MARLBOROUGH, Mass.,
Nov. 8, 2017 /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
third quarter ended September 30,
2017, and provided a business update.
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"RXi maintained a conservative spend rate in the third quarter
in line with its projected budget as it continues to execute on its
strategy with anticipated readouts this quarter from our
dermatology and ophthalmology clinical programs. Data
collection and analysis is ongoing, and the release of data is on
track as previously reported," said Dr. Geert Cauwenbergh, President and CEO of RXi
Pharmaceuticals. He further added that, "Our team has made
notable progress with research efforts and data generation using
our proprietary self-delivering RNAi technology platform (sd-rxRNA)
for use in cancer therapeutics. sd-rxRNA compounds
demonstrate high transfection efficiency with high cell viability
in a number of immune cells. We believe that these assets have the
potential to become a foundation for future growth opportunities,
including several therapeutic approaches in the rapidly growing
field of cell therapy for oncology. We look forward to
successful and meaningful growth through our work as well as
partnerships in this exciting and highly valuable medical
field."
A live audio webcast will begin today at 4:30 p.m. ET. The webcast link is available under
the "Investors – Events and Presentations" section of the Company's
website, www.rxipharma.com. The event may also be
accessed by dialing toll-free in the
United States: +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 Third Quarter 2017 Financial Highlights
Cash Position
At September 30, 2017, the Company
had cash of $5.4 million, 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 over the 30-month term of the agreement.
We expect to use proceeds from the purchase agreement for general
corporate purposes, including but not limited to the advancement of
our immunotherapy program, our clinical trials, and general and
administrative expenses. As of September 30,
2017, there have been no purchases under the agreement with
LPC.
Research and Development Expenses
Research and development expenses for the quarter ended
September 30, 2017 were $1.5 million, as compared with $1.5 million for the quarter ended September 30, 2016. Research and development
expenses were consistent quarter over quarter, with slight
increases due to subject fees for the second cohort in the
Samcyprone™ Phase 2 clinical trial and preclinical work in the
Company's new immunotherapy program that was integrated into the
Company with the acquisition of MirImmune in the first quarter of
2017, which were offset by a decrease in stock-based compensation
expense.
General and Administrative Expenses
General and administrative expenses for the quarter ended
September 30, 2017 were $1.0 million, as compared with $0.8 million for the quarter ended September 30, 2016. The increase in general and
administrative expenses was primarily due to payroll-related
expenses, including severance benefits, with the hire of the
Company's former chief business officer in connection with the
acquisition of MirImmune, resulting in a higher employee headcount
as compared to the same period of the prior year, offset by a
decrease in stock-based compensation expense.
Net Loss
Net loss for the three months ended September 30, 2017 was $2.5 million, compared with $2.2 million for the three months ended
September 30, 2016. The increase in
net loss was primarily driven by the changes in general and
administrative expenses, as discussed above.
Nasdaq Compliance
On August 2, 2017, the NASDAQ
Stock Market provided written notice and granted the Company an
additional 180 calendar days to regain compliance with the minimum
bid price requirements set forth in the NASDAQ listing rules. As a
result of this extension, the Company has until January 29, 2018 to regain compliance by
maintaining a closing bid price of at least $1.00 for 10 consecutive business days. The
NASDAQ written notice has no effect on the listing of the Company's
common stock at this time.
Select Third Quarter 2017 and Recent Corporate
Highlights
Select Business and Corporate Highlights
sd-rxRNA: Broadly applicable to numerous development
areas providing continued and expanded growth
Grant Award – Development of self-delivering RNAi targeted
to PTEN for treatment of spinal cord injury
The Company's proprietary self-delivering platform (sd-rxRNA) is
broadly applicable to numerous therapeutic areas. For
example, BioAxone Biosciences was recently awarded a grant from
the National Institute of Neurological Disorders and
Stroke (NINDS), part of the agency's SBIR Phase II funding
program, to fund further development of BioAxone's preclinical
candidate BA-434 in collaboration with RXi Pharmaceuticals. This
two-year grant provides funding for further development of BA-434,
a novel sd-rxRNA compound that targets PTEN for the treatment of
spinal cord injury.
