Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s
health innovation, today reported financial results for the year
ended December 31, 2019 and provided a company update.
“During the fourth quarter of 2019 and into
early 2020, we made considerable progress against our longer-term
strategic and operational objectives, particularly with our
later-stage candidates Ovaprene®, DARE-BV1, and Sildenafil Cream,
3.6%. This progress has helped position us for what we expect to be
a transformative year for Daré. In 2020, we expect to achieve a
number of important milestones that we believe will deliver value
to our shareholders,” said Sabrina Martucci Johnson, President and
CEO of Daré.
“We started 2020 with the announcement of our
exclusive licensing agreement with Bayer, a world leader in women’s
health, for U.S. commercial rights to Ovaprene, our investigational
hormone-free, monthly contraceptive. Our agreement with Bayer is
perhaps the most significant deal in our company’s history as we
are eligible to receive a $20 million payment to reimburse Ovaprene
clinical development costs and commercial milestone payments
potentially totaling up to $310 million, in addition to tiered,
double-digit royalties on net sales. Moreover, we believe that
Bayer is the ideal partner for Ovaprene, given its track record in
women’s health and unparalleled expertise commercializing
first-in-category contraceptive products. We ended 2019 with
the announcement of the positive Ovaprene data that led to the
partnership with Bayer, as well as important alignment with the FDA
on the planned DARE-BV1 Phase 3 clinical study for the treatment of
bacterial vaginosis and on the planned Phase 2b clinical study of
Sildenafil Cream, 3.6% for Female Sexual Arousal Disorder.”
Ms. Johnson added, “We are currently on track to
conduct and report topline results from the planned Phase 3 study
of DARE-BV1 before the end of 2020, as well as to report topline
results of the planned Sildenafil Cream, 3.6% Phase 2b study in
2021 and the planned Ovaprene pivotal study in 2022. As a result of
the COVID-19 pandemic, these are unprecedented times, circumstances
are rapidly evolving, both from a macroeconomic perspective and in
our industry, and we will continue to assess our circumstances and
development timelines. We believe our unique accelerator
model, with our variety of programs and diversity of indications
and development stages, enables us to react quickly to the highly
dynamic and uncertain environment that we find ourselves facing
today. As a result, we believe we are well-positioned to
deliver the topline clinical data and regulatory actions projected
over the next three years.”
Portfolio Highlights:
- Ovaprene - 4Q 2019 – announced positive topline results of the
postcoital test (PCT) clinical study of Ovaprene, Daré’s
investigational hormone-free, monthly contraceptive.
- Sildenafil Cream, 3.6% - 4Q 2019 – announced alignment with FDA
on the design and novel primary endpoint patient-reported outcome
(PRO) instruments for the planned Phase 2b clinical study of
Sildenafil Cream, 3.6% for the treatment of Female Sexual Arousal
Disorder (FSAD), the female sexual dysfunction disorder most
analogous to erectile dysfunction in men.
- DARE-BV1 – 4Q 2019 – announced FDA clearance of the
investigational new drug (IND) application for DARE-BV1, enabling a
2020 pivotal Phase 3 study of DARE-BV1 for the treatment of
bacterial vaginosis.
Corporate Highlights
- 4Q 2019 – Completed acquisition of Microchips Biotech,
Inc.
- 1Q 2020 – Executed Ovaprene license agreement with Bayer
HealthCare, LLC
Operating Results
- General and administrative expenses were approximately $5.3
million for 2019, as compared to approximately $4.7 million
for 2018, with the increase due primarily to additional staff and
staff-related expenses and higher insurance costs, partially offset
by a decrease in expenses for accounting, legal and other
professional services.
- Research and development expenses were approximately $8.5
million for 2019, as compared to approximately $6.4
million for 2018, due primarily to increased costs of
development activities for DARE-BV1, Ovaprene, DARE-HRT1, DARE-FRT1
and Sildenafil Cream, 3.6%, and increased personnel costs,
partially offset by an increase in grant funding related to
Ovaprene and decreased costs of development activities for
pre-clinical stage product candidates.
- License expenses were approximately $0.5 million for 2019, as
compared to $0.6 million for 2018 and represent fees due under
Daré’s various product license agreements.
- Comprehensive loss for 2019 was approximately $15.1
million, as compared to approximately $16.8 million for the
prior year. While Daré’s overall operating expenses were higher in
2019, comprehensive loss decreased primarily because there was an
impairment of goodwill for 2018 totaling approximately $5.2 million
and no impairment charge in 2019.
Cash
and Cash Equivalents
- Cash and cash equivalents were approximately $4.8 million at
December 31, 2019, as compared to $6.8 million at December 31,
2018.
