MARLBOROUGH, Mass.,
Aug. 14, 2018 /PRNewswire/ -- RXi
Pharmaceuticals Corporation (NASDAQ: RXII) a biotechnology company
developing the next generation of immuno-oncology therapeutics
based on its proprietary self-delivering RNAi (sd-rxRNA®)
therapeutic platform today reported its financial results for the
second quarter ended June 30, 2018
and provided a business update.
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"The Q2 financial report provides good insights into the
progress of the transition announced in January 2018, when RXi management informed its
shareholders of the corporate focus on immuno-oncology and adoptive
cell transfer therapy," said Dr. Geert
Cauwenbergh, President & CEO of RXi Pharmaceuticals. He
added that, "For the first 6 months of 2018, spending has been
reduced by 26% as compared to the first half of 2017, with about
half the reduction from one-time charges relating to the
acquisition of MirImmune in Q1 of 2017, and the remainder resulting
from a reduction in general and administrative expenses as compared
to the same period last year." He indicated that: "The successful
completion of our clinical studies in dermatology and ophthalmology
have added significant human clinical data on efficacy and safety
of the sd-rxRNA platform to our data packages, that should be
valuable for companies that are considering a potential acquisition
of those assets, including potential licenses to our
self-delivering platform for those therapeutic categories. We would
expect the execution of such an agreement to provide us with
non-dilutive cash that could extend our financial runway
significantly." He finally added that: "In comparison with our
track record for deal-making in dermatology and ophthalmology
between 2012 and 2017, our partnering history of the past 9 months,
including strong IO & ACT partnerships with leading academic
and industrial partners, indicates a much better visibility with
stronger interest in our sd-rxRNA approach than ever before. We aim
to take advantage of this surge in partnering interest, to enhance
the value of our Company for our shareholders."
The Company will host a conference call today at 4:30 p.m.
ET 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:
+1 844-376-4678. International participants may access the
event by dialing: +1 209-905-5958. An archive of the webcast will
be available on the Company's website approximately two hours after
the presentation.
Select Second Quarter 2018 Financial Highlights
Cash Position
At June 30, 2018, the Company had
cash and cash equivalents of $5.3
million as compared with $3.6
million at December 31,
2017.
On April 11, 2018, the Company closed on a registered
direct offering of 1,510,604 shares of the Company's common
stock at a purchase price of $3.15
per share. Concurrently, the Company also commenced a private
placement, whereby it issued and sold warrants exercisable for a
total of 1,132,953 shares of common stock with a purchase price per
share of $0.125 per underlying
warrant share and with an exercise price of $3.15 per share. Assuming the warrants are not
exercised, net proceeds to the Company were approximately
$4.2 million after deducting
placement agent fees and estimated offering expenses.
Under the Company's purchase agreement with Lincoln Park Capital
Fund, LLC ("LPC"), the Company sold a total of 420,000 shares of
common stock to LPC for net proceeds of approximately $1.3 million during the six months ended
June 30, 2018. There remains
approximately $13 million available
under the purchase agreement with LPC, subject to certain
limitations and conditions set forth therein.
Revenues
Revenues for the three months ended June
30, 2018 were $58,000 and
related to the work performed by the Company as a sub-awardee under
the government grant awarded to our collaborator BioAxone
Biosciences, Inc. from the National Institute of Neurological
Disorders and Stroke. The grant provides funding for the
development of a novel sd-rxRNA compound, BA-434, that targets PTEN
for the treatment of spinal cord injury. The Company had no
revenues during the three months ended June
30, 2017.
Research and Development Expenses
Research and development expenses for the quarter ended
June 30, 2018 were $1.2 million, as compared with $1.3 million for the quarter ended June 30, 2017. The decrease was primarily due to
a decrease in clinical-trial related expenses as subject
participation is now complete for all of the Company's clinical
trials.
