MARLBOROUGH, Mass.,
March 27, 2019 /PRNewswire/
-- Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a biotechnology
company developing the next generation of immuno-oncology
therapeutics based on its proprietary self-delivering RNAi
(sd-rxRNA®) therapeutic platform, today reported its
financial results for the fourth quarter and year ended
December 31, 2018 and provided a
business update.
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"One of the Company's major accomplishments during the year was
the successful transition to focus on developing novel
immuno-oncology treatments, a strategic decision made in early
2018," said Dr. Gerrit Dispersyn, President and CEO of Phio
Pharmaceuticals. "Based on our internal R&D, and together with
our corporate and academic partners, we have been demonstrating the
potential of using our self-delivering RNAi platform in
immuno-oncology applications. Our results to date suggest that we
can improve existing and developing forms of adoptive cell
therapies (ACT) based on T-cells and on NK cells. In addition,
through direct intratumoral use of self-delivering RNAi compounds,
we showed that we have the potential to reprogram the tumor
micro-environment. With this latter approach, we hope to lower the
barriers that hamper ACT success in solid tumors, a significant
clinical unmet need. Based on these successes, we now have three
well defined immuno-oncology R&D pipeline programs that may
provide compelling alternatives to other therapeutic approaches
such as antibody therapy and/or genetic engineering. Our progress
laid the groundwork for us to successfully complete an equity
offering in October, providing us the capital to confidently
execute our R&D pipeline programs towards clinical development
and further partnerships."
Year in Review and Recent Corporate Updates
- On March 1, 2019, Gerrit
Dispersyn, Dr. Med. Sc. became the Company's President and Chief
Executive Officer. Dr. Dispersyn succeeded Geert Cauwenbergh, Dr. Med. Sc., who retired as
CEO of the Company and remains as a member of the Company's Board
of Directors.
- Effective November 19, 2018, the
Company changed its corporate name from RXi Pharmaceuticals
Corporation to Phio Pharmaceuticals Corp. This change reflects the
Company's transition from a platform company in dermatology and
ophthalmology to one that is focused on developing groundbreaking
immuno-oncology therapeutics.
- Research conducted using the Company's self-delivering RNAi
platform in the field of immunotherapy to treat cancer was
published in a leading peer-reviewed journal, Molecular Therapy.
The published paper is titled, "Self-Delivering RNAi (sd-rxRNA®)
Targeting PD-1 using Adoptive Cell Therapy Approach for the
Treatment of Malignant Melanoma."
- Presented new data on NK cells at the 16th Annual
Discovery on Target Conference and the 33rd Annual
Meeting & Pre-Conference Programs of the Society for
Immunotherapy of Cancer (SITC).
-
- Data demonstrated potent silencing activity as well as
phenotypic effect of NK cells treated with sd-rxRNA compounds
targeting checkpoints such as Cbl-b and TIGIT. By treating NK cells
ex-vivo with sd-rxRNA compounds the anti-tumor response of
these cells can be improved.
- Entered into collaborations with industry and academic leaders
in immuno-oncology:
-
- The Karolinska Institutet in
Sweden is exploring the use of our
sd-rxRNA compounds against targets involved in T-cell and NK cell
differentiation and/or in the immune cell tumor-induced stress
response with the aim of producing anti-tumor adoptive cell therapy
grafts with improved functionality and persistence.
- Iovance Biotherapeutics, Inc. is evaluating the potential
synergies of our novel sd-rxRNA therapeutic compounds with their
autologous cell therapy based on tumor-infiltrating lymphocytes for
the use in the treatment of cancer.
- Completed and reported positive results from the Company's
clinical trials in dermatology and ophthalmology:
-
- Study RXI-109-1501, a Phase 1/2 clinical trial for retinal
scarring in subjects with wet age-related macular degeneration with
evidence of subretinal fibrosis, successfully met its primary
objective as shown by the absence of dose-limiting and serious
toxicities. The secondary objective of the study was also met with
improved or stable disease in the study eyes of several
subjects.
- Study RXI-SCP-1502, a Phase 2 clinical trial with
Samcyprone® for the treatment of cutaneous warts,
successfully met its primary effectiveness objectives as shown by
high levels of immunotherapeutic and therapeutic response. The
immunotherapeutic response rate was 97.7% across all enrolled
subjects and from a therapeutic response viewpoint, more than 70%
of all warts showed a positive wart response rate. The study
results showed furthermore that Samcyprone was safe and well
tolerated.
- Successfully completed equity offerings in April and
October 2018 for total net proceeds
of $17.4 million, which the Company
expects to provide ample funding for operations into the second
half of 2020.
Select Financial Results
Cash Position
At December 31, 2018, the Company
had cash of $14.9 million as compared
with $3.6 million at December 31, 2017.
Revenues
Revenues for the year ended December 31,
2018 were $138,000, as
compared with $15,000 for the year
ended December 31, 2017. Revenues for
the years ended 2018 and 2017 related to the work performed by the
Company as a sub-awardee under the government grant awarded to
BioAxone Biosciences, Inc. for the development of a novel sd-rxRNA
compound, BA-434, that targets PTEN for the treatment of spinal
cord injury.
Research and Development Expenses
Research and development expenses for the year ended
December 31, 2018 were $4.3 million as compared with $5.4 million for the year ended December 31, 2017. The decrease was primarily due
to the completion of the work in the Company's dermatology and
ophthalmology programs, including clinical trial-related and
manufacturing-related expenses, and a decrease in payroll expenses
due to a reduction in headcount as compared with the prior year
period.
