MARLBOROUGH, Mass.,
Nov. 13, 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 September 30,
2014, and provided a business update.
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"During the quarter, RXi has steadily progressed its clinical
development program with RXI-109 to reduce or inhibit scar
formation following scar revision surgery. In addition, the Company
has identified and synthesized potent new compounds against two
important clinical targets; collagenase and tyrosinase," said Dr.
Geert Cauwenbergh, President and CEO
of RXi Pharmaceuticals. He added that, "The initial results in our
first Phase 2a study (RXI-109-1301) have provided us with valuable
insights to identify the best time to start treatment with RXI-109
and have indicated that the compound may be clinically active in
the target population. This provides us with the ability to
optimize the dosing regimen to be used in future studies. The new
potent compounds against collagenase and tyrosinase further
demonstrate the strength of our self-delivering RNAi platform
(sd-rxRNA®), which has stimulated discussions with several
pharmaceutical companies with programs in therapeutic and in
esthetic skin care. All this has been achieved while maintaining a
strict discipline in our quarterly spending."
Third Quarter 2014 and Recent Corporate Highlights
- 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.
- Initiated a Third Phase 2a Study with
RXI-109 for Treatment of Hypertrophic Scars: The Company
initiated its third Phase 2a study (RXI-109-1402) with RXI-109 in
July 2014, for the reduction of
recurrence of hypertrophic scars following elective scar revision
surgery. In this study, subjects receive scar revision surgery on
one hypertrophic scar, or two scars comparable in length,
anatomical location and characteristics. For a single scar, a
portion of the revised scar segment will be treated with RXI-109
and a comparably sized length on the opposite end of the excised
scar segment will be left untreated. If two scars are revised, one
revised scar will be treated with RXI-109 and one scar will be left
untreated after revision surgery. This third Phase 2a study will
follow subjects for nine months.
- Presented an Update on the Company's
Dermatology and Ophthalmology Franchises: In September 2014, the Company announced that based
on early 1-month observations, the dosing regimen in our clinical
trials can be fine-tuned, allowing the Company to more rapidly move
forward with treatment optimization for the prevention of scarring
after surgery. In October 2014, the
Company then presented 3-month photographs from the first two
subjects enrolled in study RXI-109-1301 that indicate treatment
with RXI-109 may show a clinical benefit. The Company also
announced that collagenase and tyrosinase were selected as new
discovery stage targets for our self-delivering platform. For each
of these two targets, we have identified potent sd-rxRNA compounds
for further evaluation. As part of the ongoing ophthalmology
program, the Company filed a request for a pre-IND meeting with the
FDA in advance of filing an IND for RXI-109 for diseases in the
eye. In addition, the Company announced that a potent anti-VEGF
sd-rxRNA has been identified. The VEGF compound is based in part on
the target sequence of Bevasiranib, the siRNA compound acquired,
along with additional RNAi assets, from OPKO Health, Inc.
- Strengthening of the Company's
Intellectual Property Portfolio: In September 2014, the Company was granted a patent
from the United States Patent and Trademark Office on our unique
delivery system for delivering its "original" RNAi compounds
(rxRNAori®) to phagocytic cells for the treatment of diseases with
an inflammatory component. U.S. Patent Number 8,815,818 will expire
in 2029. In addition, the Company announced that it has been
granted a patent by the European Patent Office for a siRNA sequence
targeting ICAM-1 for treatment of several diseases. European Patent
Number EP 2 251 434, will expire in 2024. Furthermore, the Company
received a notice of allowance from the Japanese Patent Office for
the delivery of double stranded siRNAs (21 to 23 nucleotides in
length) across the blood-retina barrier.
Financial Highlights
Cash, Cash Equivalents and Short-term Investments
At September 30, 2014, the Company
had cash, cash equivalents and short-term investments of
approximately $10.1 million,
compared to $14.4 million at
December 31, 2013.
Research and Development Expenses
Research and development expenses for the three months ended
September 30, 2014 were $1.5 million, compared to $1.2 million for the three months ended
September 30, 2013. The increase of
$0.3 million is primarily
attributable to an increase of $0.2
million during the quarter related to preclinical
ophthalmology studies in support of an investigational new drug
application for an ocular indication.
Research and development expenses for the nine months ended
September 30, 2014 were $4.1 million, compared to $16.2 million for the nine months ended
September 30, 2013. The decrease of
$12.1 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 Health, Inc. ("OPKO") for the purchase of
substantially all of OPKO's RNAi-related assets offset by an
increase in research and development expenses for the Company's
three ongoing Phase 2a clinical trials.
General and Administrative Expenses
General and administrative expenses for the three months ended
September 30, 2014 were $0.8 million, compared to $0.9 million for the three months ended
September 30, 2013. The decrease of
$0.1 million was primarily due to a
decrease in legal and consulting fees as compared with the same
period in 2013.
General and administrative expenses for the nine months ended
September 30, 2014 were $2.5 million, compared to $2.6 million for the nine months ended
September 30, 2013. The decrease of
$0.1 million was primarily due to a
decrease in legal fees in connection with the Company's reverse
split which was completed in July
2013.
Net Loss
Net loss for the three months ended September 30, 2014 was $2.2 million, including $0.5 million in non-cash share-based compensation
expense, compared to a net loss of $2.1
million, including $0.4
million in non-cash share-based compensation expense, for
the three months ended September 30,
2013.
