MARLBOROUGH, Mass.,
Aug. 12, 2015 /PRNewswire/
-- RXi Pharmaceuticals Corporation (NASDAQ: RXII), a
biotechnology company focused on discovering and developing
innovative therapeutics primarily in the areas of dermatology and
ophthalmology, today reported its financial results for the quarter
ended June 30, 2015 and provided a
business update.
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"In the second quarter, RXi reached a major milestone in our
shareholder structure with the elimination of the preferred shares
and their associated dilutive quarterly dividend. In addition,
several investment funds became new shareholders in our recently
completed financing," said Dr. Geert
Cauwenbergh, President and CEO of RXi Pharmaceuticals. He
added, "This financing provides us with at least an additional year
of cash. This cash and time will allow us to focus on rebuilding
our share price, which was significantly affected in the last 18
months by the conversion and sale of the preferred into common
shares. We will aim to: (1) advance our preclinical and clinical
pipeline, (2) generate partnership deals, and (3) deploy our
sd-rxRNA® technology platform in a portfolio approach akin to the
way venture capital firms deploy their capital, through
establishing equity positions in young biotechnology companies to
create value for our investors."
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" 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.
Selected Second Quarter 2015 Financial Highlights
Preferred Shares
The Company's capital structure has been simplified with the
full conversion of all remaining outstanding shares of Series A and
Series A-1 convertible preferred stock during the second quarter of
2015 and with the acceleration of the next quarterly dividend
payment date from June 30, 2015 to
May 27, 2015, at which time the
dividend shares were immediately converted into common stock. As a
result, no shares of preferred stock remain outstanding and no
further dividends on those preferred shares will accrue.
Cash Position
At June 30, 2015, the Company had
cash, cash equivalents and short-term investments of approximately
$14.0 million, compared with
cash and cash equivalents of $8.5
million at December 31,
2014.
The Company enhanced its balance sheet with the completion of a
public offering of common stock and warrants. The Company sold a
total of 26 million units at a price per unit of $0.40 in the public offering that included both
institutional and retail investors. Each unit consisted of one
share of common stock, a 13-month overallotment purchase right to
purchase one-half of one share of common stock at a price of
$0.455 per full share and a 5-year
warrant to purchase one-half of one share of common stock at a
price of $0.52 per full share. The
Company received gross proceeds of $10.4
million and net proceeds of $9.2
million after payment of placement agent fees and other
offering expenses, and assuming the overallotment purchase rights
and warrants are not exercised.
The Company believes that its existing cash, cash equivalents
and short-term investments should be sufficient to fund operations
for at least one year.
Research and Development Expenses
Research and development expenses for the quarter ended
June 30, 2015 were $1.4 million, which included $0.2 million of non-cash stock-based compensation
expense, as compared with $1.2
million for the quarter ended June
30, 2014, which included $0.2
million of non-cash stock-based compensation expense. The
increase in research and development expenses in the second quarter
of 2015 as compared to the second quarter of 2014 was primarily due
to subject and trial-related fees for the Company's ongoing three
clinical trials, mainly Study 1402.
General and Administrative Expenses
General and administrative expenses for the quarter ended
June 30, 2015 were $0.8 million, which included $0.2 million of non-cash stock-based compensation
expense, as compared with $0.9
million for the quarter ended June
30, 2014, which included $0.3
million of non-cash stock-based compensation expense. The
decrease in general and administrative expenses in the second
quarter of 2015 as compared to the second quarter of 2014 was
primarily due to a reduction in legal fees.
Net Loss Applicable to Common Stockholders
Net loss applicable to common stockholders for the quarter ended
June 30, 2015 was $2.2 million, compared with $3.2 million for the quarter ended June 30, 2014. The decrease in net loss
applicable to common stockholders in the second quarter of 2015 as
compared to the second quarter of 2014 was due to the change in
operating expenses, as described above, and a decrease in the
Company's preferred stock dividends related to decreases in the
Company's closing common stock price on the dividend payment dates
and the number of preferred shares earning dividends each
quarter.
Second Quarter 2015 and Recent Corporate Highlights
Positive Advancements within our Ophthalmology
Franchise
As projected in the Company's 2015 corporate goals, RXi
submitted an IND application to the U.S. Food and Drug
Administration (FDA) for RXI-109 as a potential therapeutic for the
scarring component of retinal diseases in the eye, such as wet
age-related macular degeneration. Following the FDA 30-day review
period for the IND, the Company plans to initiate a Phase 1 / 2
clinical trial before the end of 2015.
Positive Advancements within our Dermatology
Franchise
The Company continues to advance additional preclinical and
discovery programs using our sd-rxRNA technology. In particular,
the Company has selected collagenase and tyrosinase as new
discovery stage targets for our self-delivering RNAi platform.
