio Pharmaceuticals Corp.
(Exact name of registrant as specified in its
charter)
Delaware
45-3215903
(State or other jurisdiction of incorporation or organization)
(I.R.S. Employer Identification No.)
411 Swedeland Road , Suite 23-1080 , King of Prussia ,
PA 19406
(Address of principal executive office) (Zip
code)
Registrant’s telephone number, including
area code: ( 508 ) 929-3640
Securities registered pursuant to Section 12(b)
of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, par value, $0.0001 per share
PHIO
The Nasdaq Capital Market
Indicate by check mark whether the registrant
(1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements
for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant
has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405
of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes
☒ No ☐
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company.
See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,”
and "emerging growth company" in Rule 12b-2 of the Exchange Act.
Large accelerated filer
☐
Accelerated filer
☐
Non-accelerated filer
☒
Smaller reporting company
☒
Emerging growth company
☐
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by checkmark whether the registrant is
a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As of August 12, 2025, Phio Pharmaceuticals Corp. had 5,726,750 shares
of common stock, $0.0001 par value, outstanding.
PHIO PHARMACEUTICALS CORP.
FORM 10-Q — QUARTER ENDED JUNE 30, 2025
INDEX
Part No.
Item No.
Description
Page
No.
I
FINANCIAL INFORMATION
3
1
Financial Statements (Unaudited)
3
Condensed Consolidated Balance Sheets as of June 30, 2025 and December 31, 2024
3
Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2025 and 2024
4
Condensed Consolidated Statements of Stockholders’ Equity for the Three and Six Months Ended June 30, 2025 and 2024
5
Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2025 and 2024
6
Notes to Condensed Consolidated Financial Statements
7
2
Management’s Discussion and Analysis of Financial Condition and Results of Operations
18
3
Quantitative and Qualitative Disclosures About Market Risk
25
4
Controls and Procedures
25
II
OTHER INFORMATION
26
1
Legal Proceedings
26
1A
Risk Factors
26
2
Unregistered Sales of Equity Securities and Use of Proceeds
27
3
Defaults Upon Senior Securities
27
4
Mine Safety Disclosures
27
5
Other Information
27
6
Exhibits
28
Signatures
30
2
PART I — FINANCIAL INFORMATION
ITEM 1.
FINANCIAL STATEMENTS
PHIO PHARMACEUTICALS CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share and per
share data)
(Unaudited)
June 30,
2025
December 31,
2024
ASSETS
Current assets:
Cash and cash equivalents
$ 10,775
$ 5,382
Prepaid expenses and other current assets
519
354
Total current assets
11,294
5,736
Property and equipment, net
7
2
Total assets
$ 11,301
$ 5,738
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$ 235
$ 253
Accrued expenses
971
762
Total current liabilities
1,206
1,015
Total liabilities
1,206
1,015
Commitments and contingencies (Note 2)
–
–
Stockholders’ equity:
Series D Preferred Stock, $ 0.0001 par value; 10,000,000 shares authorized, 0 issued and outstanding at June 30, 2025 and December 31, 2024
–
–
Common stock, $ 0.0001 par value, 100,000,000 shares authorized; 4,798,154 and 1,733,717 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively
–
–
Additional paid-in capital
160,386
151,079
Accumulated deficit
( 150,291 )
( 146,356 )
Total stockholders’ equity
10,095
4,723
Total liabilities and stockholders’ equity
$ 11,301
$ 5,738
The accompanying notes are an integral part of
these condensed consolidated financial statements.
3
PHIO PHARMACEUTICALS CORP.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per
share data)
(Unaudited)
Three Months Ended
June 30,
Six Months Ended
June 30,
2025
2024
2025
2024
Operating expenses:
Research and development
$ 1,074
$ 866
$ 1,960
$ 2,014
General and administrative
1,235
1,048
2,221
2,109
Total operating expenses
2,309
1,914
4,181
4,123
Operating loss
( 2,309 )
( 1,914 )
( 4,181 )
( 4,123 )
Total other income (expense), net
143
68
246
123
Net loss
$ ( 2,166 )
$ ( 1,846 )
$ ( 3,935 )
$ ( 4,000 )
Net loss per common share:
Basic and diluted
$ ( 0.45 )
$ ( 3.62 )
$ ( 0.86 )
$ ( 7.85 )
Weighted average number of common shares outstanding
Basic and diluted
4,794,857
510,188
4,551,061
509,542
The accompanying notes are an integral part of
these condensed consolidated financial statements.
4
PHIO PHARMACEUTICALS CORP.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’
EQUITY
(Amounts in thousands, except share data)
(Unaudited)
Common
Stock
Additional Paid
in
Accumulated
For the Three and Six Months Ended June
30, 2025
Shares
Amount
Capital
Deficit
Total
Balance at December
31, 2024
1,733,717
$ –
$ 151,079
$ ( 146,356 )
$ 4,723
Issuance of common stock upon
exercise of warrants
537,432
–
2,680
–
2,680
Issuance of common stock and warrants,
net of offering costs of $ 1,278
2,507,005
–
6,493
–
6,493
Stock-based compensation expense
–
–
43
–
43
Net loss
–
–
–
( 1,769 )
( 1,769 )
Balance at March 31, 2025
4,778,154
$ –
$ 160,295
$ ( 148,125 )
$ 12,170
Stock-based compensation expense
–
–
51
–
51
Issuance of common stock upon
exercise of warrants
20,000
–
40
–
40
Net loss
–
–
–
( 2,166 )
( 2,166 )
Balance
at June 30, 2025
4,798,154
$ –
$ 160,386
$ ( 150,291 )
$ 10,095
Common Stock
Additional Paid in
Accumulated
For the Three and Six Months Ended June 30, 2024
Shares
Amount
Capital
Deficit
Total
Balance at December 31, 2023
416,368
$ –
$ 146,936
$ ( 139,206 )
$ 7,730
Issuance of common stock upon exercise of warrants
91,820
–
–
–
–
Issuance of common stock upon vesting of restricted stock units
2,689
–
–
–
–
Shares withheld for payroll taxes
( 689 )
–
( 4 )
–
( 4 )
Stock-based compensation expense
–
–
32
–
32
Net loss
–
–
–
( 2,154 )
( 2,154 )
Balance at March 31, 2024
510,188
$ –
$ 146,964
$ ( 141,360 )
$ 5,604
Stock-based compensation expense
–
–
15
–
15
Net loss
–
–
–
( 1,846 )
( 1,846 )
Balance at June 30, 2024
510,188
$ –
$ 146,979
$ ( 143,206 )
$ 3,773
The accompanying notes are an integral part of
these condensed consolidated financial statements.
5
PHIO PHARMACEUTICALS CORP.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Amounts in thousands)
(Unaudited)
Six Months Ended
June 30,
2025
2024
Cash flows from operating activities:
Net loss
$ ( 3,935 )
$ ( 4,000 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
–
2
Amortization of right of use asset
–
33
Loss on disposal of property and equipment
–
3
Stock-based compensation
94
47
Changes in operating assets and liabilities:
Prepaid expenses and other assets
( 165 )
238
Accounts payable
( 18 )
( 322 )
Accrued expenses
209
246
Lease liability
–
( 35 )
Net cash used in operating activities
( 3,815 )
( 3,788 )
Cash flows from investing activities:
Cash paid for the purchase of property and equipment
( 5 )
–
Net cash used in financing activities
( 5 )
–
Cash flows from financing activities:
Net proceeds from the issuance of common stock and warrants
6,493
–
Net proceeds from the exercise of warrants
2,720
–
Payment of taxes on net share settlements of restricted stock units
–
( 4 )
Net cash provided by (used in) financing activities
9,213
( 4 )
Net increase (decrease) in cash and cash equivalents
5,393
( 3,792 )
Cash and cash equivalents at the beginning of period
5,382
8,490
Cash and cash equivalents at the end of period
$ 10,775
$ 4,698
2025
2024
Supplemental cash flow information
Cash paid during the year for:
Interest
$ –
$ 4
See accompanying notes to consolidated financial
statements.
6
PHIO PHARMACEUTICALS CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1. Organization and Significant Accounting Policies
Nature of Operations
Phio Pharmaceuticals Corp.
(“ Phio ” or the “ Company ”) is a clinical stage biopharmaceutical company whose proprietary INTASYL®
self-delivering small interfering RNAi(siRNA) technology 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. The Company is committed to discovering and developing
innovative cancer treatments for patients by creating new pathways toward a cancer-free future.
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 condensed
consolidated financial statements are unaudited and have been prepared in accordance with accounting principles generally accepted in
the United States (“ GAAP ”). Certain information and footnote disclosures that are included in the Company’s annual
consolidated financial statements, but that are not required for interim reporting purposes, have been condensed or omitted. In the opinion
of management, the interim condensed consolidated financial statements reflect all adjustments necessary for a fair presentation of results
for the periods presented.
