MARLBOROUGH, Mass.,
May 11, 2017 /PRNewswire/ -- RXi
Pharmaceuticals Corporation (NASDAQ: RXII), a clinical-stage RNAi
company developing innovative therapeutics that address significant
unmet medical needs, today reported its financial results for the
first quarter ended March 31, 2017,
and provided a business update.
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"During the first quarter of 2017, RXi has been integrating
MirImmune into its existing R&D operations. Through careful
planning and execution of this integration, the Company has been
able to maintain its cash use in line with that of last year," said
Dr. Geert Cauwenbergh, President and
CEO of RXi Pharmaceuticals. He also commented that, "RXi has added
two new executives to its senior management team who will be
instrumental in driving the development of novel therapeutics. Dr.
Gerrit Dispersyn as Chief
Development Officer and Dr. Alexey
Eliseev as Chief Business Officer will provide significant
leadership in the new and exciting space of immuno-oncology and
cell therapy, while we continue to advance our dermatology and
ophthalmology trials toward our planned readouts later this
year." He further added that, "Recently, RXi also
announced that Dr. Pamela Pavco will
retire this month. During her tenure as Chief Development Officer,
she has been an integral part of the development of RXi's
technology platform and clinical programs. We are grateful
that she will remain involved with the Company as part of its
Scientific Advisory Board where her expertise in the field of
oligonucleotides will continue to support the advancement of our
development pipeline."
The Company will host a conference call today at 4:30 p.m. EDT 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 +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 First Quarter 2017 Financial Highlights
Cash Position
At March 31, 2017, the Company had
cash of $10.2 million, compared with
$12.9 million at December 31, 2016. The Company believes that its
existing cash should be sufficient to fund operations for at least
the next twelve months.
Research and Development Expenses
Research and development expenses for the quarter ended
March 31, 2017 was $1.3 million, which included less than
$0.1 million of non-cash stock-based
compensation expense, as compared with $1.3
million for the quarter ended March
31, 2016, which included $0.1
million of non-cash stock-based compensation expense.
Research and development expenses were consistent quarter over
quarter, but did see slight increases due to the commencement of
the Company's new immunotherapy program with the acquisition of
MirImmune Inc. ("MirImmune"), a privately-held biotechnology
company that was engaged in the development of cancer
immunotherapies, in January 2017,
which were offset by a decrease in stock-based compensation
expense.
Acquired In-process Research and Development
The Company had acquired in-process research and development
expense of $3.0 million for the
quarter ended March 31, 2017. There
was no such expense for the three months ended March 31, 2016. The expense related to the
Company's acquisition of MirImmune in January 2017. Per the terms of the acquisition,
the Company acquired all of the outstanding capital stock of
MirImmune in exchange for shares of the Company's common stock and
Series C Convertible Preferred Stock, which were subject to a 3%
holdback for any purchase price adjustments. The fair value of the
consideration given during the quarter totaling $3.0 million was expensed as in-process research
and development expense. The fair value of the securities subject
to the 3% holdback, which were released and issued on April 12, 2017, will be recorded as in-process
research and development expense during the second quarter of
2017.
General and Administrative Expenses
General and administrative expenses for the quarter ended
March 31, 2017 were $1.1 million, which included $0.1 million of non-cash stock-based compensation
expense, as compared with $1.0
million for the quarter ended March
31, 2016, which included $0.2
million of non-cash stock-based compensation expense.
The increase in general and administrative expenses was due to
an increase in employee headcount with the hire of the Company's
Chief Business Officer as part of the acquisition of MirImmune and
an increase in legal fees, offset by a decrease in stock-based
compensation expense.
Net Loss
Net loss for the three months ended March
31, 2017 was $5.5 million,
compared with $2.2 million for the
three months ended March 31, 2016.
The increase in net loss was primarily driven by the one-time
charge of $3.0 million of acquired
in-process research and development expense related to the
acquisition of MirImmune in January
2017.
Select First Quarter 2017 and Recent Corporate
Highlights
Select Business and Corporate Highlights
Management Team: The Company announced that Dr.
Pamela Pavco, RXi's Chief
Development Officer, will retire effective May 19, 2017. At that time, Dr. Pavco will
join the Company's Scientific Advisory Board where her expertise in
the field of oligonucleotides and the development of RNAi
therapeutics will continue to support RXi's ongoing research and
development initiatives.
On April 24, 2017, Dr.
Gerrit Dispersyn was appointed as
RXi's new Chief Development Officer. Dr. Dispersyn brings a
wealth of experience to RXi as an accomplished leader in clinical,
product and business development.
