MARLBOROUGH, Mass.,
March 30, 2015 /PRNewswire/
-- RXi Pharmaceuticals Corporation (NASDAQ: RXII), a
biotechnology company focused on discovering and developing
innovative therapeutics primarily in the areas of dermatology and
ophthalmology that address high-unmet medical needs, today reported
its financial results for the fourth quarter and year ended
December 31, 2014, and provided a
business update.
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"The past year has seen a steady growth and evolution for RXi
Pharmaceuticals," said Dr. Geert
Cauwenbergh, President and CEO of the Company. He added
that, "In 2014 we harvested the first results from our first Phase
2a study with RXI-109 that demonstrate that our drug is active in
the target population. These results provided us with guidance on
treatment regimen and duration for RXI-109 in patients with
hypertrophic scars. Add to that our progress in ophthalmology
towards a clinical trial for retinal scarring, as well as the
acquisition of Samcyprone™, and we feel that we are well positioned
to extend our growth curve into the current year; all while
focusing on containing cash burn in line with expectations for a
biotechnology stage company that is in mid-stage development with
its first two products."
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" 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.
Fourth Quarter 2014 and Recent Company Highlights
Clinical Programs: RXI-109
RXI-109 is an sd-rxRNA® compound developed for the reduction
of dermal scar formation. RXI-109 is designed to reduce connective
tissue growth factor (CTGF), a critical regulator of biological
pathways involved in fibrosis, including scar formation in the
skin.
Reported Positive Advancements in our RXI-109 Dermatology
Program:
- In December 2014, the Company
announced that enrollment for its first Phase 2a clinical trial,
Study 1301, is complete. The Company is continuing to monitor
subjects according to the trial protocol.
- In December 2014, the Company
announced results from preliminary data in its first Phase 2a
clinical trial for hypertrophic scars, Study 1301. The Company has
learned from RXI-109-1301 that initiating treatment with RXI-109
2-weeks post scar revision surgery is beneficial versus initiating
treatment immediately. The Company has also shown, in Study 1301,
that when treatment with RXI-109 was initiated 2-weeks post scar
revision surgery, blinded evaluators were able to identify
accurately the RXI-109 treated site at the 1-month and 3-month
follow-up more frequently than when treatment was initiated
immediately post scar revision surgery.
- From these early observations in Study 1301, the Company's
third Phase 2a clinical trial, RXI-109-1402, was designed with an
increased dosing and duration regimen. In March 2015, the Company announced that subject
enrollment for Study 1402 is more than 50% complete.
- In March 2015, the Company
announced that enrollment has completed and data collection and
analysis is ongoing for the Company's Phase 2a clinical study
RXI-109-1401, in which the clinical effect of RXI-109 treatment is
being evaluated for its ability to reduce the recurrence of keloids
following keloidectomy. Additionally, the Company held a meeting
with an expert panel where the panel conducted a review of
preliminary data from this study. Panel members often identified
the placebo-treated site as showing faster recurrence of the keloid
and provided a unanimous recommendation to the Company to lengthen
the treatment regimen and to increase the number of doses with
RXI-109 to reflect the chronic and aggressive nature of the
formation process of a keloid. The Company plans to move forward
with these recommendations and initiate an additional keloid trial
in the near future.
Clinical Programs: Samcyprone™
Samcyprone™ is a propriety topical formulation of
diphenylcyclopropenone (DPCP), an immunomodulating agent that works
by eliciting a T-cell response. Samcyprone™ is expected to
demonstrate an improved safety and tolerability profile while
maintaining the known efficacy of DPCP. Samcyprone™ is currently
being evaluated for the treatment of warts, alopecia areata and
cutaneous metastasis of malignant melanoma.
- Expansion of the Company's Clinical
Pipeline with an Exclusive Global License for a Phase 2 Clinical
Compound. In December 2014, the
Company announced that it had entered into an assignment and
exclusive license agreement with Hapten Pharmaceuticals, LLC. Under
the agreement, Hapten agreed to sell and assign to RXi certain
patent rights and related assets and rights, including an IND and
clinical data, for Hapten's Samcyprone™ products for therapeutic
and prophylactic use. Upon the satisfaction of certain closing
conditions, the Company closed the agreement in February 2015 and paid a one-time up-front cash
payment of $100,000 and issued
200,000 shares of common stock to Hapten.