These statements should be
read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s most recent Annual
Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “ SEC ”)
on March 31, 2025 (the “ 2024 Form 10-K ”). Interim results are not necessarily indicative of results for a full year.
Principles of Consolidation
The condensed 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
E ffective
July 5, 2024, the Company completed a 1-for-9 reverse stock split of the Company’s outstanding common stock, including
reclassifying an amount equal to the reduction in par value to additional paid-in capital. The reverse stock split did not reduce the
number of authorized shares of the Company’s common or preferred stock. All share and per share amounts have been adjusted to give
effect to the reverse stock split.
7
Use of Estimates
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 judgment 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 the Company’s 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 the Company 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.
The Company has limited cash
resources, has reported recurring losses from operations since inception, has 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 condensed 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 condensed
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.
Summary of Significant Accounting Policies
Cash and Cash Equivalents
Cash and cash equivalents
include unrestricted cash accounts, money market investments and highly liquid investment instruments with original maturity of three
months or less at the date of purchase.
Other than as set forth above,
there have been no material changes to the significant accounting policies disclosed in the Company’s 2024 Form 10-K.
8
Recent Accounting Pronouncements
In December 2023, the Financial
Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-09, “Income Taxes (Topic
740): Improvements to Income Tax Disclosures,” which requires public business entities to disclose additional information in specified
categories with respect to the reconciliation of the effective tax rate to the statutory rate for federal, state, and foreign income taxes.
It also requires greater detail about individual reconciling items in the rate reconciliation to the extent the impact of those items
exceeds a specified threshold. In addition to new disclosures associated with the rate reconciliation, the ASU requires information pertaining
to taxes paid (net of refunds received) to be disaggregated for federal, state, and foreign taxes and further disaggregated for specific
jurisdictions to the extent the related amounts exceed a quantitative threshold. The ASU also describes items that need to be disaggregated
based on their nature, which is determined by reference to the item’s fundamental or essential characteristics, such as the transaction
or event that triggered the establishment of the reconciling item and the activity with which the reconciling item is associated. The
ASU eliminates the historic requirement that entities disclose information concerning unrecognized tax benefits having a reasonable possibility
of significantly increasing or decreasing in the 12 months following the reporting date. This ASU is effective for annual periods beginning
after December 15, 2024. Early adoption is permitted for annual financial statements that have not yet been issued or made available for
issuance. This ASU should be applied on a prospective basis; however, retrospective application is permitted. The Company is currently
evaluating the impact that ASU 2023-09 will have on its consolidated financial statements.
In November 2024, the FASB
issued ASU 2024-03, “Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosure (Subtopic 220-40): Disaggregation
of Income Statement Expenses,” which requires additional disclosure about the specific expense categories in the notes to financial
statements at interim and annual reporting periods. The amendments in this ASU do not change or remove current expense disclosure requirements
but affect where this information appears in the notes to financial statements. This ASU is effective for annual reporting periods beginning
after December 15, 2026, and interim reporting periods beginning after December 15, 2027, with early adoption permitted. Upon adoption,
the guidance can be applied prospectively or retrospectively. The Company is currently evaluating the impact that ASU 2024-03 will have
on its consolidated financial statements.
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 were 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.
In May 2024, the Company terminated
the Clinical Co-Development Agreement with AgonOx, effective immediately. Effective as of the date of termination, the Clinical Co-Development
Agreement and the continuing obligations of the Company and AgonOx thereunder were terminated in their entirety. The Company is no longer
required to provide financial support for the development costs incurred in the Clinical Co-Development Agreement and the Company is no
longer entitled to future development milestones or royalty payments from AgonOx’s licensing of its DP TIL technology.
The Company paid AgonOx all
payment obligations that accrued prior to the termination of the Clinical Co-Development Agreement. Pursuant to the terms of the Clinical
Co-Development Agreement, each of the Company and AgonOx were responsible for its own costs and expenses incurred in connection with the
wind-down of the Phase 1 clinical trial. The Company made the remaining payment of $34,320, which primarily related to accrued obligations
for patient fees and other miscellaneous costs as of the date of termination, to AgonOx on March 21, 2025. This settled all future obligations
to AgonOx.
9
The Company did no t recognize
expense with respect to the Clinical Co-Development Agreement during the three and six months ended June 30, 2025. During the three and
six months ending June 30, 2024, the Company recognized approximately $ 56,000 and $ 106,000 , respectively, of expense with respect to the
Clinical Co-Development Agreement.
3. Leases
The Company leases space for
various corporate and research purposes. It is the Company’s policy to apply the provisions of ASC 842 when accounting for arrangements
that meet the criteria to be a lease. The Company calculates the lease liability as the present value of the lease’s cash flows
using the interest rate implicit in the lease, if determinable. If the rate implicit in the lease is not determinable, the Company uses
its incremental borrowing rate. The incremental borrowing rate is defined as the rate the Company would have to pay to borrow on a collateralized
basis over the lease term. The Company has elected the accounting policy election available under ASC 842 to not record a lease liability
for leases with a term of less than one year.
From April 2014 to March
2024, the Company leased space that was utilized as its corporate headquarters and primary laboratory. The lease expired on March
31, 2024. On March 1, 2024, the Company commenced a lease for a laboratory facility located at 17 Briden Street, Worcester,
Massachusetts. The lease had an original expiration date of August 31, 2024 and was subsequently extended through February
28, 2025 . The Company continues to lease the space on a month-to-month basis. Monthly rent is
approximately $ 2,500 .
In March 2025, the Company contracted with LifeSciences PA located at 411 Swedeland Road, King of Prussia, PA 19406 for access to
full working space for normal hours of operations at a fee of $ 300
per month, which can be cancelled at any time.
Operating lease costs included
in operating expense were approximately $ 8,400 and $ 0 for the three months ended June 30, 2025 and 2024, respectively. Operating lease
costs included in operating expense were approximately $ 16,800 and $ 33,000 for the six months ended June 30, 2025 and 2024, respectively.
There was no cash paid for
the amounts included in the measurement of the operating lease liability on the Company’s condensed consolidated balance sheets
and included within changes in the lease liability in the operating activities of the Company’s condensed consolidated statements
of cash flows for the Company’s former corporate headquarters for the three months ended June 30, 2025 and 2024. Cash paid for the
amounts included in the measurement of the operating lease liability on the Company’s condensed consolidated balance sheets and
included within changes in the lease liability in the operating activities of the Company’s condensed consolidated statements of
cash flows was $ 0 and $ 35,000 for the six months ended June 30, 2025 and 2024, respectively.
4. Stockholders’ Equity
Financings
May 2024 Financing
On May 16, 2024, the Company
entered into a purchase agreement (the “ Purchase Agreement ”) with Triton Funds LP (“ Triton ”), pursuant
to which the Company agreed to sell, and Triton agreed to purchase, upon the Company’s request in one or more transactions, up to 95,833 shares
of Common Stock at a purchase price of $ 6.48 per share (the “ Purchase Price ”), for aggregate gross proceeds of
up to $ 621,000 . The Company recorded expense of approximately $ 100,000 , primarily related to legal fees, in connection with the execution
of the Purchase Agreement with Triton. On July 3, 2024, the Company terminated the Purchase Agreement with Triton effective immediately.
No shares of Common Stock were sold by the Company pursuant to the Purchase Agreement prior to termination.
10
July 2024 Financing
On July 11, 2024, the Company
entered into inducement letter agreements (the “ July 2024 Inducement Letter Agreements ”) with certain holders of certain
of the Company’s existing warrants to purchase up to an aggregate of 545,286 shares of Common Stock. The existing warrants
were originally issued in February 2020 through December 2023, having exercise prices between $324.00 and $9.72 per share. Pursuant to
the July 2024 Inducement Letter Agreements, these warrants were exercised for cash at a reduced exercise of $ 5.45 per share in consideration
of the Company’s agreement to issue new unregistered five and one-half year term Series C warrants to purchase up to 583,098 shares
of Common Stock at an exercise price of $ 5.45 and new unregistered eighteen month term Series D warrants to purchase up to 507,474 shares
of Common Stock at an exercise price of $ 5.45 , both issued and sold at a price of $0.125 per warrant share (the “ July 2024 Financing ”).
In addition, the Company issued warrants to H.C. Wainwright & Co., LLC (the “ Placement Agent ”) to purchase a total
of 40,896 shares of Common Stock at an exercise price of $ 6.8125 per share. The net proceeds to the Company from the July 2024 Financing
were approximately $ 2,646,000 , after deducting placement agent fees and offering expenses. The Company incurred non-cash equity issuance
costs of approximately $ 2.4 million for the incremental fair value of the outstanding equity classified warrants and approximately
$ 0.2 million for placement agent warrants.