Acquired In-process Research and Development
Expense
The Company did not have acquired in-process research and
development expense for the three months ended June 30, 2018. During the three months ended
June 30, 2017, the Company recorded
acquired in-process research and development expense related to the
fair value of consideration given in the acquisition of
MirImmune.
General and Administrative Expenses
General and administrative expenses for the quarter ended
June 30, 2018 were $0.8 million, as compared with $1.1 million for the quarter ended June 30, 2017. The decrease was primarily due to
decreases in professional fees for legal-related services and
payroll-related expenses as a result of a decrease in
headcount.
Net Loss
Net loss for the quarter ended June 30,
2018 was $1.9 million,
compared with $2.5 million for the
quarter ended June 30, 2017. The
decrease was primarily due to a decrease in operating expenses, as
discussed above.
Select Second Quarter 2018 and Recent Corporate
Highlights
Select Business and Corporate Highlights
Immuno-oncology
In addition to its internal development programs, the Company
has entered into several partnerships across the globe to expand
its pipeline to advance development of the next generation
immunotherapies for the treatment of cancer. In May 2018, RXi established a research
collaboration with Iovance Biotherapeutics to evaluate
potential synergies between RXi's novel sd-rxRNA therapeutic
compounds and Iovance's autologous cell therapy based on
tumor-infiltrating lymphocytes (TILs) for use in the treatment of
cancer.
On April 16, 2018, the journal
Molecular Therapy published "Self-Delivering RNAi (sd-rxRNA®)
Targeting PD-1 using Adoptive Cell Therapy Approach for the
Treatment of Malignant Melanoma". In this paper scientists
demonstrate the potential of improving therapy with patient-derived
tumor infiltrating lymphocytes (TILs) by treatment with RXi's novel
sd-rxRNA compound that specifically targets PD-1.
Clinical Trials – Dermatology and Opthalmology
The Company issued positive news from both its Dermatology and
Opthalmology Franchises, with each franchise comprising advanced
clinical programs, robust discovery assets and substantial
Intellectual Property rights. The Company has an active process
underway to monetize these assets, which would support a return on
investment for stockholders and accelerated growth in the
immuno-oncology focus area.
Samcyprone™ for the Treatment of Cutaneous
Warts
Samcyprone™ is a proprietary topical formulation of the small
molecule diphenylcyclopropenone (DPCP), a topical immunomodulator
that works by initiating a T-cell response. Completed Phase 2
trial RXI-SCP-1502, was 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 study successfully met its
primary effectiveness objectives and its secondary safety and
tolerability objectives. In addition to the key study objectives, a
large amount of data was collected that can inform the design of
further pivotal studies in support of future marketing
applications.
RXI-109 for the Reduction of Retinal Scarring
RXI-109 is a self-delivering therapeutic RNAi compound that
targets connective tissue growth factor (CTGF), a key regulator in
fibrosis and scar formation. RXI-109-1501 was a multi-dose,
dose escalation trial conducted in subjects with advanced
neovascular or 'wet' age-related macular degeneration and
accompanying subretinal fibrosis. This study successfully met its
primary objective by showing that RXI-109 is safe and well
tolerated in this dose escalation study. This was shown by
the absence of dose-limiting and serious toxicities, and only mild
to moderate procedure-related adverse events. None of the adverse
events were drug related. In addition, comprehensive ocular
examinations showed no indications of inflammation or any other
tolerability issues related to the treatment. In addition, RXI-109
met its secondary objectives, with improved or stable disease in
the study eyes in several subjects.
Intellectual Property
The European Patent Office (EPO) and Japan Patent Office
(JPO) have granted patents for the Company's novel self-delivering
RNAi (sd-rxRNA®) therapeutic platform. The EPO Patent #:
2949752 B1 and JPO Patent #: 620309 cover composition of matter,
specifically structural and chemical attributes of sd-rxRNA.
These patents will be set to expire in 2029.