Intellectual Property Estate: The Company has been
diligent and proactive with its approach to broadly protect its
valuable corporate assets by securing patent protection for its
RNAi platform and Samcyprone™, a small molecule that is a
proprietary ointment formulation of diphenylcyclopropenone
(DPCP).
Most recently, the Company was granted a patent by the Japan
Patent Office (JPO) for the composition of matter of sd-rxRNAs
targeting connective tissue growth factor (CTGF) for the treatment
or prevention of fibrotic disorders, including but not limited to
skin fibrosis and proliferative vitreoretinopathy. This
patent includes the Company's lead clinical candidate RXI-109, an
sd-rxRNA® therapeutic compound, which is currently being evaluated
in Phase 2 clinical trials.
Our portfolio currently includes 79 issued patents and 60
pending applications. This includes coverage in the United States, Canada, Europe, Japan
and other markets. In addition, Samcyprone™ has been granted
orphan-drug designation for malignant melanoma stage IIb to IV.
The Company's intellectual property estate provides for
numerous commercial, regional and strategic partnering
opportunities.
Development Programs
Immuno-oncology: The Company's ongoing program to
develop cell-based immunotherapies to treat cancer is based on our
proprietary self-delivering RNAi (sd-rxRNA) technology
platform. RXi's novel sd-rxRNA technology differs from
natural and most synthetic RNA interference (RNAi) molecules in
that they are chemically modified to allow for an easy
internalization of the compounds by most types of cells and
silencing of the targeted genes.
sd-rxRNA offers unprecedented flexibility in targeting
immunosuppressive pathways with the potential to modulate multiple
checkpoint genes in a single therapeutic treatment. The
built-in delivery and therapeutic properties of sd-rxRNA lend
themselves well for local therapeutic applications, such as ex
vivo treatment of the immune cells. The ex vivo
use of sd-rxRNA to pre-treat immune cells prior to infusion may
prove advantageous as an immuno-therapeutic in that there is the
potential to simultaneously reduce multiple checkpoints or targets,
including both intracellular and extracellular targets, with little
change to current protocols. As outlined at the beginning of the
year in our 2017 Corporate Goals, we are actively working on
multiple checkpoint-inhibiting sd-rxRNA compounds co-transfected in
CAR T-cells in mouse models for solid tumors and conducting
preclinical studies on the use of sd-rxRNA with tumor infiltrating
lymphocytes (TILs) in melanoma. Data from this ongoing work
is expected to be available in the second half of 2017.
RXI-109-1402 – Hypertrophic Scarring: The Company's
ongoing Phase 2 clinical trial, RXI-109-1402, is being conducted to
evaluate its first clinical candidate RXI-109, an sd-rxRNA compound
targeting connective tissue growth factor (CTGF) to reduce scar
formation in the skin following scar revision surgery. The Company
will provide a full read-out, for Cohorts 3 and 4, in the second
half of 2017.
RXI-109-1501 – Retinal Scarring in Advanced Age-related
Macular Degeneration (AMD): As in dermal scarring, CTGF
is known to play a role in retinal scarring. Reduction of
CTGF in the eye by RXI-109 treatment may reduce the formation of
retinal fibrosis that often accompanies late stage AMD and
contributes to permanent vision loss. Enrollment in the first
two cohorts in the Company's Phase 1/2 trial, RXI-109-1501, is
complete. RXI-109 has been well-tolerated in the eye to date;
enrollment into the third cohort at the next higher dose level is
ongoing.
RXI-SCP-1502 – Treatment of Cutaneous Warts:
Samcyprone™, the Company's second clinical candidate, is being
evaluated in a Phase 2a clinical trial. RXI-SCP-1502 is a
multi-center, multi-dose trial conducted in subjects with at least
one cutaneous, plantar or periungual wart. The Company
expects to share early read-outs in the second half of 2017.
Consumer/Functional Health Care: The Company
presented an update on its consumer health program at the
76th annual meeting of the Society for Investigative
Dermatology. RXI-231, an sd-rxRNA targeting tyrosinase, is in
development as a cosmetic ingredient that may improve the
appearance of uneven skin tone and pigmentation. RXi has
developed a proprietary formulation that allows for the
non-invasive penetration of sd-rxRNA compounds to the
epidermal-dermal junction where the reduction of tyrosinase in the
resident melanocytes would lead to a reduction of melanin. We are
in the process of finalizing the first two protocols for testing in
volunteers.
