MARLBOROUGH, Mass.,
May 14, 2014 /PRNewswire/ -- RXi
Pharmaceuticals Corporation (NASDAQ: RXII), a biotechnology company
focused on discovering, developing and commercializing innovative
therapies addressing major unmet medical needs using RNA-targeted
technologies, today reported its financial results for the quarter
ended March 31, 2014, and provided a
business update.
"The first quarter of 2014 has been one of steady progress in
the clinical development of RXI-109, our sd-rxRNA®, for the
treatment of fibrotic conditions of the skin, with our second Phase
2 study in keloids being initiated a few weeks ago," said
Geert Cauwenbergh, President and CEO
of RXI Pharmaceuticals. He added that, "the availability of the
financing facility with Lincoln Park Capital, LLC has provided us
with the necessary financial band width to accelerate the
development of our ophthalmology franchise, which should yield
additional interesting data that could contribute to the growth of
our company."
First Quarter 2014 and Recent Corporate Highlights
- Announcement of Listing on The NASDAQ Capital Market:
Announced in February 2014 that the
Company received approval to list its common stock on The NASDAQ
Capital Market. The Company's common stock commenced trading
under the same ticker symbol, "RXII," on The NASDAQ Capital Market
effective at the opening of trading on Tuesday, February 11,
2014.
- Grant of Key Patent Related to Self-Delivering Technology
for the Treatment of Fibrotic Disorders: In March 2014, the Company announced that it had
been granted a patent by the U.S. Patent and Trademark Office on
its unique self-delivering RNAi compounds (sd-rxRNA), for the
treatment of fibrosis. The patent covers the use of sd-rxRNAs
targeting CTGF for the treatment of fibrotic disorders. The patent
(U.S. Patent Number 8,664,189) is scheduled to expire in 2029.
- Entered into a Purchase Agreement with Lincoln Park Capital,
LLC: Announced in April 2014 that
the Company had entered into a purchase agreement with Lincoln Park
Capital Fund, LLC ("LPC"), a Chicago-based institutional investor, whereby
LPC is committed to purchase up to an aggregate of $20 million of shares of the Company's common
stock. Upon execution, LPC purchased 500,000 shares of common stock
at $4.00 per share, for an initial
investment of $2 million. Upon the
filing of the first investigational drug application for an
ophthalmologic project with the U.S. Food and Drug Administration,
LPC will make an additional $1
million share purchase at prevailing market prices of the
Company's common stock. In addition, at the sole discretion of the
Company, we may sell up to $17
million worth of common stock to LPC over the 30-month term
of the agreement. The funds, in part, will serve to advance
research and development activities for the Company's
ophthalmological pre-clinical drug pipeline.
Quarterly Financial Highlights
Cash and Cash Equivalents
At March 31, 2014, RXi had cash,
cash equivalents and short-term investments of approximately
$12.0 million, compared with
$14.4 million at December 31, 2013.
Net Loss
Net loss for the three months ended March
31, 2014 was $2.3 million,
including $0.5 million in non-cash
share-based compensation expense, compared with a net loss of
$14.4 million, including $0.6 million in non-cash share-based compensation
expense, for the three months ended March
31, 2013. The decrease in net loss of $12.1 million was primarily attributable to a
one-time charge of $12.3 million in
the first quarter of 2013 related to the fair value of common
shares issued to OPKO Health, Inc. ("OPKO") for the purchase of
substantially all of OPKO's RNAi-related assets.
Net Loss Applicable to Common Stockholders
Net loss applicable to common stockholders for the three months
ended March 31, 2014 was $4.0 million compared with a net loss applicable
to common stockholders of $17.9
million for the comparable period in 2013. The decrease in
net loss applicable to common stockholders of $13.9 million was primarily attributable to the
aforementioned decrease in net loss as compared to prior year and a
decrease of $1.8 million in the fair
value of dividends paid in additional preferred stock to the
Company's preferred shareholders.
Research and Development Expenses
Research and development expenses for the three months ended
March 31, 2014 were $1.5 million, compared with $13.8 million for the three months ended
March 31, 2013. The decrease of
$12.3 million is primarily related to
the one-time charge of $12.3 million
in the first quarter of 2013 related to the fair value of common
shares issued to OPKO for the purchase of substantially all of
OPKO's RNAi-related assets.
General and Administrative Expenses
General and administrative expenses for the three months ended
March 31, 2014 were $0.8 million, compared with $0.7 million for the three months ended
March 31, 2013. The increase of
$0.1 million was due was primarily
due to an increase in employee share-based compensation expense and
an increase in general and administrative expenses due to listing
fees incurred by the Company in connection with the recent listing
the on the NASDAQ Capital Market.
Preferred Stock Dividends
Preferred stock dividends were $1.8
million for the three months ended March 31, 2014, compared with $3.5 million for the comparable period in 2013.
