LA JOLLA, Calif., May 6, 2019 /PRNewswire/ -- Regulus
Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company
focused on the discovery and development of innovative medicines
targeting microRNAs, today announced that it has entered into an
amendment (the "Amendment") with Oxford Finance LLC. The
Amendment to the Term Loan, with a principal balance outstanding of
$14.7 million, provides the Company
with a new twelve-month period of interest-only payments,
commencing May 2019 and a two-year
extension of its maturity date to May 2022. Upon the closing
of the second tranche of the Company's recently announced private
financing, the Company will receive an additional twelve-month
period of interest-only payments, commencing May 2020.
"This restructuring of our Term Loan, coupled with our recently
announced private financing extends our cash runway and provides
the necessary capital for Regulus to complete our Phase 1 program
for RGLS4326, pending FDA alignment on the re-initiation of the
Multiple Ascending Dose study, as well as advancement of our
preclinical programs targeting HBV and NASH," said Jay Hagan, CEO of Regulus. "We appreciate
the continued support of Oxford as we advance our pipeline of
promising therapeutics."
About Autosomal Dominant Polycystic Kidney Disease
(ADPKD)
ADPKD, caused by the mutations in the PKD1 or PKD2 genes, is
among the most common human monogenic disorders and a leading cause
of end-stage renal disease. The disease is characterized by the
development of multiple fluid filled cysts primarily in the
kidneys, and to a lesser extent in the liver and other organs.
Excessive kidney cyst cell proliferation, a central pathological
feature, ultimately leads to end-stage renal disease in
approximately 50% of ADPKD patients by age 60. It is estimated that
approximately 1 in 1,000 people bear a mutation in either PKD1
or PKD2 genes worldwide.
About RGLS4326
RGLS4326 is a novel oligonucleotide designed to inhibit miR-17
and designed to preferentially target the kidney. Preclinical
studies with RGLS4326 have demonstrated direct regulation of PKD1
and PKD2 in human ADPKD cyst cells, a reduction in kidney cyst
formation, improved kidney weight/body weight ratio, decreased cyst
cell proliferation, and preserved kidney function in mouse models
of ADPKD.
About Regulus
Regulus Therapeutics Inc. (Nasdaq: RGLS) is a biopharmaceutical
company focused on the discovery and development of innovative
medicines targeting microRNAs. Regulus has leveraged its
oligonucleotide drug discovery and development expertise to develop
a pipeline complemented by a rich intellectual property estate in
the microRNA field. 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 RGLS4326 or its preclinical programs), Regulus'
sales of securities, its estimated cash runway, 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.
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SOURCE Regulus Therapeutics Inc.