MARLBOROUGH, Mass.,
Nov. 14, 2018 /PRNewswire/
-- RXi Pharmaceuticals Corporation (NASDAQ: RXII), a
biotechnology company developing the next generation of
immuno-oncology therapeutics based on its proprietary
self-delivering RNAi (sd-rxRNA®) therapeutic platform, reports its
financial results for the third quarter ended September 30, 2018 and announces several
business updates, including new management appointments and a new
Company name and ticker symbol.
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"In the past few months, we have focused on continuing to
generate meaningful data through our R&D activities, while at
the same time being extremely diligent in spending our cash in a
way that can maximize the outcome," said Dr. Geert Cauwenbergh, President and CEO of RXi
Pharmaceuticals. "The significant reduction in net loss for the
third quarter, and for the first nine months of 2018, has been the
result of a careful selection of academic and industrial partners
who have shown a high interest in the potential of our
self-delivering platform for RNAi in immuno-oncology (IO) and
adoptive cell transfer therapy (ACT). In addition, we have been
able to complete a financing of $15
million last month, providing us with a financial runway we
expect to last until at least through the first half of 2020."
Dr. Cauwenbergh continued, "The pending name change from RXi
Pharmaceuticals to Phio Pharmaceuticals signifies our commitment to
develop our sd-rxRNA platform as a key therapeutic modality in the
rapidly expanding field of IO and ACT by weaponizing the body's
immune system in its fight against cancer. Also, in that context, I
am very pleased to announce the appointment of Dr. Gerrit Dispersyn
as our President and Chief Operating Officer. In the past 18
months, Gerrit has shown a remarkable aptitude in handling the
complexities of preclinical and clinical R&D activities in our
Company and I believe that under his leadership our Company will
succeed in executing its goals, which should result in our
shareholders doing well, and most importantly, patients doing
well."
Dr. Gerrit Dispersyn said, "I am grateful for the opportunity to
provide additional leadership for our Company's new chapter and
looking forward to delivering on our upcoming milestones. Under
Geert's direction, the Company built an impressive dataset that
allows us to confidently develop the next generation of
immuno-oncology therapeutics based on our sd-rxRNA platform. I look
forward to building on that foundation alongside Geert."
Conference Call Information
The Company will host a conference call today at 4:30 p.m.
EST to discuss financial results and provide an update on the
Company. The webcast link will be available under the "Investors –
Event Calendar" section of the Company's
website, www.rxipharma.com. The event may also be accessed by
dialing toll-free in the United States and Canada:
+1 844-376-4678. International participants may access the
event by dialing: +1 209-905-5958. An archive of the webcast will
be available on the Company's website approximately two hours after
the presentation.
Select Financial Highlights for Q3 2018
Cash Position
At September 30, 2018, the Company
had cash and cash equivalents of $3.2
million as compared with $3.6
million at December 31,
2017.
On October 3, 2018, the Company
closed an underwritten public offering of (i) 3,725,714 units, at a
public offering price of $0.70 per
unit, with each unit consisting of one share of common stock and
one warrant to purchase one share of common stock and (ii)
17,702,858 pre-funded units, at a public offering price of
$0.69 per pre-funded unit, with each
pre-funded unit consisting of one pre-funded warrant to purchase
one share of common stock and one warrant. Assuming the warrants
are not exercised, net proceeds from the offering were
approximately $13.3 million after
deducting underwriting discounts and commissions and offering
expenses paid by the Company.
The Company believes that with its current cash on hand and the
proceeds from the underwritten offering, it has sufficient cash to
fund operations through the first half of 2020, which includes
initiating a clinical trial with RXI-762 and advancing our
immuno-oncology programs toward clinical development. This assumes
no new funding through licensing or collaboration agreements.
Revenues
Revenues for the three months ended September 30, 2018 were $57,000 and related to the work performed by the
Company as a sub-awardee under the government grant awarded for the
development of a novel sd-rxRNA compound, BA-434, that targets PTEN
for the treatment of spinal cord injury. The Company had no
revenues during the three months ended September 30, 2017.
Research and Development Expenses
Research and development expenses for the quarter ended
September 30, 2018 were $0.8 million as compared with $1.5 million for the quarter ended September 30, 2017. The decrease was primarily
due to a decrease in clinical trial-related expenses as subject
participation is complete for all of the Company's clinical trials
in dermatology and ophthalmology and a decrease in payroll-related
expenses due to a reduction in headcount as compared with the prior
year period.
General and Administrative Expenses
General and administrative expenses for the quarter ended
September 30, 2018 were $0.7 million as compared with $1.0 million for the quarter ended September 30, 2017. The decrease was primarily
due to a decrease in payroll-related expenses, including those as a
result of a reduction in headcount, as compared to the prior year
period.
Net Loss
Net loss for the quarter ended September
30, 2018 was $1.5 million
compared with $2.5 million for the
quarter ended September 30, 2017. The
decrease was primarily due to a decrease in operating expenses, as
discussed above.
Recent Business Highlights
Research Collaboration with Karolinska Institutet
In August 2018, the Company
announced it entered into a research collaboration with the
Karolinska Institutet in Stockholm, Sweden. This collaboration will
explore RXi's 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.