- Entered into Collaborations with
The Rockefeller University and the
University of Minnesota and the
National Alopecia Areata Foundation. In March 2015, the Company announced it has entered
into collaborations with Dr. James
Krueger of The Rockefeller
University for the study of the effects of Samcyprone™ on
the changes in gene expression profiles influenced by DPCP in
patients with cutaneous metastases of solid tumors and with Dr.
Maria Hordinsky of the University of Minnesota and the National Alopecia
Areata Foundation for the study of Samcyprone™ in the treatment of
alopecia areata.
Corporate Highlights
Strengthened Intellectual Property Portfolio for Ocular
Indications. In February 2015,
the Company announced that we had been granted a patent by the
United States Patent and Trademark Office for the delivery of
double stranded siRNAs (21 to 23 nucleotides in length) across the
blood-retina barrier (e.g. topical or systemic delivery) for the
treatment of wet age-related macular degeneration or diabetic
retinopathy. The patent, which was part of the RNAi assets acquired
from OPKO Health, Inc. ("OPKO"), is scheduled to expire in
2023.
Successfully Executed Purchase Agreement for up to
$10.8 million in Funding with Lincoln
Park Capital. The purchase agreement with Lincoln Park Capital
provides the Company with access to up to $10.8 million in funding to support the Company's
clinical and preclinical programs. With the purchase agreement, in
addition to the Company's current cash, we expect that the Company
has sufficient cash to fund operations for at least one
year.
Entered into an Exclusive License Agreement with MirImmune
LLC for our Self-Delivering RNAi (sd-rxRNA®) Technology to Develop
Cell-based Immunotherapies to Treat Cancer. In March 2015, the Company announced that it had
entered into an exclusive license agreement with MirImmune LLC for
use of the Company's novel and proprietary sd-rxRNA technology in
developing innovative cell-based cancer immunotherapies. MirImmune
will develop cell-based therapeutics utilizing our sd-rxRNA
technology to target immune inhibitory pathways, which are in part
responsible for limiting the efficacy of cancer
immunotherapeutics.
Fourth Quarter and Full Year 2014 Financial
Highlights
Cash Position
At December 31, 2014, the Company
had cash and cash equivalents of approximately $8.5 million, compared with cash, cash
equivalents and short-term investments of $14.4 million at December
31, 2013. We believe that our existing cash and cash
equivalents, along with our equity facility with Lincoln Park
Capital, should be sufficient to fund our operations for at least
one year.
Research and Development Expenses
Research and development expenses for the quarter ended
December 31, 2014 were $1.6 million, compared with $1.4 million for the quarter ended December 31, 2013. Research and development
expenses for the year ended December 31,
2014 were $5.7 million,
compared with $17.7 million for the
year ended December 31, 2013.
Research and development expenses were relatively consistent in the
fourth quarter of 2014 as compared to the same period in the prior
year. For the full year, research and development expenses
decreased from the prior year primarily due to a one-time charge of
$12.3 million in March 2013 related to the fair value of common
stock issued in exchange for the acquisition of RNAi assets from
OPKO.
General and Administrative Expenses
General and administrative expenses for the quarter ended
December 31, 2014 were $0.8 million, compared with $1.1 million for the quarter ended December 31, 2013. General and administrative
expenses for the year ended December 31,
2014 were $3.2 million,
compared with $3.7 million for the
comparable period in 2013. General and administrative expenses for
the quarter and year ended December 31,
2014 as compared to the prior periods decreased primarily
due to professional services required in 2013, such as the
Company's reverse stock split and Nasdaq listing application, as
well as a decrease in Delaware
franchise tax as a result of the Company's reduction in authorized
common stock approved by shareholders in 2014.
Net Loss Applicable to Common Stockholders
Net loss attributable to common stockholders for the quarter
ended December 31, 2014 was
$2.8 million, compared with
$3.7 million for the same period in
2013. Net loss attributable to common stockholders for the year
ended December 31, 2014 was
$12.9 million compared with
$29.5 million for the year ended
December 31, 2013. The decrease in
net loss applicable to common stockholders for the full year 2014
was primarily attributable to the one-time charge of $12.3 million in research and development
expenses in 2013 related to the acquisition of RNAi assets from
OPKO, as described above, and decreases in the value of preferred
share dividends due to changes in the Company's closing common
stock price on the dividend payment dates and the number of
preferred shares earning dividends each quarter.
