MARLBOROUGH, Mass.,
May 12, 2016 /PRNewswire/ -- RXi
Pharmaceuticals Corporation (NASDAQ: RXII), a clinical-stage RNAi
company developing innovative therapeutics in dermatology and
ophthalmology that address significant unmet medical needs, today
reported its financial results for the first quarter ended
March 31, 2016, and provided a
business update.
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"RXi has continued to work in line with its strong operational
plan as outlined in our previous communications to our shareholders
and the public, while maintaining a strict discipline in our
spending," said Dr. Geert
Cauwenbergh, President and CEO of RXi Pharmaceuticals. He
added that, "The Company currently has clinical programs ongoing
for both dermatologic and ophthalmic conditions. We continue our
research and development work towards local delivery of our
sd-rxRNA oligonucleotides to the skin and to the eye through
internal evaluations and through partnerships. Most recently, we
have significantly increased our business development efforts and
have out-licensed our proprietary platform in the CNS space, which
provides the Company with an equity position in a promising
company, Thera Neuropharma, as well as the potential for downstream
milestones and royalty revenue. In addition, our Company is
exploring several corporate development activities, and has
appointed Griffin Securities to advise them on one of these ongoing
projects. We have extended our cash runway one quarter, into Q2
2017, through an assessment of our priorities as a function of time
to data. In parallel, we are exploring various possibilities in
which to increase capital that are in line with our goal to create
value for our existing shareholders."
The Company will host a conference call today at 4:30 p.m. EDT to discuss financial results and
provide an update on the Company. The webcast link will be
available under the "Investors – Event Calendar" section of the
Company's website, www.rxipharma.com. The event may also be
accessed by dialing toll-free in the
United States and Canada:
+1 888-669-0684. International participants may access the event by
dialing: +1 862-225-5361. An archive of the webcast will be
available on the Company's website approximately two hours after
the presentation.
Select First Quarter 2016 Financial Highlights
Cash Position
At March 31, 2016, the Company had
cash, cash equivalents and short-term investments of approximately
$7.7 million, compared with
$10.6 million at December 31, 2015.
The Company believes that its existing cash, cash equivalents
and short-term investments should be sufficient to fund operations
for at least one year.
Net Revenue
Net revenue for the quarter ended March
31, 2016 was $10,000 as
compared with $34,000 for the quarter
ended March 31, 2015. Net revenue
during the first quarter of 2016 was due to the Company's licensed
technology agreement with MirImmune, Inc. and net revenue during
the first quarter of 2015 was driven by the Company's government
grant, the work of which was completed in 2015.
Research and Development Expense
Research and development expense for the quarter ended
March 31, 2016 was $1.3 million, compared with $2.1 million for the quarter ended March 31, 2015. Research and development expense
decreased from the prior quarter primarily due to the cash and
equity fees payable to Hapten Pharmaceuticals, LLC upon the close
of the exclusive license agreement for Samcyprone™ and toxicology
studies performed in connection with the Company's investigational
drug application for retinal scarring, both of which were completed
in the first quarter of 2015.
General and Administrative Expense
General and administrative expense for the quarter ended
March 31, 2016 was $1.0 million as compared with $0.9 million for the quarter ended March 31, 2015. The increase in general and
administrative expense was primarily due to an increase in the use
of professional service providers due to the Company's focus on
business development activities in line with our key corporate
initiatives as compared with the same period in the prior year.
Net Loss
Net loss for the quarter ended March 31,
2016 was $2.2 million,
compared with $2.9 million for the
quarter ended March 31, 2015. Net
loss decreased from the prior quarter primarily due the change in
research and development expense, as discussed above.
NASDAQ Compliance
On May 2, 2016, the Company
received written notice from the Nasdaq Stock Market, LLC notifying
the Company that it had regained compliance with the minimum bid
price requirement for continued listing on The NASDAQ Capital
Market. The written notice was sent following the implementation of
the Company's one-for-ten reverse split of the Company's common
stock, which became effective on April 18,
2016. At the effective time of the reverse stock split,
every ten (10) shares of RXi Pharmaceuticals common stock was
combined into one (1) share of common stock. This reduced the
Company's issued and outstanding common stock from 65.3 million
shares to 6.5 million shares. The number of the Company's
authorized shares remained unchanged.
Select First Quarter 2016 and Recent Corporate
Highlights
Business and Corporate Development
As mentioned over the course of the last several months, the
Company has been actively pursuing multiple business development
opportunities to drive growth, innovation and shareholder value.
RXi's robust pipeline and extensive patent portfolio provides for a
broad spectrum of possibilities including technology and research
collaborations, strategic partnerships and out-licensing
opportunities.
