LA JOLLA, Calif., Nov. 7, 2017 /PRNewswire/ -- Regulus
Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company
leading the discovery and development of innovative medicines
targeting microRNAs, today summarized recent events and reported
financial results for the three and nine months ended September 30, 2017.
"The third quarter was marked by the successful completion of
our financing, as well as significant operational progress on our
two clinical programs," said Jay
Hagan, President and Chief Executive Officer of Regulus. "We
are very pleased that both of our Alport studies are now active,
the investigational new drug (IND) for the treatment of autosomal
dominant polycystic kidney disease (ADPKD) has been filed, and a
Phase I study remains on track to initiate by year-end."
Third Quarter Corporate Highlights and Recent Events
- In July 2017, Regulus completed a
public offering of its common stock, and received net proceeds of
approximately $43.0 million after
deducting underwriting discounts, commissions and other offering
expenses.
- In September, Regulus initiated HERA, the Phase II randomized,
double-blinded, placebo-controlled study evaluating the safety and
efficacy of RG-012 in Alport syndrome patients. In parallel, the
Phase I renal biopsy study was also initiated.
- Recently, Regulus filed an IND application with the FDA for
RGLS4326, targeting microRNA-17 for the treatment of ADPKD.
Third Quarter Financial Results
Cash Position: As of September 30, 2017, Regulus had cash, cash
equivalents and short-term investments of $71.4 million.
Research and Development (R&D) Expenses:
R&D expenses were $12.7 million
and $42.7 million for the three and
nine months ended September 30, 2017,
respectively, compared to $14.6
million and $49.3 million for
the same periods in 2016. The decrease in R&D expenses for the
three months ended September 30, 2017
compared to 2016 was driven by the planned reduction in
personnel-related costs as a result of our May 2017 corporate restructuring. The decrease in
R&D expenses for the nine months ended September 30, 2017 compared to 2016 was primarily
driven by the wind-down of clinical activities related to the
RG-101 program.
General and Administrative (G&A)
Expenses: G&A
expenses were $2.7 million and
$13.8 million for the three and nine
months ended September 30, 2017,
respectively, compared to $4.8
million and $13.6 million for
the same periods in 2016. The decrease in G&A expenses for the
three months ended September 30, 2017
compared to 2016 was attributable to the planned reduction in
personnel-related costs and non-cash stock-based
compensation.
Revenue: Revenue was less than $0.1 million for each of the three and nine
months ended September 30, 2017,
compared to $0.2 million and
$1.2 million for the same periods in
2016.
Net Loss: Net loss was $15.8
million and $57.5 million for
the three and nine months ended September
30, 2017, respectively, compared to a net loss of
$19.5 million and $61.8 million for the same periods in 2016.
Basic and diluted net loss per share was $0.18 and $0.88 for
the three and nine months ended September
30, 2017, respectively, compared to $0.37 and $1.17 for
the same periods in 2016.
Conference Call Details
Regulus will host a conference call and webcast today at
5:00 p.m. Eastern Time to discuss
third quarter 2017 financial results and corporate
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 9297128. To access the telephone replay of
the call, dial (855) 859-2056 (domestic) or (404) 537-3406
(international), conference ID 9297128. 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 clinical stage
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 rich intellectual property estate to retain its
leadership in the microRNA field. Regulus is advancing
several programs in renal, hepatic and central nervous systems
diseases. 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-012 or RGLS4326), 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,
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
|
|
(Unaudited)
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue under
strategic
alliances
|
|
$
|
18
|
|
$
|
204
|
|
$
|
54
|
|
$
|
1,176
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
12,697
|
|
14,554
|
|
42,727
|
|
49,326
|
General and
administrative
|
|
2,736
|
|
4,842
|
|
13,752
|
|
13,609
|
Total operating
expenses
|
|
15,433
|
|
19,396
|
|
56,479
|
|
62,935
|
Loss from
operations
|
|
(15,415)
|
|
(19,192)
|
|
(56,425)
|
|
(61,759)
|
Other expense,
net
|
|
(420)
|
|
(323)
|
|
(1,171)
|
|
(66)
|
Loss before income
taxes
|
|
(15,835)
|
|
(19,515)
|
|
(57,596)
|
|
(61,825)
|
Income tax benefit
(expense)
|
|
|
7
|
|
|
(4)
|
|
139
|
|
9
|
Net loss
|
|
$
|
(15,828)
|
|
$
|
(19,519)
|
|
$
|
(57,457)
|
|
$
|
(61,816)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
|
$
|
(0.18)
|
|
$
|
(0.37)
|
|
$
|
(0.88)
|
|
$
|
(1.17)
|
Weighted average
shares used to compute basic and diluted net loss per
share:
|
|
|
90,072,045
|
|
|
52,835,414
|
|
|
65,550,749
|
|
|
52,776,459
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September
30, 2017
|
|
December 31, 2016
|
|
|
(Unaudited)
|
Cash, cash
equivalents and short-term investments
|
|
$
|
71,370
|
|
$
|
76,111
|
Total
assets
|
|
90,847
|
|
100,661
|
Term loan, less debt
issuance costs
|
|
19,845
|
|
19,802
|
Stockholders'
equity
|
|
|
48,582
|
|
|
56,075
|
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SOURCE Regulus Therapeutics Inc.