MARLBOROUGH, Mass.,
Aug. 11, 2016 /PRNewswire/ -- RXi
Pharmaceuticals Corporation (NASDAQ: RXII), a clinical-stage RNAi
company developing innovative therapeutics that address significant
unmet medical needs, today reported its financial results for the
second quarter ended June 30, 2016,
and provided a business update.
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"First of all, I am proud to report that careful execution of
RXi's clinical programs by our team has resulted in the complete
enrollment of our Phase 2 study RXI-109-1402 for hypertrophic
scars, and has exceeded our expected enrollment target for the full
year in our Phase 1/2 study, RXI-109-1501 in retinal scarring,
allowing us to adhere to our originally projected readout
timelines. I am also pleased to say that we have been able to
do that while maintaining our quarterly burn rate at about
$2 million," said Dr. Geert Cauwenbergh, President and CEO of RXi
Pharmaceuticals. He further added, "We also continue to
aggressively pursue strategic transactions that will enhance RXi's
pipeline for long-term success and increase shareholder value. We
are satisfied with the traction we have experienced thus far in
that process."
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 Second Quarter 2016 Financial Highlights
Cash Position
At June 30, 2016, the Company had
cash, cash equivalents and short-term investments of approximately
$5.8 million, compared with
$10.6 million at December 31, 2015.
Per the terms of the Company's public offering in June 2015, the Company could not sell shares of
the Company's common stock under the purchase agreement with
Lincoln Park Capital Fund, LLC ("LPC") until the expiration of the
13-month overallotment purchase rights ("Purchase Rights"). On
July 2, 2016, with the expiration of
the Purchase Rights, the Company's restriction on selling common
stock under the purchase agreement was lifted. Under the purchase
agreement, the Company has the right to sell LPC up to $10.8 million shares of the Company's common
stock. To date, the Company has sold a total of 40,000 shares of
common stock to LPC for net proceeds of $146,000.
Net Revenue
Net revenue for the quarter ended June
30, 2016 was $9,000 as
compared with no revenues for the quarter ended June 30, 2015. Net revenue during the second
quarter of 2016 was due to the value of the common stock and
warrants issued by Thera Neuropharma, Inc. to the Company per the
terms of the exclusive licensing agreement for RXi's proprietary
sd-rxRNA® platform to develop therapeutics for neurodegenerative
diseases.
Research and Development Expenses
Research and development expenses for the quarter ended
June 30, 2016 was $1.3 million, compared with $1.4 million for the quarter ended June 30, 2015. Research and development expenses
decreased from the prior quarter primarily related to a decrease in
stock-based compensation expense due to the full vesting of stock
options granted in 2012 offset by increases in research and
development expenses due to manufacturing costs for Samcyprone™ and
clinical trial expenses for Study 1502, the Company's common warts
trial, which commenced in December
2015.
General and Administrative Expenses
General and administrative expenses for the quarter ended
June 30, 2016 was $0.9 million as compared with $0.8 million for the quarter ended June 30, 2015. The increase in general and
administrative expenses was primarily due to an increase in legal
and proxy-related fees for the Company's special meeting and
reverse stock split in April 2016 and
the use of professional service providers due to the Company's
focus on business development activities in line with its key
corporate initiatives offset by a decrease in stock-based
compensation expense due to the full vesting of stock options
granted in 2012.
Net Loss
Net loss for the quarter ended June 30,
2016 was $2.2 million,
compared with $2.2 million for the
quarter ended June 30, 2015. Net loss
was consistent quarter over quarter with fluctuations in operating
expenses discussed above.
NASDAQ Compliance
On April 18, 2016, the Company
effected a one-for-ten reverse stock split of the Company's common
stock, resulting in total common shares issued and outstanding of
6.5 million. All share and per share amounts in the financial
statements have been retroactively adjusted for all periods
presented to give effect to the reverse stock split. 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.
Select Business and Corporate Highlights
Since inception in 2012, RXi has achieved each one of its
projected corporate goals on time and within budget. In
January of this year, the Company outlined its 2016 corporate goals
at the Biotech Showcase conference. We have made significant
progress towards successfully completing these goals and remain on
track to fully execute against each goal before the end of
2016.
Business Development
The Company has been actively pursuing multiple business
development opportunities to drive growth, innovation and
shareholder value. As shown with the completed licensing
deals with both MirImmune, Inc. and Thera Neuropharma, Inc., 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.
Recently, the Company 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. These efforts are actively progressing and the Company
remains committed to enhancing its growth through this type of
transaction.
