MARLBOROUGH, Mass.,
March 30, 2016 /PRNewswire/
-- RXi Pharmaceuticals Corporation (NASDAQ: RXII), a
clinical-stage RNAi company developing innovative therapeutics in
dermatology and ophthalmology that address significant unmet
medical needs, today reported its financial results for the fourth
quarter and year ended December 31,
2015, and provided a business update.
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"During the last quarter of 2015, RXi advanced its pipeline with
the initiation of three clinical trials and the selection of two
self-delivering RNAi (sd-rxRNA®) compounds for cosmetic product
development, all while staying within the financial projections we
have provided in the course of 2015," said Dr. Geert Cauwenbergh, President and CEO of the
Company. He added that, "We have now repeatedly shown the value of
our proprietary sd-rxRNA platform over the course of this past
year. Clinical observations have confirmed efficacy with RXI-109,
an sd-rxRNA compound, in our Phase 2 clinical trials in patients
with hypertrophic scars. We further showed that sd-rxRNAs
reduce expression levels in the retina and cornea of primates, as
well as long-non coding RNAs in cell cultures, in a potent and
target specific manner. While working to accomplish our long term
development goals, we also selected two sd-rxRNA compounds to
advance on a much shorter cosmetic product development path, which
we hope may bring shareholder value in the nearer term. As
mentioned on several occasions in the recent past; with the
necessary clinical studies ongoing for RXI-109 in dermatology and
ophthalmology, and with Samcyprone™ for the treatment
of cutaneous warts, we foresee our news flow this year to include
new data points in preclinical R&D throughout the whole year,
as well as early read-outs of the ongoing clinical studies in the
second half of 2016. In addition, business development contacts and
interactions with other pharmaceutical and biotech companies have
more than tripled in the past 6 months as compared to the previous
6-month period. As you can see from our progress in the last
several months, our team continues to be very dedicated to
continuing this momentum through 2016."
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 and Canada:
+1 888-669-0684. International participants may access the event by
dialing: +1 862-225-5361. An archive of the webcast will be
available on the Company's website approximately two hours after
the presentation.
Select Fourth Quarter and Fiscal 2015 Financial
Highlights
Cash Position
At December 31, 2015, the Company
had cash, cash equivalents and short-term investments of
approximately $10.6 million,
compared with cash and cash equivalents of $8.5 million at December
31, 2014.
The Company believes that its existing cash, cash equivalents
and short-term investments should be sufficient to fund operations
for at least one year.
Research and Development Expenses
Research and development expense for the quarter ended
December 31, 2015 was $1.7 million, which included $0.1 million of non-cash stock-based compensation
expense, as compared with $1.6
million for the quarter ended December 31, 2014, which included $0.2 million of non-cash stock-based compensation
expense. Research and development expense for the year ended
December 31, 2015 was $6.9 million, which included $0.6 million of non-cash stock-based compensation
expense, as compared with $5.7
million for the year ended December
31, 2014, which included $0.8
million of non-cash stock-based compensation expense.
The increase in research and development expense quarter over
quarter and year over year was primarily due to manufacturing
expense for the RXI-109 and Samcyprone™ drug products
for use in the Company's clinical trials. Additionally,
research and development expense increased due to an increase in
headcount and for lab supplies and materials used as the Company
moves forward in the development of our cosmetic targets and
topical delivery applications.
General and Administrative Expenses
General and administrative expense for the quarter ended
December 31, 2015 was $0.9 million, which included $0.2 million of non-cash stock-based compensation
expense, as compared with $0.8
million for the quarter ended December 31, 2014, which included $0.2 million of non-cash stock-based compensation
expense. General and administrative expense for the year ended
December 31, 2015 was $3.3 million, which included $0.9 million of non-cash stock-based compensation
expense, as compared with $3.2
million for the year ended December
31, 2014, which included $1.0
million of non-cash stock-based compensation expense.
The increase in general and administrative expense quarter over
quarter and year over year was primarily due to an increase in
compensation expense, as well as an increase in professional
services expense due to the Company's focus on business development
activities as one of its key corporate initiatives.
Net Loss Applicable to Common Stockholders
Net loss applicable to common stockholders for the quarter ended
December 31, 2015 was $2.6 million, compared with $2.8 million for the quarter ended December 31, 2014. Net loss applicable to common
stockholders for the year ended December 31,
2015 was $10.4 million,
compared with $12.9 million for the
year ended December 31, 2014.
