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 a definitive
securities purchase agreement with certain institutional and other
accredited investors for aggregate gross proceeds of up to
approximately $41.8 million in a
two-tranche private placement of equity. The initial tranche
of approximately $16.7 million,
priced at the market, is anticipated to close on or about
May 7, 2019, subject to the
satisfaction of customary closing conditions. Investors in the
private placement include the Company's two largest existing
institutional shareholders, New Enterprise Associates (NEA) and BVF
Partners L.P., and several members of the Board and
management. The financing also includes participation from
several new institutional investors, including Acorn Bioventures,
Altium Capital, EcoR1 Capital, Samsara BioCapital, and Sarissa
Capital. H.C. Wainwright and Co. is acting as exclusive
placement agent for the financing.
Under the securities purchase agreement the investors have
agreed to purchase, at an initial closing, approximately 9.7
million shares of the Company's Common Stock ("Common Stock") and
accompanying warrants to purchase up to an aggregate of
approximately 9.7 million shares of Common Stock, at a combined
purchase price of $1.205 per share
and accompanying warrant. Certain investors have also agreed to
purchase, in lieu of shares of Common Stock, an aggregate of
approximately 416,000 shares of non-voting Class A-1 convertible
preferred stock at a price of $10.80
per share, and accompanying warrants to purchase an aggregate of up
to approximately 4.16 million shares of Common Stock at a price of
$0.125 for each share of Common Stock
underlying the warrants. Each share of non-voting Class A-1
convertible preferred stock will be convertible into 10 shares of
Common Stock, subject to certain beneficial ownership conversion
limitations. The warrants will be exercisable for a period of
five years following the date of issuance and will have an exercise
price of $1.08 per share, subject to
proportional adjustments in the event of stock splits or
combinations or similar events. The total gross proceeds to
the Company from the sale of these securities at the initial
closing is expected to be approximately $16.7 million. The initial closing is
expected to occur on or about May 7,
2019, subject to customary closing conditions.
Subject to the Company's public announcement on or before
December 31, 2019 of its plan to
recommence the Phase 1 multiple ascending dose clinical trial of
RGLS4326 based upon correspondence from FDA (the "Public
Announcement"), the investors have agreed to purchase shares of
non-voting convertible preferred stock and accompanying warrants to
purchase shares of Common Stock ("Milestone Securities") in a
second closing (collectively, "Milestone Closing"). The
Milestone Closing will have aggregate gross proceeds of
approximately $25.1 million.
Each additional share of non-voting convertible preferred stock
will be convertible into 10 shares of common stock, subject to
certain beneficial ownership conversion limitations. The
additional non-voting preferred stock will be sold at a price per
share of $10.80 in the event the
volume-weighted average price per share of Common Stock on Nasdaq
("VWAP") during the five full trading days following the Public
Announcement is at least $1.08.
In the event the VWAP during the five full trading days following
the Public Announcement is less than $1.08, the price per share of the additional
non-voting preferred stock will be based on a VWAP preceding the
Milestone Closing, and the issuance of the Milestone Securities
will be subject to stockholder approval under Nasdaq Listing Rule
5635. The accompanying warrants will be sold at a price of
$0.125 for each share of Common Stock
underlying the warrants, will have an exercise price equal to 100%
of the purchase price of the non-voting convertible preferred stock
sold in the Milestone Closing (priced on an as-converted to Common
Stock basis), subject to proportional adjustments in the event of
stock splits or combinations or similar events, and will have an
exercise term of five years from the date of issuance.
The offer and sale of the foregoing securities are being made in
a transaction not involving a public offering and have not been
registered under the Securities Act of 1933, as amended (the
"Securities Act"), or applicable state securities laws.
Accordingly, the securities may not be reoffered or resold in
the United States except pursuant
to an effective registration statement or an applicable exemption
from the registration requirements of the Securities Act and such
applicable state securities laws.
This press release does not constitute an offer to sell or the
solicitation of an offer to buy the securities, nor shall there be
any sale of the securities in any state in which such offer,
solicitation or sale would be unlawful prior to the registration or
qualification under the securities laws of such state.
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 maintains its
corporate headquarters in La
Jolla, CA.
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 timing, size and
completion of the proposed private financing, including statements
regarding the Milestone Closing. 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, feedback
from the FDA and market conditions. 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.