The decrease of $1.7 million is due
to due 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, developing and
commercializing innovative therapies based on its proprietary,
self-delivering RNAi (sd-rxRNA®) platform. Therapeutics that use
RNA interference, or "RNAi," have great promise because of their
ability to down-regulate the expression of specific genes that may
be over-expressed in disease conditions. Building on the pioneering
work of scientific founder and Nobel Laureate Dr. Craig Mello, a member of the Company's
Scientific Advisory Board, RXi's first RNAi product candidate,
RXI-109, entered into human clinical trials in June 2012 and is currently in Phase 2. RXI-109
targets connective tissue growth factor (CTGF) to reduce dermal
scarring (fibrosis). For more information, please visit
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 can be identified by words such
as: "intend," "believe," "expect," "may," "should," "designed to,"
"will" and similar references. Such statements include, but are not
limited to, statements about: our ability to successfully develop
RXI-109 and our other product candidates; the timing and future
success of our clinical trials with RXI-109; our expectation that
we will complete our Phase 2 clinical trials for RXI-109 within
anticipated time periods and budgets; our ability to implement
cost-saving measures and statements about other future
expectations. Forward-looking statements are neither historical
facts nor assurances of future performance. Instead they 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 and financial
condition may differ materially from those indicated in the
forward-looking statements. Therefore, you should not rely on any
of these forward-looking statements. Important factors that could
cause our actual results and financial condition to differ
materially from those indicated in the forward-looking statements
include, among others: the risk that our clinical trials with
RXI-109 may not be successful in evaluating the continued safety
and tolerability of RXI-109 or providing preliminary evidence of
the reduction of formation of surgical scars; the successful and
timely completion of clinical studies; uncertainties regarding the
regulatory process; the availability of funds and resources to
pursue our research and development projects, including our
clinical trials with RXI-109; and those identified under "Risk
Factors" in the Company's most recently filed Annual Report on Form
10-K, Quarterly Report on Form 10-Q and in other filings the
Company periodically makes with the SEC. The Company does not
undertake to update any of these forward-looking statements to
reflect a change in its views or events or circumstances that occur
after the date of this press release.
Contacts
RXi Pharmaceuticals Corporation
Tamara McGrillen, 508-929-3646
tmcgrillen@rxipharma.com
RXi
PHARMACEUTICALS CORPORATION
|
(A Development
Stage Company)
|
CONDENSED
STATEMENTS OF OPERATIONS
|
(Amounts in
thousands, except share and per share data)
(Unaudited)
|
|
|
For the
Three
|
|
For the
Three
|
Months
Ended
March 31,
2014
|
|
Months
Ended
March 31,
2013
|
|
|
|
|
Total
revenues
|
$
29
|
|
$
53
|
|
|
|
|
Research and
development expenses
|
1,476
|
|
13,771
|
General and
administrative expenses
|
843
|
|
676
|
Operating
loss
|
(2,290)
|
|
(14,394)
|
Interest income,
net
|
6
|
|
—
|
Other expense,
net
|
—
|
|
(3)
|
Net loss
|
(2,284)
|
|
(14,397)
|
Series A and Series
A-1 preferred stock dividends
|
(1,755)
|
|
(3,547)
|
Net loss applicable
to common stockholders
|
$
(4,039)
|
|
$
(17,944)
|
Net loss per common share applicable to common
stockholders:
|
|
|
|
Basic and diluted
loss per share
|
$
(0.32)
|
|
$
(2.76)
|
Weighted average
common shares outstanding:
|
|
|
|
Basic and
diluted
|
12,616,086
|
|
6,496,095
|
RXi
PHARMACEUTICALS CORPORATION
|
(A Development
Stage Company)
|
CONDENSED BALANCE
SHEETS
|
(Amounts in
thousands)
(Unaudited)
|
|
|
March 31,
|
|
December
31,
|
2014
|
|
2013
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
9,010
|
|
$
11,390
|
Restricted
cash
|
50
|
|
50
|
Short-term
investments
|
3,000
|
|
3,000
|
Prepaid expenses and
other current assets
|
226
|
|
303
|
Total current
assets
|
12,286
|
|
14,743
|
Equipment and
furnishings, net
|
155
|
|
177
|
Other
assets
|
18
|
|
18
|
Total
assets
|
$
12,459
|
|
$
14,938
|
|
|
|
|
LIABILITIES,
CONVERTIBLE PREFERRED STOCK AND
STOCKHOLDERS'
EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
277
|
|
$
163
|
Accrued expenses and
other current liabilities
|
1,024
|
|
1,795
|
Deferred
revenue
|
89
|
|
118
|
Total current
liabilities
|
1,390
|
|
2,076
|
Total convertible
preferred stock
|
4,850
|
|
7,920
|
Total stockholders'
equity
|
6,219
|
|
4,942
|
Total liabilities,
convertible preferred stock and stockholders' equity
|
$
12,459
|
|
$
14,938
|
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SOURCE RXi Pharmaceuticals Corporation