The decrease in net loss applicable to common stockholders for
the quarter and year ended December 31,
2015 as compared to prior year periods was due to a decrease
in the fair value of the Company's preferred stock dividends offset
by an increase in operating expenses, as described above. The
decrease in the preferred stock dividends for the quarter ended and
year ended periods was due to the full conversion of all shares of
preferred stock during the second quarter of 2015, resulting in no
further accumulation and future payments of dividends.
Select Fourth Quarter 2015 and Recent Corporate
Highlights
Dermatology
Results from the Company's Phase 2 clinical trial, RXI-109-1402
for the treatment of hypertrophic scars, demonstrated that
RXI-109-treated sites scored better as compared to untreated sites
in the same subjects, three months after the scar revision
surgery. The results from clinical trials to date have helped
guide the selection of dose timing and dose level. The
Company initiated two new cohorts in its Phase 2 clinical trial in
Q4 2015 to help define best treatment length and number of doses.
The Company expects to report early results from these two cohorts
later this year.
RXi selected two sd-rxRNA compounds for cosmetic product
development, RXI-231 and RXI-185. Topical delivery strategies are
currently in development and we expect to explore a candidate in
consumer testing in 2016. These candidates are part of RXi's
partnering and business development initiative providing multiple
development opportunities for non-therapeutic skin health. The
combined global market potential for cosmetic product development
is approximately $200 billion for
skin lightening and skin rejuvenation. While preventative or
therapeutic claims are not allowed for cosmetic products, they may
be developed more rapidly than therapeutics, therefore their path
to market may be much shorter and less expensive.
In the first quarter of 2015, the Company broadened its clinical
pipeline with the addition of a topical immunotherapy,
Samcyprone™. This proprietary formulation of
diphenylcyclopropenone (DPCP) is a Phase 2 clinical asset with
large combined market potential in the target indications of warts,
alopecia areata, non-malignant skin tumors and cutaneous metastases
of melanoma. In December of 2015, a Phase 2 clinical trial
was initiated with Samcyprone™ for cutaneous warts.
RXI-SCP-1502 is a multi-center, multi-dose trial conducted in
subjects with at least one cutaneous, plantar or periungual wart
present for at least four weeks. The Company anticipates that this
trial will be fully enrolled by the end of 2016 with preliminary
readouts available in the second half of 2016.
Ophthalmology
The Company initiated a Phase 1/2 study, RXI-109-1501, in Q4
2015 to evaluate the safety and clinical activity of RXI-109 to
prevent the progression of retinal scarring, a harmful component of
numerous retinal diseases. Currently, there is no effective way to
prevent the formation or progression of retinal scars that may
occur as a consequence of several devastating ocular
diseases. The Company anticipates sharing preliminary safety
readouts in the second half of 2016.
Research
Through a collaboration with Biogazelle NV, RXi discovered that
specifically designed sd-rxRNAs demonstrated robust and potent
reduction of the levels of long non-coding RNAs (lncRNAs) in a
target specific manner. This remarkable finding represents a
significant additional value inflection point for our
self-delivering platform and expands the breadth of potential
therapeutic targets by four fold, thus opening additional business
development and partnering opportunities for our sd-rxRNA
platform.
Intellectual Property
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 immunotherapy agent,
Samcyprone™. Our RNAi portfolio currently includes 72
issued patents broadly covering the composition and methods of use
of our self-delivering platform technology and uses of our
sd-rxRNAs targeting CTGF for the treatment of fibrotic disorders,
including RXI-109 for the treatment of dermal and ocular fibrosis;
new RNAi compounds and their use as therapeutics and/or cosmetics,
chemical modifications of RNAi compounds that improve the
compounds' suitability for therapeutic uses (including delivery)
and compounds directed to specific targets (i.e., that address
specific disease states).
The Samcyprone™ portfolio includes one issued
patent and three patent applications. The patent and patent
applications cover both the compositions and methods of use of
Samcyprone™ for the treatment of warts, human
papilloma virus (HPV) skin infections, skin cancer (including
melanoma) and immunocompromised patients.
The issuance of these patents not only expands and strengthens
our intellectual property estate, it further increases the value
proposition of both our Dermatology and Ophthalmology Franchises
and positions the Company for numerous strategic partnering
opportunities.
