0001533040
false
0001533040
2023-08-10
2023-08-10
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported):
August 10, 2023
PHIO
PHARMACEUTICALS CORP.
(Exact name of registrant as specified in its
charter)
Delaware |
|
001-36304 |
|
45-3215903 |
(State or other jurisdiction of incorporation)
|
|
(Commission File Number) |
|
(I.R.S. Employer Identification No.) |
257 Simarano Drive, Suite 101
|
|
Marlborough, Massachusetts |
01752 |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including
area code: (508) 767-3861
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2.
below):
☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
|
☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
|
☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
|
☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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 is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§240.12b-2 of this chapter).
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. ☐
Item 2.02. Results of Operations and Financial Condition.
On August 10, 2023, Phio Pharmaceuticals Corp. reported its financial
results for the period ended June 30, 2023. A copy of the press release is furnished herewith as Exhibit 99.1 to this Current Report on
Form 8-K (the “Report”).
The information in this Item 2.02 and attached as Exhibit 99.1 to
this Report will not be treated as “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended
(the “Exchange Act”), or otherwise subject to the liabilities of that section. This information will not be incorporated
by reference into any filing under the Securities Act of 1933, as amended, or into another filing under the Exchange Act, unless that
filing expressly incorporates this information by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
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 hereunto duly authorized.
|
|
|
|
PHIO PHARMACEUTICALS CORP. |
|
|
|
|
|
|
|
|
|
Date: August 10, 2023 |
|
|
|
By: |
/s/
Robert Bitterman |
|
|
|
|
|
Robert Bitterman
President & Chief Executive Officer |
Exhibit 99.1
Phio Pharmaceuticals
Reports Second Quarter 2023 Financial Results and Provides Business Update
MARLBOROUGH, Mass., August 10, 2023—Phio Pharmaceuticals Corp.
(Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL™ RNAi platform technology is designed to make immune
cells more effective in killing tumor cells, today reported its financial results for the quarter ended June 30, 2023 and provided a business
update.
“Following FDA clearance of our IND for PH-762, we are moving
forward with plans for a clinical trial for stages one, two and four of cutaneous squamous cell (cSCC), stage four melanoma and Merkel
cell,” said Robert Bitterman, President and CEO.
The initial multi-center, dose-escalating, Phase 1b clinical trial
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.
Recent Corporate Updates
| · | Announced initiation of a collaborative clinical trial with PH-762, AgonOx's
Tumor Infiltrating Lymphocyte Program (AGX148) and Providence Cancer Institute. AgonOx is expected to enroll the first patient this summer. |
| · | Retained Jennifer Phillips, Pharm.D., as Vice-President for Regulatory Affairs
and Corporate Affairs. |
Financial Results
Cash Position
At June 30, 2023, the Company had cash of $11.3 million as compared
with $11.8 million at December 31, 2022.
Research and Development Expenses
Research and development expenses were $1.4 million for the quarter
ended June 30, 2023 compared with $1.3 million for the quarter ended June 30, 2022, an increase of 6%. The increase was primarily due
to increased clinical-related costs to support the two PH-762 Phase 1 clinical trials in the U.S., partially offset by decreased costs
related to the completion of the Company’s IND-enabling preclinical studies for PH-894 as compared to the prior year period.
General and Administrative Expenses
General and administrative expenses were $1.2 million for the quarter
ended June 30, 2023 compared with $1.2 million for the quarter ended June 30, 2022. General and administrative expenses were primarily
consistent with the prior year period.
Net Loss
Net loss was $2.5 million, or $1.47 per share, for the quarter ended
June 30, 2023, compared with $2.5 million, or $2.22 per share, for the quarter ended June 30, 2022. Overall, net loss was primarily consistent
with the prior year period with changes in research and development expense as described above.