Collagenase, or MMP1, is a matrix metalloproteinase involved in the
breakdown of extracellular matrix. Selected reduction of MMP1 may
be beneficial in the treatment of skin aging disorders, arthritis,
acne scarring, blistering skin disorders, corneal erosions,
endometriosis and possible cancer metastasis. Tyrosinase is the key
enzyme in the synthesis of melanin. Melanin is produced by
melanocytes and is the pigment that gives human skin, hair and eyes
their color. The inhibition of tyrosinase can play a key role in
the management of diseases such as cutaneous hyperpigmentation
disorders such as lentigines (freckles, age spots and liver spots),
and possibly melanoma.
These two discovery targets were selected because they have
great potential as clinically relevant pharmaceutical gene targets,
however, they also have great potential as cosmeceutical
targets. The term 'cosmeceuticals' refers to compounds that
can affect the appearance of the skin. For example, by targeting
tyrosinase, a superficial reduction of melanin could potentially
change the appearance of the darkened skin spots known as age spots
and freckles or lighten the skin overall. Cosmeceuticals that
make no therapeutic claims can be developed more rapidly than
pharmaceutical drugs, and the path to market could be much shorter
and less expensive.
The Company presented promising new data in June at the
74th Annual Meeting of the Society for Investigative
Dermatology with its self-delivering RNAi (sd-rxRNA®) compounds
developed to target tyrosinase (TYR) and collagenase (MMP1).
sd-rxRNA compounds developed to target TYR lead to a visible
reduction of pigmentation in melanocytes in a 3-dimensional tissue
culture model of human epidermis. Results from experiments in this
model show that sd-rxRNA compounds targeting TYR are at least one
hundred times more potent than kojic acid, a well-characterized
skin lightening agent. sd-rxRNA compounds developed to target MMP1
resulted in a reduction in MMP1 mRNA levels that correspond to a
similar reduction in MMP1 enzyme activity in cell culture in
vitro. In addition, silencing of MMP1 expression in an in
vitro scratch assay resulted in reduced migration of A549
cells, a clinically relevant non-small cell lung cancer cell line.
Reduced migration in a scratch assay may indicate a reduction in
the invasive nature of the cancer cell due to MMP1 reduction as a
result of sd-rxRNA treatment.
In our clinical program with RXI-109, an sd-rxRNA compound
developed for the reduction of dermal scar formation, there are
currently three ongoing Phase 2a clinical trials evaluating the
effect of RXI-109 on scar formation at surgical revision sites for
either hypertrophic scars or keloids. Two of the three studies are
fully enrolled and the subjects are being followed to completion.
Preliminary data from these two trials helped to amend the initial
design of Study 1402 to include an extended dosing regimen for
longer coverage of the proliferation phase of wound healing in
order to better reduce the excess collagen production that can lead
to hypertrophic scars or keloids. Additional cohorts are
being designed for Study 1402 that will be submitted in the near
future, which will further extend the dosing
regimen.
Samcyprone™, RXi's second clinical candidate, is a proprietary
topical formulation of diphenylcyclopropenone (DPCP), which is an
immunomodulator that works by initiating a T-cell response.
Samcyprone™ is initially being developed for the treatment of such
disorders as alopecia areata, warts, and cutaneous metastases of
melanoma. The Company expects to initiate a Phase 2 trial
evaluating the effect of Samcyprone™ on warts before the end of the
year.
In April of this year, the FDA granted Orphan Drug Designation
to RXi for Samcyprone™ for the treatment of Malignant Melanoma
Stage IIb to IV. A number of patients with Stage IIb to IV
malignant melanoma develop cutaneous metastases. Samcyprone™ is
being studied for treatment of these metastases in an ongoing
investigator-sponsored trial.
Intellectual Property
The Company has strengthened its patent portfolio by securing
protection for its novel RNAi platform through three granted
patents from the United States Patent and Trademark Office
(USPTO).
A core patent that covers methods of use of the Company's
VEGF-targeting and CTGF-targeting sd-rxRNAs, including RXI-109, for
use in the eye has been issued. A therapeutic, such as
RXI‑109, that is effective in reducing the activity of CTGF could
have great benefit for patients whose ocular condition has an
active scarring component.
The second issued patent expands the scope of coverage to RXi's
novel, self-delivering RNAi platform (sd-rxRNA). Importantly, this
patent incorporates novel oligonucleotide chemical modifications
which result in improved biodistribution following systemic
administration and may be beneficial for local delivery
applications in the central nervous system.
In addition, RXi was also issued a patent covering the
composition and methods of use for rxRNAori® compounds targeting
Mitogen-activated protein kinase kinase kinase kinase 4 (MAP4K4).
