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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):
November 9, 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 November 9, 2023, Phio Pharmaceuticals Corp.
(the “Company”) reported its financial results for the period ended September 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 8.01. Other Events.
On November 9, 2023, the Company issued a press
release announcing that the first patient has been dosed in the Company’s U.S. Phase 1b clinical trial with intratumoral PH-762
for the treatment of patients with cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma. The full text of the press
release is attached hereto as Exhibit 99.2 and incorporated herein 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: November 9, 2023 |
|
|
|
By: |
/s/
Robert Bitterman |
| |
|
|
|
|
Robert Bitterman
President & Chief Executive Officer |
Exhibit 99.1
Phio Pharmaceuticals
Reports Third Quarter 2023 Financial Results and Provides Business Update
MARLBOROUGH, Mass., November 9, 2023 (GLOBE NEWSWIRE)—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 September 30, 2023
and provided a business update.
“We have enrolled the first patient in our U.S. clinical trial
with PH-762,” announced Phio’s President & CEO, Robert Bitterman. “The initiation of enrollment in this trial represents
a milestone as we develop PH-762 for the treatment of squamous cell and other skin cancers. We are optimistic that this novel, alternative
immuno-oncology therapy may offer patients and their care providers, enhanced therapeutic outcomes
while minimizing invasive intervention.”
Recent Corporate Updates
| · | Enrolled the first patient in its Phase 1b clinical trial of lead product
candidate, PH-762. |
| · | Presented new data about its PH-894 INTASYL compound, which targets BRD4,
at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston. |
| · | Presented new data new data showing INTASYL compound targeting CTLA-4 enhances
tumor control at the Annual Meeting of the Society for Immunotherapy of Cancer (SITC). |
Financial Results
Cash Position
At September 30, 2023, the Company had cash of $8.4 million as compared
with $11.8 million at December 31, 2022.
Research and Development Expenses
Research and development expenses were $1.8 million for the quarter
ended September 30, 2023 as compared with $2.5 million for the quarter ended September 30, 2022, a decrease of 28%. The decrease was primarily
due to decreased costs with the completion of the Company’s IND-enabling preclinical studies for PH-894 partially offset by an increase
in clinical-related costs for the Company’s two U.S. PH-762 Phase 1 clinical trials as compared to the prior year period.
General and Administrative Expenses
General and administrative expenses were $1.0 million for the quarter
ended September 30, 2023 as compared with $1.1 million for the quarter ended September 30, 2022, a decrease of 9%. The decrease was primarily
due to the reduced use of business development consultants as compared to the prior year period.
Net Loss
Net loss was $2.8 million, or $1.14 per share, for the quarter ended
September 30, 2023 as compared with $3.6 million, or $3.14 per share, for the quarter ended September 30, 2022. The decrease was primarily
due to the changes in research and development expenses, as described above.
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 Contact:
Michael Adams
Bridge View Media
pr@phiopharma.com
PHIO PHARMACEUTICALS CORP.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per
share data)
(Unaudited)
| | |
Three Months Ended
September 30, | | |
Nine Months Ended
September 30, | |
| | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| Operating expenses: | |
| | | |
| | | |
| | | |
| | |
| Research and development | |
$ | 1,808 | | |
$ | 2,508 | | |
$ | 5,325 | | |
$ | 5,398 | |
| General and administrative | |
| 968 | | |
| 1,063 | | |
| 3,600 | | |
| 3,334 | |
| Total operating expenses | |
| 2,776 | | |
| 3,571 | | |
| 8,925 | | |
| 8,732 | |
| Operating loss | |
| (2,776 | ) | |
| (3,571 | ) | |
| (8,925 | ) | |
| (8,732 | ) |
| Total other expense, net | |
| (4 | ) | |
| (5 | ) | |
| (6 | ) | |
| (17 | ) |
| Net loss | |
$ | (2,780 | ) | |
$ | (3,576 | ) | |
$ | (8,931 | ) | |
$ | (8,749 | ) |
| Net loss per common share: | |
| | | |
| | | |
| | | |
| | |
| Basic and diluted | |
$ | (1.14 | ) | |
$ | (3.14 | ) | |
$ | (5.03 | ) | |
$ | (7.70 | ) |
| Weighted average number of common shares outstanding | |
| | | |
| | | |
| | | |
| | |
| Basic and diluted | |
| 2,440,164 | | |
| 1,138,571 | | |
| 1,775,043 | | |
| 1,135,744 | |
PHIO PHARMACEUTICALS CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share data)
(Unaudited)
| | |
September 30,
2023 | | |
December 31,
2022 | |
| ASSETS | |
| | | |
| | |
| Cash | |
$ | 8,407 | | |
$ | 11,781 | |
| Restricted cash | |
| 50 | | |
| 50 | |
| Prepaid expenses and other current assets | |
| 871 | | |
| 615 | |
| Right of use asset | |
| 66 | | |
| 161 | |
| Property and equipment, net | |
| 142 | | |
| 183 | |
| Other assets | |
| 3 | | |
| 24 | |
| Total assets | |
$ | 9,539 | | |
$ | 12,814 | |
| LIABILITIES, PREFERRED STOCK AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
| Accounts payable | |
$ | 173 | | |
$ | 779 | |
| Accrued expenses | |
| 2,083 | | |
| 1,025 | |
| Lease liability | |
| 70 | | |
| 170 | |
| Total preferred stock | |
| – | | |
| 2 | |
| Total stockholders’ equity | |
| 7,213 | | |
| 10,838 | |
| Total liabilities, preferred stock and stockholders’ equity | |
$ | 9,539 | | |
$ | 12,814 | |
Exhibit 99.2
Phio
Pharmaceuticals Announces First US Patient Enrolled in Phase 1B Clinical Trial with Intratumoral PH-762 anti-PD-1 Therapy for Treatment
of Skin Carcinomas
MARLBOROUGH, Mass., November 9, 2023 (GLOBE NEWSWIRE)—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 announced that the first patient has been dosed in the Phase 1b clinical
trial of PH-762, an INTASYL compound that reduces the expression of PD-1, a protein
that inhibits T cells’ ability to kill cancer cells. This 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 in patients with cutaneous squamous cell carcinoma, melanoma, or Merkel cell carcinoma.
“The initiation of enrollment in this trial represents a milestone
as we develop PH-762 for the treatment of squamous cell and other skin cancers,” said Phio’s President and CEO Robert Bitterman.
“We are optimistic that this novel, alternative immuno-oncology therapy may offer patients
and their care providers, enhanced therapeutic outcomes while minimizing invasive intervention.”
The Phase 1b trial is a non-comparative study of neoadjuvant
monotherapy using PH-762 in adult patients with cutaneous squamous cell carcinoma, melanoma, or Merkel cell carcinoma. The study
treatment consists of four intratumoral injections of PH-762 at weekly intervals within a single tumor lesion. Excision of the tumor
occurs approximately two weeks following the fourth intratumoral dose of PH-762. Escalating doses of PH-762 are to be tested in
separate cohorts. The clinical study is expected to enroll up to 30 patients and will be conducted across 4 to 6 centers in the
United States. More information about this clinical trial is available at clinicaltrials.gov (identifier: NCT06014086).
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 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.
Examples of forward looking statements include statements regarding the timing of, as well as the progress of, and data reported from,
this Phase 1b clinical trial and the therapeutic potential of PH-762 to treat patients with cutaneous squamous cell carcinoma, melanoma,
or Merkel cell carcinoma. 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 Contact:
Michael Adams
Bridge View Media
pr@phiopharma.com
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