WESTBOROUGH, Mass.,
March 28, 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 full year 2013, and provided a business update.
"RXi's proprietary self-delivering RNAi platform (sd-rxRNA®)
provided a solid foundation for our continued product development
efforts in 2013, and continues to offer potential opportunities for
future value creation," said Dr. Geert
Cauwenbergh, President and CEO of the Company. He added
that, "Conservative use of our available cash, combined with the
professional strengths of our employees and the support of our
shareholders, has been instrumental in moving RXI-109, our
anti-scarring compound, into Phase 2 clinical studies, from which
we expect to see the first results in the course of 2014."
Fourth Quarter 2013 and Recent Company Highlights
- Announcement of the Start of our First Phase 2 Clinical
Trial: In November 2013,
we announced the initiation and enrollment of the first patient in
a Phase 2 study with the anti-scarring product RXI-109. In this
study, patients with a long hypertrophic scar in the lower
abdominal area are eligible to receive scar revision surgery and
subsequent treatment with RXI-109 in one of two treatment regimens.
Patients will receive RXI-109 or placebo on a blinded basis at the
distal ends of the revised scar, leaving a central untreated
section of the scar. Each patient's revised scar will provide the
opportunity to compare the appearance of the revised areas after
treatment with RXI-109 or placebo or when left untreated.
- Signing of a Distribution Agreement for RXI-109 in the
European Union with Ethicor Ltd.: In November 2013, we signed a distribution agreement
with Ethicor Ltd. ("Ethicor"), a UK based unlicensed medicinal
products ("Specials") pharmaceutical company. The agreement
provides Ethicor with the distribution rights to RXI-109 in the
European Union, with the possibility to negotiate in the future to
extend such rights to other regions of the world, excluding
the United States, Canada and Mexico. Should we obtain marketing
authorization for RXI-109 in any of the countries covered by the
agreement, we have the option to terminate the agreement with
respect to each such country in which marketing authorization has
been obtained. The gross profits generated from any sales of
RXI-109 by Ethicor will be shared between us and Ethicor.
- Announcement of mRNA Data of an Additional Cohort in our
Second Phase 1 Clinical Trial: In December 2013, we announced the results from
additional cohorts in our second Phase 1 clinical trial, Study
1202. In the additional fourth cohort of this study, RXI-109 was
dosed over the initial 2-week period following the incision which
resulted in a 50% reduction of CTGF mRNA expression compared to the
placebo when measured three days after the last dose. In the fifth
cohort of the study, the dosing period was delayed by two weeks
after the incisions were made. No additional benefit was seen on
mRNA reduction. Multiple dermal injections were well tolerated at
all doses, and treatment with RXI‑109 resulted in dose-dependent
silencing of CTGF mRNA in the treated areas.
- 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.
Selected Full Year Financial Highlights
Cash and Cash Equivalents
At December 31, 2013, RXi had
cash, cash equivalents, and short-term investments of approximately
$14.4 million, compared with
$5.1 million at December 31, 2012.
Net Loss and Net Loss Applicable to Common
Stockholders
Net loss for the year ended December 31,
2013 was $20.9 million,
including $2.0 million in non-cash
share-based compensation expense, compared with a net loss of
$12.9 million, including $1.0 million in non-cash share-based compensation
expense, for the year ended December 31,
2012. The increase in the net loss of $8.0 million was primarily attributable to a
one-time non-cash charge of $12.3
million related to the fair value of common shares issued in
exchange for certain RNAi-related assets from OPKO Health, Inc. as
compared with a one-time non-cash charge of $6.2 million related to the fair value of common
shares issued in exchange for patent and technology rights for the
same period in 2012.
Net loss applicable to common stockholders for the year ended
December 31, 2013 was $29.5 million compared with a net loss applicable
to common stockholders of $25.7
million for the comparable period in 2012. The increase in
net loss applicable to common stockholders of $3.8 million was primarily attributable to the
aforementioned increase in net loss as compared to prior year and
an increase of $5.3 million related
to the fair value of Series A and Series A-1 Preferred Stock offset
by a decrease of $9.5 million related
to a one-time charge for the beneficial conversion feature of the
Series A Preferred Stock recorded in the second quarter of
2012.
Revenues
Total revenues for the year ended December 31, 2013 were $0.4 million as compared with $0.1 million for the comparable period in 2012.
The increase in total revenues for the year ended December 31, 2013 was due to the recognition of
work completed on the Company's government grants during the
period.
Research and Development Expenses
Research and development expenses for the year ended
December 31, 2013 were $17.7 million, compared with $10.5 million for the year ended December 31, 2012. The increase of $7.2 million was primarily due to increases of
$6.1 million in expense related to
the fair value of common shares issued in exchange for patent and
technology rights, $0.7 million in
research and development expenses largely due to costs related to
the manufacture of RXI-109 for use in the Company's on-going
clinical trials and $0.4 million in
employee stock-based compensation expense.
