Agile Therapeutics Announces $20 Million Private Placement and Provides Clinical Trial Update
20 1월 2015 - 9:20PM
Agile Therapeutics, Inc. (Nasdaq:AGRX), a women's health specialty
pharmaceutical company focused on the development and
commercialization of new prescription contraceptive products,
announced today that it has entered into a definitive stock
purchase agreement with a group of institutional accredited
investors, including both existing and new investors, for the
private placement of approximately 3.4 million shares of common
stock at $5.85 per share yielding expected gross proceeds of $20.0
million. The price per share represents the market value of the
Company's common stock as defined by Nasdaq as of January 16,
2015. The private placement is expected to close on or about
January 23, 2015, subject to customary closing conditions.
"We are very pleased to have completed this private placement,"
said Al Altomari, President and Chief Executive Officer. "This
financing strengthens our balance sheet and validates our corporate
strategy for developing Twirla®."
The private placement was led by RA Capital Management with
participation by existing investors, including ProQuest
Investments, Aisling Capital, and Caxton Alternative
Management.
Agile Therapeutics plans to use the net proceeds of the offering
to fund working capital and general corporate purposes, which may
include scheduled payments of principal and interest on an
outstanding loan.
The securities issued in the private placement have not been
registered under the Securities Act of 1933, as
amended. Accordingly, these 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. This press
release shall not constitute an offer to sell or the solicitation
of an offer to buy these securities, nor shall there be any sale of
the securities in any jurisdiction in which such offer,
solicitation or sale would be unlawful prior to the registration or
qualification under the securities laws of such jurisdiction.
The Company also reported on the status of its Phase 3 SECURE
Study, a single-arm, open-label, multicenter Phase 3 trial that
will assess the efficacy, safety and tolerability of the Company's
investigational once-weekly transdermal contraceptive patch, Twirla
(AG200-15). Approximately 74 sites experienced in conducting
contraceptive trials have been selected and trained, and the active
treatment phase of the trial began in September 2014. As
previously announced, the Company now expects to complete screening
by the end of the first quarter 2015, and to complete enrollment
early in the second quarter 2015. "Our strategy has been to
carefully select high quality, experienced clinical sites and focus
on implementation of measures to optimize patient compliance and
continuation in the study. So far, we are pleased with the
quality of the execution," reported Altomari. "Our
observations are consistent with what we would expect to see at
this early stage of the trial, with no pregnancies or loss of
patients to follow-up. Of course it is too early to draw any
conclusions regarding final efficacy outcomes. We do not intend to
update the number of pregnancies or other clinical trial details
going forward unless there has been a material
development."
William Blair & Company, L.L.C. acted as the exclusive
placement agent for the offering.
About Agile
Agile Therapeutics is a women's health specialty pharmaceutical
company focused on the development and commercialization of new
prescription contraceptive products. Our product candidates are
designed to provide women with contraceptive options that offer
greater convenience and facilitate compliance. Our lead product
candidate, Twirla®, (ethinyl estradiol and levonorgestrel
transdermal system), also known as AG200-15, is a once-weekly
prescription contraceptive patch currently in Phase 3 clinical
development. Twirla is based on our proprietary transdermal patch
technology, called Skinfusion®, which is designed to provide
advantages over currently available patches and is intended to
optimize patch adherence and patient acceptability. For more
information, please visit the company website at
www.agiletherapeutics.com. The company may occasionally
disseminate material, nonpublic information on the company
website.
Forward-Looking Statement
Certain information contained in this press release includes
"forward-looking statements" related to the Company's timeline for
clinical trials and potential market opportunity for its product
candidates. We may, in some cases use terms such as "predicts,"
"believes," "potential," "continue," "anticipates", "estimates,"
"expects," "plans," "intends," "may," "could," 'might," "will,"
"should" or other words that convey uncertainty of the future
events or outcomes to identify these forward-looking statements.
Our forward-looking statements are based on current expectations
that involve risks, potential changes in circumstances, assumptions
and uncertainties. Any or all of the forward-looking statements may
turn out to be wrong, or be affected by inaccurate assumptions we
might make or by known or unknown risks and uncertainties. For
example, our statements about the timing and conduct of our
clinical trial could be affected by the potential that we
experience difficulty in identifying and initiating sites and
enrolling subjects, we identify serious side effects or other
safety issues, we do not have clinical supply of our product
candidate that is adequate in amount and quality and supplied in a
timely fashion, and the inherent risks of clinical development; our
statements about the potential commercial opportunity could be
affected by the potential that our product does not receive
regulatory approval, does not receive reimbursement by third party
payors, or a commercial market for the product does not develop
because of any of the risks inherent in the commercialization of
contraceptive products. For all these reasons, actual results and
developments could be materially different from those expressed in
or implied by our forward-looking statements. All forward looking
statements are subject to risks detailed in our filings with the
U.S. Securities and Exchange Commission, including the Company's
Registration Statement on Form S-1, and the prospectus filed in
connection therewith and our Reports on Form 10-Q. You are
cautioned not to place undue reliance on these forward-looking
statements, which are made only as of the date of this press
release. We undertake no obligation to publicly update such
forward-looking statements to reflect subsequent events or
circumstances.
CONTACT: Agile Therapeutics
Mary Coleman 609-683-1880
Agile Therapeutics (NASDAQ:AGRX)
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