LA JOLLA, Calif., Aug. 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 three and six
months ended June 30, 2016 and
provided a summary of corporate highlights.
"The second quarter was very busy from both the clinical and
corporate perspectives," said Paul
Grint, MD, Regulus' President and Chief Executive Officer.
"We remain on track to deliver follow-up results from RG-101
studies while working to address the deficiencies outlined in the
clinical hold letter from the FDA. In addition, we are
initiating a Phase II study in Alport Syndrome for RG-012, and plan
to nominate our fourth clinical candidate by year-end."
Financial Results
Revenue: Revenue was $0.5
million and $1.0 million for
the three and six months ended June 30,
2016, respectively, compared with $3.8 million and $8.0
million for the same periods in 2015. Revenue for the three
and six months ended June 30, 2016
and 2015 consisted of amortization of up-front payments from
Regulus' strategic alliances and collaborations. Revenue for the
three months ended June 30, 2015
included $2.6 million for research
services under Regulus' strategic alliances and collaborations.
Revenue for the six months ended June 30,
2015 included $3.2 million for
research services and $2.9 million in
pre-clinical and other milestones under Regulus' strategic
alliances and collaborations.
Research and Development (R&D) Expenses:
R&D expenses were $18.0 million
and $34.8 million for the three and
six months ended June 30, 2016,
respectively, compared with $19.2
million and $32.6 million for
the same periods in 2015. R&D expenses were consistent for the
three months ended June 30, 2016 and
2015, excluding non-recurring severance charges recorded in
June 2015. The increase for the
six months ended June 30, 2016 was
driven by an increase in our aggregate clinical trial program
costs.
General and Administrative (G&A) Expenses: G&A
expenses were $3.7 million and
$8.8 million for the three and six
months ended June 30, 2016,
respectively, compared with $5.8
million and $9.5 million for
the same periods in 2015. These decreases were primarily driven by
non-recurring severance charges recorded in June 2015, partially offset by an increase in
recurring personnel costs for the three and six months ended
June 30, 2016.
Net Loss: Net loss was $21.1
million, or $0.40 per share,
and $42.3 million, or $0.80 per share, for the three and six months
ended June 30, 2016, respectively,
compared with a net loss of $21.0
million, or $0.41 per share,
and $35.5 million, or $0.70 per share, for the same periods in
2015.
Cash Position: Cash, cash equivalents and short-term
investments were $108.0 million as of
June 30, 2016, compared with
$106.0 million at March 31, 2016.
Highlights and Recent Events
- In July, as anticipated, Regulus received a formal clinical
hold letter from the FDA outlining information required to address
the clinical hold for the IND of RG-101, which was announced in
late June. The FDA initiated the clinical hold after the company
reported a second serious adverse event (SAE) of jaundice. This
second SAE occurred in a HCV patient with end-stage renal disease
on dialysis enrolled in its on-going Phase I US study.
- In June, Regulus secured a $30.0
million growth capital credit facility with Oxford Finance
LLC and received $20.0 million at
closing under an initial term loan. An additional
$10.0 million will be available
subject to the achievement of a certain specified milestone.
The loans provide for interest-only payments for the first 24
months of the term, and will bear interest at a rate equal to the
sum of 8.51% plus the greater of 0.44% or the 30-day LIBOR
rate.
- In June, Regulus reported positive top-line data from the
primary endpoint analysis of our Phase II "closed-face sandwich"
study, which demonstrated significant virologic response through 24
weeks of follow-up.
- In May, Regulus expanded the clinical trial collaboration
agreement with GSK to conduct a multi-centered, randomized,
dose-ranging Phase II study evaluating the combination of RG-101
and GSK's long-acting parenteral ("LAP") formulation of GSK2878175
as a potential single-visit cure in patients chronically infected
with HCV.
- In May, Regulus presented preclinical and longitudinal data
from ATHENA, a natural history of disease study in patients with
Alport Syndrome, at the ERA-EDTA 53rd Congress.
Conference Call Details
Regulus will host a conference call and webcast at 5:00 p.m. Eastern Time today to discuss second
quarter financial results and provide a general business
update. 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 52355021. To access the telephone replay of the call,
dial (855) 859-2056 (domestic) or (404) 537-3406 (international),
passcode 52355021. 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 AstraZeneca. 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 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), 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 and
biomarkers 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
June
30,
|
|
Six months
ended June
30,
|
|
2016
|
|
|
2015
|
|
2016
|
|
2015
|
|
(Unaudited)
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
Revenue under
strategic
alliances
|
$
|
483
|
|
$
|
3,834
|
|
$
|
972
|
|
$
|
8,034
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
18,007
|
|
19,201
|
|
34,772
|
|
32,628
|
General and
administrative
|
3,664
|
|
5,814
|
|
8,767
|
|
9,458
|
Total operating
expenses
|
21,671
|
|
25,015
|
|
43,539
|
|
42,086
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(21,188)
|
|
(21,181)
|
|
(42,567)
|
|
(34,052)
|
Other income
(expense), net
|
90
|
|
144
|
|
258
|
|
(1,476)
|
|
|
|
|
|
|
|
|
Loss before income
taxes
|
(21,098)
|
|
(21,037)
|
|
(42,309)
|
|
(35,528)
|
Income tax
benefit
|
|
8
|
|
|
2
|
|
13
|
|
6
|
Net loss
|
$
|
(21,090)
|
|
$
|
(21,035)
|
|
$
|
(42,296)
|
|
$
|
(35,522)
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
|
(0.40)
|
|
$
|
(0.41)
|
|
$
|
(0.80)
|
|
$
|
(0.70)
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares used to compute basic and diluted net loss per
share:
|
|
52,782,643
|
|
|
51,073,488
|
|
|
52,746,657
|
|
|
50,575,096
|
|
|
Regulus
Therapeutics Inc.
|
|
Condensed Balance
Sheets
|
|
(In
thousands)
|
|
|
June 30,
2016
|
|
December 31,
2015
|
|
(Unaudited)
|
|
|
Assets
|
|
|
|
Cash, cash
equivalents, short-term investments and restricted cash
|
$
|
108,004
|
|
$
|
115,319
|
Other current
assets
|
8,230
|
|
18,939
|
Non-current
assets
|
13,694
|
|
6,825
|
Total
assets
|
$
|
129,928
|
|
$
|
141,083
|
Liabilities and
stockholders' equity
|
|
|
|
Current
liabilities
|
$
|
10,839
|
|
$
|
11,438
|
Total deferred
revenue
|
2,287
|
|
3,259
|
Term Loan, less debt
issuance costs
|
19,786
|
|
—
|
Other long-term
liabilities
|
8,570
|
|
2,308
|
Stockholders'
equity
|
88,446
|
|
124,078
|
Total
liabilities and stockholders' equity
|
$
|
129,928
|
|
$
|
141,083
|
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SOURCE Regulus Therapeutics Inc.