Pursuant to the terms of the
July 2024 Inducement Letter Agreements, in the event that the exercise of the existing warrants in the July 2024 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, an aggregate of 328,758 shares of Common Stock were held in abeyance (the “ July 2024
Abeyance Shares ”) with such July 2024 Abeyance Shares evidenced through the holder’s existing warrants and which are deemed
to be prepaid. The July 2024 Abeyance Shares were held until notice was received by the holder that the balance of the shares of Common
Stock could be issued in compliance with such beneficial ownership limitations and were exercised pursuant to a notice of exercise from
the holder. Until such time, the Abeyance Shares were evidenced through the holder’s existing warrants and have been included in
the Company’s table of outstanding warrants below. During the year ended December 31, 2024, all of the July 2024 Abeyance
Shares were released.
December 19, 2024 Concurrent Registered Direct Offering and Private
Placement
On December 19, 2024, the
Company entered into a securities purchase agreement (the “ December 19, 2024 Securities Purchase Agreement ”) with certain
institutional and accredited investors in connection with a registered direct offering (the “ December 19, 2024 Registered Direct
Offering ”) and concurrent private placement (the “ December 19, 2024 Private Placement ” and, together with
the December 19, 2024 Registered Direct Offering, the “ December 19, 2024 Offerings ”). The December 19, 2024 Offerings
closed on December 20, 2024. The net proceeds to the Company from the December 19, 2024 Offerings were approximately $ 900,000 , after deducting
placement agent fees and offering expenses.
Pursuant to the December 19,
2024 Securities Purchase Agreement, the Company offered and sold in the December 19, 2024 Registered Direct Offering 437,192 shares
of Common Stock at a purchase price of $ 2.635 per share. In the December 19, 2024 Private Placement, the Company also issued to such institutional
and accredited investors unregistered warrants to purchase up to 437,192 shares of Common Stock (the “ Series E Warrants ”).
Under the terms of the December 19, 2024 Securities Purchase Agreement, for each share of Common Stock issued in the December 19, 2024
Registered Direct Offering, an accompanying Series E Warrant was issued to the purchaser thereof. Each Series E Warrant is exercisable
for one share of Common Stock at an exercise price of $ 2.51 per share and will expire on December 20, 2029 . The Series E Warrants were
offered and sold at a purchase price of $0.125 per Series E Warrant, which purchase price is included in the offering price per share
of Common Stock issued in the December 19, 2024 Registered Direct Offering.
11
December 23, 2024 Concurrent Registered Direct Offering and Private
Placement
On December 23, 2024, the
Company entered into a securities purchase agreement (the “ December 23, 2024 Securities Purchase Agreement ”) with certain
institutional and accredited investors in connection with a registered direct public offering (the “ December 23, 2024 Registered
Direct Offering ”) and concurrent private placement (the “ December 23, 2024 Private Placement ” and, together
with the December 23, 2024 Registered Direct Offering, the “ December 23, 2024 Offerings ” and, together with the December
19, 2024 Offerings, the “ December 2024 Offerings ”). The December 23, 2024 Offerings closed on December 24, 2024. The
net proceeds to the Company from the December 23, 2024 Offerings were approximately $ 480,000 , after deducting placement agent fees and
offering expenses.
Pursuant to the December 23,
2024 Securities Purchase Agreement, the Company offered and sold in the December 23, 2024 Registered Direct Offering 240,000 shares of
Common Stock at a purchase price of $ 2.00 per share. In the December 23, 2024 Private Placement, the Company also issued to such institutional
and accredited investors unregistered warrants to purchase up to 240,000 shares of Common Stock (the “ Series F Warrants ”).
Under the terms of the December 23, 2024 Securities Purchase Agreement, for each share of Common Stock issued in the December 23, 2024
Registered Direct Offering, an accompanying Series F Warrant was issued to the purchaser thereof. Each Series F Warrant is exercisable
for one share of Common Stock at an exercise price of $ 2.00 per share and will expire on December 24, 2029 . The Series F Warrants were
offered and sold at a purchase price of $0.125 per Series F Warrant, which purchase price is included in the offering price per share
of Common Stock issued in the December 23, 2024 Registered Direct Offering.
In connection with the December
2024 Offerings, the Company agreed to issue to the Placement Agent, or its designees, warrants to purchase up to an aggregate of 50,789
shares of Common Stock (the “ Placement Agent Warrants ”), which represent 7.5% of the aggregate number of shares of
Common Stock sold in the December 19, 2024 Registered Direct Offering and the December 23, 2024 Registered Direct Offering. The Placement
Agent Warrants have substantially the same terms as the Series E Warrants and the Series F Warrants, except that (i) 32,789 of the Placement
Agent Warrants have an exercise price equal to $ 3.2938 , or 125% of the offering price per share of Common Stock sold in the December 19,
2024 Registered Direct Offering, and are exercisable until December 19, 2029 , and (ii) 18,000 of the Placement Agent Warrants have an
exercise price equal to $ 2.50 , or 125% of the offering price per share of Common Stock sold in the December 23, 2024 Registered Direct
Offering, and are exercisable until December 23, 2029 .
January 13, 2025 Concurrent Registered Direct Offering and Private
Placement
On January 13, 2025,
the Company entered into a securities purchase agreement (the “ January 13, 2025 Securities Purchase Agreement ”) with
certain institutional and accredited investors in connection with a registered direct public offering (the “ January 13, 2025
Registered Direct Offering ”) and concurrent private placement (the “ January 13, 2025 Private Placement ” and,
together with the January 13, 2025 Registered Direct Offering, the “ January 13, 2025 Offerings ”). The January 13, 2025
Offerings closed on January 14, 2025. In addition, the Company issued warrants to the Placement Agent to purchase a total of 79,775 shares
of Common Stock at an exercise price of $ 3.75 per share. The net proceeds to the Company from the January 13, 2025 Registered Direct Offerings
and the January 13, 2025 Private Placement were approximately $ 2.9 million , after deducting fees and estimated offering expenses.
Pursuant to the January 13,
2025 Securities Purchase Agreement, the Company offered and sold in the January 13, 2025 Registered Direct Offering 1,063,670 shares of
Common Stock at a purchase price of $3.00 per share. In the January 13, 2025 Private Placement, the Company also issued to certain institutional
and accredited investors unregistered warrants to purchase up to 2,127,340 shares of Common Stock (the “ Series G Warrants ”).
Under the terms of the January 13, 2025 Securities Purchase Agreement, for each share of Common Stock issued in the January 13, 2025 Registered
Direct Offering, two accompanying Series G Warrants were issued to the purchaser thereof. Each Series G Warrant is exercisable for one
share of Common Stock at an exercise price of $ 3.00 per share and will expire on January 14, 2027 .
12
January 14, 2025 Concurrent Registered Direct Offering and Private
Placement
On January 14, 2025, the
Company entered into a securities purchase agreement (the “ January 14, 2025 Securities Purchase Agreement ”) with
certain institutional and accredited investors in connection with a registered direct public offering (the “ January 14,
2025 Registered Direct Offering ”) and concurrent private placement (the “ January 14, 2025 Private
Placement ” and together with the January 14, 2025 Registered Direct Offering, the “ January 14, 2025
Offerings ”). The January 14, 2025 Offerings closed on January 15, 2025. In addition, the Company issued warrants to the
Placement Agent to purchase a total of 62,500 shares of Common Stock at an exercise price of $ 3.75 per share. The net proceeds to
the Company from the January 14, 2025 Registered Direct Offering and the January 14, 2025 Private Placement were approximately $ 2.2
million , after deducting fees and estimated offering expenses.
Pursuant to the January
14, 2025 Securities Purchase Agreement, the Company offered and sold in the January 14, 2025 Registered Direct
Offering 833,335 shares of Common Stock at a purchase price of $3.00 per share. In the January 14, 2025 Private Placement, the
Company also issued to such institutional and accredited investors unregistered warrants to purchase up to 1,666,670 shares of
Common Stock (the “ Series H Warrants ”). Under the terms of the January 14, 2025 Securities Purchase
Agreement, for each share of Common Stock issued in the January 14, 2025 Registered Direct Offering, two accompanying
Series H Warrants were issued to the purchaser thereof. Each Series H Warrant is exercisable for one share of Common Stock at an
exercise price of $ 3.00 per share and will expire on January 15, 2027 .