About INTASYL
INTASYL compounds are chemically modified siRNAs that provide efficient,
spontaneous cellular uptake and potent, long lasting intracellular activity, targeting a broad range of cell types and tissues. INTASYL
drugs are designed to precisely target specific proteins that reduce the body's ability to fight cancer, without the need for specialized
formulations or drug delivery systems. INTASYL has demonstrated preclinical efficacy in both Direct-to-Tumor and Adoptive Cell Therapy
(ACT) applications.
In comparison to biologics and cell and gene therapies, INTASYL has
a favorable preclinical toxicity and safety profile, and a streamlined chemical synthesis that reduces costs and offers substantial dosing
convenience to the prescriber and patient.
About Phio Pharmaceuticals Corp.
Phio Pharmaceuticals Corp. (Nasdaq: PHIO) is a clinical stage biotechnology
company whose proprietary INTASYL™ RNAi technology is designed to make immune cells more effective in killing tumor cells. INTASYL
is the only self-delivering RNAi technology focused on immuno-oncology therapeutics. INTASYL drugs are designed to precisely target specific
proteins that reduce the body's ability to fight cancer, without the need for specialized formulations or drug delivery systems.
For additional information, visit the Company's website, www.phiopharma.com.
Forward Looking Statements
This press release 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. These statements are based only on our current beliefs, expectations and assumptions and 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 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, the impact to our business and operations by inflationary pressures, rising interest rates, recession fears,
the development of our product candidates, results from our preclinical and clinical activities, our ability to execute on business strategies,
our ability to develop our product candidates with collaboration partners, and the success of any such collaborations, the timeline and
duration for advancing our product candidates into clinical development, the timing or likelihood of regulatory filings and approvals,
the success of our efforts to commercialize our product candidates if approved, our ability to manufacture and supply our product candidates
for clinical activities, and for commercial use if approved, the scope of protection we are able to establish and maintain for intellectual
property rights covering our technology platform, our ability to obtain future financing, market and other conditions and those identified
in our Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q under the caption "Risk Factors" and in other
filings the Company periodically makes with the SEC. Readers are urged to review these risk factors and to not act in reliance on any
forward-looking statements, as actual results may differ from those contemplated by our forward-looking statements. Phio does not undertake
to update forward-looking statements to reflect a change in its views, events or circumstances that occur after the date of this release,
except as required by law.
Contact Phio Pharmaceuticals Corp.
ir@phiopharma.com pr@phiopharma.com
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, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
$ | 1,383 | | |
$ | 1,304 | | |
$ | 3,517 | | |
$ | 2,890 | |
General and administrative | |
| 1,164 | | |
| 1,217 | | |
| 2,632 | | |
| 2,271 | |
Total operating expenses | |
| 2,547 | | |
| 2,521 | | |
| 6,149 | | |
| 5,161 | |
Operating loss | |
| (2,547 | ) | |
| (2,521 | ) | |
| (6,149 | ) | |
| (5,161 | ) |
Total other expense, net | |
| (2 | ) | |
| (10 | ) | |
| (2 | ) | |
| (12 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (2,549 | ) | |
$ | (2,531 | ) | |
$ | (6,151 | ) | |
$ | (5,173 | ) |
Net loss per common share: Basic and diluted | |
$ | (1.47 | ) | |
$ | (2.22 | ) | |
$ | (4.28 | ) | |
$ | (4.56 | ) |
Weighted average number of common shares outstanding: Basic and diluted | |
| 1,728,490 | | |
| 1,138,227 | | |
| 1,436,971 | | |
| 1,134,307 | |
PHIO PHARMACEUTICALS CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share data)
(Unaudited)
| |
June 30, 2023 | | |
December 31, 2022 | |
ASSETS | |
| | | |
| | |
Cash | |
$ | 11,307 | | |
$ | 11,781 | |
Restricted cash | |
| 50 | | |
| 50 | |
Prepaid expenses and other current assets | |
| 678 | | |
| 615 | |
Right of use asset | |
| 98 | | |
| 161 | |
Property and equipment, net | |
| 157 | | |
| 183 | |
Other assets | |
| 6 | | |
| 24 | |
Total assets | |
$ | 12,296 | | |
$ | 12,814 | |
| |
| | | |
| | |
LIABILITIES, PREFERRED STOCK AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
Accounts payable | |
$ | 641 | | |
$ | 779 | |
Accrued expenses | |
| 1,647 | | |
| 1,025 | |
Lease liability | |
| 104 | | |
| 170 | |
Total preferred stock | |
| – | | |
| 2 | |
Total stockholders’ equity | |
| 9,904 | | |
| 10,838 | |
Total liabilities, preferred stock and stockholders’ equity | |
$ | 12,296 | | |
$ | 12,814 | |
v3.23.2
X |
- DefinitionBoolean flag that is true when the XBRL content amends previously-filed or accepted submission.
