Company focused on the development and
commercialization of women’s reproductive health productsDaré to
Host Conference Call on Monday, July 24, 2017, at 4:30 p.m. Eastern
Time / 1:30 p.m. Pacific Time to Discuss Business Opportunity
Daré Bioscience, Inc. (NASDAQ:DARE) (formerly known as Cerulean
Pharma Inc., and formerly traded under NASDAQ:CERU) announced today
the outcomes of three important transactions: (i) approval by
Cerulean stockholders of the purchase of all of the outstanding
common shares and options of Daré Bioscience (which has been
renamed Daré Bioscience Operations, Inc. to avoid confusion with
the renamed Cerulean), (ii) approval by Cerulean stockholders of
the sale of all rights related to the Dynamic Tumor Targeting™
Platform to Novartis for $6 million in cash, and (iii) approval by
Cerulean stockholders and authorization by the Cerulean board of
directors of a 10 to 1 reverse stock split. As a result of these
transactions, the stockholders of pre-closing Daré have become
owners of approximately 51% of the issued and outstanding shares of
the combined company, while the stockholders of pre-closing
Cerulean will continue to own approximately 49% of the issued and
outstanding shares of the combined company, which represents the
maximum ownership possible for the pre-closing Cerulean
stockholders under the stock purchase agreement entered into
between the companies on March 19, 2017.
Following the closing of the transaction, Sabrina Martucci
Johnson, President and CEO of Daré, became the President and CEO of
Cerulean and joined its board of directors and Lisa
Walters-Hoffert, CFO of Daré, became Cerulean’s CFO. The
operations of Daré and Cerulean are being combined, with the
combined company operating under the name “Daré Bioscience, Inc.”
and led solely by Daré’s management team.
“Daré's transition to the public market represents a significant
milestone for us,” stated Sabrina Martucci Johnson, President and
CEO of Daré. “We are grateful for the support of the Cerulean
stockholders. Daré is committed to building a strong company in
women’s reproductive health, beginning with our first clinical
candidate, Ovaprene®. We believe Daré represents an attractive
business with considerable product candidate opportunities and
market potential.”
Conference Call and WebcastDaré will hold a
conference call on Monday, July 24, 2017, at 4:30 p.m. Eastern Time
/ 1:30 p.m. Pacific Time to provide an overview and business
update. Interested parties may access the conference call by
dialing (844) 831-3031 from the U.S. and (443) 637-1284 from
outside the U.S. and should request the Daré Call, conference ID
58451998. The conference call also will be webcast live over the
Internet and can be accessed at
http://edge.media-server.com/m/p/mmj5wibt.
About Daré Bioscience, Inc. (formerly Cerulean Pharma
Inc.)
Daré is a healthcare company committed to the development and
commercialization of innovative products in women’s reproductive
health. We have identified areas within this market segment that
remain underserved and believe they offer opportunities to generate
value for both investors and women.
The problem isn’t early innovation. The global
donor community of foundations and governments has invested tens of
millions of dollars in early-stage and clinical-stage research to
expand options, improve outcomes and advance global women’s
reproductive health. In addition, independent private innovators
have developed new approaches to address unmet needs. Yet,
promising candidates often fail to advance for reasons unrelated to
results, but rather because of shifting strategic priorities or a
lack of dedicated funding.
The problem isn’t commercialization. Large and
medium-size pharmaceutical companies with established sales and
marketing franchises in women’s health exist. However, many
of these companies prefer to get involved in later stages of
development, e.g., in pivotal trials or following an application
for regulatory approval.
The problem is the gap. We believe that this
gap between innovation and commercialization in women’s
reproductive health creates an opportunity for Daré. Our business
model is to license the rights to promising product candidates
(many with clinical proof-of-concept data), advance their clinical
development, and if successful, implement a comprehensive global
commercialization strategy in combination with established
pharmaceutical partners and regional distributors. We believe this
approach is efficient in both its use of time and financial
resources.
The contraceptive market in particular represents an interesting
segment for Daré. Since the approval of the birth control pill by
the FDA in 1960, most contraception innovation has focused on the
use of hormones. Little innovation has occurred to create new
non-hormonal options, leaving a void in the method mix and creating
a potential opportunity. Today’s non-hormonal alternatives
include condoms, diaphragms, and spermicides, all of which require
intervention at the time of intercourse and most of which have
marginal efficacy. There is a need for something better.
First product candidate, Ovaprene®
Ovaprene® is a clinical stage, non-hormonal contraceptive ring
intended to provide protection over multiple weeks of use, require
no intervention at the time of intercourse, and fill a void in
today’s contraception method mix.
- Research has shown that as many as 40% of women using
contraception say they are not satisfied with their current method,
reporting difficulty of use, problems with side effects, and
concerns about effectiveness and reduced sexual pleasure.
- A convenient, easy-to-use and effective non-hormonal option
could appeal to a portion of the 22% of women currently using one
of today’s non-hormonal methods.
- Ovaprene® would represent a new category of birth control
and expand options.