January 16, 2025 Concurrent Registered Direct Offering and Private
Placement
On January 16, 2025, the
Company entered into a securities purchase agreement (the “ January 16, 2025 Securities Purchase Agreement ”) with certain
institutional and accredited investors in connection with a registered direct public offering (the “ January 16, 2025 Registered
Direct Offering ”) and concurrent private placement (the “ January 16, 2025 Private Placement ” and, together
with the January 16, 2025 Registered Direct Offering, the “ January 16, 2025 Offerings ” and the January 16, 2025 Offerings,
together with the January 13, 2025 Offerings and the January 14, 2025 Offerings, the “ January 2025 Offerings” ). The
January 16, 2025 Offerings closed on January 17, 2025. In addition, the Company issued warrants to the Placement Agent to purchase a total
of 45,750 shares of Common Stock at an exercise price of $ 3.75 per share The net proceeds to the Company from the January 16, 2025 Registered
Direct Offering and the January 16, 2025 Private Placement are approximately $ 1.6 million , after deducting fees and estimated offering
expenses.
Pursuant to the January 16,
2025 Securities Purchase Agreement, the Company offered and sold in the January 16, 2025 Registered Direct Offering 610,000
shares of Common Stock at a purchase price of $3.00 per share. In the January 16, 2025 Private Placement, the Company also issued
to such institutional and accredited investors unregistered warrants to purchase up to 1,220,000 shares of Common Stock (the
“ Series I Warrants ”). Under the terms of the January 16, 2025 Securities Purchase Agreement, for each share
of Common Stock issued in the January 16, 2025 Registered Direct Offering, two accompanying Series I Warrants were issued to
the purchaser thereof. Each Series I Warrant is exercisable for one share of Common Stock at an exercise price of $ 3.00 per share and
will expire on January 19, 2027 .
Warrants
The Company first assesses
warrants that are issued by the Company under the FASB ASC Topic 480, “ Distinguishing Liabilities from Equity ” (“ ASC
480 ”) to determine whether the warrants are within the scope of ASC 480. If there are no instances outside of the Company’s
control that could require cash settlement, the Company then applies and follows the applicable accounting guidance in the FASB ASC Topic
815, “ Derivatives and Hedging ” (“ ASC 815 ”). Financial instruments are accounted for as either derivative
liabilities or equity instruments depending on the specific terms of the agreement. Based on the assessment of the warrants issued by
the Company under the guidance in ASC 480 and ASC 815, the warrants issued by the Company have been classified within stockholder’s
equity.
During the three months ended
June 30, 2025 and 2024, there were 20,000 and 0 warrants exercised, respectively. During the six months ended June 30, 2025 and 2024,
there were 557,432 and 91,820 warrants exercised, respectively.
13
The following table summarizes
the Company’s outstanding warrants, all of which are classified as equity instruments, at June 30, 2025:
Schedule of outstanding warrants
Number
of Shares
Weighted-
Average
Exercise Price
Per Share
Outstanding at December 31, 2024
1,925,867
$ 12.66
Issued
5,242,342
3.06
Exercised
( 557,432 )
5.33
Expired
( 9,659 )
457.92
Outstanding at June 30, 2025
6,601,118
$ 5.00
5. Stock-based Compensation
Restricted Stock Units
Restricted stock units (“ RSUs ”)
are issued under the Company’s 2020 Long-Term Incentive Plan (the “ 2020 Plan ”). RSUs are generally subject to
the satisfaction of certain service requirements. RSUs granted by the Company to employees generally cliff vest 1 year after the grant
date. 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 withholding 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
is based upon the Company’s closing stock price at the grant date and is expensed over the requisite service period.
The following table summarizes
the activity of the Company’s RSUs for the six months ended June 30, 2025:
Summary of RSUs activity
Number
of Shares
Weighted-
Average
Grant Date Fair Value
Per Share
Unvested units at December 31, 2024
71,000
$ 2.77
Granted
–
–
Vested
–
–
Forfeited
–
–
Unvested units at June 30, 2025
71,000
$ 2.77
There were no RSUs granted
during the three or six months ended June 30, 2025 or June 30, 2024.
Stock-based compensation expense
related to RSUs was $ 51,000 and $ 15,000 for the three months ended June 30, 2025 and 2024, respectively. Stock-based compensation expense
related to RSUs was $ 94,000 and $ 41,000 for the six months ended June 30, 2025 and 2024, respectively.
The aggregate fair value of
awards that vested during the six months ended June 30, 2024 was $ 17,000 , which represents the market value of the Company’s common
stock on the date that the RSUs vested. No RSUs vested during the six months ended June 30, 2025.
14
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
the FASB ASC Topic 718, “ Compensation — Stock Compensation ”. 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
any stock options during the three or six months ended June 30, 2025 or 2024.
The following table summarizes
the activity of the Company’s stock options for the six months ended June 30, 2025:
Summary of stock options activity
Number
of Shares
Weighted-
Average
Exercise
Price
Per Share
Aggregate
Intrinsic
Value
Balance at December 31, 2024
1,126
$ 1,206.29
Granted
–
–
Exercised
–
–
Forfeited
–
–
Expired
( 2 )
225,720.00
Balance at June 30, 2025
1,124
$ 806.80
$ –
Exercisable at June 30, 2025
1,124
$ 806.80
$ –
Stock-based compensation expense
related to stock options for the six months ended June 30, 2025 and 2024 was $ 0 and $ 6,000 , respectively. The Company did no t have any
stock-based compensation expense related to stock options for the three months ended June 30, 2025 and 2024.
Compensation Expense Related to Equity Awards
The following table sets forth
total stock-based compensation expense for the three months ended June 30, 2025 and 2024, in thousands:
Schedule of stock-based compensation expense
Three Months Ended
Six Months Ended
June 30,
June 30,
2025
2024
2025
2024
Research and development
$ 23
$ –
$ 38
$ ( 11 )
General and administrative
28
15
56
58
Total stock-based compensation
$ 51
$ 15
$ 94
$ 47
As of June 30, 2025,
the total unrecognized compensation cost related to non-vested RSUs was approximately $ 48,000 . This cost is expected to be recognized
over a weighted-average period of 0.2 years.
15
6. Net Loss per Common 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 shares
June 30,
2025
2024
Stock options
1,124
1,133
Unvested RSUs
71,000
1,850
Warrants
6,601,118
611,710
Total
6,673,242
614,693
7. Segment Information
The Company is a clinical
stage biopharmaceutical company that has yet to generate operating revenues. Management has determined that the Company operates with
a single operating segment and a single reporting segment – the Clinical segment. The Chief Operating Decision Maker (CODM) is the
Chief Executive Officer (CEO). The CEO assesses performance and allocates resources to achieve the Company’s goals based on net
income/(loss) as reported in the Consolidated Statements of Operations. The measure of segment assets is Total Assets as presented on
the Consolidated Balance Sheets. All of the Company’s operations occur within the United States.
The following table presents selected financial
information with respect to the Company's single operating segment (in thousands):
Schedule of operating segment information
Three Months Ended
Six Months Ended
June 30,
June 30,
2025
2024
2025
2024
Research and development expense
$ ( 1,074 )
$ ( 866 )
$ ( 1,960 )
$ ( 2,014 )
General and administrative expense
( 1,235 )
( 1,048 )
( 2,221 )
( 2,109 )
Impairment loss on property and equipment
–
–
–
–
Other income
24
4
2
6
Interest income
119
66
244
121
Interest expense
–
( 2 )
–
( 4 )
Net loss
$ ( 2,166 )
$ ( 1,846 )
$ ( 3,935 )
$ ( 4,000 )
Total assets
$ 11,301
$ 5,296
$ 11,301
$ 5,296
16
8. Subsequent Events
On July 4, 2025, the One Big
Beautiful Bill Act (the “ OBBBA ”) was enacted in the U.S. The OBBBA includes significant provisions, such as the permanent
extension of certain expiring provisions of the Tax Cuts and Jobs Act, modifications to the international tax framework and the restoration
of favorable tax treatment for certain business provisions. The legislation has multiple effective dates, with certain provisions effective
in 2025 and others implemented through 2027. The Company is currently assessing the OBBBA’s impact on its consolidated financial
statements.
On July 25, 2025, the
Company entered into inducement letter agreements (the “ July 2025 Inducement Letter Agreements ”) with certain
holders of certain of the Company’s existing warrants to purchase an aggregate of 928,596 shares of the
Company’s common stock. The existing warrants were originally issued in December 2024 and January 2025, having exercise prices
between $2.00 and $3.00 per share. Warrants to purchase 100,000 shares of common stock at the existing exercise
price of $2.00 per share were exercised at their existing exercise price of $2.00 per share, and warrants to purchase 828,596 shares
of common stock were exercised at a reduced exercise price of $2.485 per share. Pursuant to the July 2025 Inducement Letter
Agreements, in consideration for the immediate exercise of such warrants for cash and the payment of an additional $0.125 per New
Warrant (as defined below), or an aggregate of $232,149 for all New Warrants, the Company agreed to issue new unregistered five-year
term Series J warrants (the “ Series J Warrants ”) to purchase an aggregate of up to 318,596 shares of
common stock at an exercise price of $2.485 and new unregistered 24-month term Series K warrants (the “ Series K
Warrants ” and, together with the Series J Warrants, the “ New Warrants ”) to purchase an aggregate of up
to 1,538,596 shares of common stock at an exercise price of $2.485 (the “ July 2025 Financing ”). In
addition, the Company issued warrants to the placement agent, H.C. Wainwright & Co., LLC, to purchase up to 69,645 shares
of common stock (the “Placement Agent Warrants ”). 7,500 of the Placement Agent Warrants issued have an exercise
price of $2.8125 per share of Common Stock and a term of five years, 16,395 of the Placement Agent Warrants issued have an exercise
price of $3.4188 per share of Common Stock and a term of five years, and 45,750 of the Placement Agent Warrants issued have an
exercise price of $3.4188 per share of Common Stock and a term of twenty-four months. The net proceeds to the Company from the July
2025 Financing are approximately $2,200,000, after deducting placement agent fees and offering expenses.
17
ITEM 2.