+ References
+ Details
Name: |
dei_AmendmentFlag |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionFor the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.
+ References
+ Details
Name: |
dei_DocumentPeriodEndDate |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:dateItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.
+ References
+ Details
Name: |
dei_DocumentType |
Namespace Prefix: |
dei_ |
Data Type: |
dei:submissionTypeItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionAddress Line 1 such as Attn, Building Name, Street Name
+ References
+ Details
Name: |
dei_EntityAddressAddressLine1 |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionAddress Line 2 such as Street or Suite number
+ References
+ Details
Name: |
dei_EntityAddressAddressLine2 |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- Definition
+ References
+ Details
Name: |
dei_EntityAddressCityOrTown |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionCode for the postal or zip code
+ References
+ Details
Name: |
dei_EntityAddressPostalZipCode |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionName of the state or province.
+ References
+ Details
Name: |
dei_EntityAddressStateOrProvince |
Namespace Prefix: |
dei_ |
Data Type: |
dei:stateOrProvinceItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionA unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityCentralIndexKey |
Namespace Prefix: |
dei_ |
Data Type: |
dei:centralIndexKeyItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionIndicate if registrant meets the emerging growth company criteria.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityEmergingGrowthCompany |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionCommission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.
+ References
+ Details
Name: |
dei_EntityFileNumber |
Namespace Prefix: |
dei_ |
Data Type: |
dei:fileNumberItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTwo-character EDGAR code representing the state or country of incorporation.
+ References
+ Details
Name: |
dei_EntityIncorporationStateCountryCode |
Namespace Prefix: |
dei_ |
Data Type: |
dei:edgarStateCountryItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityRegistrantName |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityTaxIdentificationNumber |
Namespace Prefix: |
dei_ |
Data Type: |
dei:employerIdItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionLocal phone number for entity.
+ References
+ Details
Name: |
dei_LocalPhoneNumber |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 13e -Subsection 4c
+ Details
Name: |
dei_PreCommencementIssuerTenderOffer |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 14d -Subsection 2b
+ Details
Name: |
dei_PreCommencementTenderOffer |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTitle of a 12(b) registered security.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b
+ Details
Name: |
dei_Security12bTitle |
Namespace Prefix: |
dei_ |
Data Type: |
dei:securityTitleItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionName of the Exchange on which a security is registered.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection d1-1
+ Details
Name: |
dei_SecurityExchangeName |
Namespace Prefix: |
dei_ |
Data Type: |
dei:edgarExchangeCodeItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Section 14a -Number 240 -Subsection 12
+ Details
Name: |
dei_SolicitingMaterial |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTrading symbol of an instrument as listed on an exchange.
+ References
+ Details
Name: |
dei_TradingSymbol |
Namespace Prefix: |
dei_ |
Data Type: |
dei:tradingSymbolItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Securities Act -Number 230 -Section 425
+ Details
Name: |
dei_WrittenCommunications |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
Phio Pharmaceuticals (NASDAQ:PHIO)
Historical Stock Chart
From Jul 2024 to Aug 2024
Phio Pharmaceuticals (NASDAQ:PHIO)
Historical Stock Chart
From Aug 2023 to Aug 2024