Daré Bioscience Closes Previously Announced Acquisition of Microchips Biotech with a First-in-Class Wireless, User-Controlle...
November 21 2019 - 8:00AM
Daré Bioscience, Inc. (NASDAQ:DARÉ), a leader in women’s health
innovation, today announced the closing of the previously announced
acquisition by merger of privately-held Microchips Biotech,
Inc. As a result of the transaction, Microchips is a wholly
owned subsidiary of Daré. Microchips is developing an innovative,
wireless, user-controlled drug delivery technology with potential
utility across multiple therapeutic areas, including contraception.
The technology is designed to store and precisely deliver hundreds
of therapeutic doses, over months or years in a single implant and
is intended to allow for changes to dosage levels via a wireless
remote. The application of this technology in developing a
contraceptive product has been supported by the Gates Foundation in
the form of approximately $17.9 million in grant funding to
date. Microchips is eligible to receive up to $2.5 million in
additional grant funding from the Gates Foundation in 2020 to cover
the costs of ongoing development activities of the contraceptive
program.
The microchip-based implant was originally
developed at the Massachusetts Institute of Technology by renowned
researchers Robert Langer, Ph.D. and Michael J. Cima, Ph.D., and is
protected by 98 patents granted and 19 patent applications
pending.
“We are excited to integrate this exciting new
technology into our novel portfolio of women’s health product
candidates. We believe this product has the opportunity to
revolutionize the way women use contraception,” said Sabrina
Martucci Johnson, President and CEO of Daré Bioscience. “We
continue to focus our efforts on accelerating novel innovation
capable of addressing persistent unment needs in women’s health,
and we believe both the Microchips technology and our innovative
hormone-free monthly contraceptive candidate, Ovaprene, represent
truly novel advancements in an area in need of
innovation.”
Acquisition Highlights
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Cash at closing. Microchips’ cash and cash
equivalents at the closing of the merger, less estimated
transaction-related expenses, were approximately $5.7 million.
Cash resources that are not committed to funding the contraceptive
program activities under the grant from the Gates Foundation will
be used by Daré for working capital and general corporate
purposes. |
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Contraceptive program. Microchips, with financial
support from the Gates Foundation, has been developing an
implantable long-acting, reversible contraceptive application of
its drug delivery technology, which, if successful, will provide
women with unparalleled control over the management of their
fertility, which can be individually timed to meet her family
planning goals and objectives. The device is intended to
deliver all the benefits of a traditional long-acting, reversible
contraceptive product, utilizing the active pharmaceutical
ingredient levonorgestrel, to provide precise dosing and extended
implant duration with the added flexibility of wirelessly
controlling the duration of ovulatory suppression based on
individual user needs. |
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Stockholders. Daré will issue an aggregate of
approximately three million shares of its common stock in exchange
for the cash and cash equivalents, less any liabilities, of
Microchips at closing. With the issuance of such shares, the former
stockholders of Microchips, which include Polaris Venture Partners,
MS Pace, Intersouth Partners, and Teva Pharmaceutical, will become
stockholders of Daré. |
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New Board member. Cheryl Blanchard, Ph.D., the
former president and CEO of Microchips, joined Daré’s board of
directors upon the closing of the merger. Dr. Blanchard has served
on a number of public, private equity and venture-backed company
boards and currently is a member of the boards of directors of
Anika Therapeutics (NASDAQ: ANIK) and Neuronetics (NASDAQ: STIM).
Dr. Blanchard previously served as Senior Vice President, Chief
Scientific Officer and general manager of Zimmer Biologics during
her 12 years at Zimmer, Inc., with responsibility for global
leadership of R&D, advanced technologies, quality and
regulatory affairs, medical affairs, medical education, health
economics and reimbursement. |
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About Daré Bioscience
Daré Bioscience is a clinical-stage
biopharmaceutical company committed to the advancement of
innovative products for women’s health. The company’s mission is to
identify, develop and bring to market a diverse portfolio of
differentiated therapies that expand treatment options, improve
outcomes and facilitate convenience for women, primarily in the
areas of contraception, vaginal health, sexual health, and
fertility.
Daré’s product portfolio includes potential
first-in-category candidates in clinical development: Ovaprene®, a
hormone-free, monthly vaginal contraceptive; Sildenafil Cream,
3.6%, a novel cream formulation of sildenafil to treat female
sexual arousal disorder utilizing the active ingredient in Viagra®;
DARE-BV1, a unique hydrogel formulation of clindamycin phosphate 2%
to treat bacterial vaginosis via a single application; and
DARE-HRT1, a combination bioidentical estradiol and progesterone
intravaginal ring for hormone replacement therapy following
menopause. To learn more about Daré’s full portfolio of women’s
health product candidates, and mission to deliver differentiated
therapies for women, please visit www.darebioscience.com.
