MARLBOROUGH, Mass.,
Aug. 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 June 30,
2014, and provided a business update.
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"Despite the general market down-turn in sentiment about biotech
values, RXi Pharmaceuticals has continued to grow value in line
with its promises to shareholders," said Dr. Geert Cauwenbergh, President and CEO of the
Company. He added that, "We expect the company to continue to add
data in the coming months that should add value to the unique IP
position that we have in the RNAi space."
Second Quarter 2014 and Recent Corporate Highlights
- Entered into a Purchase Agreement with
Lincoln Park Capital, LLC: The Company 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; the Company also issued
100,000 shares to LPC as a commitment fee for the facility. 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.
- Announced the Initiation of a Phase 2
Keloid Study: The Company announced in April 2014 that the first patient in the
Company's Phase 2a study (RXI-109-1401) was enrolled for the
prevention of keloid recurrence. In this study, patients with two
keloids of similar size and location are selected for keloidectomy.
After this procedure, the lesions are closed and one is treated
with RXI-109, and the other is treated with placebo. Patients will
be followed for several months after the end of treatment.
- Positive Results with RXI-109 in the Eyes
of Cynomolgus Monkeys as Part of a Dose-Range Finding Study:
The Company announced results from the assessment of connective
tissue growth factor (CTGF) protein levels following intravitreal
injection of RXI-109 in the eyes of cynomolgus monkeys as part of a
dose-range finding study. Intravitreal administration of RXI-109
resulted in a reduction of CTGF protein levels in a dose-dependent
manner in the retina, as well as in cornea tissue. IND-supporting
toxicity testing of RXI-109 in the eye is slated to begin
soon.
- Granted U.S. Notice of Allowance Covering
Self-Delivering (sd-rxRNA®) Technology Platform: The Company
received a Notice of Allowance from the United States Patent and
Trademark Office in May 2014 on a
patent covering our novel, self-delivering RNAi platform
(sd-rxRNA). The patent titled "Reduced Size Self-Delivering RNAi
Compounds" broadly covers both the composition and methods of use
of our self-delivering platform technology. The patent, once
issued, will be scheduled to expire in 2029.
- Appointment of Peter Campochiaro, M.D. to the Company's
Scientific Advisory Board: Dr. Peter
Campochiaro joined the Company's Scientific Advisory Board
in July 2014. Dr. Campochiaro is the
George S. and Dolores Dore Eccles Professor of Ophthalmology and
Neuroscience in the Johns Hopkins University
School of Medicine. He is a prominent researcher, clinician
and educator in the field of ophthalmology and sees patients at the
Wilmer Eye Institute at Johns
Hopkins.
Financial Highlights
Cash and Cash Equivalents
At June 30, 2014, the Company had
cash and cash equivalents of approximately $11.9 million, compared to $14.4 million cash, cash equivalents and
short-term investments at December 31,
2013.
Net Loss
Net loss for the three months ended June
30, 2014 was $2.0 million,
including $0.5 million in non-cash
share-based compensation expense, compared with a net loss of
$2.0 million, including $0.4 million in non-cash share-based compensation
expense, for the three months ended June 30,
2013.
Net loss for the six months ended June
30, 2014 was $4.3 million,
including $0.9 million in non-cash
share-based compensation expense, compared to a net loss of
$16.4 million, including $1.1 million in non-cash share-based compensation
expense, for the six months ended June 30,
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 June 30, 2014 was $3.2 million compared to a net loss applicable to
common stockholders of $4.4 million
for the comparable period in 2013. The decrease in net loss
applicable to common stockholders of $1.2
million was primarily attributable to a decrease of
$1.2 million in the fair value of
dividends paid in additional preferred stock to the Company's
preferred shareholders.
Net loss applicable to common stockholders for the six months
ended June 30, 2014 was $7.3 million compared to a net loss applicable to
common stockholders of $22.3 million
for the comparable period in 2013. The decrease in net loss
applicable to common stockholders of $15.0
million was primarily attributable to the aforementioned
decrease in net loss as compared to prior year and a decrease of
$2.9 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
June 30, 2014 were $1.2 million, compared to $1.2 million for the three months ended
June 30, 2013 and were consistent
year over year.
Research and development expenses for the six months ended
June 30, 2014 were $2.7 million, compared to $15.0 million for the six months ended
June 30, 2013. The decrease of
$12.3 million is primarily related to
the one-time charge 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
June 30, 2014 were $0.9 million, compared to $1.0 million for the three months ended
June 30, 2013. The decrease of
$0.1 million was due was primarily
due to a decrease in printing fees related to our public filings
and a decrease in legal fees in connection with the Company's
reverse split which was completed in July
2013.
