http://www.businesswire.com/news/home/20091116005488/en
WORCESTER, Mass.--(Business Wire)--
RXi Pharmaceuticals Corporation (Nasdaq: RXII), a biopharmaceutical company
pursuing the development and commercialization of proprietary therapeutics based
on RNA interference (RNAi), today reported its financial results for the quarter
ended September 30, 2009.
"RXi continues to make excellent progress advancing its RNAi therapeutic
platform, most notably self-delivering rxRNA compounds for both local and
systemic administration," said Noah Beerman, President and Chief Executive
Officer of RXi. "We have reported positive pre-clinical data that outline the
unique capabilities of our technology and how RXi is addressing important
factors that we believe will lead to the successful development and eventual
commercialization of RNAi therapeutics. With my successful track record of
building a pipeline of biopharmaceutical products, I believe RXi should be well
positioned to capitalize on these opportunities."
Quarterly and Other Recent Highlights
Corporate Highlights:
* Appointment of Noah D. Beerman as President and Chief Executive Officer.
Following this quarter, Noah D. Beerman joined RXi as its new President and
Chief Executive Officer as part of a planned succession in leadership as the
company looks to advance from the research stage to product development and
execution of therapeutic collaborations and partnerships. Mr. Beerman succeeds
RXi`s co-founder, Tod Woolf, Ph.D., who will continue as a member of RXi`s
Scientific Advisory Board.
* Completed $8.3 million Public Offering. RXi received approximately $7.8
million in net proceeds from the offering that closed on August 4, 2009.
Proceeds from the transaction are being used to meet working capital needs and
for general corporate purposes.
* Provided Updates at Annual Investor Day. RXi held its 2nd annual investor day
where the public was updated on the status of RXi`s therapeutic indications,
research findings, intellectual property and business development efforts.
* Strengthened Position in RXi Proprietary Self-delivering rxRNA. RXi acquired
direct ownership of previously licensed RNAi delivery intellectual property from
Advirna LLC. RXi`s self-delivering rxRNA (sd-rxRNA) technology platform, which
is based on a combination of Advirna technology and RXi`s internally developed
technology, has shown extremely promising pre-clinical results prompting RXi to
acquire direct ownership of the Advirna technology. By including the Advirna
intellectual property in RXi`s proprietary portfolio, the company gains full
control of patent prosecution, enhancing the potential of obtaining broader
claims that would further strengthen RXi`s intellectual property position.
* Received Notices of Allowance for a Set of Patents Encompassing siRNA
Sequences. Notices of Allowance were issued by the United States Patent Office
(USPTO) on patent applications filed by Thermo Fisher Scientific Inc. and
licensed to RXi Pharmaceuticals encompassing small interfering RNA (siRNA)
sequences targeting a number of human genes. These applications, which contain
claims that cover specific siRNA sequences, are the first to have received
notices of allowance by the USPTO of many patent applications encompassing siRNA
sequences licensed by RXi from Thermo Fisher Scientific. RXi has obtained broad
rights to these sequence-specific patent applications.
Scientific Achievements:
* Presented Pre-clinical Animal Data on Self-delivering rxRNA Compounds. RXi
presented encouraging animal data on its sd-rxRNA compounds at its investor day
and other key scientific conferences. The new data includes improved
pharmacology with both local and systemic administration in animal models. This
research with sd-rxRNAs additionally show:
* Increased serum stability
* Improved retention in the circulation
* Minimal immune response activation
* Efficient cellular uptake and internalization to many diverse cell types
* Systemic delivery to the liver with effective gene silencing
* Local delivery via intradermal injection with effective gene silencing
* Continued the Advancement of RNAi Therapeutics Platform. RXi`s comprehensive
therapeutic platform, which is comprised of next generation rxRNA compounds and
advanced delivery approaches, continues to produce promising pre-clinical data,
especially as it relates to RXi`s proprietary sd-rxRNA compounds. Data has been
presented demonstrating the robustness and potential for broad-based
applications using sd-rxRNA compounds in diverse therapeutic areas that may
enable multiple opportunities for developing a sustainable pipeline of RNAi
therapeutics for unmet medical needs.
* Established Oligonucleotide Production Capabilities. To progress the
development of RXi`s internal programs, collaborations and future partnerships,
the company established the expertise to produce oligonucleotides for RNAi
compounds at its facility. This will allow the optimization and manufacture of
sd-rxRNA and other proprietary RNAi compounds and compress discovery timelines.
Financial Highlights:
The Company reported a net loss of $12.2 million, or $0.85 per share, for the
nine months ended September 30, 2009, compared to a net loss of $10.3 million,
or $0.79 per share, for the same period in 2008. The Company had 16,207,625
common shares outstanding at September 30, 2009, as compared to 13,763,231
common shares outstanding at December 31, 2008.
Research and development expenses for the nine months ended September 30, 2009
were $6.5 million, including approximately $1.6 million in stock based
compensation, compared to $5.1 million including $1.8 million in stock-based
compensation, for the nine months ended September 30, 2008. The increase of $1.4
million, or 27%, was primarily due to higher staff-related costs resulting from
growth in R&D staff, higher supplies cost and increased patent application and
prosecution expenses coupled with a decrease of approximately $0.2 million in
stock-based compensation. General and administrative expenses for the nine
months ended September 30, 2009 were $5.7 million, including $1.5 million in
stock based compensation, compared to $5.5 million, including $1.4 million in
stock based compensation, for the nine months ended September 30, 2008. The
increase of $.2 million, or 4%, was primarily due to non-cash expense totaling
$1.1 million associated with warrants issued for business advisory services and
common stock issued pursuant to Standby Equity Distribution Agreement (SEDA)
that the Company entered into in January 2009 offset by a $1.0 million gain from
the change in fair value of common stock warrants issued with our registered
direct offering that closed in August 2009.