To that end, the Company recently announced that it is in the
process of exploring strategic options including a range of
potential M&A and business development opportunities that are
complementary with current RXi activities and may significantly
advance our clinical pipeline. As part of this effort, RXi has
engaged Griffin Securities, Inc. for one of these
transactions. Although there can be no assurance that the
exploration of any alternatives will result in RXi entering into or
consummating a transaction, the Company is committed to enhancing
its growth through this type of transaction. As previously
disclosed, the Company does not intend to provide updates unless or
until it determines that disclosure is appropriate or
necessary.
In addition, on May 3, 2016, and
independent from the corporate development activities mentioned
above, the Company announced an exclusive license agreement for
RXi's novel and proprietary self-delivering RNAi (sd-rxRNA®)
platform to develop therapeutics for neurodegenerative diseases to
privately-held Thera Neuropharma, Inc. (Thera). At the close
of the transaction, the Company received an equity position in
Thera with the potential to receive future cash, additional equity
and potential royalties based on the achievement of certain
milestones.
Ophthalmology Franchise
Therapeutic Development
Corneal scarring refers to an injury of the cornea of the eye
that causes opacity and visual impairment. The effects of corneal
scarring can vary from blurring to blindness in the eye. On
May 1, 2016, the Company presented
new data, based on its proprietary sd-rxRNA platform, at the
Association for Research in Vision and Ophthalmology (ARVO) 2016
annual meeting. Evaluation sd-rxRNA delivery in a gel formulation
in a corneal wound model resulted in successful delivery to all
layers of the corneal stroma within 24 hours of topical
administration.
The Company initiated a Phase 1/2 study, RXI-109-1501, in Q4
2015 to evaluate the safety and clinical activity of RXI-109, an
sd-rxRNA compound, to prevent the progression of retinal scarring,
a harmful component of numerous retinal diseases. One of the three
cohorts is enrolled and the Company anticipates sharing preliminary
safety readouts in the second half of 2016.
Dermatology Franchise
Therapeutic Development
The Company continues to advance its clinical program with
RXI-109, an sd-rxRNA compound in development to reduce the
formation of dermal scarring following scar-revision surgery. A
Phase 2 trial is ongoing with two new cohorts initiated in Q4 2015.
This trial is now approximately 75% enrolled and the Company
expects enrollment to be completed by the end of this year as
previously outlined in its 2016 corporate goals.
Samcyprone™, the Company's second clinical candidate, is a
topical immunotherapy currently being evaluated in a Phase 2
clinical trial. RXI-SCP-1502 is a multi-center, multi-dose trial
conducted in subjects with at least one cutaneous, plantar or
periungual wart present for at least four weeks. The Company
anticipates it will be fully enrolled by the end of 2016.
Both of these trials are progressing as expected and the Company
will provide early readouts, from each of these trials, in the
second half of 2016.
Consumer Health Program
RXi's consumer health compounds are intended to affect the
appearance of the skin. As a consumer health product, no
preventative or therapeutic claims can be made. However, these
compounds may be developed more rapidly than therapeutics and,
therefore, the path to market may be shorter and less expensive.
Two sd-rxRNA compounds, RXI-231 and RXI-185, are currently in
development and updates on our research activities were presented
at the Society of Investigational Dermatology (SID) 75th Annual
Meeting.
RXI-231 targets tyrosinase (TYR), a key enzyme involved in the
synthesis of melanin. Initial results with RXI-231 lead to a
visible reduction of pigmentation in 3-dimensional reconstituted
human epidermal culture. Further testing has shown a reduction
melanin content in primary human melanocytes lasting for at least
one week after a single dose. These results demonstrate the
potential for a once weekly consumer health product that may
improve the appearance of uneven skin tone and pigmentation.
The Company is also developing RXI-185, which targets
collagenase (MMP1), a key enzyme involved in the breakdown of the
extracellular matrix. As previously announced, data will be
shown on May 14, 2016 at SID showing
that RXI-185 is a more potent compound with a good safety profile
in a standard in vitro skin irritation assay. RXI-185 also
diminished the upregulation of MMP1 after ultraviolet radiation in
a 3D skin culture model. UV induced MMP1 upregulation is linked to
the effects of photo-aging. This compound is being developed as a
cosmetic ingredient that may improve the appearance of wrinkles or
skin laxity.
Both RXI-231 and RXI-185 are part of RXi's partnering and
business growth initiatives providing multiple development
opportunities for non-therapeutic skin health.
Intellectual Property Estate
The Company broadly and diligently protects its valuable
intellectual property. To date, its RNAi platform includes 74
issued patents and the Samcyprone™ portfolio includes one
issued patent and three patent applications. This robust estate
protects our current pipeline, future developments and provides a
competitive advantage to the Company for numerous strategic
partnering opportunities.