RXI-185, an sd-rxRNA targeting MMP1, is in development as a
cosmetic ingredient that may improve the appearance of wrinkles,
skin laxity or photo-aging. A study conducted in collaboration with
DSM, showed that RXI-185 is capable of reducing MMP1 mRNA levels
following topical administration in an ex vivo human skin
model. A topical formulation of RXI-185 is currently in
development to lessen the effects of photo-aging.
About RXi Pharmaceuticals Corporation
RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a
clinical-stage company developing innovative therapeutics that
address significant unmet medical needs. Building on the
pioneering discovery of RNAi, scientists at RXi have harnessed the
naturally occurring RNAi process which has the ability to "silence"
or down-regulate the expression of a specific gene that may be
overexpressed in a disease condition. RXi developed a robust
RNAi therapeutic platform including self-delivering RNA (sd-rxRNA®)
compounds, that have the ability to selectively block the
expression of any target in the genome, thus providing
applicability to many therapeutic areas. Our current programs
include dermatology, ophthalmology and cell-based cancer
immunotherapy. RXi's extensive patent portfolio provides for
multiple product and business development opportunities across a
broad spectrum of therapeutic areas and we actively pursue research
collaborations, partnering and out-licensing opportunities with
academia and pharmaceutical companies. Additional information
may be found on 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. Such statements include, but are not limited to, statements
about: our ability to successfully develop RXI-109, Samcyprone™ and
our other product candidates (collectively "our product
candidates"); the future success of our clinical trials with our
product candidates; the timing for the commencement and completion
of clinical trials; our ability to enter into strategic
partnerships and the future success of these strategic
partnerships; and our ability to deploy our sd-rxRNA® technology
through partnerships, as well as the prospects of these
partnerships to provide positive returns. Forward-looking
statements about expectations and development plans of RXi's
product candidates and partnerships involve significant risks and
uncertainties, including the following: risks that we may not be
able to successfully develop and commercialize our product
candidates; risks that product development and clinical studies may
be delayed, not proceed as planned and/or be subject to significant
cost over-runs; risks related to the development and
commercialization of products by competitors; risks related to our
ability to control the timing and terms of collaborations with
third parties; and risks that other companies or organizations may
assert patent rights preventing us from developing or
commercializing our product candidates. Additional risks are
detailed in our most recent Annual Report on Form 10-K and
subsequent Quarterly Reports on Form 10-Q under the caption "Risk
Factors." 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
Tamara McGrillen
508-929-3646
tmcgrillen@rxipharma.com
RXi
PHARMACEUTICALS CORPORATION
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(Amounts in
thousands, except share and per share
data) (Unaudited)
|
|
|
For the
|
|
For the
|
|
Quarter
Ended
|
|
Quarter
Ended
|
|
March 31,
2017
|
|
March 31,
2016
|
|
Net revenues
|
$
—
|
|
$
10
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
Research
and development
|
1,347
|
|
1,305
|
|
Acquired
in-process research and development
|
2,990
|
|
—
|
|
General
and administrative
|
1,123
|
|
950
|
|
Total
operating expenses
|
5,460
|
|
2,255
|
|
Operating
loss
|
(5,460)
|
|
(2,245)
|
|
Total other
income
|
—
|
|
14
|
|
Net loss
|
$
(5,460)
|
|
$
(2,231)
|
|
Net loss per common
share:
|
|
|
|
|
Basic
and diluted
|
$
(0.27)
|
|
$
(0.34)
|
|
Weighted average common
shares: Basic and diluted
|
20,571,143
|
|
6,534,846
|
|
|
|
|
|
|
|
RXi
PHARMACEUTICALS CORPORATION
|
|
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
|
(Amounts in
thousands)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
December
31,
|
|
|
2017
|
|
2016
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
$
10,205
|
|
$
12,906
|
|
Restricted
cash
|
50
|
|
50
|
|
Prepaid
expenses
|
125
|
|
150
|
|
Total current
assets
|
10,380
|
|
13,106
|
|
Property and
equipment, net
|
105
|
|
114
|
|
Notes
receivable
|
—
|
|
150
|
|
Other
assets
|
27
|
|
27
|
|
Total
assets
|
$
10,512
|
|
$
13,397
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
$
672
|
|
$
917
|
|
Accrued
expenses
|
1,593
|
|
1,625
|
|
Total current
liabilities
|
2,265
|
|
2,542
|
|
Total stockholders'
equity
|
8,247
|
|
10,855
|
|
Total liabilities and
stockholders' equity
|
$
10,512
|
|
$
13,397
|
|
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SOURCE RXi Pharmaceuticals Corporation