A contraceptive ring, whose use is initiated and controlled by a
woman, has numerous attributes that women find appealing. Published
surveys revealed the following:
- A vaginal ring has most of the features they deemed extremely
important,
- 85% of women surveyed reported they would prefer a monthly
option with a lower hormone dose than the pill, and
- 80% currently use a non-coital dependent method, meaning there
is no intervention at the time of intercourse.
The only contraceptive ring on the market today is NuvaRing®, a
hormonal contraceptive ring with 2016 sales of $777 million.
Our goal for Ovaprene® is to provide similar monthly convenience
and protection but without the use of hormones.
Ovaprene® has a custom intravaginal ring design, with a
permeable mesh in the center of the ring that creates a partial
barrier to sperm, and a mechanism to release locally acting
spermiostatic agents through the ring. The unique combination
of these two complementary approaches seeks to produce attractive
contraceptive efficacy outcomes that are consistent with the most
effective barrier option, the diaphragm, and short-acting hormonal
options (oral pill, patches and vaginal ring) that
provide 88-91% effectiveness in typical use.
Typical use refers to effectiveness experienced among all couples
who use the method, including inconsistent and incorrect use.
In a pilot postcoital test (“PCT”) clinical trial conducted in
21 women and published in the Journal of Reproductive Medicine in
2009, Ovaprene® demonstrated the following:
- Ability to immobilize sperm and prevent their progression into
the cervical mucus,
- Acceptability of the device to both partners, and
- No serious adverse events were reported.
While the original pilot PCT clinical trial was not designed to
be utilized as part of a regulatory submission, its data provide
preliminary proof-of-concept contraceptive efficacy. PCT clinical
trials have been used to assess the preliminary efficacy of other
contraception methods that work by preventing or blocking the
progression of sperm into the cervical mucus.
Our stockholders can expect the following benefits from the
combination of Daré (formerly Cerulean) and Daré Operations:
- Daré intends to commence a PCT clinical trial of
Ovaprene® with CONRAD, a non-profit organization that oversaw
the successful development and FDA approval of the
Caya® diaphragm, the most recently approved barrier
contraceptive device in combination with a locally-acting
spermiostatic agent.
- Based on our current projections and the cash from the
transaction, we believe Daré will be adequately funded to advance
Ovaprene® through the completion of the PCT clinical trial within
the next two years. A successful PCT clinical trial outcome would
represent a meaningful milestone and should allow Daré to proceed
directly to a pivotal contraceptive efficacy trial in the United
States.
- Daré is currently in discussions regarding other product
candidates that meet our selection criteria. We are also exploring
co-development opportunities with non-profit partners and
foundations as a way to leverage their tremendous investment
capacity and breadth of product candidates.
In addition to contraception, women’s reproductive health
encompasses a broad spectrum of categories, including vaginal
health, fertility and pain, among others. Daré is committed
to identifying, licensing and developing candidates that expand
options, improve outcomes, and enhance safety for women across the
broad spectrum. We look forward to advancing the Ovaprene®
development program while evaluating other clinical stage
opportunities that meet our objectives.
Forward Looking Statements
This press release contains “forward-looking statements”
regarding matters that are not historical facts, including
statements relating to Daré’s expectations regarding the timing and
availability of results from its clinical trials, the timing of
commencement of manufacturing its products, the safety and
effectiveness of its products and the continued ability of Daré to
develop and market Ovaprene® under its license with ADVA-Tec.
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
"anticipate," "believe," "continue," "could," "estimate," "expect,"
"hypothesize," "intend," "may," "plan," "potential," "predict,"
"project," "should," "target," "would," and similar expressions,
constitute forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. Actual results
may differ materially from those indicated by such forward-looking
statements as a result of various important factors, including:
whether cash resources will be sufficient to fund the operations of
Daré it will undertake; the uncertainties inherent in the
initiation and completion of clinical trials; availability and
timing of data from ongoing and future clinical trials and the
results of such trials; whether preliminary results from a clinical
trial will be predictive of the final results of that trial or
whether results of early clinical trials will be indicative of the
results of later clinical trials; whether the company will maintain
its NASDAQ listing, expectations for regulatory approvals; claims
of infringement and other risks relating to Daré’s owned and
licensed intellectual property rights; and other factors discussed
in the "Risk Factors" section of Daré’s Quarterly Report on Form
10-Q filed with the SEC on May 12, 2017, and in other filings that
Daré made with the SEC, including the definitive proxy statement
relating to the transaction with Daré Operations filed with the SEC
on June 19, 2017. In addition, any forward-looking statements
included in this press release represent our views only as of the
date of this release and should not be relied upon as representing
our views as of any subsequent date. Daré and Daré Operations
specifically disclaim any obligation to update any forward-looking
statements included in this press release.
For more information on Daré, please visit
www.darebioscience.com
Daré Bioscience, Inc.
11119 North Torrey Pines Road
Suite 200
La Jolla, CA 92037
Telephone: 858-769-9145
innovations@darebioscience.com
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