LA JOLLA, Calif.,
May 2, 2016 /PRNewswire/ -- Regulus
Therapeutics Inc. (NASDAQ: RGLS), a biopharmaceutical company
leading the discovery and development of innovative medicines
targeting microRNAs, today reported financial results for the first
quarter ended March 31, 2016 and
provided a summary of recent corporate highlights.
"2016 is shaping up to be a pivotal year of growth for
Regulus. Our progress in the first quarter has continued to
demonstrate our ability to advance multiple clinical programs and
execute well on our stated goals," said Paul Grint, M.D., President and CEO of
Regulus. "RG-101, with curative potential for hepatitis C
viral infection, remains our primary focus and we are very
gratified with the efficacy and safety reported thus far. The
unique mechanism of action for RG-101, targeting a human factor
necessary for viral replication within the liver, supports the
potential of RG-101 to become a backbone agent for combinations
with all classes of direct anti-HCV therapies. In the coming
quarters, we look forward to accelerating our broad Phase II
development program and reporting additional data that will help
define the regulatory pathway for potential
approval."
First Quarter 2016 Financial Results &
Highlights
Regulus reported a net loss of $21.2 million for the quarter ended March 31, 2016, compared to a net loss of
$14.5 million for the quarter ended
March 31, 2015. Basic and diluted net
loss per share was $0.40 for the
quarter ended March 31, 2016,
compared to $0.29 for the quarter
ended March 31,
2015.
Regulus recognized revenue of $0.5
million for the quarter ended March
31, 2016, compared to $4.2
million for the quarter ended March
31, 2015. Revenue for the quarter ended March 31, 2016 consisted of amortization of
up-front payments from Regulus' strategic alliances and
collaborations, which are recognized over the estimated period of
performance. Revenue for the quarter ended March 31, 2015 included $3.1 million in milestones and other payments
earned under our collaboration with AstraZeneca.
Research and development expenses were $16.8 million for the quarter ended March 31, 2016, compared to $13.4 million for the quarter ended March 31, 2015. This increase was primarily
driven by Phase II clinical trial costs for RG-101 and an increase
in ongoing clinical trial costs associated with our global ATHENA
natural history of disease study and manufacturing costs for
RG-012.
General and administrative expenses were $5.1 million for the quarter ended March 31, 2016, compared to $3.6 million for the quarter ended March 31, 2015. This increase was primarily
driven by non-cash stock-based compensation.
As of March 31, 2016,
Regulus had $106.0 million in cash,
cash equivalents and short-term investments, including restricted
cash of $0.9 million, and 52,774,550
shares of common stock outstanding.
Recent Highlights
RG-101 (GalNAc-conjugated anti-miR122
for the treatment of Hepatitis C Virus)
- Reported Interim Results at ILC 2016. At the
International Liver Congress Meeting (ILC 2016), Regulus announced
interim results during an oral presentation in the general session
from one of the company's ongoing Phase II studies of RG-101 for
the treatment of HCV. The study was designed to evaluate a
shortened, four-week treatment regimen containing a subcutaneous
administration of 2 mg/kg of RG-101 at Day 1 and Day 29, in
combination with 4 weeks of once/daily approved anti-viral agents
Harvoni®, Olysio®, or Daklinza™. The study enrolled 79 treatment
naïve genotype 1 and 4 HCV patients (Harvoni® arm, n=27, Olysio®
arm, n=27, Daklinza™ arm, n=25). Available data from 64 patients at
the interim analysis demonstrated high virologic response rates in
all treatment groups, providing further evidence of RG-101's
potential to successfully shorten the duration of oral regimens. To
date, RG-101 has been generally well tolerated with the majority of
adverse events considered mild or moderate, and with no study
discontinuations. The primary endpoint analysis (12 week follow up)
for all 79 patients in the study are anticipated to be reported in
late Q2 2016.
