MARLBOROUGH, Mass.,
March 30, 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
fourth quarter and year ended December 31,
2016, and provided a business update.
"We believe RXi is well positioned for a strong business and
development performance in 2017 due to the acquisition of MirImmune
Inc. and the strengthening of our balance sheet through a
financing at the end of 2016. As a result, the Company has
already initiated programs in the immuno-oncology and cell therapy
space, an exciting therapeutic area in health care today," said Dr.
Geert Cauwenbergh, President and CEO
of RXi Pharmaceuticals. He further added that, "The capital that we
received from our shareholders allows us to put a strong focus on
these immuno-oncology programs while completing and reporting our
ongoing clinical trials in dermatology and ophthalmology in the
second half of 2017."
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 Fourth Quarter and Fiscal 2016 Financial
Highlights
Cash Position
On December 21, 2016, the Company
closed an underwritten public offering of (i) 2,131,111 Class A
Units, at a public offering price of $0.90 per unit, consisting of one share of the
Company's common stock, and a five-year warrant to purchase one
share of common stock at an exercise price of $0.90 per share and (ii) 8,082 Class B Units, at
a public offering price of $1,000 per
unit, consisting of one share of Series B convertible preferred
stock, which is convertible into 1,111.11 shares of common stock,
and 1,111.11 warrants. The offering included an over-allotment
option for the underwriters to purchase an additional 1,666,666
Class A Units, which the underwriters fully exercised. The total
net proceeds of the offering, including the exercise of the
over-allotment option, was $10.1
million after deducting underwriting discounts and
commissions and offering expenses paid by the Company.
At December 31, 2016, the Company
had cash of $12.9 million,
compared with cash, cash equivalents and short-term investments of
$10.6 million at December 31, 2015. The Company believes that its
existing cash should be sufficient to fund operations for at least
the next twelve months.
Research and Development Expenses
Research and development expense for the quarter ended
December 31, 2016 was $1.3 million, which included less than
$0.1 million of non-cash stock-based
compensation expense, as compared with $1.7
million for the quarter ended December 31, 2015, which included $0.1 million of non-cash stock-based compensation
expense.
Research and development expense for the year ended December 31, 2016 was $5.4
million, which included $0.2
million of non-cash stock-based compensation expense, as
compared with $6.9 million for the
year ended December 31, 2015, which
included $0.6 million of non-cash
stock-based compensation expense.
The decrease in research and development expense quarter over
quarter and year over year was primarily due to cash and equity
fees payable to Hapten Pharmaceuticals, LLC upon the close of the
Samcyprone™ licensing agreement and manufacturing expenses for the
RXI-109 drug product, both of which occurred in 2015.
Additionally, the Company saw a decrease in stock-based
compensation expense due to the full vesting of stock options in
2016 from stock options that had been granted in 2012.
General and Administrative Expenses
General and administrative expense for the quarter ended
December 31, 2016 was $1.0 million, which included $0.1 million of non-cash stock-based compensation
expense, as compared with $0.9
million for the quarter ended December 31, 2015, which included $0.2 million of non-cash stock-based compensation
expense.
General and administrative expense for the year ended
December 31, 2016 was $3.6 million, which included $0.5 million of non-cash stock-based compensation
expense, as compared with $3.3
million for the year ended December
31, 2015, which included $0.9
million of non-cash stock-based compensation expense.
The increase in general and administrative expense quarter over
quarter and year over year was primarily due to the Company's focus
on business development activities and an increase in legal
expenses due to the Company's acquisition of MirImmune Inc. These
increases in general and administrative expense were offset by a
decrease in stock-based compensation expense due to the full
vesting of stock options in 2016 from stock options that had been
granted in 2012.
Convertible Preferred Stock
Accretion of convertible preferred stock and dividends were
$2.1 million for the quarter ended
December 31, 2016. There was no such
expense for the quarter ended December 31,
2015.
Accretion of convertible preferred stock and dividends were
$2.1 million for the year ended
December 31, 2016, compared with
$0.2 million for the year ended
December 31, 2015.
The increase quarter over quarter and year over year was due to
the one-time charge related to the beneficial conversion feature of
the Series B convertible preferred stock issued in connection with
the completion of the Company's December
2016 underwritten public offering offset by a decrease
related to the fair value of dividends on the Company's Series A
and Series A-1 convertible preferred stock. The Company no longer
had any Series A or Series A-1 convertible preferred stock
authorized, issued or outstanding as of December 31, 2016 and 2015.
Net Loss Applicable to Common Stockholders
Net loss applicable to common stockholders for the quarter ended
December 31, 2016 was $4.4 million, compared with $2.6 million for the quarter ended December 31, 2015.
Net loss applicable to common stockholders for the year ended
December 31, 2016 was $11.1 million, compared with $10.4 million for the year ended December 31, 2015.
The increase in net loss applicable to common stockholders for
the quarter and year ended December 31,
2016 as compared to the same prior year periods was due to
the one-time charge related to the beneficial conversion feature of
the Company's Series B convertible preferred stock offset by a
decrease in operating expenses, as described above.
Select Fourth Quarter 2016 and Recent Corporate
Highlights
Select Business and Corporate Highlights
Building on the pioneering discovery of RNAi by RXi founder and
Nobel Laureate, Dr. Craig Mello,
scientists at RXi have harnessed the naturally occurring RNAi
process which has the ability 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 highly selectively block the expression of any
target in the genome, thus providing applicability to many
therapeutic areas.
