MARLBOROUGH, Mass.,
March 26, 2018 /PRNewswire/ -- RXi
Pharmaceuticals Corporation (NASDAQ: RXII) a biotechnology company
developing immuno-oncology therapeutics based on its proprietary
self-delivering RNAi (sd-rxRNA®) therapeutic platform today
reported its financial results for the fourth quarter and year
ended December 31, 2017 and provided
a business update.
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"In early 2018, RXi announced a strategic decision to solely
focus its development efforts on novel immuno-oncology treatments
based on its self-delivering RNAi platform. We have made good
progress by entering in development collaborations with some major
cancer research centers in Europe
and in the US. The first results from these collaborations are
promising and support our goals to enter into clinical testing in
the coming 12 to 18 months," said Dr. Geert
Cauwenbergh, President and CEO of RXi Pharmaceuticals. He
further added, "RXi is well-positioned for success with the
potential to match and possibly surpass current antibody treatments
by exploiting the self-delivering attributes of our therapeutic
compounds for immuno-oncology using an adoptive cell transfer
approach. As outlined in January of this year, RXi is seeking
to monetize our dermatology and ophthalmology assets through
out-licensing or partnerships for which we have achieved proof of
concept in clinical trials, as such demonstrating the significant
therapeutic potential of our self-delivering RNAi platform. The
success of this initiative should provide additional non-dilutive
means to advance our ongoing internal programs and external
collaborations for our immuno-oncology pipeline and prepare for
entering the clinic in 2019."
The Company will host a conference call today at 5:00 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 (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 Fourth Quarter and Fiscal 2017 Financial
Highlights
Cash
At December 31, 2017, the Company
had cash of $3.6 million as
compared with $12.9 million at
December 31, 2016.
On August 8, 2017, the Company entered into a purchase
agreement with Lincoln Park Capital Fund, LLC ("LPC"), pursuant to
which the Company has the right to sell to LPC up to $15 million in shares of the Company's common
stock, subject to certain limitations and conditions set forth
therein, over the 30-month term of the purchase agreement. To date,
the Company has sold a total of 285,000 shares of common stock to
LPC for net proceeds of approximately $1.2
million.
Revenues
In September 2017, the Company's
collaborative partner BioAxone Biosciences, Inc. received a grant
award from the National Institute of Neurological Disorders and
Stroke. BioAxone has been awarded a total of $1,794,895 to fund the collaborative project over
24 months. For our contribution, RXi will receive approximately
$129,000 in the first year with the
potential to receive an additional $118,800 in the second year after achieving
certain milestones. The two-year grant provides funding for further
development of BioAxone's preclinical candidate BA-434, a novel
sd-rxRNA compound that targets PTEN for the treatment of spinal
cord injury.
Revenues for the quarter ended December
31, 2017 were $15,000. The
Company had no revenue during the quarter ended December 31, 2016. Revenues for the year ended
December 31, 2017 were $15,000, as compared with $19,000 for the year ended December 31, 2016. Revenues for the quarter and
year ended December 31, 2017 were due
to the work performed by the Company under the grant with BioAxone.
Revenues for the year ended December 31,
2016 were due to the Company's exclusive out-licensing
agreements with MirImmune, prior to its acquisition by the Company,
and Thera Neuropharma, Inc.
Research and Development Expenses
Research and development expense for the quarter ended
December 31, 2017 was $1.2 million, as compared with $1.3 million for the quarter ended December 31, 2016. The decrease was due to lower
spending on clinical trial-related expenses as subject visits in
each of the Company's ongoing clinical trials came to an end.
Research and development expense for the year ended December 31, 2017 was $5.4
million, as compared with $5.4
million for the year ended December
31, 2016. Overall, expenses were consistent year over year
despite an increase in direct research and development expenses due
to the addition of the immuno-oncology program to the Company's
development pipeline in the first quarter of 2017 with the
acquisition of MirImmune, which was offset by a decrease in
non-cash stock-based compensation expense.
Acquired In-process Research and Development
In January 2017, the Company
acquired all of the issued and outstanding capital stock of
MirImmune Inc., a privately-held biotechnology company that was
engaged in the development of cancer immunotherapies, in exchange
for securities of the Company. The aggregate fair value of the
consideration given, which includes transaction costs, liabilities
assumed and cancellation of notes receivable, and the deferred tax
impact of the acquisition was recorded as in-process research and
development expense.
Acquired in-process research and development expense related to
the acquisition of MirImmune was $5.0
million for the year ended December
31, 2017. The Company did not have acquired in-process
research and development expense for the three months ended
December 31, 2017 and 2016 and the
year ended December 31, 2016.
General and Administrative Expenses
General and administrative expense for the quarter ended
December 31, 2017 was $0.8 million, as compared with $1.0 million for the quarter ended December 31, 2016. The decrease was due to a
reduction in mailing and printing-related fees for the Company's
annual meeting, which last year was held in the December
time-frame, as well as a reduction in professional fees for legal
services and employee-related expenses as compared to the prior
year quarter.