New Data Using sd-rxRNA in NK Cells
In September 2018, the Company
presented data from its immuno-oncology program using sd-rxRNA
therapeutic compounds targeting intracellular checkpoint Cbl-b in
NK cells at the 16th Annual Discovery on Target Conference. Data
showed that sd-rxRNAs are rapidly and efficiently taken up by
immune effector cells without the use of transfection reagents.
Using sd-rxRNA compounds against checkpoint inhibitors, we can
suppress their expression levels up to 95% in immune cells,
including T-cells and NK cells. By treating NK cells ex-vivo, prior
to adoptive cell transfer with sd-rxRNA reducing the expression of
proteins such as Cbl-b, the anti-tumor response of these cells may
be improved.
In November 2018, the Company
presented a poster highlighting data demonstrating the potential of
sd-rxRNA to improve NK cell potency in ACT at the 33rd Annual
Meeting & Pre-Conference Programs of the Society for
Immunotherapy of Cancer (SITC). Data showed that by treating NK
cells with sd-rxRNA targeting inhibitory receptors such as TIGIT ex
vivo, prior to ACT, the anti-tumor response of these cells may be
enhanced resulting in a more effective therapy for hematological
malignancies.
Additional Corporate Events Announced
Corporate Name Change
As the Company transformed into an immuno-oncology company with
the acquisition of MirImmune in 2017 and the strategic decision to
focus solely on immuno-oncology in 2018, it became clear that the
name RXi Pharmaceuticals no longer accurately reflected the
Company's current business and future direction. The new name
reflects the Company's commitment to providing new treatment
options for patients battling cancer.
The Company expects the change in the Company's name from RXi
Pharmaceuticals Corporation to Phio Pharmaceuticals Corp. and the
change in the Company's ticker symbol from RXII to the new trading
symbol PHIO to become effective in the coming week.
Appointment of Gerrit Dispersyn as President and Chief
Operating Officer
Dr. Dispersyn has been the Company's Chief Development Officer
since April 2017. In connection with
the Company's recently announced corporate name change to better
reflect its core focus on immuno-oncology, Dr. Dispersyn will
become the Company's President and Chief Operating Officer as of
today. As COO, he will oversee all day-to-day activities of the
Company and is in line to become the next CEO of the Company. Dr.
Cauwenbergh remains as CEO and a member of the Board of Directors
of the Company and will focus on financial, intellectual property
and strategic matters.
About RXi Pharmaceuticals Corporation
RXi Pharmaceuticals Corporation (NASDAQ: RXII) 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. RXi intends to
develop immuno-oncology therapeutics on our own and in
collaboration with partners. For additional information, visit the
Company's website, www.rxipharma.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. RXi 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
RXi Pharmaceuticals Corporation
ir@rxipharma.com
RXI
PHARMACEUTICALS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share data)
(Unaudited)
|
|
|
For the
Three
|
|
For the
Three
|
|
For the
Nine
|
|
For the
Nine
|
Months
Ended
|
|
Months
Ended
|
|
Months
Ended
|
|
Months
Ended
|
September 30,
2018
|
|
September
30,
2017
|
|
September 30,
2018
|
|
September 30,
2017
|
Revenues
|
$
57
|
|
$
—
|
|
$
138
|
|
$
—
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
838
|
|
1,490
|
|
3,382
|
|
4,166
|
Acquired
in-process research and
development
|
—
|
|
—
|
|
—
|
|
4,696
|
General and
administrative
|
711
|
|
986
|
|
2,386
|
|
3,209
|
Total operating expenses
|
1,549
|
|
2,476
|
|
5,768
|
|
12,071
|
Operating
loss
|
(1,492)
|
|
(2,476)
|
|
(5,630)
|
|
(12,071)
|
Total other expense,
net
|
(1)
|
|
—
|
|
(3)
|
|
—
|
Loss before income
taxes
|
(1,493)
|
|
(2,476)
|
|
(5,633)
|
|
(12,071)
|
Income tax
benefit
|
—
|
|
—
|
|
—
|
|
1,621
|
Net loss
|
$
(1,493)
|
|
$
(2,476)
|
|
$
(5,633)
|
|
$
(10,450)
|
Net loss per share: Basic and diluted
|
$
(0.34)
|
|
$
(1.05)
|
|
$
(1.54)
|
|
$
(4.71)
|
Weighted average shares: Basic and diluted
|
4,371,259
|
|
2,351,144
|
|
3,662,924
|
|
2,216,775
|
RXI
PHARMACEUTICALS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
September
30,
|
|
December
31,
|
|
|
2018
|
|
2017
|
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
$
3,240
|
|
$
3,581
|
|
Restricted
cash
|
50
|
|
50
|
|
Prepaid expenses and
other current assets
|
332
|
|
201
|
|
Total current
assets
|
3,622
|
|
3,832
|
|
Property and
equipment, net
|
187
|
|
248
|
|
Other
assets
|
—
|
|
18
|
|
Total
assets
|
$
3,809
|
|
$
4,098
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
$
491
|
|
$
511
|
|
Accrued
expenses
|
1,568
|
|
1,754
|
|
Total current
liabilities
|
2,059
|
|
2,265
|
|
Total stockholders'
equity
|
1,750
|
|
1,833
|
|
Total liabilities and
stockholders' equity
|
$
3,809
|
|
$
4,098
|
|
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SOURCE RXi Pharmaceuticals Corporation