- Initiated Phase II Combination Study with GSK. In
accordance with Regulus' clinical trial collaboration with GSK, the
companies have initiated a Phase II clinical trial evaluating the
combination of RG-101 and GSK2878175, an oral, non-nucleoside NS5B
polymerase inhibitor, in HCV patients. In parallel, GSK is working
to develop a long-acting parenteral ("LAP") formulation of
GSK2878175 as a single intra-muscular injection, providing the
potential for a single-visit therapeutic treatment for HCV. Regulus
anticipates reporting interim safety and efficacy data from this
study by the end of 2016.
- Enrollment Initiated in US Phase I Study. Today,
Regulus announced that enrollment is near completion in a
multi-center, open label, non-randomized Phase I study to compare
the safety, tolerability, pharmacokinetics, and pharmacodynamics of
RG-101 in subjects with severe renal insufficiency or end-stage
renal disease ("ESRD") to healthy control subjects, and further
explore RG-101 in hepatitis C infected subjects with severe renal
insufficiency or ESRD. Regulus anticipates reporting safety and
efficacy data from the HCV/severe renal impairment or ESRD arm in
the second half of 2016.
RG-012 (anti-miR21 for the treatment of
Alport syndrome)
- Advanced ATHENA Natural History Study. Regulus
continues to advance the ATHENA natural history study in patients
with Alport syndrome and anticipates reporting initial observations
in the second quarter of 2016. Longitudinal data obtained in the
ATHENA natural history study will help inform the design of the
Phase II study.
- Phase II Study. Planning is underway to initiate
the Phase II study by mid-2016.
- Multiple RG-012 Poster Presentations Have Been
Accepted for the ERA-EDTA 53rd Congress in Vienna, AUS in May
21-24, 2016. Poster presentations will include
preclinical data and longitudinal data obtained in the Athena
natural history of disease study.
Additional Highlights
- Advanced Preclinical Portfolio. Regulus advanced
several programs against undisclosed microRNA targets, and is on
track to nominate a fourth candidate for clinical development by YE
2016.
- Regulus to Present at Multiple Upcoming Healthcare
Conferences. Upcoming presentations include the Bank of America
Merrill Lynch 2016 Health Care Conference, May 10-13, 2016 in Las
Vegas, the UBS 2016 Global Healthcare Conference, May 23–25
in New York City and the Jeffries
2016 Healthcare Conference, June 7-10,
2016 in New York
City.
Conference Call & Webcast
Information
Regulus will host a conference call and webcast at
5:00 p.m. Eastern Daylight Time today
to discuss its first quarter 2016 financial results and recent
company highlights. A live webcast of the call will be available
online at www.regulusrx.com. To access the call, please dial
(877) 257-8599 (domestic) or (970) 315-0459 (international) and
refer to conference ID 99852289. To access the telephone
replay of the call, dial (855) 859-2056 (domestic) or (404)
537-3406 (international), passcode 99852289. The webcast and
telephone replay will be archived on the company's website
following the call.
About Regulus
Regulus Therapeutics Inc. (NASDAQ:RGLS) is a
biopharmaceutical company leading the discovery and development of
innovative medicines targeting microRNAs. Regulus has
leveraged its oligonucleotide drug discovery and development
expertise to develop a well-balanced microRNA therapeutics pipeline
complemented by a maturing microMarkersSM biomarkers
platform and a rich intellectual property estate to retain its
leadership in the microRNA field. Regulus is developing
RG-101, a GalNAc-conjugated anti-miR targeting microRNA-122 for the
treatment of chronic hepatitis C virus infection, and RG-012, an
anti-miR targeting microRNA-21 for the treatment of Alport
syndrome, a life-threatening kidney disease driven by genetic
mutations with no approved therapy. In addition, RG-125, a
GalNAc-conjugated anti-miR targeting microRNA-103/107 for the
treatment of NASH in patients with type 2 diabetes/pre-diabetes,
has entered Phase I clinical development through its strategic
alliance with AstraZeneca. Regulus is also advancing several
programs toward clinical development in renal, hepatic and central
nervous systems diseases, both independently and with our strategic
alliance partners, Sanofi and Astra Zeneca. Regulus' commitment to
innovation has resulted in multiple peer-reviewed publications in
notable scientific journals and has resulted in the formation of
strategic alliances with AstraZeneca and Sanofi. Regulus
maintains its corporate headquarters in La Jolla, CA. For more information,
please visit http://www.regulusrx.com.