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
In this report, “we,” “our,”
“ours,” “us,” “Phio” and the “Company” refers to Phio Pharmaceuticals Corp. and our subsidiary,
MirImmune, LLC and the ongoing business operations of Phio Pharmaceuticals Corp. and MirImmune, LLC, whether conducted through Phio Pharmaceuticals
Corp. or MirImmune, LLC.
This management’s discussion and analysis
of financial condition as of June 30, 2025 and results of operations for the three and six months ended June 30, 2025 and 2024 should
be read in conjunction with the audited financial statements included in our Annual Report on Form 10-K for the year ended December 31,
2024, which was filed with the Securities and Exchange Commission (the “ SEC ”) on March 31, 2025 (the “ 2024
Form 10-K ”).
This report contains forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such
as “intends,” “believes,” “anticipates,” “indicates,” “plans,” “expects,”
“suggests,” “may,” “would,” “should,” “potential,” “designed to,”
“will,” “ongoing,” “estimate,” “forecast,” “target,” “predict,”
“could” and similar references, although not all forward-looking statements contain these words. Forward-looking statements
are neither historical facts nor assurances of future performance. These statements are based only on our current beliefs, expectations
and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy
and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks
and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial
condition may differ materially from those indicated in the forward-looking statements as a result of a number of important factors, including,
but not limited to:
· we are dependent on the success of our INTASYL™
technology, and our product candidates based on this technology, which is unproven and may never lead to approved and marketable products;
· our product candidates are in an early stage
of development and we may fail, experience significant delays, never advance in clinical development or not be successful in our efforts
to identify or discover additional product candidates, which may materially and adversely impact our business;
· disruptions at the FDA, including due to a
reduction in the FDA’s workforce and/or inadequate funding for the FDA, could prevent the FDA from performing normal functions on
which our business relies, which could negatively impact our business;
· if we experience delays or difficulties in
identifying and enrolling subjects in clinical trials, it may lead to delays in generating clinical data and the receipt of necessary
regulatory approvals;
· topline data may not accurately reflect or
may materially differ from the complete results of a clinical trial;
· we rely upon third parties for the manufacture
of the clinical supply for our product candidates;
· our business and operations would suffer in
the event of computer system failures, cyberattacks or a deficiency in our cybersecurity;
· we are dependent on the patents we own and
the technologies we license, and if we fail to maintain our patents or lose the right to license such technologies, our ability to develop
new products would be harmed;
· we will require substantial additional funds
to complete our research and development activities;
· future financing may be obtained through,
and future development efforts may be paid for by, the issuance of debt or equity, which may have an adverse effect on our stockholders
or may otherwise adversely affect our business;
· disruptions at the FDA, including due to a
reduction in the FDA’s workforce and/or inadequate funding for the FDA;
· changes in U.S. and international trade policies
may adversely impact our business and operating results;
· we may not be able to remain compliant with
the continued listing requirements of The Nasdaq Capital Market; and
· the price of our Common Stock has been and
may continue to be volatile.
Therefore, you should not rely on any of these
forward-looking statements. Forward-looking statements contained in this Quarterly Report on Form 10-Q speak as of the date hereof and
the Company does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances
that occur after the date of this report except as required by law.
18
Overview
Phio Pharmaceuticals Corp.
(“ Phio ,” “ we ,” “ our ” or the “ Company ”) is a clinical stage
biopharmaceutical company whose proprietary INTASYL® self-delivering small interfering RNAi (siRNA) technology is designed to make
immune cells more effective in killing tumor cells. We are 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. We are committed to discovering and developing innovative cancer treatments for patients by creating new pathways toward a cancer-free
future.
In 2023, the Company implemented
a cost rationalization program driven by its transition from discovery research to product development. This resulted in a decision not
to renew the lease for office and laboratory space in Marlborough, Massachusetts, which expired on March 31, 2024. Beginning in April
2024, we have continued operations as a remote business with a laboratory facility in Worcester, Massachusetts. Beginning in January 2024,
we rationalized discovery research personnel resulting in an overall headcount reduction by greater than 50%. Expense reductions have
been redirected to funding the Phase 1b clinical trial with PH-762.
PH-762
PH-762 is an INTASYL
compound designed to reduce the expression of cell death protein 1 (“ PD-1 ”). PD-1 is a protein that inhibits T cells’
ability to kill cancer cells and is a clinically validated target in immunotherapy. Decreasing the expression of PD-1 can thereby increase
the capacity of T cells, which protect the body from cancer cells and infections, to kill cancer cells.
Our preclinical
studies have demonstrated that direct-to-tumor application of PH-762 resulted in potent anti-tumoral effects and have shown that direct-to-tumor
treatment with PH-762 inhibits tumor growth in a dose dependent fashion in PD-1 responsive and refractory models. Importantly, direct-to-tumor
administration of PH-762 resulted in activity against distant untreated tumors, indicative of a systemic anti-tumor response. We believe
these data further support the potential for PH-762 to provide a strong local immune response without the dose immune-related adverse
effects seen with systemic antibody therapy.
PH-762 is currently being
evaluated in a U.S. multi-center Phase 1b dose-escalating clinical trial through the intratumoral injection of PH-762 for the treatment
of patients with cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma. The trial (NCT 06014086) is designed to evaluate
the safety and tolerability of neoadjuvant use of intratumorally injected PH-762, assess the tumor response, and determine the dose or
dose range for continued study of PH-762 and is expected to enroll up to 30 patients. In November 2023, we announced the dosing of the
first patient under a previously cleared Investigational New Drug (“ IND ”) application by the U.S. Food and Drug Administration.
A Safety Monitoring Committee (SMC) reviewed data from the first, second, third and fourth dose cohorts treated with PH-762 and, in each
case, recommended escalation to the next dose concentration. To date, a total of 15 patients with cutaneous carcinomas have been treated
in Cohorts 1, 2, 3 and 4. These cohorts included 13 patients with cutaneous squamous cell carcinoma (cSCC), one patient with metastatic
melanoma and one patient with metastatic Merkel cell carcinoma. At Day 36 (planned tumor excision), of the 13 patients with cSCC, five
patients had a pathologic complete response (100% tumor clearance). One patient had a near complete response (>90% clearance) and one
patient had a partial response (>50% clearance). The other six cSCC patients and one metastatic melanoma patient had a pathologic non-response
(< 50% clearance). The Merkel cell patient had a partial response (> 50% clearance). Patients with pathologic complete response
(100% tumor clearance) may have visual signs of residual scar or subdermal inflammation prior to resection. No patients, however, exhibited
clinical progression of disease. To date, there were no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects
in the patients receiving intratumoral PH-762 in this trial. Moreover, PH-762 has been well tolerated in all enrolled patients in each
escalating dose cohort. On June 25, 2025, we announced that the SMC recommended dose escalation to the fifth cohort in our Phase 1b clinical
trial. The fifth cohort is currently enrolling patients, and we expect to complete enrollment in the trial in the third quarter of 2025.
19
Due to INTASYL’s
ease of administration, we have shown that our compounds can easily be incorporated into current Adoptive Cell Therapy (ACT) manufacturing
processes. In ACT, T cells are usually taken from a patient's own blood or tumor tissue, grown in large numbers in a laboratory, and then
given back to the patient to help the immune system fight cancer. By treating T cells with our INTASYL compounds while they are being
grown in the laboratory, we believe our INTASYL compounds can improve these immune cells to make them more effective in killing cancer.
Preclinical data generated in collaboration with AgonOx, Inc. (“ AgonOx ”), a private company developing a pipeline of
novel immunotherapy drugs targeting key regulators of the immune response to cancer, demonstrated that treating AgonOx’s “double
positive” tumor infiltrating lymphocytes (“ DP TIL ”) with PH-762 increased their tumor killing activity by two-fold.
