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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): August
14, 2024
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.) |
11 Apex Drive, Suite 300A, PMB 2006
|
|
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 14, 2024, Phio Pharmaceuticals Corp.
(the “Company”) reported its financial results for the period ended June 30, 2024. 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 14, 2024 |
|
|
|
By: |
/s/
Robert Bitterman |
|
|
|
|
|
Robert Bitterman
President & Chief Executive Officer |
Exhibit 99.1
![A blue and white logo
Description automatically generated with medium confidence](https://www.sec.gov/Archives/edgar/data/1533040/000168316824005707/image_001.jpg)
Phio Pharmaceuticals Reports Second Quarter
2024
Financial Results and Provides Business Update
MARLBOROUGH, Mass., August 14, 2024—Phio Pharmaceuticals Corp.
(Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL™ siRNA gene silencing technology is designed to
make immune cells more effective in killing tumor cells, today reported its financial results for the quarter ended June 30, 2024 and
provided a business update.
Recent Corporate Updates
| · | The Phase 1b clinical trial for our lead product candidate, PH-762, received
a positive safety recommendation from the Safety Monitoring Committee (SMC). There were no dose-limiting toxicities, or clinically relevant
treatment-emergent adverse events in the initial cohort receiving intratumoral PH-762. The injections were well tolerated. The SMC recommended
dose escalation and enrollment of the next planned cohort in the clinical study. |
| · | The clinical trial is currently enrolling patients for the 2nd
cohort. |
| · | A fifth clinical trial site has been added to our Phase 1b study of PH-762.
The University of Pittsburgh Medical Center (UPMC) Department of Dermatology joins four other sites engaged in the clinical study: The
George Washington University-Medical Faculty Associates in Washington, D.C; Banner MD Anderson Cancer Center in Gilbert, Arizona; Integrity
Research Clinical Associates in Delray Beach, Florida; and Centricity Research in Dublin Ohio. |
| · | An additional patent in a family of patents covering INTASYL compounds that
target aging skin disorders was recently granted in South Korea. The patent covers the INTASYL RXI-185 compound that treats aging and
skin disorders, including photo-aging. RXI-185 is a potent silencer of MMP1 expression in the skin, interrupting ultraviolet radiation
(UVR) induced collagen breakdown, thereby improving and/or slowing the progression for skin thickening, elasticity and wrinkles. |
| · | Phio entered into definitive agreements to exercise certain outstanding warrants
to purchase up to an aggregate of 545,286 shares of common stock of the Company, originally issued in February 2020 through December 2023,
having exercise prices between $324.00 and $9.72 per share, at a reduced exercise price of $5.45 per share. The gross proceeds to the
Company from the exercise of these warrants were approximately $3.1 million. |
| · | A reverse Stock Split became effective on July 5, 2024. Every nine (9) shares
of the Company's common stock were combined into one (1) share of common stock, with no change to the par value of $0.0001 per share.
This reduced the Company's outstanding common stock from approximately 4.6 million shares to approximately 0.5 million shares. The reverse
stock split affects all stockholders uniformly and will not alter any stockholder's percentage interest in the Company's common stock,
except for adjustments that may result from the treatment of fractional shares. |
| · | On July 19, 2024, we received written notice from The Nasdaq Stock Market
LLC that stated that the Company was now in compliance with the minimum $1.00 bid price requirement for continued listing on the Nasdaq
Capital Market. |
| · | Phio announced appointment of Robert M. Infarinato to the position of vice
president and chief financial officer effective August 1, 2024. He will serve in the capacity of Principal Financial Officer including
responsibility for accounting, finance, treasury, investor relations and administration. |
| · | We entered into an exploratory collaboration with a global, multi-billion
dollar skin care company regarding opportunities for Phio’s proprietary compounds targeting cosmeceutical
skin care applications. |
Financial Results
Cash Position
At June 30, 2024, the Company had cash of $4.7 million as compared
with $8.5 million at December 31, 2023.