As of September 30, 2009, cash and cash equivalents totaled $9.0 million,
compared to cash and cash equivalents of $9.9 million at December 31, 2008. This
decrease is due to cash used in operations of $8.5 million for the nine months
ended September 30, 2009 partially offset by the proceeds from the Company's
registered direct offering. On July 31, 2009, the Company entered into a
definitive agreement relating to the registered direct offering for the purchase
of 2,385,715 shares of its common stock at $3.50 per share, and warrants to
purchase up to 954,286 shares of common stock at an exercise price of $4.50 per
share which will be exercisable beginning on February 3, 2010. The offering
closed on August 4, 2009. The Company received approximately $7.8 million in net
proceeds from the offering. Proceeds from the transaction will be used to meet
working capital needs and for general corporate purposes.
About RXi Pharmaceuticals Corporation
RXi Pharmaceuticals is a discovery-stage biopharmaceutical company pursuing the
development and potential commercialization of proprietary therapeutics based on
RNA interference (RNAi) for the treatment of human diseases. RXi Pharmaceuticals
has a comprehensive RNAi platform that includes both RNAi compounds and delivery
methods. RXi Pharmaceuticals' rxRNA compounds are distinct from the siRNA
compounds used by many other companies developing RNAi therapeutics and are very
active and potent (10-100 pM activity in cell culture), in addition to being
nuclease resistant and readily manufactured. RXi Pharmaceuticals believes it is
well positioned to compete successfully in the RNAi-based therapeutics market
with its accomplished scientific advisors, including Dr. Craig Mello, recipient
of the 2006 Nobel Prize for his co-discovery of RNAi; a management team that is
experienced in developing RNAi products; and a strong, early intellectual
property position in RNAi chemistry and delivery. 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 future expectations, plan and future
development of RXi Pharmaceutical Corporation`s products and technologies. These
forward-looking statements about future expectations, plans and prospects of the
development of RXi Pharmaceutical Corporation`s products and technologies
involve significant risks, uncertainties and assumptions, including the risk of
delays in satisfying the conditions to selling any of the securities to YA
Global Investments pursuant to the Standby Equity Distribution Agreement that we
have in place with them and the potential adverse impact on the market price of
our securities due to resale by YA Global Investments of securities purchased
from the Company if the Company sells them securities, the risk that the
proceeds from the recently completed securities offering will be insufficient to
meet all of the capital needed to support our operations, the risk that
pre-clinical results of our oral delivery technology obtained to date may not be
reproducible in subsequent pre-clinical or clinical trials, the risk that
unanticipated safety or efficacy issues may arise in the course of developing
our oral delivery technology, the risk that the development of our RNAi-based
therapeutics may be delayed or may not proceed as planned and we may not be able
to complete development of any RNAi-based product, the risk that the FDA
approval process may be delayed for any drugs that we develop, risks related to
development and commercialization of products by our competitors, risks related
to our ability to control the timing and terms of collaborations with third
parties and the possibility that other companies or organizations may assert
patent rights that prevent us from developing our products. Actual results may
differ materially from those RXi Pharmaceuticals Corporation contemplated by
these forward-looking statements. RXi Pharmaceuticals Corporation 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
release.
RXi Pharmaceuticals Corporation
(A Development Stage Company)
Condensed Statements of Expenses
(in thousands, except share and per share data)
(Unaudited)
For the Three Months Ended For the Three Months Ended For the Nine Months Ended For the Nine Months Ended
September 30, September 30, September 30, September 30,
2009 2008 2009 2008
Research and development
expense $ 2,091 $ 1,200 $ 6,533 $ 5,054
General and administrative
expense 895 2,264 5,699 5,477
Operating loss (2,986 ) (3,464 ) (12,232 ) (10,531 )
Other income( expense), net (1 ) 56 (7 ) 159
Net loss $ (2,987 ) $ (3,408 ) $ (12,239 ) $ (10,372 )
Net loss per common share:
Basic and diluted loss per
share ($0.19 ) ($0.25 ) ($0.85 ) ($0.79 )
Weighted average common
shares outstanding:
Basic and diluted 15,327,482 13,757,731 14,319,262 13,064,396
RXi Pharmaceuticals Corporation
(A Development Stage Company)
Condensed Balance Sheets
(in thousands)
(Unaudited)
September 30, December 31,
2009 2008
Cash and cash equivalents $ 8,988 $ 9,856
Prepaid expenses and other current assets 245 73
Equipment and furnishings, net 472 414
Deposits 16 16
Total assets $ 9,721 $ 10,359
Accounts payable $ 534 $ 394
Accrued expense and other current liabilities 1,477 976
Warrants potentially settled in cash 1,867 -
Current maturities of capital lease obligations 24 17
Total current liabilities 3,902 1,387
Capital lease obligations, net of current maturities 80 4
Total liabilities 3,982 1,391
Total stockholders` equity 5,739 8,968
Total liabilities and stockholders` equity $ 9,721 $ 10,359
RXi Pharmaceuticals
Donna Falcetti, 508-929-3615
ir@rxipharma.com
or
Investors
S. A. Noonan Communications
Susan Noonan, 212-966-3650
susan@sanoonan.com
or
Media
Rx Communications Group
Eric Goldman, 917-322-2563
egoldman@rxir.com
Copyright Business Wire 2009