Daré may announce material information about its
finances, product candidates, clinical trials and other matters
using its investor relations website
(http://ir.darebioscience.com), SEC filings, press releases, public
conference calls and webcasts. Daré will use these channels to
distribute material information about the company, and may also use
social media to communicate important information about the
company, its finances, product candidates, clinical trials and
other matters. The information Daré posts on its investor relations
website or through social media channels may be deemed to be
material information. Daré encourages investors, the media, and
others interested in the company to review the information Daré
posts on its investor relations website
(https://darebioscience.gcs-web.com/) and to follow these Twitter
accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the
list of social media channels the company may use to communicate
information will be posted on the investor relations page of Daré’s
website mentioned above.
Forward-Looking Statements
Daré cautions you that all statements, other
than statements of historical facts, contained in this press
release, are forward-looking statements. Forward-looking
statements, in some cases, can be identified by terms such as
“believe,” “may,” “will,” “estimate,” “continue,” “anticipate,”
“design,” “intend,” “expect,” “could,” “plan,” “potential,”
“predict,” “seek,” “should,” “would,” “contemplate,” project,”
“target,” “tend to,” or the negative version of these words and
similar expressions. Such statements include, but are not limited
to, statements relating to the potential for up to $2.5
million of additional funding from the Gates Foundation in 2020,
the ability of the Microchips drug delivery system to operate as
designed in human clinical trials, the potential application of the
Microchips drug delivery system in multiple therapeutic
indications, including contraception, and Microchips’
transaction-related expenses. Forward-looking statements
involve known and unknown risks, uncertainties and other factors
that may cause Daré’s actual results, performance or achievements
to be materially different from future results, performance or
achievements expressed or implied by the forward-looking statements
in this press release, including, without limitation, risk and
uncertainties related to: Daré’s ability to raise additional
capital when and as needed to advance its product candidates;
receipt of additional grant funding from the Gates Foundation;
Daré’s ability to develop, obtain regulatory approval for, and
commercialize its product candidates; the failure or delay in
starting, conducting and completing clinical trials or obtaining
FDA or foreign regulatory approval for Daré’s product candidates in
a timely manner; Daré’s ability to conduct and design successful
clinical trials, to enroll a sufficient number of patients, to meet
established clinical endpoints, to avoid undesirable side effects
and other safety concerns, and to demonstrate sufficient safety and
efficacy of its product candidates; the risk that promising results
in pre-clinical studies may not be replicated when a product
candidate is tested in human subjects; Daré’s ability to retain its
licensed rights to develop and commercialize a product candidate;
Daré’s ability to satisfy the monetary obligations and other
requirements in connection with its exclusive, in-license
agreements covering the critical patents and related intellectual
property related to its product candidates; developments by Daré’s
competitors that make its product candidates less competitive or
obsolete; Daré’s dependence on third parties to conduct clinical
trials and manufacture clinical trial material; Daré’s ability to
adequately protect or enforce its, or its licensor’s, intellectual
property rights; the lack of patent protection for the active
ingredients in certain of Daré’s product candidates which could
expose its products to competition from other formulations using
the same active ingredients; the risk of failure associated with
product candidates in preclinical stages of development that may
lead investors to assign them little to no value and make these
assets difficult to fund; and disputes or other developments
concerning Daré’s intellectual property rights. Daré’s
forward-looking statements are based upon its current expectations
and involve assumptions that may never materialize or may prove to
be incorrect. All forward-looking statements are expressly
qualified in their entirety by these cautionary statements. For a
detailed description of Daré’s risks and uncertainties, you are
encouraged to review its documents filed with the SEC including
Daré’s recent filings on Form 8-K, Form 10-K and Form 10-Q. You are
cautioned not to place undue reliance on forward-looking
statements, which speak only as of the date on which they were
made. Daré undertakes no obligation to update such statements to
reflect events that occur or circumstances that exist after the
date on which they were made, except as required by law.
Contacts:
Investors on behalf of Daré Bioscience, Inc.:Lee
RothBurns McClellanlroth@burnsmc.com212.213.0006
OR
Media on behalf of Daré Bioscience, Inc.:Jake
RobisonCanale Communicationsjake@canalecomm.com619.849.5383
Source: Daré Bioscience
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