General and administrative expenses for the six months ended
June 30, 2014 were $1.7 million, compared to $1.7 million for the six months ended
June 30, 2013. General and
administrative expenses were consistent year over year.
Preferred Stock Dividends
Preferred stock dividends were $1.2
million for the three months ended June 30, 2014, compared to $2.4 million for the comparable period in 2013.
The decrease of $1.2 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.
Preferred stock dividends were $3.0
million for the six months ended June
30, 2014, compared to $5.9
million for the comparable period in 2013. The decrease of
$2.9 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 being evaluated in
Phase 2 clinical trials to reduce dermal scarring (fibrosis).
RXI-109 is also being evaluated in pre-clinical studies for retinal
scarring. RXI-109 targets connective tissue growth factor
(CTGF), a key player in development of dermal scarring, retinal
scarring and fibrosis. RXi's sd‑rxRNA oligonucleotides are designed
for therapeutic use and have drug-like properties, such as high
potency, target specificity, serum stability, reduced immune
response activation, and efficient cellular uptake. These hybrid
oligonucleotide molecules combine the beneficial properties of
conventional RNAi and antisense technologies. This allows sd‑rxRNAs
to achieve efficient cellular uptake and potent, long-lasting
intracellular activity. 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; 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.
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)
|
(Unaudited)
|
|
|
For the
Three
|
|
For the
Three
|
|
For the
Six
|
|
For the
Six
|
Months
Ended
|
|
Months
Ended
|
|
Months
Ended
|
|
Months
Ended
|
June 30,
2014
|
|
June 30,
2013
|
|
June 30,
2014
|
|
June 30,
2013
|
|
|
|
|
|
|
|
|
Total
revenues
|
$
12
|
|
$
225
|
|
$
41
|
|
$
278
|
|
|
|
|
|
|
|
|
Research and
development expenses
|
1,183
|
|
1,213
|
|
2,659
|
|
14,985
|
General and
administrative expenses
|
850
|
|
977
|
|
1,693
|
|
1,652
|
Operating
loss
|
(2,021)
|
|
(1,965)
|
|
(4,311)
|
|
(16,359)
|
Interest income,
net
|
5
|
|
4
|
|
11
|
|
4
|
Other income
(expense), net
|
10
|
|
—
|
|
10
|
|
(3)
|
Net loss
|
(2,006)
|
|
(1,961)
|
|
(4,290)
|
|
(16,358)
|
Series A and
Series A-1 convertible
preferred stock dividends
|
(1,213)
|
|
(2,399)
|
|
(2,968)
|
|
(5,946)
|
Net loss
applicable to common
stockholders
|
$
(3,219)
|
|
$
(4,360)
|
|
$
(7,258)
|
|
$ (22,304)
|
Net loss per common share applicable
to
common stockholders:
|
|
|
|
|
|
|
|
Basic and diluted loss
per share
|
$
(0.23)
|
|
$
(0.39)
|
|
$
(0.54)
|
|
$
(2.52)
|
Weighted average
common shares
outstanding:
|
|
|
|
|
|
|
|
Basic and
diluted
|
14,015,451
|
|
11,168,144
|
|
13,319,634
|
|
8,845,026
|
RXi PHARMACEUTICALS
CORPORATION
|
CONDENSED BALANCE
SHEETS
|
(Amounts in
thousands)
(Unaudited)
|
|
|
June 30,
|
|
December
31,
|
2014
|
|
2013
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$ 11,911
|
|
$
11,390
|
Restricted
cash
|
50
|
|
50
|
Short-term
investments
|
—
|
|
3,000
|
Prepaid expenses and
other current assets
|
367
|
|
303
|
Total current
assets
|
12,328
|
|
14,743
|
Equipment and
furnishings, net
|
204
|
|
177
|
Other
assets
|
18
|
|
18
|
Total
assets
|
$ 12,550
|
|
$ 14,938
|
|
|
|
|
LIABILITIES,
CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
293
|
|
$
163
|
Accrued expenses and
other current liabilities
|
682
|
|
1,795
|
Deferred
revenue
|
78
|
|
118
|
Total current
liabilities
|
1,053
|
|
2,076
|
Total Series A
convertible preferred stock
|
4,935
|
|
7,920
|
Total stockholders'
equity
|
6,562
|
|
4,942
|
Total liabilities,
Series A convertible preferred stock and stockholders' equity
|
$
12,550
|
|
$ 14,938
|
SOURCE RXi Pharmaceuticals Corporation