These compounds may be beneficial for the treatment of inflammatory
diseases and/or metabolic diseases. RXi's rxRNAori platform are
highly potent RNAi compounds which will require delivery vehicles
to facilitate transport to the tissues of interest and to be taken
up by cells.
About RXi Pharmaceuticals Corporation
RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a
biotechnology company focused on discovering and developing
innovative therapeutics primarily in the areas of dermatology and
ophthalmology that address high-unmet medical needs. Our discovery
and clinical development programs are based on siRNA technology, as
well as immunotherapy agents. These compounds include, but are not
limited to, our proprietary, self-delivering RNAi (sd-rxRNA®)
compounds for the treatment of dermal and ocular scarring. It also
includes an immunomodulator, Samcyprone™, a proprietary topical
formulation of diphenylcyclopropenone (DPCP), for the treatment of
such disorders as alopecia areata, warts, and cutaneous metastases
of melanoma.
RXi's novel, self-delivering RNAi (sd‑rxRNA®) compounds 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. sd-rxRNAs have
been shown, in vitro and in vivo, to
achieve efficient spontaneous cellular uptake and potent,
long-lasting intracellular activity.
RXI-109, an sd-rxRNA compound, is the Company's first clinical
development candidate. RXI-109 silences Connective Tissue Growth
Factor (CTGF), which plays a key role in tissue regeneration and
repair and is initially being developed to reduce or inhibit scar
formation in the skin and in the eye. RXI-109 is currently
being evaluated in Phase 2a clinical trials in dermatology. The
Company's sd-rxRNA technology platform is broadly protected by
multiple issued patents and numerous patent applications.
RXi's robust pipeline, coupled with an extensive patent
portfolio, provides for product and business development
opportunities across a broad spectrum. 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,
2015
|
|
June 30,
2014
|
|
June 30,
2015
|
|
June 30,
2014
|
|
Total
revenues
|
$
—
|
|
$
12
|
|
$
34
|
|
$
41
|
|
|
|
|
|
|
|
|
|
|
Research and
development expenses
|
1,361
|
|
1,183
|
|
3,468
|
|
2,659
|
|
General and
administrative expenses
|
804
|
|
850
|
|
1,677
|
|
1,693
|
|
Operating
loss
|
(2,165)
|
|
(2,021)
|
|
(5,111)
|
|
(4,311)
|
|
Interest income,
net
|
1
|
|
5
|
|
2
|
|
11
|
|
Other income
(expense), net
|
(2)
|
|
10
|
|
(2)
|
|
10
|
|
Net loss
|
(2,166)
|
|
(2,006)
|
|
(5,111)
|
|
(4,290)
|
|
Series A and Series
A-1 convertible preferred stock dividends
|
(24)
|
|
(1,213)
|
|
(209)
|
|
(2,968)
|
|
Net loss applicable
to common stockholders
|
$
(2,190)
|
|
$
(3,219)
|
|
$
(5,320)
|
|
$
(7,258)
|
|
Net loss per common
share applicable to common stockholders:
|
|
|
|
|
|
|
|
|
Basic and diluted
loss per share
|
$
(0.05)
|
|
$
(0.23)
|
|
$
(0.16)
|
|
$
(0.54)
|
|
Weighted average
common shares outstanding:
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
44,190,583
|
|
14,015,451
|
|
34,033,463
|
|
13,319,634
|
|
|
|
|
|
|
|
|
|
|
|
|
RXi
PHARMACEUTICALS CORPORATION
|
|
|
|
|
CONDENSED BALANCE
SHEETS
|
|
|
|
|
(Amounts in
thousands)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
December
31,
|
|
|
2015
|
|
2014
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
$ 5,986
|
|
$ 8,496
|
|
Restricted
cash
|
50
|
|
50
|
|
Short-term
investments
|
8,000
|
|
—
|
|
Prepaid expenses and
other current assets
|
718
|
|
442
|
|
Total current
assets
|
14,754
|
|
8,988
|
|
Property and
equipment, net
|
181
|
|
183
|
|
Other
assets
|
18
|
|
18
|
|
Total
assets
|
$ 14,953
|
|
$ 9,189
|
|
|
|
|
|
|
LIABILITIES,
CONVERTIBLE PREFERRED STOCK AND
|
|
|
|
|
STOCKHOLDERS'
EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
$
635
|
|
$
285
|
|
Accrued expenses and
other current liabilities
|
1,187
|
|
1,002
|
|
Deferred
revenue
|
—
|
|
47
|
|
Total current
liabilities
|
1,822
|
|
1,334
|
|
Total convertible
preferred stock
|
—
|
|
5,110
|
|
Total stockholders'
equity
|
13,131
|
|
2,745
|
|
Total liabilities,
convertible preferred stock and stockholders' equity
|
$ 14,953
|
|
$ 9,189
|
|
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SOURCE RXi Pharmaceuticals Corporation