In July 2024, the Company entered into inducement letter agreements
with certain holders of the Company’s existing warrants to purchase up to an aggregate of 545,286 shares of common stock at a reduced
exercise price of $5.45 per share. In consideration for the immediate exercise of the existing warrants, the Company agreed to issue five
and one-half year term Series C warrants to purchase up to 583,098 shares of common stock and eighteen month term Series D warrants to
purchase up to 507,474 shares of common stock, both at an exercise price of $5.45. The net proceeds to the Company are expected to be
approximately $2.6 million, after deducting placement agent fees and offering expenses.
Research and Development Expenses
Research and development expenses were $0.9 million for the three months
ended June 30, 2024 as compared with $1.4 million for the three months ended June 30, 2023, a decrease of 37%. The decrease was primarily
driven by a decrease in clinical consulting fees incurred in connection with our IND filing for PH-762 in the prior year period in addition
to the Company’s cost rationalization measures in transitioning from a research company to a product development company resulting
in decreases in salary-related costs, including stock-based compensation expense, and lab supplies associated with the reduction in headcount.
General and Administrative Expenses
General and administrative expenses were $1.0 million for the three
months ended June 30, 2024 as compared with $1.2 million for the three months ended June 30, 2023, a decrease of 10%. The decrease was
primarily due to decreases in salary-related expenses for the Company’s President & CEO and in professional fees related to
consulting as compared to the prior year period.
Net Loss
Net loss was $1.8 million for the three months ended June 30, 2024
as compared with $2.5 million for the three months ended June 30, 2023. The decrease in net loss 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™ siRNA gene silencing 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 without the need for specialized formulations
or drug delivery systems. INTASYL drugs precisely down regulate specific proteins that inhibit the body’s ability to overcome chronic
diseases and other disorders.
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
adams@bridgeviewmedia.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, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
$ | 866 | | |
$ | 1,383 | | |
$ | 2,014 | | |
$ | 3,517 | |
General and administrative | |
| 1,048 | | |
| 1,164 | | |
| 2,109 | | |
| 2,632 | |
Total operating expenses | |
| 1,914 | | |
| 2,547 | | |
| 4,123 | | |
| 6,149 | |
Operating loss | |
| (1,914 | ) | |
| (2,547 | ) | |
| (4,123 | ) | |
| (6,149 | ) |
Total other income (expense), net | |
| 68 | | |
| (2 | ) | |
| 123 | | |
| (2 | ) |
Net loss | |
$ | (1,846 | ) | |
$ | (2,549 | ) | |
$ | (4,000 | ) | |
$ | (6,151 | ) |
Net loss per common share: Basic and diluted | |
$ | (3.62 | ) | |
$ | (13.27 | ) | |
$ | (7.85 | ) | |
$ | (38.52 | ) |
Weighted average number of common shares outstanding: Basic and diluted | |
| 510,188 | | |
| 192,054 | | |
| 509,542 | | |
| 159,663 | |
PHIO PHARMACEUTICALS CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share data)
(Unaudited)
| |
June 30, 2024 | | |
December 31, 2023 | |
ASSETS | |
| | | |
| | |
Cash and cash equivalents | |
$ | 4,698 | | |
$ | 8,490 | |
Prepaid expenses and other current assets | |
| 594 | | |
| 832 | |
Right of use asset | |
| – | | |
| 33 | |
Property and equipment, net | |
| 1 | | |
| 6 | |
Other assets | |
| 3 | | |
| 3 | |
Total assets | |
$ | 5,296 | | |
$ | 9,364 | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
Accounts payable | |
$ | 335 | | |
$ | 657 | |
Accrued expenses | |
| 1,188 | | |
| 942 | |
Lease liability | |
| – | | |
| 35 | |
Total liabilities | |
| 1,523 | | |
| 1,634 | |
Total stockholders’ equity | |
| 3,773 | | |
| 7,730 | |
Total liabilities and stockholders’ equity | |
$ | 5,296 | | |
$ | 9,364 | |
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