Acquired In-process Research and Development
Expenses
The Company recorded acquired in-process research and
development expense of $4.7 million
during the year ended December 31,
2017. The expense related to the fair value of consideration
given, which includes transaction costs, liabilities assumed and
cancellation of notes receivable, and the deferred tax impact of
the Company's acquisition of MirImmune. The Company had no such
expense during the year ended December 31,
2018.
General and Administrative Expenses
General and administrative expenses for the year ended
December 31, 2018 were $3.2 million as compared with $4.0 million for the year ended December 31, 2017. The decrease was primarily due
to a decrease in payroll expenses due to a reduction in headcount
as compared with the prior year period, as well as a decrease in
professional fees for legal-related services.
Income Tax
The Company had no income tax benefit or expense for the year
ended December 31, 2018. The Company
recognized an income tax benefit of $1.6 million for the
year ended December 31, 2017 due to the tax-related
impact of the Company's acquisition of MirImmune.
Net Loss
Net loss for the year ended December 31,
2018 was $7.4 million, or
$1.04 per share, compared with
$12.5 million, or $5.52 per share, for the year ended December 31, 2017. The decrease was primarily due
to a decrease in acquired in-process research and development
expense and the changes in operating expenses, as discussed
above.
About Phio Pharmaceuticals Corp.
Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a biotechnology
company developing the next generation of immuno-oncology
therapeutics based on its self-delivering RNAi
(sd-rxRNA®) therapeutic platform. The Company's
discovery and research efforts are focused on developing sd-rxRNA
therapeutic compounds to be used in the context of adoptive cell
transfer by targeting checkpoints or other gene targets, or to be
used in immunotherapy following intratumoral injection. We aim to
maximize the power of our sd-rxRNA therapeutic compounds by
weaponizing therapeutic immune effector cells to attack cancer, and
to make tumors more susceptible to such attacks, and ultimately
provide patients battling cancers with a powerful new treatment
option that goes beyond current treatment modalities. 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 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 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 safety and efficacy of our product
candidates, future success of our clinical trials and scientific
studies, expected duration of available cash runway, our ability to
enter into strategic partnerships and the future success of these
strategic partnerships, the availability of funds and resources to
pursue our research and development projects and general economic
conditions. Our Annual Report on Form 10-K and subsequent
Quarterly Reports on Form 10-Q include detailed risks under the
caption "Risk Factors" that may affect our business, results of
operations and financial condition. 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.
Contact
Phio Pharmaceuticals Corp.
ir@phiopharma.com
PHIO
PHARMACEUTICALS CORP.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(Amounts in
thousands, except share and per share data)
|
|
|
For the
Three
|
|
For the
Three
|
|
For the
Year
|
|
For the
Year
|
Months
Ended
|
|
Months
Ended
|
|
Ended
|
|
Ended
|
December 31,
2018
|
|
December
31,
2017
|
|
December 31,
2018
|
|
December 31,
2017
|
Revenues
|
$
—
|
|
$
15
|
|
$
138
|
|
$
15
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
944
|
|
1,204
|
|
4,326
|
|
5,370
|
Acquired in-process research and
development
|
—
|
|
—
|
|
—
|
|
4,696
|
General and
administrative
|
790
|
|
802
|
|
3,176
|
|
4,011
|
Total operating expenses
|
1,734
|
|
2,006
|
|
7,502
|
|
14,077
|
Operating
loss
|
(1,734)
|
|
(1,991)
|
|
(7,364)
|
|
(14,062)
|
Total other income
(expense), net
|
7
|
|
(11)
|
|
4
|
|
(11)
|
Loss before income
taxes
|
(1,727)
|
|
(2,002)
|
|
(7,360)
|
|
(14,073)
|
Income tax
benefit
|
—
|
|
—
|
|
—
|
|
1,621
|
Net loss
|
$
(1,727)
|
|
$
(2,002)
|
|
$
(7,360)
|
|
$
(12,452)
|
Net loss per share: Basic and diluted
|
$
(0.10)
|
|
$
(0.84)
|
|
$
(1.04)
|
|
$
(5.52)
|
Weighted average shares: Basic and diluted
|
17,079,824
|
|
2,379,335
|
|
7,044,718
|
|
2,257,754
|
PHIO
PHARMACEUTICALS CORP.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(Amounts in
thousands)
|
|
|
|
|
|
|
|
|
|
|
December
31,
|
|
December
31,
|
|
|
2018
|
|
2017
|
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash
|
$
14,879
|
|
$
3,581
|
|
Restricted
cash
|
50
|
|
50
|
|
Prepaid expenses and
other current assets
|
221
|
|
201
|
|
Total current
assets
|
15,150
|
|
3,832
|
|
Property and
equipment, net
|
172
|
|
248
|
|
Other
assets
|
—
|
|
18
|
|
Total
assets
|
$
15,322
|
|
$
4,098
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
$
550
|
|
$
511
|
|
Accrued
expenses
|
1,194
|
|
1,754
|
|
Total current
liabilities
|
1,744
|
|
2,265
|
|
Total stockholders'
equity
|
13,578
|
|
1,833
|
|
Total liabilities and
stockholders' equity
|
$
15,322
|
|
$
4,098
|
|
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SOURCE Phio Pharmaceuticals Corp.