Forward-Looking Statements
Statements contained in this press release regarding
matters that are not historical facts are "forward-looking
statements" within the meaning of the Private Securities Litigation
Reform Act of 1995, including statements associated with financial
estimates, the projected sufficiency of Regulus' capital position
for future periods, the expected ability of Regulus to undertake
certain activities and accomplish certain goals (including with
respect to development and other activities related to RG-101 and
RG-012), the projected timeline of clinical development activities,
and expectations regarding future therapeutic and commercial
potential of Regulus' business plans, technologies and intellectual
property related to microRNA therapeutics or the Regulus
microMarkersSM division being discovered and developed
by Regulus. Because such statements are subject to risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. Words such
as "believes," "anticipates," "plans," "expects," "intends,"
"will," "goal," "potential" and similar expressions are intended to
identify forward-looking statements. These forward-looking
statements are based upon Regulus' current expectations and involve
assumptions that may never materialize or may prove to be
incorrect. Actual results and the timing of events could
differ materially from those anticipated in such forward-looking
statements as a result of various risks and uncertainties, which
include, without limitation, risks associated with the process of
discovering, developing and commercializing drugs that are safe and
effective for use as human therapeutics, and in the endeavor of
building a business around such drugs. These and other risks
concerning Regulus' financial position and programs are described
in additional detail in Regulus filings with the Securities and
Exchange Commission. All forward-looking statements contained
in this press release speak only as of the date on which they were
made. Regulus undertakes no obligation to update such statements to
reflect events that occur or circumstances that exist after the
date on which they were made.
Regulus
Therapeutics Inc.
|
Selected Financial
Information
|
Condensed
Statement of Operations
|
(In thousands,
except share and per share data)
|
|
|
Three months
ended
March
31,
|
|
|
2016
|
|
2015
|
|
|
(Unaudited)
|
Revenues:
|
|
|
Revenue under
strategic
alliances
|
|
$
489
|
|
$
4,200
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
|
16,764
|
|
13,427
|
General and
administrative
|
|
5,103
|
|
3,644
|
Total operating
expenses
|
|
21,867
|
|
17,071
|
Loss from
operations
|
|
(21,378)
|
|
(12,871)
|
Other income
(expense), net
|
|
166
|
|
(1,620)
|
Loss before income
taxes
|
|
(21,212)
|
|
(14,491)
|
Income tax
benefit
|
|
|
5
|
|
|
4
|
Net loss
|
|
$
(21,207)
|
|
$
(14,487)
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
|
$
(0.40)
|
|
$
(0.29)
|
Weighted average
shares used to compute basic and diluted net loss per
share
|
|
|
52,710,672
|
|
|
50,071,165
|
Regulus
Therapeutics Inc.
Condensed Balance
Sheets
(In
thousands)
|
|
|
March
31, 2016
|
|
December 31, 2015
|
|
|
(Unaudited)
|
Assets
|
|
|
|
|
Cash, cash
equivalents, short-term investments and restricted cash
|
|
$
106,016
|
|
$
115,319
|
Other current
assets
|
|
9,743
|
|
18,939
|
Non-current
assets
|
|
12,379
|
|
6,825
|
Total
assets
|
|
$
128,138
|
|
$
141,083
|
Liabilities and
stockholders' equity
|
|
|
|
|
Current
liabilities
|
|
$
10,289
|
|
$
11,438
|
Total deferred
revenue
|
|
2,770
|
|
3,259
|
Other long-term
liabilities
|
|
7,850
|
|
2,308
|
Stockholders'
equity
|
|
107,229
|
|
124,078
|
Total
liabilities and stockholders' equity
|
|
$
128,138
|
|
$
141,083
|
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SOURCE Regulus Therapeutics Inc.