Immuno-Oncology
In March 2015, MirImmune Inc., a
privately-held company focused on the development of next
generation immunotherapies for the treatment of cancer, entered
into an exclusive license agreement for use of RXi's sd-rxRNA
technology in developing innovative cell-based cancer
immunotherapies. MirImmune's progress in cell therapy using
RXi's technology formed a strong foundation for therapeutic
development in the immuno-oncology space. As a result, RXi entered
into an agreement to acquire MirImmune which was completed earlier
this year. The Company's goal, through internal research and
external partnerships, is to develop more effective treatments
resulting in better quality of life and extended survival for
patients.
The Company has initiated a program developing cell-based
immunotherapies to treat cancer based on its proprietary sd‑rxRNA
therapeutic compounds. To date, the unique applicability of
sd-rxRNA for immune checkpoint modulation in cellular
immuno-oncology therapies has been demonstrated, including:
- Selection of lead sd-rxRNA compounds against six different
extracellular and intracellular immune check points
- Demonstrated silencing of all tested checkpoint
targets in vitro, singly and in combinations
- Efficient and long-lasting silencing of immune
checkpoints in vivo
- Applicability of sd-rxRNA transfection in cell therapy to solid
tumors
- Filing of intellectual property that covers the use of RNAi
compounds for use in cell therapy
To support this ongoing initiative, Alexey Eliseev, PhD has been appointed as RXi's
Chief Business Officer. Dr. Eliseev is a highly accomplished
leader with over 20 years of experience in academia, biotechnology
industry and venture capital and most recently was the founder and
CEO of MirImmune Inc. In addition, RXi has appointed two leading
oncology experts to its Scientific Advisory Board. 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.
Dermatology
The Company's ongoing Phase 2 clinical trial, RXI-109-1402, is
being conducted to evaluate 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. This study is now fully enrolled and the Company
will provide full read-out, for Cohorts 3 and 4, H2-2017.
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. The Company expects to share early read-outs
H2 2017.
Consumer Health Program
RXi's consumer health compound RXI-231 targets tyrosinase, a key
player in the production of melanin. A formulation has been
developed at RXi that allows delivery of the compound into the
epidermis. We are in the process of finalizing the first two
protocols for testing in volunteers. To support these initial
studies, RXI-231 was manufactured and is being formulated for
topical use.
Ophthalmology
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 permanent vision loss.
Enrollment in the first two cohorts in the Company's Phase 1/2
trial, RXI-109-1501, is complete. RXI-109 has been
well-tolerated in the eye to date; enrollment into the third cohort
at the next higher dose level is ongoing.
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 has the ability 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
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. 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)
|
|
|
|
|
|
|
|
For the
Three
Months
Ended
December 31,
2016
|
|
For the
Three Months Ended
December 31,
2015
|
|
For
the
Year Ended
December 31,
2016
|
|
For the
Year Ended
December 31,
2015
|
|
|
|
|
|
|
|
|
|
|
|
Net
revenues
|
$
|
—
|
$
|
—
|
$
|
19
|
$
|
34
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
1,307
|
|
1,723
|
|
5,415
|
|
6,925
|
|
General and
administrative
|
|
1,032
|
|
899
|
|
3,619
|
|
3,346
|
|
Total
operating expenses
|
|
2,339
|
|
2,622
|
|
9,034
|
|
10,271
|
|
Operating
loss
|
|
(2,339)
|
|
(2,622)
|
|
(9,015)
|
|
(10,237)
|
|
Total other
income
|
|
—
|
|
6
|
|
21
|
|
14
|
|
Loss before income
taxes
|
|
(2,339)
|
|
(2,616)
|
|
(8,994)
|
|
(10,223)
|
|
Provision for income
taxes
|
|
—
|
|
—
|
|
—
|
|
—
|
|
Net loss
|
|
(2,339)
|
|
(2,616)
|
|
(8,994)
|
|
(10,223)
|
|
Accretion of
convertible preferred stock
dividends
|
|
(2,075)
|
|
—
|
|
(2,075)
|
|
(209)
|
|
Net loss applicable to
common stockholders
|
$
|
(4,414)
|
$
|
(2,616)
|
$
|
(11,069)
|
$
|
(10,432)
|
|
Net loss per common
share applicable to
common
stockholders:
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
$
|
(0.60)
|
$
|
(0.40)
|
$
|
(1.64)
|
$
|
(2.10)
|
|
Weighted average
common shares
outstanding:
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
7,333,940
|
|
6,528,825
|
|
6,746,080
|
|
4,970,382
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RXi
PHARMACEUTICALS CORPORATION
|
CONDENSED BALANCE
SHEETS
|
(Amounts in
thousands)
|
|
|
|
|
|
|
|
|
|
|
December
31,
2016
|
|
December
31,
2015
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
$
12,906
|
|
$
5,117
|
|
Restricted
cash
|
50
|
|
50
|
|
Short-term
investments
|
—
|
|
5,500
|
|
Prepaid
expenses
|
150
|
|
311
|
|
Total current
assets
|
13,106
|
|
10,978
|
|
Property and
equipment, net
|
114
|
|
163
|
|
Notes
receivable
|
150
|
|
—
|
|
Other
assets
|
27
|
|
18
|
|
Total
assets
|
$
13,397
|
|
$
11,159
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
$
917
|
|
$
1,163
|
|
Accrued
expenses
|
1,625
|
|
1,106
|
|
Total current
liabilities
|
2,542
|
|
2,269
|
|
Total stockholders'
equity
|
10,855
|
|
8,890
|
|
Total liabilities and
stockholders' equity
|
$
13,397
|
|
$
11,159
|
|
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SOURCE RXi Pharmaceuticals Corporation