General and administrative expense for the year ended
December 31, 2017 was $4.0 million, as compared with $3.6 million for the year ended December 31, 2016. The increase was primarily due
to payroll-related expenses, including severance benefits, related
to the Company's former Chief Business Officer and professional
fees for legal-related services.
Income Tax
The Company recognized an income tax benefit of $1.6 million for the year ended December 31, 2017 due to the tax-related impact
of the Company's acquisition of MirImmune Inc. The Company did not
have income tax expense or benefit for the three months ended
December 31, 2017 and 2016 and the
year ended December 31, 2016.
Net Loss Applicable to Common Stockholders
Net loss applicable to common stockholders for the quarter ended
December 31, 2017 was $2.0 million, compared with $4.4 million for the quarter ended December 31, 2016. The decrease was due to the
one-time charge related to the beneficial conversion feature of the
Company's Series B Convertible Preferred Stock in 2016.
Net loss applicable to common stockholders for the year ended
December 31, 2017 was $12.5 million, compared with $11.1 million for the year ended December 31, 2016. The increase was primarily
driven by acquired in-process research and development expense
incurred for the acquisition of MirImmune, offset by the one-time
charge related to the beneficial conversion feature of the
Company's Series B Convertible Preferred Stock in 2016.
Nasdaq Compliance
On January 23, 2018, 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 1-for-10 reverse split of the Company's common stock,
which became effective on January 8,
2018. At the effective time of the reverse stock split,
every ten shares of RXi common stock was combined into one share of
common stock, reducing the Company's issued and outstanding common
stock from 24.3 million shares to 2.4 million shares.
Select Fourth Quarter 2017 and Recent Corporate
Highlights
Select Business and Corporate Highlights
Immuno-Oncology
RXi Pharmaceuticals developed a robust self-delivering
RNAi-based technology platform, termed sd-rxRNA®, a key value
driver unique to RXi. The robust technology platform
provides a strong foundation that we have leveraged to build a
leading Immuno-oncology company, with a short-term focus using
Adoptive Cell Transfer (ACT). sd-rxRNA offers unprecedented
flexibility in targeting immunosuppressive pathways with the
potential to modulate multiple checkpoint genes in a single
therapeutic treatment. The built-in delivery and therapeutic
properties of sd-rxRNA lend themselves well for local therapeutic
applications, such as ex vivo treatment of the
immune cells. The ex vivo use of sd-rxRNA to
pre-treat immune cells prior to infusion may prove advantageous as
an immuno-therapeutic in that there is the potential to
simultaneously reduce multiple checkpoints or targets, including
both intracellular and extracellular targets, with little change to
current protocols.
During 2017, the Company advanced its development strategy by
selecting a lead preclinical compound and commencing cGMP
manufacturing to prepare for the initiation of a clinical trial in
2019. In addition, the Company entered into a number of
partnerships across the globe to expand its pipeline, which
include:
- PCI Biotech: A collaboration is underway with this
biopharmaceutical company located in Norway, to evaluate technology compatibilities
and synergies between our respective technology platforms for the
potential applicability of combination therapy in immuno-oncology.
- Gustave Roussy: This
leading Comprehensive Cancer Centre in Europe is evaluating the potential of RXi's
novel sd-rxRNA technology platform for use in cancer
treatments.
- Center for Cancer Immune Therapy (CCIT) at Herlev
Hospital: Based in Denmark,
CCIT is a leading European center evaluating the potential of the
sd-rxRNA technology platform in TILs for the use in treatment for a
number of cancer types, including melanoma and ovarian cancer.
- Medigene AG: A German based biotechnology company is
exploring potential synergies of using sd-rxRNA in combination
with Medigene's recombinant TCRs to develop modified T
cells with enhanced efficacy and/or safety.
To further support these efforts, RXi appointed two leading
oncology experts to its Scientific Advisory Board (SAB). RXi's new
SAB members are Dr. Rolf Kiessling,
Professor in Experimental Oncology at Karolinska Institutet and Senior Chief Physician of
Radiumhemmet at Karolinska Hospital as well as medical oncology
expert Dr. James D. Griffin,
Chairman, Department of Medical Oncology, Dana-Farber Cancer
Institute. Dr. Griffin also serves as Professor, Medicine,
Harvard Medical School and Director,
Medical Oncology, Brigham and Women's Hospital.
The Company also added additional strategic business development
and immuno-oncology expertise to its Board of Directors through the
appointment of Dr. Jonathan Freeman.
Dr. Freeman is an established leader with positions spanning
from Senior Vice President, Head of Strategy
Development and Portfolio Management at Merck KGaA to a number
of senior positions at Baxter and Serono, in M&A and, Corporate
and Business Development, respectively.
In addition to the expansion of our SAB and Board of Directors,
Dr. Gerrit Dispersyn, Dr. Med. Sc.
joined RXi as its Chief Development Officer in May 2017. Dr.