About RXi Pharmaceuticals Corporation
RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a
clinical-stage RNAi company developing innovative therapeutics in
dermatology and ophthalmology that address significant unmet
medical needs. Building on the pioneering work of RXi's
Scientific Advisory Board Chairman and Nobel Laureate Dr.
Craig Mello, our discovery and
clinical development programs are based on our proprietary RNAi
(sd-rxRNA) platform and Samcyprone™, a topical
immunomodulator. Our clinical development programs include RXI-109,
an sd-rxRNA, for the treatment of dermal and ocular scarring, and
Samcyprone™ for the treatment of such disorders as
warts, alopecia areata, non-malignant skin tumors and cutaneous
metastases of melanoma. RXi's robust pipeline, coupled with
an extensive patent portfolio, provides for multiple product and
business development opportunities across a broad spectrum of
therapeutic areas. We are committed to being a partner of choice
for academia, small companies, and large multinationals. We welcome
ideas and proposals for strategic alliances, including in- and
out-licensing opportunities, to advance and further develop
strategic areas of interest. 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
STATEMENTS OF OPERATIONS
|
(Amounts in
thousands, except share and per share data)
|
|
|
For the
Three
|
|
For the
Three
|
|
For the
|
|
For the
|
Months
Ended
|
|
Months
Ended
|
|
Year
Ended
|
|
Year Ended
|
December 31,
2015
|
|
December 31,
2014
|
|
December 31,
2015
|
|
December 31,
2014
|
Revenue
|
$
—
|
|
$
14
|
|
$
34
|
|
$
71
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and development
|
1,723
|
|
1,562
|
|
6,925
|
|
5,680
|
General and
administrative
|
899
|
|
758
|
|
3,346
|
|
3,217
|
Total operating
expenses
|
2,622
|
|
2,320
|
|
10,271
|
|
8,897
|
Operating
loss
|
(2,622)
|
|
(2,306)
|
|
(10,237)
|
|
(8,826)
|
Interest income,
net
|
6
|
|
2
|
|
16
|
|
17
|
Other income
(expense), net
|
—
|
|
—
|
|
(2)
|
|
9
|
Net loss
|
(2,616)
|
|
(2,304)
|
|
(10,223)
|
|
(8,800)
|
Series A and Series
A-1 convertible
preferred stock dividends
|
—
|
|
(462)
|
|
(209)
|
|
(4,130)
|
Net loss applicable
to common stockholders
|
$
(2,616)
|
|
$
(2,766)
|
|
$ (10,432)
|
|
$
(12,930)
|
Net loss per common
share applicable to
common stockholders:
|
|
|
|
|
|
|
|
Basic and diluted
|
$
(0.04)
|
|
$
(0.13)
|
|
$
(0.21)
|
|
$
(0.79)
|
Weighted average
common shares
outstanding:
|
|
|
|
|
|
|
|
Basic and diluted
|
65,288,251
|
|
21,219,004
|
|
49,703,822
|
|
16,362,905
|
|
|
|
|
|
|
|
|
|
RXi
PHARMACEUTICALS CORPORATION
|
|
|
|
CONDENSED BALANCE
SHEETS
|
|
|
|
(Amounts in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
December
31,
|
|
December
31,
|
|
2015
|
|
2014
|
|
|
|
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$ 5,117
|
|
$ 8,496
|
Restricted
cash
|
50
|
|
50
|
Short-term
investments
|
5,500
|
|
—
|
Prepaid
expenses
|
311
|
|
442
|
Total current
assets
|
10,978
|
|
8,988
|
Property and
equipment, net
|
163
|
|
183
|
Other
assets
|
18
|
|
18
|
Total
assets
|
$ 11,159
|
|
$
9,189
|
|
|
|
|
LIABILITIES,
CONVERTIBLE PREFERRED STOCK AND
|
|
|
|
STOCKHOLDERS'
EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$ 1,163
|
|
$
285
|
Accrued
expenses
|
1,106
|
|
1,002
|
Deferred
revenue
|
—
|
|
47
|
Total current
liabilities
|
2,269
|
|
1,334
|
Total convertible
preferred stock
|
—
|
|
5,110
|
Total stockholders'
equity
|
8,890
|
|
2,745
|
Total liabilities,
convertible preferred stock and stockholders' equity
|
$ 11,159
|
|
$
9,189
|
To view the original version on PR Newswire,
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SOURCE RXi Pharmaceuticals Corporation