MARLBOROUGH, Mass.,
May 13, 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, today
reported its financial results for the quarter ended March 31, 2015, and provided a business
update.
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"RXi has continued its efforts to increase shareholder value
with key developments during this first quarter," said Dr.
Geert Cauwenbergh, President and CEO
of RXi Pharmaceuticals. "The exclusive license of our sd-rxRNA®
technology to MirImmune for ex vivo cell-based cancer
immunotherapies not only provides the potential for long-term
financial return, it also highlights the potential therapeutic
development opportunities for our propriety platform.
Furthermore, the completion of the global license agreement for
Samcyprone™ now allows us to drive this program forward and further
broadens our clinical pipeline. Lastly, as communicated in
our year-end earnings call, top-line results from our first Phase
2a trial three months after scar revision surgery have provided
clear guidance for our ongoing and future clinical development and
strategy with RXI-109. We anticipate sharing additional updates
later this year for both our dermal and ocular programs."
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.
Financial Highlights
Preferred Shares
At March 31, 2015, there were
3,085 and 21 shares of Series A Preferred Stock and Series A-1
Preferred Stock outstanding, respectively, or approximately 19%
ownership on a fully-diluted basis. Subsequent to the quarter ended
March 31, 2015, 2,026 shares of
Series A Preferred Stock were converted into shares of the
Company's common stock. As a result of these conversions, as of
May 13, 2015 the Company had 1,059
and 21 shares of Series A Preferred Stock and Series A-1 Preferred
Stock outstanding, respectively, or approximately 7% ownership on a
fully-diluted basis.
The Company had 36,160,133 shares of common stock outstanding as
of May 13, 2015 and the number of
common stock underlying the Series A Preferred Stock and Series A-1
Preferred Stock, as of the same date, totaled approximately 2.6
million shares.
Cash Position
At March 31, 2015, the Company had
cash and cash equivalents of approximately $6.6 million, compared with cash and cash
equivalents of $8.5 million at
December 31, 2014. We believe that
our existing cash and cash equivalents and the potential proceeds
available under 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
March 31, 2015 were $2.1 million, compared with $1.5 million for the quarter ended March 31, 2014. Research and development expenses
increased from the prior quarter primarily due to toxicology
studies required for the Company's ophthalmology IND,
subject-related fees for the Company's three ongoing Phase 2a
clinical trials and expenses related to the close of the
Samcyprone™ license agreement in February
2015.
General and Administrative Expenses
General and administrative expenses for the quarter ended
March 31, 2015 were $0.9 million, compared with $0.8 million for the quarter ended March 31, 2014. General and administrative
expenses increased primarily due to legal fees required during the
quarter as compared with the same period in the prior year.
Net Loss Applicable to Common Stockholders
Net loss attributable to common stockholders for the quarter
ended March 31, 2015 was $3.1 million, compared with $4.0 million for the same period in 2014. The
decrease in net loss applicable to common stockholders for the
quarter was primarily attributable to a decrease in the Company's
closing common stock price on the dividend payment dates and the
number of preferred shares earning dividends each quarter.
First Quarter 2015 and Recent Corporate Highlights
Reported Positive Advancements within our Dermatology
Franchise
Early top line results from our first Phase 2a study,
RXI-109-1301, have shaped the Company's ongoing and future clinical
development strategy. Based on three month data, the Company has
shown that treatment with RXI-109 has a clinical effect in the
target population. In addition, initiating treatment with RXI-109
two weeks after scar revision surgery, during the proliferation
phase of the wound healing process, is beneficial as compared to
initiating treatment immediately after surgery (during the
inflammation phase). Based on these observations, the Company
is implementing an optimized dosing regimen in study
RXI-109-1402. In study RXI-109-1402, RXI-109 is being
evaluated to reduce recurrence of hypertrophic scars after scar
revision surgery. In this study, enrollment is more than 50%
complete.
Enrollment is complete and data collection is ongoing for the
Company's Phase 2a clinical trial, RXI-109-1401, which is
evaluating RXI-109 to reduce recurrence of keloids after scar
revision surgery.
The Company completed the global license agreement for
Samcyprone™. This propriety topical formulation of
diphenylcyclopropenone (DPCP) is being evaluated for the treatment
of warts, alopecia areata and cutaneous metastases of malignant
melanoma. DPCP is an immunomodulating agent that works by eliciting
a T-cell response. While the drug DPCP has been used for
decades, it is expected that Samcyprone™ will result in a better
safety profile, a more consistent drug product and equivalent
efficacy at lower doses. In April of this year, the U.S. Food and
Drug Administration (FDA) granted Orphan Drug Designation to RXi
for Samcyprone™ for the treatment of Malignant Melanoma Stage IIb
to IV. A number of patients with Stage IIb to IV malignant melanoma
develop cutaneous metastases. Samcyprone™ is being developed for
treatment of these metastases.