About RXi Pharmaceuticals Corporation
RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a
clinical-stage RNAi company developing innovative therapeutics in
dermatology and ophthalmology that address significant high-unmet
medical needs. Building on the pioneering work of RXi's
Scientific Advisory Board Chairman and Nobel Laureate Dr.
Craig Mello, our discovery and
clinical development programs are based on our proprietary RNAi
(sd-rxRNA) platform and Samcyprone™, a topical immunomodulator. Our
clinical development programs include RXI-109, an sd-rxRNA, for the
treatment of dermal and ocular scarring, and Samcyprone™ for the
treatment of such disorders as warts, alopecia areata,
non-malignant skin tumors and cutaneous metastases of melanoma.
RXi's robust pipeline, coupled with an extensive patent portfolio,
provides for multiple product and business development
opportunities across a broad spectrum of therapeutic areas. We are
committed to being a partner of choice for academia, small
companies, and large multinationals. We welcome ideas and proposals
for strategic alliances, including in- and out-licensing
opportunities, to advance and further develop strategic areas of
interest. Additional information may be found on the Company's
website, 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: our ability to successfully develop RXI-109, Samcyprone™ and
our other product candidates (collectively "our product
candidates"); the future success of our clinical trials with our
product candidates; the timing for the commencement and completion
of clinical trials; our ability to enter into strategic
partnerships and the future success of these strategic
partnerships; and our ability to deploy our sd-rxRNA® technology
through partnerships, as well as the prospects of these
partnerships to provide positive returns. Forward-looking
statements about expectations and development plans of RXi's
product candidates and partnerships involve significant risks and
uncertainties, including the following: risks that we may not be
able to successfully develop and commercialize our product
candidates; risks that product development and clinical studies may
be delayed, not proceed as planned and/or be subject to significant
cost over-runs; risks related to the development and
commercialization of products by competitors; risks related to our
ability to control the timing and terms of collaborations with
third parties; and risks that other companies or organizations may
assert patent rights preventing us from developing or
commercializing our product candidates. Additional risks are
detailed in our most recent Annual Report on Form 10-K and
subsequent Quarterly Reports on Form 10-Q under the caption "Risk
Factors." Readers are urged to review these risk factors and to not
act in reliance on any forward-looking statements, as actual
results may differ from those contemplated by our forward-looking
statements. RXi does not undertake to update forward-looking
statements to reflect a change in its views, events or
circumstances that occur after the date of this 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
|
|
For the
|
|
|
Quarter
Ended
|
|
Quarter
Ended
|
|
|
March 31,
2016
|
|
March 31,
2015
|
|
Net
revenues
|
|
$
10
|
|
$
34
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
Research and
development
|
|
1,305
|
|
2,107
|
|
General and
administrative
|
|
950
|
|
873
|
|
Total
operating expenses
|
|
2,255
|
|
2,980
|
|
Operating
loss
|
|
(2,245)
|
|
(2,946)
|
|
Interest income,
net
|
|
7
|
|
1
|
|
Other income,
net
|
|
7
|
|
—
|
|
Net loss
|
|
(2,231)
|
|
(2,945)
|
|
Series A and Series
A-1 convertible preferred stock dividends
|
|
—
|
|
(185)
|
|
Net loss applicable to
common stockholders
|
|
$
(2,231)
|
|
$
(3,130)
|
|
Net loss per common share applicable to common
stockholders:
|
|
|
|
|
|
Basic and diluted
|
|
$
(0.34)
|
|
$
(1.32)
|
|
Weighted average
common shares: Basic and diluted
|
|
6,534,846
|
|
2,376,349
|
|
|
|
|
|
|
|
|
RXi
PHARMACEUTICALS CORPORATION
|
CONDENSED BALANCE
SHEETS
|
(Amounts in
thousands)
|
(Unaudited)
|
|
|
|
|
|
March 31,
|
|
December
31,
|
|
|
2016
|
|
2015
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
$ 4,192
|
|
$
5,117
|
|
Restricted
cash
|
50
|
|
50
|
|
Short-term
investments
|
3,500
|
|
5,500
|
|
Prepaid
expenses
|
265
|
|
311
|
|
Total current
assets
|
8,007
|
|
10,978
|
|
Property and
equipment, net
|
149
|
|
163
|
|
Other
assets
|
18
|
|
18
|
|
Total
assets
|
$ 8,174
|
|
$
11,159
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
$
281
|
|
$ 1,163
|
|
Accrued
expenses
|
940
|
|
1,106
|
|
Total current
liabilities
|
1,221
|
|
2,269
|
|
Total stockholders'
equity
|
6,953
|
|
8,890
|
|
Total liabilities and
stockholders' equity
|
$ 8,174
|
|
$
11,159
|
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/rxi-pharmaceuticals-reports-first-quarter-2016-financial-results-and-highlights-recent-corporate-developments-300267499.html
SOURCE RXi Pharmaceuticals Corporation