In February 2021,
we entered into a clinical co-development collaboration agreement (the “ Clinical Co-Development Agreement ”) with AgonOx
to develop a T cell-based therapy using PH-762 and AgonOx’s DP TIL. Under the Clinical Co-Development Agreement, we had agreed to
reimburse AgonOx up to $4 million 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. We were also eligible to receive certain future development milestones and low single-digit
sales-based royalty payments from AgonOx’s licensing of its DP TIL technology.
In May 2024, we
terminated the Clinical Co-Development Agreement with AgonOx, effective immediately. Effective as of the date of termination, the Clinical
Co-Development Agreement and our and AgonOx’s continuing obligations thereunder were terminated in their entirety. We are no longer
required to provide financial support for the development costs incurred in the Clinical Co-Development Agreement and we are no longer
entitled to future development milestones or royalty payments from AgonOx’s licensing of its DP TIL technology. We paid to AgonOx
all payment obligations that accrued prior to the termination of the Clinical Co-Development Agreement. Pursuant to the terms of the Clinical
Co-Development Agreement, each of the Company and AgonOx were responsible for its own costs and expenses incurred in connection with the
wind-down of the Phase 1 clinical trial. We made the remaining payment of $34,320, which primarily related to accrued obligations for
patient fees and other miscellaneous costs as of the date of termination to AgonOx on March 21, 2025. This settled all future obligations
to AgonOx.
Prior to the termination
of the Clinical Co-Development Agreement with AgonOx, PH-762 treated DP TIL were being evaluated in a Phase 1 clinical trial in the U.S.
with up to 18 patients with advanced melanoma and other advanced solid tumors by AgonOx. The primary trial objectives were to evaluate
the safety and to study the potential for enhanced therapeutic benefit from the administration of PH-762 treated DP TIL. AgonOx had enrolled
three patients. The first two patients were treated with DP TIL only and a third patient was treated with a combination of DP TIL and
PH-762. Clinical results for the single patient who received a combination of DP TIL and PH-762 showed tumor size reductions of 65%, 100%
and 81%, respectively, in three melanoma lesions.
PH-894
PH-894 is an INTASYL compound
that is designed to silence BRD4, a protein that controls gene expression in both T cells and tumor cells, thereby affecting the immune
system as well as the tumor. Intracellular and/or commonly considered “undruggable” targets, such as BRD4, represent a challenge
for small molecule and antibody therapies. Therefore, what sets this compound apart is its dual mechanism: PH-894 suppression of BRD4
in T cells results in T cell activation, and suppression of BRD4 in tumor cells results in tumors becoming more sensitive to being killed
by T cells.
Preclinical studies conducted
have demonstrated that PH-894 resulted in a strong, concentration dependent and durable silencing of BRD4 in T cells and in various cancer
cells. Similar to PH-762, preclinical studies have also shown that direct-to-tumor application of PH-894 resulted in potent and statistically
significant anti-tumoral effects against distant untreated tumors, indicative of a systemic anti-tumor response. These preclinical data
indicate that PH-894 can reprogram T cells and other cells in the tumor microenvironment to provide enhanced immunotherapeutic activity.
We have completed the IND-enabling studies and are in the process of finalizing the study reports required for an IND submission with
PH-894. As a result of the reprioritization to advance our clinical trial with PH-762 in the U.S., we have elected to defer the IND submission
for PH-894.
20
Critical Accounting Policies and Estimates
The discussion and analysis
of our financial condition and results of operations are based upon our condensed consolidated financial statements, which have been prepared
in accordance with accounting principles generally accepted in the United States. The preparation of these condensed consolidated financial
statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses,
and related disclosure of contingent assets and liabilities. On an ongoing basis, we evaluate our estimates and base our estimates on
historical experience and various other assumptions that are believed to be reasonable under the circumstances. Actual results may differ
from these estimates under different assumptions or conditions and could have a material impact on our reported results.
There have been no material
changes to our critical accounting policies and estimates as compared to those disclosed in our 2024 Form 10-K. For a discussion of our
critical accounting policies and estimates, refer to “ Management’s Discussion and Analysis of Financial Condition and Results
of Operations - Critical Accounting Policies and Estimates ” in Part II, Item 7 of our Form 10-K for the fiscal year
ended December 31, 2024.
Results of Operations
The following data summarizes the results of our
operations for the periods indicated, in thousands:
Three Months Ended June 30,
Six Months Ended June 30,
Description
2025
2024
Dollar
Change
2025
2024
Dollar
Change
Operating expenses
$ 2,309
$ 1,914
$ 395
$ 4,181
$ 4,123
$ 58
Operating loss
$ (2,309 )
$ (1,914 )
$ (395 )
$ (4,181 )
$ (4,123 )
$ (58 )
Net loss
$ (2,166 )
$ (1,846 )
$ (320 )
$ (3,935 )
$ (4,000 )
$ 65
Comparison of the Three Months Ended June 30, 2025 and 2024
Operating Expenses
The following table summarizes our total operating
expenses, for the periods indicated, in thousands:
Three Months Ended
June 30,
Six Months Ended
June 30,
Description
2025
2024
Dollar
Change
2025
2024
Dollar
Change
Research and development
$ 1,074
$ 866
$ 208
$ 1,960
$ 2,014
$ (54 )
General and administrative
1,235
1,048
187
2,221
2,109
112
Total operating expenses
$ 2,309
$ 1,914
$ 395
$ 4,181
$ 4,123
$ 58
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 collaboration agreement, expenses associated with preclinical and
clinical development activities and other operating costs. Our research and development programs are focused on the development of immuno-oncology
therapeutics based on our INTASYL technology. Since we commenced operations, research and development expenses have been a significant
portion of our total operating expenses and are expected to constitute the majority of our spending for the foreseeable future.
21
Research and development (R&D)
expenses for the three months ended June 30, 2025 increased 24% as compared with the three months ended June 30, 2024. The increase in
research and development expenses was primarily driven by an $81,000 increase in pass-through costs in connection with higher patient
enrollment, a $53,000 increase in consultant fees, and an increase in salary-related costs of $70,000.
Research and development expenses
for the six months ended June 30, 2025 decreased 3% as compared with the six months ended June 30, 2024. The Company considers this to
be an immaterial fluctuation.
General and Administrative Expenses
General and administrative
expenses relate to compensation and benefits for general and administrative personnel, facility-related expenses, professional fees for
legal and patent-related activities, audit, tax and consulting services, as well as other general corporate expenses.
General and administrative
expenses for the three months ended June 30, 2025 increased 18% as compared with the three months ended June 30, 2024. The increase in
general and administrative expenses was primarily driven by a $185,000 increase in salary-related costs for new hires.
General and administrative
expenses for the six months ended June 30, 2025 increased 5% as compared with the six months ended June 30, 2024. The Company considers
this to be an immaterial fluctuation.
Liquidity and Capital Resources
Historically, our primary
source of funding has been through the sale of our securities. In the future, we will be 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 our operations. We have reported
recurring losses from operations since inception and expect that we will continue to have negative cash flows from our operations for
the foreseeable future. At June 30, 2025, we had cash and cash equivalents of $10,775,000 as compared with $5,382,000 at December 31,
2024.
In July 2025, the Company
entered into inducement letter agreements (the “ July 2025 Inducement Letter Agreements ”) with certain holders of certain
of the Company’s existing warrants to purchase an aggregate of 928,596 shares of the Company’s common stock. The
existing warrants were originally issued in December 2024 and January 2025, having exercise prices between $2.00 and $3.00 per
share. Warrants to purchase 100,000 shares of common stock at the existing exercise price of $2.00 per share were exercised at their
existing exercise price of $2.00 per share, and warrants to purchase 828,596 shares of common stock were exercised at a reduced exercise
price of $2.485 per share. Pursuant to the July 2025 Inducement Letter Agreements, in consideration for the immediate exercise of
such warrants for cash and the payment of an additional $0.125 per New Warrant (as defined below), or an aggregate of $232,149 for all
New Warrants, the Company agreed to issue new unregistered five-year term Series J warrants (the “ Series J Warrants ”)
to purchase an aggregate of up to 318,596 shares of common stock at an exercise price of $2.485 and new unregistered 24-month
term Series K warrants (the “ Series K Warrants ” and, together with the Series J Warrants, the “ New Warrants ”)
to purchase an aggregate of up to 1,538,596 shares of common stock at an exercise price of $2.485 (the “ July 2025 Financing ”).
In addition, the Company issued warrants to the placement agent, H.C. Wainwright & Co., LLC, to purchase up to 69,645 shares
of common stock (the “ Placement Agent Warrants ”). 7,500 of the Placement Agent Warrants issued have an exercise price
of $2.8125 per share of Common Stock and a term of five years, 16,395 of the Placement Agent Warrants issued have an exercise price of
$3.4188 per share of Common Stock and a term of five years, and 45,750 of the Placement Agent Warrants issued have an exercise price
of $3.4188 per share of Common Stock and a term of twenty-four months. The net proceeds to the Company from the July 2025 Financing are
approximately $2,200,000, after deducting placement agent fees and offering expenses.