BioAxone has been awarded a total of $1,794,895 to fund the collaborative project over
24 months. For their 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.
Cell Therapy for Oncology
The Company's ongoing research programs with its sd-rxRNA
platform have demonstrated robust cellular uptake in a number of
immune cell types including, human T-cells, meso CAR-T, human NK,
and dendritic cells. Our internal preclinical programs are
focused on development of sd-rxRNA compounds for optimizing
existing cell-based therapy treatment paradigms in
oncology. In addition, the Company is actively seeking
partnerships and collaborations with industry and academia to
develop new technologies using engineered cells and our sd-rxRNA
compounds. Our scientific team and advisors provide a strong
foundation for the development of novel therapeutic treatment
approaches using sd-rxRNA. This support positions RXi well
with opportunities to provide meaningful growth for the
Company.
Direct Therapeutic Use
RXI-109-1402 – Hypertrophic Scarring
The Company's ongoing Phase 2 clinical trial, RXI-109-1402, is
being conducted to evaluate RXI-109, a sd-rxRNA compound targeting
connective tissue growth factor (CTGF), a key regulator of scar
formation. This open-label, multi-center study is designed to
evaluate the effectiveness and safety of RXI-109 to reduce scar
formation in healthy volunteers post scar revision surgery. The
Company expects to share final study outcomes before the end of
this year.
RXI-109-1501 – Retinal Scarring in Advanced Age-related
Macular Degeneration (AMD)
Enrollment is complete in this Phase 1/2 study evaluating the
safety and clinical activity of RXI-109 to prevent the progression
of retinal scarring, a harmful component of numerous retinal
diseases. This study is a multi-dose, dose escalation trial
conducted in patients with advanced neovascular or wet age-related
macular degeneration (AMD) where retinal scarring can result in
continued vision loss. The primary endpoint for RXI-109-1501 is to
evaluate the safety and tolerability of RXI-109. Additional
endpoints will assess RXI-109's potential for clinical activity
using numerous assessments to monitor ocular health and visual
acuity. The Company expects to complete subject participation
in the study by the end of 2017 and share top-line data in early
2018.
RXI-SCP-1502 – Treatment of Cutaneous Warts
Samcyprone™, a proprietary topical formulation of the small
molecule diphenylcyclopropenone (DPCP), is 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. The Company expects to share early read-outs
before the end of this year.
Direct Consumer Care Use
RXI-231 - Consumer Care Products
The Company initiated a consumer testing program with RXI-231, a
cosmetic ingredient based on sd-rxRNA that targets tyrosinase
(TYR). The cosmetic product is a gel formulation designed to aid in
the reduction of pigmentation and thereby improving skin
appearance. The consumer testing program will evaluate the use and
consumer acceptability of RXI-231.
There are three studies under this program. The first two
studies in volunteers are performed to determine irritation and
sensitization potential of the gel product containing RXI-231 when
applied to the skin. A third study investigates the potential
of the product to improve the appearance of skin pigmentation
induced by UV exposure. The Company projects to report results
before the end of this year.
Corporate Update
Management Team
On September 15, 2017, the Company
announced the departure of Dr. Alexey
Eliseev, former CEO of MirImmune Inc. Dr. Eliseev
joined RXi on January 6, 2017 as
Chief Business Officer of the Company in connection with its
acquisition of MirImmune. MirImmune was a privately-held company
developing cell-based therapeutics for cancer treatments based on a
license to RXi's proprietary self-delivering RNAi technology. In
his role as Chief Business Officer of RXi, Dr. Eliseev was
responsible for the integration of this new therapeutic approach
into the activities of RXi Pharmaceuticals, and for introducing the
Company to several key industry and academic groups active in this
emerging field.