Net loss for the nine months ended September 30, 2014 was $6.5 million, including $1.4 million in non-cash share-based compensation
expense, compared to a net loss of $18.4
million, including $1.5
million in non-cash share-based compensation expense, for
the nine months ended September 30,
2013. The decrease in net loss of $11.9 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 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 September 30, 2014 was
$2.9 million compared to a net loss
applicable to common stockholders of $3.5
million for the comparable period in 2013. The decrease in
net loss applicable to common stockholders of $0.6 million was primarily attributable to a
decrease of $0.7 million in the fair
value of dividends paid on preferred stock to the Company's
preferred shareholders.
Net loss applicable to common stockholders for the nine months
ended September 30, 2014 was
$10.2 million compared to a net loss
applicable to common stockholders of $25.8
million for the comparable period in 2013. The decrease in
net loss applicable to common stockholders of $15.6 million was primarily attributable to the
aforementioned decrease in net loss as compared to the prior year
and a decrease of $3.7 million in the
fair value of dividends paid on preferred stock to the Company's
preferred shareholders.
Preferred Stock Dividends
Preferred stock dividends were $0.7
million for the three months ended September 30, 2014, compared to $1.4 million for the comparable period in 2013.
The decrease of $0.7 million is 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.
Preferred stock dividends were $3.7
million for the nine months ended September 30, 2014, compared to $7.4 million for the comparable period in 2013.
The decrease of $3.7 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 RXi
Scientific Advisory Board, RXi's first RNAi product candidate,
RXI‑109, a self-delivering RNAi compound (sd-rxRNA), entered into
human clinical trials in June 2012
and is currently being evaluated in Phase 2 clinical trials to
reduce the formation of dermal fibrosis (e.g., hypertrophic scars
and keloids). RXI-109 is designed to reduce the expression of
connective tissue growth factor (CTGF), a critical regulator of
biological pathways involved in fibrosis, including scar formation
in the skin. 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 dermal 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
Nine
|
|
For the
Nine
|
Months
Ended
|
|
Months Ended
|
|
Months
Ended
|
|
Months
Ended
|
September
30, 2014
|
|
September
30, 2013
|
|
September
30, 2014
|
|
September
30, 2013
|
|
|
|
|
|
|
|
|
Total
revenues
|
$
16
|
|
$
92
|
|
$
57
|
|
$
370
|
|
|
|
|
|
|
|
|
Research and
development expenses
|
1,459
|
|
1,229
|
|
4,118
|
|
16,213
|
General and
administrative expenses
|
766
|
|
934
|
|
2,459
|
|
2,588
|
Loss from
operations
|
(2,209)
|
|
(2,071)
|
|
(6,520)
|
|
(18,431)
|
Interest income,
net
|
4
|
|
10
|
|
15
|
|
14
|
Other income
(expense), net
|
(1)
|
|
2
|
|
9
|
|
—
|
Net loss
|
(2,206)
|
|
(2,059)
|
|
(6,496)
|
|
(18,417)
|
Series A and
Series A-1 convertible
preferred stock dividends
|
(700)
|
|
(1,447)
|
|
(3,668)
|
|
(7,393)
|
Net loss
applicable to common
stockholders
|
$
(2,906)
|
|
$
(3,506)
|
|
$
(10,164)
|
|
$ (25,810)
|
Net loss per common share applicable
to common
stockholders:
|
|
|
|
|
|
|
|
Basic and diluted loss
per share
|
$
(0.17)
|
|
$
(0.30)
|
|
$
(0.69)
|
|
$
(2.64)
|
Weighted average
common shares
outstanding:
|
|
|
|
|
|
|
|
Basic and
diluted
|
17,494,109
|
|
11,630,189
|
|
14,726,417
|
|
9,783,615
|
|
|
|
RXi PHARMACEUTICALS
CORPORATION
|
|
CONDENSED BALANCE
SHEETS
|
|
(Amounts in
thousands)
|
|
(Unaudited)
|
|
|
September
30,
|
|
December
31,
|
2014
|
|
2013
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$ 5,130
|
|
$
11,390
|
Restricted
cash
|
50
|
|
50
|
Short-term
investments
|
5,000
|
|
3,000
|
Prepaid expenses and
other current assets
|
510
|
|
303
|
Total current
assets
|
10,690
|
|
14,743
|
Equipment and
furnishings, net
|
193
|
|
177
|
Other
assets
|
18
|
|
18
|
Total
assets
|
$ 10,901
|
|
$ 14,938
|
|
|
|
|
LIABILITIES,
CONVERTIBLE PREFERRED STOCK AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
137
|
|
$
163
|
Accrued expenses and
other current liabilities
|
958
|
|
1,795
|
Deferred
revenue
|
61
|
|
118
|
Total current
liabilities
|
1,156
|
|
2,076
|
Total Series A
convertible preferred stock
|
5,022
|
|
7,920
|
Total stockholders'
equity
|
4,723
|
|
4,942
|
Total liabilities,
Series A convertible preferred
stock and stockholders' equity
|
$
10,901
|
|
$ 14,938
|
SOURCE RXi Pharmaceuticals Corporation