22
We have limited cash resources,
have reported recurring losses from operations since inception, have negative operating cash flows and have not yet received product revenues.
These factors raise substantial doubt regarding our ability to continue as a going concern, and our 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 the condensed consolidated financial
statements included elsewhere in this Quarterly Report. Our continuation as a going concern depends upon our ability to raise additional
capital through equity offerings, debt offerings and/or strategic opportunities to fund our operations. There can be no assurance that
we will be successful in accomplishing any of these plans in order to continue as a going concern. The condensed consolidated financial
statements included elsewhere in this Quarterly Report do not include any adjustments to the recoverability and classification of recorded
asset amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern.
The following table summarizes
our cash flows for the periods indicated, in thousands:
Six Months Ended
June 30,
2025
2024
Net cash used in operating activities
$ (3,815 )
$ (3,788 )
Net cash used in investing activities
(5 )
–
Net cash provided by (used in) financing activities
9,213
(4 )
Net increase (decrease) in cash and cash equivalents
$ 5,393
$ (3,792 )
Net Cash Used in Operating Activities
Net cash used in operating
activities for the six months ended June 30, 2025 increased 1% as compared to the six months ended June 30, 2024. The Company considers
this to be an immaterial fluctuation.
Net Cash Used in Investing Activities
Net cash used in investing
activities for the six months ended June 30, 2025 was approximately $5,000 as compared to the six months ended June 30, 2024 where net
cash used in investing activities was $0. The increase in net cash used in investing activities was primarily due to computer equipment
purchases during the six months ended June 30, 2025.
Net Cash Provided by Financing Activities
Net cash provided by financing
activities for the six months ended June 30, 2025 was approximately $9,213,000 as compared to the six months ended June 30, 2024 where
net cash used in financing activities was $4,000. The increase in net cash provided by financing activities was primarily due to the issuance
of common stock and warrants, and the exercise of warrants, both as described in Note 2 of the condensed consolidated financial statements.
Contractual Obligations
There have been no material
changes to the contractual obligations as disclosed in our 2024 Form 10-K. For a discussion of our critical accounting policies and estimates,
refer to “ Management’s Discussion and Analysis of Financial Condition and Results of Operations - Contractual Obligations ”
in Part II, Item 7 of our 2024 Form 10-K.
23
Future Funding Requirements
At June 30, 2025, we had cash
and cash equivalents of $10,775,000, which includes aggregate net proceeds of approximately $6,700,000, after deducting fees and
estimated offering expenses, from our January 2025 Financings. We expect that our cash and cash equivalents will enable us to fund our
current operating plan into the second quarter of 2026. Due to the difficulty and uncertainty associated with the design and implementation
of preclinical studies and clinical trials, we will continue to assess our cash and cash equivalents and future funding requirements.
However, there is no assurance that additional funding will be achieved and that we will succeed in our future operations. We expect to
continue to incur substantial additional operating losses for at least the next several years as we continue to develop our product candidates
and seek marketing approval and, subject to obtaining such approval, the eventual commercialization of our product candidates. If we obtain
marketing approval for any of our product candidates, we will incur significant sales, marketing and manufacturing expenses. We also expect
to continue to incur significant costs to comply with corporate governance, internal controls and similar requirements associated with
operating as a public reporting company.
Actual cash requirements could
differ from management’s projections due to many factors including additional investments in research and development programs such
as PH-894, clinical trial expenses for PH-762, competing technological and market developments, general and administrative expenses,
and the costs of any strategic acquisitions and/or development of complementary business opportunities. The amount of additional capital
we will require will be influenced by many factors, including, but not limited to:
· the scope, progress, results, and costs of clinical
trials of PH-762;
· our expectations regarding the timing and clinical
development of PH-762;
· whether and to what extent we internally fund,
whether and when we initiate, and how we conduct additional pipeline product development programs, including PH-894;
· whether and when we are able to enter into strategic
arrangements for our product candidates and the nature of those arrangements;
· the costs involved in preparing, filing, prosecuting,
maintaining, defending, and enforcing any patent claims;
· changes in our operating plan, resulting in increases
or decreases in our need for capital;
· disruptions at the FDA, including due to a reduction
in the FDA’s workforce and/or inadequate funding for the FDA;
· U.S. and international trade policies; and
· our views on the availability, timing, and desirability
of raising capital.
We expect to seek additional
funding to sustain our future operations and while we have successfully raised capital in the past, the ability to raise capital in future
periods is not assured. We do not know if additional capital will be available when needed or on terms favorable to us or our stockholders.
Collaboration, licensing or other agreements may not be available on favorable terms, or at all. If we seek to sell our equity securities,
we do not know whether and to what extent we will be able to do so, or on what terms. If available, additional equity financing may be
dilutive to stockholders, debt financing may involve restrictive covenants or other unfavorable terms and dilute our existing stockholders’
equity, and funding through collaboration, licensing or other commercial agreements may be on unfavorable terms, including requiring us
to relinquish rights to certain of our technologies or products. If adequate financing is not available if and when needed, we may delay,
reduce the scope of, or eliminate research or development programs, if any, postpone or cancel the pursuit of product candidates, or otherwise
significantly curtail our operations to reduce our cash requirements and extend our capital.
24
ITEM 3.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
As a smaller reporting company,
we are not required to provide this information.
ITEM 4.
CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Our management, with the participation
of our Principal Executive Officer and our Principal Financial Officer, evaluated the effectiveness of disclosure controls and procedures
(as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “ Exchange Act ”))
as of the end of the period covered by this report to ensure that information that we are required to disclose in reports that we file
or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the Securities and
Exchange Commission’s rules and forms.
Our disclosure controls and
procedures are designed to provide reasonable assurance of achieving their objectives. We believe that a control system, no matter how
well designed and operated, cannot provide absolute assurance that the objectives of the control system are met, and no evaluation of
controls can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected. Based
on the evaluation of our disclosure controls and procedures as of the end of the period covered by this report, management, with the participation
of our Principal Executive Officer and Principal Financial Officer, concluded that our disclosure controls and procedures were effective
at the reasonable assurance level as of such date.
Changes in Internal Control Over Financial Reporting
There have been no changes
in our internal control over financial reporting that occurred during the quarter ending June 30, 2025 that have materially affected,
or are reasonably likely to materially affect, our internal control over financial reporting.
25
PART II — OTHER INFORMATION
ITEM 1.
LEGAL PROCEEDINGS
From time to time, we may
become a party to various legal proceedings and complaints arising in the ordinary course of business. We are not currently a party to
any actual or threatened material legal proceedings of which we are aware.
ITEM 1A.
RISK FACTORS
Other than set forth below,
there have been no material changes in our risk factors set forth in “ Risk Factors in Part I , “ Item 1A ”.
in our 2024 Form 10-K. The risk factor described therein and set forth below could materially adversely affect our business, financial
condition, or results of operations. This Quarterly Report on Form 10-Q also contains forward-looking statements that involve risks and
uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of certain
factors, including these risks. Additional risks not currently known or currently material to us may also harm our business.
We may not be able to maintain compliance
with the continued listing requirements of The Nasdaq Capital Market.
To maintain continued listing
on The Nasdaq Capital Market, we must satisfy minimum financial and other requirements. For example, Nasdaq Listing Rule 5550(b)(1) requires
companies listed on the Nasdaq Capital Market to maintain stockholders’ equity of at least $2.5 million for continued listing. As
of June 30, 2025, our stockholders’ equity was $10.1 million and there can be no assurance that we will be able to maintain or increase
our stockholders’ equity in the future. If our stockholders’ equity falls below $2.5 million, as a result of operating losses
or for other reasons, or if we are unable to demonstrate to Nasdaq’s satisfaction that we subsequently regained compliance with
this requirement, Nasdaq will notify us of such non-compliance. If we receive such notice from Nasdaq, in accordance with the Nasdaq Listing
Rules, we will have 45 calendar days from the date of the notification to submit a plan to regain compliance with Nasdaq Listing Rule
5550(b)(1). If our compliance plan is accepted, we may be granted up to 180 calendar days from the date of the initial notification to
evidence compliance. If our compliance plan is not accepted or we are otherwise unable to evidence compliance within Nasdaq’s allotted
timeframe, Nasdaq may take steps to delist our Common Stock.
In addition, Nasdaq Listing
Rule 5550(a)(2) requires a minimum bid price of at least $1.00 per share, and Nasdaq Listing Rule 5810(c)(3)(A) provides that a failure
to meet the minimum bid price requirement exists if the deficiency continues for a period of 30 consecutive business days. Although the
Company is currently in compliance with this requirement, there can be no assurance that we will be able to maintain compliance. We have
in the past effected reverse stock splits of our Common Stock in order to regain or maintain compliance with this requirement (most recently
on July 5, 2024).