Therapeutic Development
The Company's ongoing Phase 2 clinical trial, RXI-109-1402, is
evaluating its first clinical candidate RXI-109, an sd-rxRNA®
compound targeting connective tissue growth factor (CTGF) to reduce
scar formation in the skin following scar revision surgery. Results
from a blinded panel and an Investigator review, released in
October 2015, showed that incision sites treated with RXI-109 after
scar revision surgery achieved better scores as compared to control
incision sites in the same subjects, three months post scar
revision surgery. The adaptive protocol in place has allowed the
Company to apply early learnings from all trials to date, to
optimize the best treatment regimen necessary to advance into the
next phase of development. As such, the Company has already
identified the best time to start treatment as well as the optimal
dose level, and is now evaluating the best treatment length
(Cohorts 3 and 4). This study is now fully enrolled and the
Company anticipates it will provide preliminary data in the second
half of 2016 with a full interim analysis, for Cohorts 3 and 4,
mid-2017.
As in dermal scarring, CTGF is known to play a role in retinal
scarring. Reduction of CTGF in the eye by RXI-109 treatment
may reduce the formation of retinal fibrosis that often accompanies
late stage AMD and contributes to vision loss. Enrollment in
the first of three cohorts in the Company's Phase 1/2 trial,
RXI-109-1501, is complete. As there were no safety issues in
the first cohort, enrollment into the second cohort at the next
higher dose lever is ongoing.
Samcyprone™, the Company's second clinical candidate, is a
topical immunotherapy currently being evaluated in a Phase 2a
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
recently presented data, from a pilot study conducted by Hapten
Pharmaceuticals, which led to the acquisition of Samcyprone™, a
proprietary formulation of Diphenylcyclopropenone (DPCP), and the
initiation of its ongoing Phase 2 clinical trial. This trial
is expected to be fully enrolled by the end of 2016 and the Company
expects to share early read-outs H2 2016.
Consumer Health Program
RXi's consumer health compounds, RXI-231 and RXI-185, are in
development and are intended to affect the appearance of the skin.
Both of these sd-rxRNA compounds are part of RXi's partnering and
business growth initiatives providing multiple development
opportunities for non-therapeutic skin health. Evaluation of
topical delivery options for these compounds is underway and the
Company expects to explore one of these candidates in consumer
testing by the end of 2016.
Intellectual Property Estate
The Company actively broadens and protects its valuable
intellectual property estate. Several new patent applications have
been filed to protect our current pipeline and future developments
providing 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 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
Three
|
|
For the
Three
|
|
For the
Six
|
|
For the
Six
|
|
Months
Ended
|
|
Months
Ended
|
|
Months
Ended
|
|
Months
Ended
|
|
June 30, 2016
|
|
June 30,
2015
|
|
June 30,
2016
|
|
June 30,
2015
|
|
Net
revenues
|
$
9
|
|
$
—
|
|
$
19
|
|
$
34
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
1,339
|
|
1,361
|
|
2,644
|
|
3,468
|
|
General and
administrative
|
885
|
|
804
|
|
1,835
|
|
1,677
|
|
Total operating expenses
|
2,224
|
|
2,165
|
|
4,479
|
|
5,145
|
|
Operating
loss
|
(2,215)
|
|
(2,165)
|
|
(4,460)
|
|
(5,111)
|
|
Interest income,
net
|
4
|
|
1
|
|
11
|
|
2
|
|
Other income
(expense), net
|
(1)
|
|
(2)
|
|
6
|
|
(2)
|
|
Net loss
|
(2,212)
|
|
(2,166)
|
|
(4,443)
|
|
(5,111)
|
|
Series A and Series
A-1 convertible preferred stock dividends
|
—
|
|
(24)
|
|
—
|
|
(209)
|
|
Net loss applicable to
common stockholders
|
$
(2,212)
|
|
$
(2,190)
|
|
$
(4,443)
|
|
$
(5,320)
|
|
Net loss per common share applicable to common
stockholders:
|
|
|
|
|
|
|
|
|
Basic and diluted loss
per share
|
$
(0.34)
|
|
$
(0.50)
|
|
$
(0.68)
|
|
$
(1.56)
|
|
Weighted average
common shares:
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
6,534,846
|
|
4,419,058
|
|
6,534,846
|
|
3,403,346
|
|
RXi
PHARMACEUTICALS CORPORATION
|
CONDENSED BALANCE
SHEETS
|
(Amounts in
thousands)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
December
31,
|
|
2016
|
|
2015
|
|
|
|
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
3,832
|
|
$
5,117
|
Restricted
cash
|
50
|
|
50
|
Short-term
investments
|
2,000
|
|
5,500
|
Prepaid
expenses
|
477
|
|
311
|
Total current
assets
|
6,359
|
|
10,978
|
Property and
equipment, net
|
135
|
|
163
|
Other
assets
|
27
|
|
18
|
Total
assets
|
$
6,521
|
|
$
11,159
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
297
|
|
$
1,163
|
Accrued
expenses
|
1,256
|
|
1,106
|
Total current
liabilities
|
1,553
|
|
2,269
|
Total stockholders'
equity
|
4,968
|
|
8,890
|
Total liabilities and
stockholders' equity
|
$
6,521
|
|
$
11,159
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/rxi-pharmaceuticals-reports-second-quarter-2016-financial-results-and-highlights-recent-corporate-developments-300312173.html
SOURCE RXi Pharmaceuticals Corporation