Dr. James Cardia, RXi's current
Director of Business Development and Intellectual Property now
leads the management of the various ongoing activities in
partnering and business development. During his tenure at
RXi, Dr. Cardia's group was responsible for the discovery and
optimization of "self-delivering" rxRNAs (sd-rxRNAs®) as well as
the development and characterization of RXI-109, a promising
anti-fibrotic agent currently in clinical trials for the treatment
of both dermal and retinal scarring.
About RXi Pharmaceuticals Corporation
RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a
clinical-stage company developing innovative therapeutics that
address significant unmet medical needs. Building on the
pioneering discovery of RNAi, scientists at RXi have harnessed the
naturally occurring RNAi process which can be used to "silence" or
down-regulate the expression of a specific gene that may be
overexpressed in a disease condition. RXi developed a robust
RNAi therapeutic platform including self-delivering RNA (sd-rxRNA®)
compounds, that have the ability to selectively block the
expression of any target in the genome, thus providing
applicability to many therapeutic areas. Our current programs
include dermatology, ophthalmology and cell-based cancer
immunotherapy. RXi's extensive patent portfolio provides for
multiple product and business development opportunities across a
broad spectrum of therapeutic areas and we actively pursue research
collaborations, partnering and out-licensing opportunities with
academia and pharmaceutical companies. 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™ 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 CONSOLIDATED STATEMENTS OF
OPERATIONS (Amounts in
thousands, except share and per share
data) (Unaudited)
|
|
For the
Three
|
|
For the
Three
|
|
For the
Nine
|
|
For the
Nine
|
Months
Ended
|
|
Months
Ended
|
|
Months
Ended
|
|
Months
Ended
|
September 30,
2017
|
|
September
30,
2016
|
|
September 30,
2017
|
|
September 30,
2016
|
Net
revenues
|
$
—
|
|
$
—
|
|
$
—
|
|
$
19
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
1,490
|
|
1,464
|
|
4,166
|
|
4,108
|
Acquired
in-process research and development
|
—
|
|
—
|
|
3,075
|
|
—
|
General and
administrative
|
986
|
|
752
|
|
3,209
|
|
2,587
|
Total operating expenses
|
2,476
|
|
2,216
|
|
10,450
|
|
6,695
|
Operating
loss
|
(2,476)
|
|
(2,216)
|
|
(10,450)
|
|
(6,676)
|
Total other
income
|
—
|
|
4
|
|
—
|
|
21
|
Net loss
|
$
(2,476)
|
|
$
(2,212)
|
|
$
(10,450)
|
|
$
(6,655)
|
Net loss per common share:
|
|
|
|
|
|
|
|
Basic and diluted loss
per share
|
$
(0.11)
|
|
$
(0.34)
|
|
$
(0.47)
|
|
$
(1.02)
|
Weighted average
common shares:
|
|
|
|
|
|
|
|
Basic and
diluted
|
23,511,444
|
|
6,576,096
|
|
22,167,753
|
|
6,548,696
|
RXi
PHARMACEUTICALS CORPORATION
|
|
|
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
|
|
(Amounts in
thousands)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
September
30,
|
|
December
31,
|
|
2017
|
|
2016
|
|
|
|
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
5,416
|
|
$
12,906
|
Restricted
cash
|
50
|
|
50
|
Prepaid
expenses
|
271
|
|
150
|
Total current
assets
|
5,737
|
|
13,106
|
Property and
equipment, net
|
269
|
|
114
|
Notes
receivable
|
—
|
|
150
|
Other
assets
|
27
|
|
27
|
Total
assets
|
$
6,033
|
|
$
13,397
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
702
|
|
$
917
|
Accrued
expenses
|
1,901
|
|
1,625
|
Total current
liabilities
|
2,603
|
|
2,542
|
Total stockholders'
equity
|
3,430
|
|
10,855
|
Total liabilities and
stockholders' equity
|
$
6,033
|
|
$
13,397
|
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SOURCE RXi Pharmaceuticals Corporation