General and Administrative Expenses
General and administrative expenses for the year ended
December 31, 2013 were $3.7 million, compared with $2.6 million for the comparable period in 2012.
The increase in general and administrative expenses of $1.1 million was primarily due to an increase of
$0.6 in employee stock-based
compensation and $0.5 million in
general and administrative expenses due to an increase in employee
headcount, employee compensation and benefits, increases in Board
fees, the annual Delaware
franchise tax for 2013 and professional services such as outside
contractors and consultants.
Series A and Series A-1 Preferred Stock and
Dividends
Accretion of Series A and Series A-1 Preferred Stock and
dividends was $8.6 million for the
year ended December 31, 2013,
compared with $12.8 million accretion
of Series A and Series A-1 Preferred Stock and dividends for the
comparable period in 2012. The decrease of $4.2 million is due to the one-time charge of
$9.5 million related to the
beneficial conversion feature of the Series A Preferred Stock
during the same period in the prior year offset by an increase of
$5.3 million in Series A and Series
A-1 Preferred Stock 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 year.
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 platform. Therapeutics that use RNA
interference, or "RNAi," have great promise because of their
ability to down-regulate, the expression of a specific gene that
may be over-expressed in a disease condition. Building on the
pioneering work of scientific founder and Nobel Laureate Dr.
Craig Mello, a member of the RXi
Scientific Advisory Board, RXi's first RNAi product candidate,
RXI-109, targets connective tissue growth factor (CTGF) to reduce
dermal scarring (fibrosis), entered into human clinical trials in
June 2012. 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 trial with
RXI-109 may not be successful in evaluating the 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)
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended
|
|
Year Ended
|
|
|
December
31,
|
|
December
31,
|
|
|
2013
|
|
2012
|
|
|
|
|
|
|
Total
revenues
|
$
399
|
|
$
97
|
|
|
|
|
|
|
Research and
development expenses
|
17,651
|
|
10,451
|
|
General and
administrative expenses
|
3,697
|
|
2,621
|
|
Operating
loss
|
(20,949)
|
|
(12,975)
|
|
Interest income
(expense)
|
24
|
|
(30)
|
|
Other
income
|
—
|
|
125
|
|
Net loss
|
(20,925)
|
|
(12,880)
|
|
Accretion of
Series A and Series A-1 preferred stock and dividends
|
(8,610)
|
|
(12,815)
|
|
Net loss applicable
to common stockholders
|
$
(29,535)
|
|
$
(25,695)
|
|
Net loss per common share applicable to common
stockholders:
|
|
|
|
|
Basic and diluted
loss per share
|
$
(2.88)
|
|
$
(5.62)
|
|
Weighted average
common shares outstanding:
|
|
|
|
|
Basic and
diluted
|
10,263,954
|
|
4,573,787
|
|
RXi
PHARMACEUTICALS CORPORATION
|
|
(A Development
Stage Company)
|
|
CONDENSED BALANCE
SHEETS
|
|
(Amounts in
thousands)
|
|
|
|
|
December
31,
|
|
December
31,
|
|
|
2013
|
|
2012
|
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
$
11,390
|
|
$
5,127
|
|
Restricted
cash
|
50
|
|
53
|
|
Short-term
investments
|
3,000
|
|
—
|
|
Prepaid expenses and
other current assets
|
303
|
|
212
|
|
Total current
assets
|
14,743
|
|
5,392
|
|
Equipment and
furnishings, net
|
177
|
|
198
|
|
Other
assets
|
18
|
|
2
|
|
|
|
|
|
|
Total
assets
|
$
14,938
|
|
$
5,592
|
|
|
|
|
|
|
LIABILITIES,
CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY
(DEFICIT)
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
$
163
|
|
$
416
|
|
Accrued expenses and
other current liabilities
|
1,795
|
|
767
|
|
Deferred
revenue
|
118
|
|
491
|
|
Current maturities of
capital lease obligations
|
—
|
|
5
|
|
Total current
liabilities
|
2,076
|
|
1,679
|
|
Deferred revenue, net
of current portion
|
—
|
|
27
|
|
Total
liabilities
|
2,076
|
|
1,706
|
|
Total convertible
preferred stock
|
7,920
|
|
9,726
|
|
Total stockholders'
equity (deficit)
|
4,942
|
|
(5,840)
|
|
Total liabilities,
convertible preferred stock and stockholders' equity
(deficit)
|
$
14,938
|
|
$
5,592
|
|
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SOURCE RXi Pharmaceuticals Corporation