About RXi Pharmaceuticals Corporation
RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a
biotechnology company focused on discovering and developing
innovative therapeutics primarily in the area of dermatology and
ophthalmology that address high-unmet medical needs. Our discovery
and clinical development programs are based on siRNA technology as
well as immunotherapy agents. These compounds include, but
are not limited to, our proprietary, self-delivering RNAi
(sd-rxRNA®) compounds for the treatment of dermal and
retinal scarring. It also includes an immunomodulator, Samcyprone™,
a proprietary gel formulation of diphenylcyclopropenone (DPCP), for
the treatment of such disorders as alopecia areata, warts, and
cutaneous metastases of melanoma.
RXi's robust pipeline, coupled with an extensive patent
portfolio, provides for product and business development
opportunities across a broad spectrum. 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.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. These statements include, but are not limited to, statements
about future expectations and planned and future development of our
product candidates, technologies and partnerships.
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.
Contacts
RXi Pharmaceuticals Corporation
Tamara McGrillen, 508-929-3646
tmcgrillen@rxipharma.com
RXi
PHARMACEUTICALS CORPORATION
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CONDENSED
STATEMENTS OF OPERATIONS
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(Amounts in
thousands, except share and per share data)
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Three Months Ended
December 31,
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Years Ended December
31,
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2014
|
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2013
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2014
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2013
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|
|
|
|
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Total
revenues
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|
$
14
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|
$
29
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|
$
71
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|
$
399
|
|
|
|
|
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|
Research and
development expenses
|
|
1,562
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|
1,438
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|
5,680
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|
17,651
|
General and
administrative expenses
|
|
758
|
|
1,109
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|
3,217
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|
3,697
|
Operating
loss
|
|
(2,306)
|
|
(2,518)
|
|
(8,826)
|
|
(20,949)
|
Interest income,
net
|
|
2
|
|
10
|
|
17
|
|
24
|
Other income,
net
|
|
—
|
|
—
|
|
9
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|
—
|
Net loss
|
|
(2,304)
|
|
(2,508)
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|
(8,800)
|
|
(20,925)
|
Series A and Series
A-1 convertible preferred stock dividends
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(462)
|
|
(1,217)
|
|
(4,130)
|
|
(8,610)
|
Net loss applicable
to common stockholders
|
|
$ (2,766)
|
|
$ (3,725)
|
|
$ (12,930)
|
|
$ (29,535)
|
Net loss per common
share applicable to common stockholders:
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Basic and diluted
loss per share
|
|
$
(0.13)
|
|
$
(0.32)
|
|
$
(0.79)
|
|
$
(2.88)
|
Weighted average
common shares outstanding:
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
21,219,004
|
|
11,689,310
|
|
16,362,905
|
|
10,263,954
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RXI
PHARMACEUTICALS CORPORATION
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CONDENSED BALANCE
SHEETS
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(Amounts in
thousands)
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December
31,
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December
31,
|
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2014
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|
2013
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ASSETS
|
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|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$ 8,496
|
|
$ 11,390
|
Restricted
cash
|
50
|
|
50
|
Short-term
investments
|
—
|
|
3,000
|
Prepaid expenses and
other current assets
|
442
|
|
303
|
Total current
assets
|
8,988
|
|
14,743
|
Equipment and
furnishings, net
|
183
|
|
177
|
Other
assets
|
18
|
|
18
|
Total
assets
|
$ 9,189
|
|
$ 14,938
|
|
|
|
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LIABILITIES,
CONVERTIBLE PREFERRED STOCK AND
|
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STOCKHOLDERS'
EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
285
|
|
$
163
|
Accrued expenses and
other current liabilities
|
1,002
|
|
1,795
|
Deferred
revenue
|
47
|
|
118
|
Total current
liabilities
|
1,334
|
|
2,076
|
Total convertible
preferred stock
|
5,110
|
|
7,920
|
Total stockholders'
equity
|
2,745
|
|
4,942
|
Total liabilities,
convertible preferred stock and stockholders' equity
|
$ 9,189
|
|
$ 14,938
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/rxi-pharmaceuticals-reports-fourth-quarter-and-year-end-2014-financial-results-and-recent-corporate-highlights-300057421.html
SOURCE RXi Pharmaceuticals Corporation