About RXi Pharmaceuticals
RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a
biotechnology company developing the next generation of
immuno-oncology therapeutics based on its self-delivering RNAi
(sd-rxRNA®) therapeutic platform. The Company's discovery and
research efforts are focused on developing sd-rxRNA therapeutic
compounds to be used with an Adoptive Cell Transfer (ACT) approach.
This process uses immune cells, such as T-lymphocytes that are
isolated from the patient or retrieved from allogeneic immune cell
banks, and then expanded and in some cases processed to express
tumor-binding receptors. Our approach introduces a new and
important step in ex-vivo processing of the immune
cells where sd-rxRNA is used to eliminate the expression of
immunosuppressive receptors or proteins from the therapeutic immune
cells, making them less sensitive to tumor resistance mechanisms
and thus improving their ability to destroy the tumor cells.
Essentially, we aim to maximize the power of our sd-rxRNA
therapeutic compounds by weaponizing therapeutic immune effector
cells to attack cancer and ultimately provide patients battling
terminal cancers with a powerful new treatment option that goes
beyond current treatment modalities. For additional
information, visit 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™,
RXI-762, RXI-804 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
RXi
PHARMACEUTICALS CORPORATION
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(Amounts in
thousands, except share and per share data)
|
(Unaudited)
|
|
|
|
For the
Three
Months
Ended
June 30,
2018
|
|
For the
Three
Months
Ended June 30, 2017
|
|
For the
Six
Months
Ended
June 30,
2018
|
|
For the
Six
Months
Ended
June 30,
2017
|
|
|
|
|
|
|
Revenues
|
$
58
|
|
$
—
|
|
$
81
|
|
$
—
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research
and development
|
1,183
|
|
1,329
|
|
2,544
|
|
2,676
|
Acquired
in-process research and
development
|
—
|
|
85
|
|
—
|
|
4,696
|
General
and administrative
|
774
|
|
1,100
|
|
1,675
|
|
2,223
|
Total operating
expenses
|
1,957
|
|
2,514
|
|
4,219
|
|
9,595
|
Operating
loss
|
(1,899)
|
|
(2,514)
|
|
(4,138)
|
|
(9,595)
|
Total other expense,
net
|
(2)
|
|
—
|
|
(2)
|
|
—
|
Loss before income
taxes
|
(1,901)
|
|
(2,514)
|
|
(4,140)
|
|
(9,595)
|
Income tax
benefit
|
—
|
|
—
|
|
—
|
|
1,621
|
Net loss
|
$
(1,901)
|
|
$
(2,514)
|
|
$
(4,140)
|
|
$
(7,974)
|
Net loss per
share:
|
|
|
|
|
|
|
|
Basic and
diluted
|
$
(0.46)
|
|
$
(1.12)
|
|
$
(1.25)
|
|
$
(3.71)
|
Weighted average
shares: Basic and diluted
|
4,102,423
|
|
2,238,836
|
|
3,302,885
|
|
2,148,477
|
RXi
PHARMACEUTICALS CORPORATION
|
|
|
|
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
(Amounts in
thousands)
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
December
31,
|
|
|
2018
|
|
2017
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
$
5,315
|
|
$
3,581
|
|
Restricted
cash
|
50
|
|
50
|
|
Prepaid expenses and
other current assets
|
459
|
|
201
|
|
Total current
assets
|
5,824
|
|
3,832
|
|
Property and
equipment, net
|
207
|
|
248
|
|
Other
assets
|
—
|
|
18
|
|
Total
assets
|
$
6,031
|
|
$
4,098
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
$
542
|
|
$
511
|
|
Accrued
expenses
|
2,217
|
|
1,754
|
|
Total current
liabilities
|
2,759
|
|
2,265
|
|
Total stockholders'
equity
|
3,272
|
|
1,833
|
|
Total liabilities and
stockholders' equity
|
$
6,031
|
|
$
4,098
|
|
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SOURCE RXi Pharmaceuticals Corporation