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 |
|
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