Such a delisting would have
an adverse effect on the market liquidity of our securities, decrease the market price of our securities, result in the potential loss
of confidence by investors, suppliers, customers and employees and fewer business development opportunities, and adversely affect our
ability to obtain financing for the continuation of our operations. We actively monitor our stockholders’ equity and minimum
bid price and will consider any and all options available to us to maintain compliance with Nasdaq Listing Rules 5550(b)(1) and (a)(2).
26
Changes in U.S. and international trade
policies may adversely impact our business and operating results.
From time to time, proposals
are made to significantly change existing trade agreements and relationships between the U.S. and other countries. In recent years, the
U.S. government has implemented substantial changes to U.S. trade policies, including import restrictions, increased import tariffs and
changes in U.S. participation in multilateral trade agreements. Because some of our vendors, manufactures and suppliers are located in
other foreign countries, we are exposed to the possibility of product supply disruption and increased costs in the event of changes in
the policies, laws, rules and regulations of the United States or foreign governments, as well as political unrest or unstable economic
conditions in foreign countries. The U.S. government has adopted a new approach to trade policy and, in some cases, entered into new trade
agreements. Our supply may in the future be subject to increased import tariffs, which could increase our manufacturing costs and could
make our products, if successfully developed and approved, less competitive than those of our competitors whose inputs are not subject
to such tariffs. We may otherwise experience supply disruptions or delays, and our suppliers may not continue to provide us with clinical
supply in our required quantities, to our required specifications and quality levels or at attractive prices. Such disruption could have
adverse effects on the development of our product candidates and our business operations.
ITEM 2.
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
No sales or issuances of unregistered
securities occurred that have not previously been disclosed in a Current Report on Form 8-K.
ITEM 3.
DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4.
MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5.
OTHER INFORMATION
Departure of Directors or Certain Officers;
Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers
Robert Infarinato’s employment as the Company’s
Vice President of Strategic Development terminated on July 31, 2025 (the “ Termination Date ”). Mr. Infarinato previously
served as the Company’s Chief Financial Officer from August 1, 2024 to June 6, 2025. In connection with his separation from the
Company, the Company entered into a separation agreement with Mr. Infarinato on August 11th, 2025, which provided for (i) severance in
the amount of twelve weeks of Mr. Infarinato’s base salary, which amounts to $60,000, (ii) payment of a lump sum of $40,000 on the
first regularly scheduled payroll date following the Termination Date, and (iii) the continued vesting of all outstanding equity-based
awards granted to Mr. Infarinato prior to the Termination Date (which amounts to 11,000 restricted stock units scheduled to vest on August
13, 2025 and September 11, 2025). In exchange for these benefits, Mr. Infarinato signed a release of claims against the Company and its
affiliates and re-affirmed certain confidentiality, non-solicitation and post-departure cooperation covenants. The foregoing description
of the separation agreement is qualified in its entirety by reference to the full text of the agreement, which is attached as Exhibit
10.3 to this Quarterly Report on Form 10-Q and is hereby incorporated herein by reference.
Insider Trading Arrangements
During the three months ended
June 30, 2025, no director or officer of the Company adopted or terminated a Rule 10b5-1 trading arrangement or non-Rule
10b5-1 trading arrangement, as each term is defined in Item 408(a) of Regulation S-K.
27
ITEM 6.
EXHIBITS
EXHIBIT INDEX
Incorporated by Reference Herein
Exhibit
Number
Description
Form
Date
3.1
Amended and Restated Certificate of Incorporation of Phio Pharmaceuticals Corp.
Current Report on Form 8-K (File No. 001-36304)
November 19, 2018
3.2
Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Phio Pharmaceuticals Corp.
Current Report on Form 8-K (File No. 001-36304)
January 14, 2020
3.3
Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Phio Pharmaceuticals Corp.
Current Report on Form 8-K (File No. 001-36304)
January 25, 2023
3.4
Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Phio Pharmaceuticals Corp.
Current Report on Form 8-K (File No. 001-36304)
July 2, 2024
3.5
Certificate of Designation of Series D Preferred Stock, dated November 16, 2022.
Current Report on Form 8-K (File No. 001-36304)
November 16, 2022
3.6
Amended and Restated Bylaws of Phio Pharmaceuticals Corp.
Current Report on Form 8-K (File No. 001-36304)
May 2, 2022
4.1
Form of Warrant.
Amendment No. 1 to the Registration Statement on Form S-1 (File No. 333-221173)
September 28, 2018
4.2
Form of Warrant.
Current Report on Form 8-K (File No. 001-36304)
February 6, 2020
4.3
Form of Warrant.
Current Report on Form 8-K (File No. 001-36304)
April 2, 2020
4.4
Form of Common Stock Warrant.
Current Report on Form 8-K (File No. 001-36304)
January 25, 2021
4.5
Form of Placement Agent Warrant.
Current Report on Form 8-K (File No. 001-36304)
February 17, 2021
4.6
Form of Series A Common Stock Warrant.
Current Report on Form 8-K (File No. 001-36304)
April 20, 2023
4.7
Form of Series B Common Stock Warrant.
Current Report on Form 8-K (File No. 001-36304)
April 20, 2023
4.8
Form of Existing Warrant Amendment.
Current Report on Form 8-K (File No. 001-36304)
April 20, 2023
4.9
Form of Series A Common Stock Warrant.
Current Report on Form 8-K (File No. 001-36304)
June 2, 2023
4.10
Form of Series B Common Stock Warrant.
Current Report on Form 8-K (File No. 001-36304)
June 2, 2023
4.11
Form of Series A/B Warrant.
Current Report on Form 8-K (File No. 001-36304)
December 8, 2023
4.12
Form of Placement Agent Warrant.
Current Report on Form 8-K (File No. 001-36304)
December 8, 2023
28
4.13
Form of Series C/D Warrant.
Current Report on Form 8-K (File No. 001-36304)
July 12, 2024
4.14
Form of Placement Agent Warrant.
Current Report on Form 8-K (File No. 001-36304)
July 12, 2024
4.15
Form of Series E Common Stock Warrant.
Current Report on Form 8-K (File No. 001-36304)
December 20, 2024
4.16
Form of Placement Agent Warrant.
Current Report on Form 8-K (File No. 001-36304)
December 20, 2024
4.17
Form of Series F Common Stock Warrant.
Current Report on Form 8-K (File No. 001-36304)
December 26, 2024
4.18
Form of Placement Agent Warrant.
Current Report on Form 8-K (File No. 001-36304)
December 26, 2024
4.19
Form of Series G Common Stock Warrant.
Current Report on Form 8-K (File No. 001-36304)
January 14, 2025
4.20
Form of Placement Agent Warrant.
Current Report on Form 8-K (File No. 001-36304)
January 14, 2025
4.21
Form of Series H Common Stock Warrant.
Current Report on Form 8-K (File No. 001-36304)
January 15, 2025
4.22
Form of Placement Agent Warrant.
Current Report on Form 8-K (File No. 001-36304)
January 15, 2025
4.23
Form of Series I Common Stock Warrant.
Current Report on Form 8-K (File No. 001-36304)
January 17, 2025
4.24
Form of Placement Agent Warrant.
Current Report on Form 8-K (File No. 001-36304)
January 17, 2025
10.1#
Offer Letter, executed April 21, 2025 by and between the Company and Lisa Carson.
Current Report on Form 8-K (File No. 001-36304)
June 12, 2025
10.2*#
Form of Indemnification Agreement.
10.3*#
Separation Agreement and General Release of Claims, dated August 11, 2025, by and between the Company and Robert Infarinato.
31.1*
Sarbanes-Oxley Act Section 302 Certification
of Principal Executive Officer.
31.2*
Sarbanes-Oxley Act Section 302 Certification
of Principal Financial Officer.
32.1**
Sarbanes-Oxley Act Section 906 Certification
of Principal Executive Officer and Principal Financial Officer.
101.INS
Inline XBRL Instance Document.*
101.SCH
Inline XBRL Taxonomy Extension Schema Document.*
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document.*
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document.*
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document.*
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document.*
104
The cover page for this report, formatted in Inline XBRL (included in Exhibit 101).*
_________________
*
Filed herewith.
**
Furnished herewith and not deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that Section or incorporated by reference into any filing under the Securities Act or the Exchange Act.
#
Indicates a management contract or compensatory plan or arrangement.
29
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized
on August 14, 2025.
Phio Pharmaceuticals Corp.
By:
/s/ Robert J. Bitterman
Robert J. Bitterman
President and Chief Executive Officer
(as Principal Executive Officer)
By:
/s/ Lisa Carson
Lisa Carson
Vice President, Finance & Administration
(as Principal Financial Officer)
30
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.