LA JOLLA, Calif., Nov. 1, 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 nine months ended September 30,
2016 and provided a summary of corporate highlights.
"Our focus in the third quarter included the advancement of the
RG-012 development program and addressing the clinical hold for
RG-101 while expanding the pre-clinical pipeline," said
Paul Grint, M.D., President and
Chief Executive Officer of Regulus. "We continue to be
excited with the progress of our research programs, and look
forward to sharing an update at our first R&D day on
December 6th."
Financial Results
Revenue: Revenue was $0.2
million and $1.2 million for
the three and nine months ended September
30, 2016, respectively, compared to $1.9 million and $9.9
million for the same periods in 2015. Revenue for the three
and nine months ended September 30,
2016 and 2015 consisted of amortization of up-front payments
from Regulus' strategic alliances and collaborations. Revenue for
the three and nine months ended September
30, 2015 included $0.9 million
and $4.1 million, respectively, for
research services under Regulus' strategic alliances and
collaborations. Preclinical milestones earned under Regulus'
strategic alliances and collaborations were $0.3 million and $3.2
million for the three and nine months ended September 30, 2015, respectively.
Research and Development (R&D) Expenses:
R&D expenses were $14.6 million
and $49.3 million for the three and
nine months ended September 30, 2016,
respectively, compared to $11.0
million and $43.6 million for
the same periods in 2015. The increases in R&D expenses were
primarily driven by the advancement of our clinical programs and
increased investment in our preclinical pipeline.
General and Administrative (G&A)
Expenses: G&A expenses were $4.8 million and $13.6
million for the three and nine months ended September 30, 2016, respectively, compared to
$4.2 million and $13.7 million for the same periods in 2015.
Net Loss: Net loss was $19.5
million, or $0.37 per share,
and $61.8 million, or $1.17 per share, for the three and nine months
ended September 30, 2016,
respectively, compared to a net loss of $13.0 million, or $0.25 per share, and $48.5
million, or $0.95 per share,
for the same periods in 2015.
Cash Position: Cash, cash equivalents, and
short-term investments were $91.7
million at September 30, 2016,
compared with $108.0 million at
June 30, 2016 and $115.3 million at December
31, 2015.
Recent Events
- In October, Dr. Timothy Wright
joined Regulus as its Chief R&D Officer.
- In September, Regulus initiated the HERA study, an
international randomized, double-blind, placebo-controlled,
multi-center Phase 2 clinical trial designed to evaluate the
safety, pharmacodynamics, pharmacokinetics, dose selection, and
preliminary efficacy of weekly RG-012 injections in approximately
30 patients with Alport syndrome. In order to address study
design comments from European regulators, a multiple-ascending dose
(MAD) study in healthy volunteers will be implemented (4-week
repeat dosing) prior to expanding to Alport patients.
Regulus anticipates the MAD study will be completed in the first
half of 2017. Based on predicted enrollment rates, Regulus
anticipates interim results from HERA in the first half
of 2018.
- In July, as anticipated, Regulus received written communication
from the U.S. Food and Drug Administration (FDA)
outlining information required to resolve the clinical hold for its
Investigational New Drug (IND) for RG-101, which was announced
on June 27, 2016. Based on the completion of additional
mechanistic pre-clinical studies, Regulus expects a response to its
submission from the FDA in the first quarter of 2017.
Upcoming Events
- On November 13, 2016, Regulus
will present three posters at American Association for the
Study of Liver Disease (AASLD) in Boston.
- On November 15, 2016 at
4:30 pm Eastern Time, Regulus will
present a corporate overview at the Stifel 2016 Healthcare
Conference in New York.
- On November 18 and 19, 2016,
Regulus will present two posters at American Society of Nephrology
(ASN) Kidney Week in Chicago.
- On December 6, 2016, Regulus will
host its first R&D Day.
- On December 13, 2016, Regulus
will participate in the 4th Annual Boston Healthcare
Conference.
- On December 14, 2016, Regulus
will participate in the BMO Capital Markets Prescriptions for
Success Healthcare Conference.
Conference Call Details
Regulus will host a conference call and webcast at 5:00 p.m. Eastern Time today to discuss third
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 99499252. To access the replay of the call, dial
(855) 859-2056 (domestic) or (404) 537-3406 (international),
passcode 99499252. 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/IIa
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. 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
September
30,
|
|
Nine months
ended
September
30,
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
|
(Unaudited)
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue under
strategic
alliances
|
|
$
|
204
|
|
$
|
1,865
|
|
$
|
1,176
|
|
$
|
9,899
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
14,554
|
|
10,965
|
|
49,326
|
|
43,593
|
General and
administrative
|
|
4,842
|
|
4,245
|
|
13,609
|
|
13,703
|
Total operating
expenses
|
|
19,396
|
|
15,210
|
|
62,395
|
|
57,296
|
Loss from
operations
|
|
(19,192)
|
|
(13,345)
|
|
(61,759)
|
|
(47,397)
|
Other (expense)
income, net
|
|
(323)
|
|
329
|
|
(66)
|
|
(1,147)
|
Loss before income
taxes
|
|
(19,515)
|
|
(13,016)
|
|
(61,825)
|
|
(48,544)
|
Income tax (expense)
benefit
|
|
|
(4)
|
|
|
16
|
|
9
|
|
22
|
Net loss
|
|
$
|
(19,519)
|
|
$
|
(13,000)
|
|
$
|
(61,816)
|
|
$
|
(48,522)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
|
$
|
(0.37)
|
|
$
|
(0.25)
|
|
$
|
(1.17)
|
|
$
|
(0.95)
|
Weighted average
shares used to compute basic and diluted net loss per
share:
|
|
|
52,835,414
|
|
|
51,990,460
|
|
|
52,776,459
|
|
|
51,052,068
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Regulus
Therapeutics Inc.
Condensed Balance
Sheets
(In
thousands)
|
|
|
September 30,
2016
|
|
December 31,
2015
|
|
|
(Unaudited)
|
Assets
|
|
|
|
|
Cash, cash
equivalents, short-term investments and restricted cash
|
|
$
|
91,663
|
|
$
|
115,319
|
Other current
assets
|
|
11,167
|
|
18,939
|
Non-current
assets
|
|
13,436
|
|
6,825
|
Total
assets
|
|
$
|
116,266
|
|
$
|
141,083
|
Liabilities and
stockholders' equity
|
|
|
|
|
Current
liabilities
|
|
$
|
13,080
|
|
$
|
11,438
|
Total deferred
revenue
|
|
2,083
|
|
3,259
|
Term Loan, less debt
issuance costs
|
|
19,787
|
|
—
|
Other long-term
liabilities
|
|
8,631
|
|
2,308
|
Stockholders'
equity
|
|
72,685
|
|
124,078
|
Total
liabilities and stockholders' equity
|
|
$
|
116,266
|
|
$
|
141,083
|
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SOURCE Regulus Therapeutics Inc.