Dispersyn is an accomplished leader and brings a wealth of
experience in clinical, product and business development. He
has held a number of senior leadership positions at Integra
LifeSciences Corporation and Barrier Therapeutics.
Business Development Opportunities
RXi has developed two robust therapeutic Franchises in
Dermatology and Ophthalmology that are comprised of advanced
clinical programs, robust discovery assets and substantial
Intellectual Property rights. RXi added to its broad patent estate
with the granting of a patent from the Japan Patent Office (JPO) in
Q1 207 for the composition of matter of sd-rxRNAs targeting
connective tissue growth factor (CTGF) for the treatment or
prevention of fibrotic disorders, including but not limited to skin
fibrosis and proliferative retinopathy (Japanese Patent #:
6060071), which includes RXI-109.
The Company has an active process underway to monetize these
assets which will support a return on investment for stockholders
and accelerated growth in the immuno-oncology focus area.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements can be identified by words
such as "intends," "believes," "anticipates," "indicates," "plans,"
"expects," "suggests," "may," "should," "potential," "designed to,"
"will" and similar references, although not all forward-looking
statements contain these words. Forward-looking statements are
neither historical facts nor assurances of future performance.
These statements are based only on our current beliefs,
expectations and assumptions regarding the future of our business,
future plans and strategies, projections, anticipated events and
trends, the economy and other future conditions. Because
forward-looking statements relate to the future, they are subject
to inherent uncertainties, risks and changes in circumstances that
are difficult to predict and many of which are outside of our
control. Our actual results and financial condition may differ
materially from those indicated in the forward-looking statements
as a result of a number of important factors, including those
identified in our most recent Annual Report on Form 10-K under the
caption "Risk Factors" And in other filings the Company
periodically makes with the Securities and Exchange
Commission. 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)
|
|
|
For the
Three
Months
Ended
December 31,
2017
|
|
For the
Three Months
Ended December 31,
2016
|
|
For the
Year
Ended
December 31,
2017
|
|
For the
Year
Ended
December 31,
2016
|
|
Revenues
|
$
15
|
|
$
—
|
|
$
15
|
|
$
19
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
1,204
|
|
1,307
|
|
5,370
|
|
5,415
|
|
Acquired in-process research
and
development
|
—
|
|
—
|
|
4,696
|
|
—
|
|
General and
administrative
|
802
|
|
1,032
|
|
4,011
|
|
3,619
|
|
Total
operating expenses
|
2,006
|
|
2,339
|
|
14,077
|
|
9,034
|
|
Operating
loss
|
(1,991)
|
|
(2,339)
|
|
(14,062)
|
|
(9,015)
|
|
Total other (expense)
income, net
|
(11)
|
|
—
|
|
(11)
|
|
21
|
|
Loss before income
taxes
|
(2,002)
|
|
(2,339)
|
|
(14,073)
|
|
(8,994)
|
|
Income tax
benefit
|
—
|
|
—
|
|
1,621
|
|
—
|
|
Net loss
|
(2,002)
|
|
(2,339)
|
|
(12,452)
|
|
(8,994)
|
|
Accretion of
beneficial conversion feature
related to Series B Convertible Preferred
Stock
|
—
|
|
(2,075)
|
|
—
|
|
(2,075)
|
|
Net loss
attributable to common stockholders
|
$
(2,002)
|
|
$
(4,414)
|
|
$
(12,452)
|
|
$
(11,069)
|
|
Net loss per
common share attributable to
common stockholders: Basic and diluted
|
$
(0.84)
|
|
$
(6.02)
|
|
$
(5.52)
|
|
$
(16.41)
|
|
Weighted average common shares:
Basic and diluted
|
2,379,335
|
|
733,394
|
|
2,257,754
|
|
674,608
|
|
RXi
PHARMACEUTICALS CORPORATION
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(Amounts in
thousands)
|
|
|
|
|
|
|
|
|
|
|
December
31,
|
|
December
31,
|
|
|
2017
|
|
2016
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
$
3,581
|
|
$
12,906
|
|
Restricted
cash
|
50
|
|
50
|
|
Prepaid expenses and
other current assets
|
201
|
|
150
|
|
Total current
assets
|
3,832
|
|
13,106
|
|
Property and
equipment, net
|
248
|
|
114
|
|
Notes
receivable
|
—
|
|
150
|
|
Other
assets
|
18
|
|
27
|
|
Total
assets
|
$
4,098
|
|
$
13,397
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
$
511
|
|
$
917
|
|
Accrued
expenses
|
1,754
|
|
1,625
|
|
Total current
liabilities
|
2,265
|
|
2,542
|
|
Total stockholders'
equity
|
1,833
|
|
10,855
|
|
Total liabilities and
stockholders' equity
|
$
4,098
|
|
$
13,397
|
|
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SOURCE RXi Pharmaceuticals Corporation