The Company 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.
The Company presented new data at the 74th Annual
Meeting of the Society for Investigative Dermatology on the
Company's proprietary self-delivering RNAi (sd-rxRNA®) compounds
developed to target tyrosinase (TYR) and collagenase (MMP1).
sd-rxRNA compounds developed to target TYR, lead to a visible
reduction of pigmentation in melanocytes in a 3-dimensional tissue
culture model of human epidermis. Results from experiments in this
model show that sd-rxRNA compounds targeting TYR are at least one
hundred times more potent than kojic acid, a well-characterized
skin lightening agent. sd-rxRNA compounds developed to target MMP1
resulted in a reduction in MMP1 mRNA levels that correspond to a
similar reduction in MMP1 enzyme activity in cell culture in
vitro. In addition, silencing of MMP1 expression in an in
vitro scratch assay resulted in reduced migration of A549
cells, a clinically relevant non-small cell lung cancer cell line.
Reduced migration in a scratch assay may indicate a reduction in
the invasive nature of the cancer cell due to MMP1 reduction as a
result of sd-rxRNA treatment.
Exclusive Licensing Agreement
The Company entered into an exclusive license agreement with
MirImmune LLC for use of the Company's novel and proprietary
sd-rxRNA technology in developing innovative ex vivo
cell-based cancer immunotherapies. MirImmune will develop ex
vivo cell-based therapeutics utilizing RXi's sd-rxRNA
technology to target immune inhibitory pathways, which are in part
responsible for limiting the efficacy of cancer immunotherapeutics.
As consideration for the license, RXi will receive an annual
licensing fee, clinical milestone payments, sublicensing income and
single digit royalties. Pending MirImmune's achievement of a few
gating milestones, RXi will also have the right to acquire a
double-digit equity stake in MirImmune.
Intellectual Property
The Company was 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., is
scheduled to expire in 2023.
About RXi Pharmaceuticals Corporation
RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a
biotechnology company focused on discovering and developing
innovative therapeutics primarily in the areas 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 topical 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. 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; and the future success of our strategic
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.
Contact
RXi Pharmaceuticals Corporation
Tamara McGrillen
508-929-3646
tmgrillen@rxipharma.com
RXi PHARMACEUTICALS
CORPORATION
|
CONDENSED
STATEMENTS OF OPERATIONS
|
(Amounts in
thousands, except share and per share data)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
For the Three Months
Ended March 31, 2015
|
|
For the Three Months
Ended March 31, 2014
|
|
|
|
|
|
|
Total
revenues
|
$
34
|
|
$
29
|
|
Research and
development expenses
|
2,107
|
|
1,476
|
|
General and
administrative expenses
|
873
|
|
843
|
|
Loss from
operations
|
(2,946)
|
|
(2,290)
|
|
Interest income,
net
|
1
|
|
6
|
|
Net loss
|
(2,945)
|
|
(2,284)
|
|
Series A and Series
A-1 convertible preferred stock dividends
|
(185)
|
|
(1,755)
|
|
Net loss applicable to
common stockholders
|
$
(3,130)
|
|
$
(4,039)
|
|
Net loss per common share applicable to common
stockholders:
|
|
|
|
|
Basic and diluted loss
per share
|
$
(0.13)
|
|
$
(0.32)
|
|
Weighted average
common shares outstanding:
|
|
|
|
|
Basic and
diluted
|
23,763,486
|
|
12,616,086
|
|
RXi
PHARMACEUTICALS CORPORATION
|
|
|
|
CONDENSED BALANCE
SHEETS
|
|
|
|
(Amounts in
thousands)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
December
31,
|
|
2015
|
|
2014
|
|
|
|
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$ 6,580
|
|
$ 8,496
|
Restricted
cash
|
50
|
|
50
|
Prepaid expenses and
other current assets
|
351
|
|
442
|
Total current
assets
|
6,981
|
|
8,988
|
Equipment and
furnishings, net
|
170
|
|
183
|
Other
assets
|
18
|
|
18
|
Total
assets
|
$ 7,169
|
|
$ 9,189
|
|
|
|
|
LIABILITIES,
CONVERTIBLE PREFERRED STOCK AND
|
|
|
|
STOCKHOLDERS'
EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
459
|
|
$
285
|
Accrued expenses and
other current liabilities
|
1,097
|
|
1,002
|
Deferred
revenue
|
—
|
|
47
|
Total current
liabilities
|
1,556
|
|
1,334
|
Total convertible
preferred stock
|
3,085
|
|
5,110
|
Total stockholders'
equity
|
2,528
|
|
2,745
|
Total liabilities,
convertible preferred stock and stockholders' equity
|
$ 7,169
|
|
$ 9,189
|
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SOURCE RXi Pharmaceuticals Corporation