- Since January 1, 2020, Daré received cash gross proceeds of
approximately $8.1 million through a combination of the
upfront payment under its license agreement with Bayer, the sale
and issuance of approximately 3.3 million shares of its common
stock in at-the-market offerings, and the sale and issuance of
approximately 1.7 million shares of its common stock upon the
exercise of warrants it issued in 2018. Net proceeds to Daré
from these transactions are approximately $7.9 million.
Conference Call
Daré will host a conference call and live
webcast today at 4:30 p.m. Eastern Time to review the
company's financial results for the year ended December 31,
2019 and to provide a company update.
To access the conference call via phone, dial
(844) 831-3031 (U.S.) or (443) 637-1284 (international). The
conference ID number for the call 3266966. The live webcast can be
accessed under “Events & Presentations" in the Investor
Relations section of the company's website
at www.darebioscience.com. Please log in approximately 5-10
minutes prior to the call to register and to download and install
any necessary software. To access the replay, please call (855)
859-2056 (U.S.) or (404) 537-3406 (international). The conference
ID number for the replay is 3266966. The call and webcast replay
will be available until April 6, 2020.
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 contraceptive intravaginal ring
whose U.S. commercial rights are under a license
agreement with Bayer; 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
bio-identical 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 Daré’s expectations for clinical
development of its product candidates, including the timing of
commencement and announcement of topline results of planned
clinical studies of DARE-BV1, Sildenafil Cream, 3.6% and Ovaprene,
the potential for regulatory approval to market DARE-BV1 and
Ovaprene based on a single successful Phase 3 study or
contraceptive effectiveness and safety clinical study,
respectively, and the potential payments and non-monetary benefits
to Daré under its agreement with Bayer. 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: the effects
of the COVID-19 pandemic on Daré’s operations, financial results
and condition, and ability to achieve current plans and objectives;
Daré’s ability to continue as a going concern; Daré’s ability to
raise additional capital when and as needed, to advance its product
candidates; 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 positive findings in early clinical
and/or nonclinical studies of a product candidate may not be
predictive of success in subsequent clinical studies of that
candidate; 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; the risks that the license agreement with Bayer may not
become effective and, if it becomes effective, that future payments
to Daré under the agreement may be significantly less than the
anticipated or potential amounts; 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
Roth Burns McClellan lroth@burnsmc.com 212.213.0006
OR
Media on behalf of Daré Bioscience, Inc.:Jake
Robison Canale Communications jake@canalecomm.com
619.849.5383
Source: Daré Bioscience, Inc.
|
|
Daré
Bioscience, Inc. |
|
Condensed
Consolidated Balance Sheets |
|
(in
thousands) |
|
|
December 31, |
|
|
|
2019 |
|
|
2018 |
|
|
|
|
|
|
Cash and
cash equivalents |
$ |
4,780 |
|
$ |
6,806 |
|
Other
receivables |
|
555 |
|
|
31 |
|
Prepaid
expenses |
|
1,109 |
|
|
403 |
|
Property and
equipment, net |
|
64 |
|
|
9 |
|
Other
non-current assets |
|
935 |
|
|
578 |
|
Total assets |
$ |
7,443 |
|
$ |
7,827 |
|
Current
liabilities |
|
5,612 |
|
|
1,091 |
|
Contingent
consideration |
|
1,000 |
|
|
- |
|
Lease
liabilities long-term |
|
390 |
|
|
9 |
|
Total
stockholders' equity |
|
441 |
|
|
6,727 |
|
Total liabilities and stockholders' equity |
$ |
7,443 |
|
$ |
7,827 |
|
|
|
|
|
|
Daré
Bioscience, Inc. |
|
Consolidated
Statement of Operations |
|
(in
thousands, except share and per share data) |
|
|
Years Ended December 31, |
|
|
|
2019 |
|
|
|
2018 |
|
|
Operating expenses |
|
|
|
|
General and administrative |
$ |
5,266 |
|
|
$ |
4,656 |
|
|
Research and development expenses |
|
8,546 |
|
|
|
6,414 |
|
|
License expenses |
|
533 |
|
|
|
625 |
|
|
Impairment of goodwill |
|
- |
|
|
|
5,187 |
|
|
Total operating expenses |
|
14,345 |
|
|
|
16,882 |
|
|
Loss
from operations |
|
(14,345 |
) |
|
|
(16,882 |
) |
|
Other
income |
|
81 |
|
|
|
143 |
|
|
Net
loss |
$ |
(14,264 |
) |
|
$ |
(16,739 |
) |
|
Deemed
dividend from trigger of round down provision feature |
|
(789 |
) |
|
|
- |
|
|
Net
loss to common shareholders |
|
(15,053 |
) |
|
|
(16,739 |
) |
|
Foreign currency translation adjustments, net of tax |
|
(6 |
) |
|
|
(78 |
) |
|
Comprehensive loss |
$ |
(15,059 |
) |
|
$ |
(16,817 |
) |
|
Loss per
common share - basic and diluted |
$ |
(0.97 |
) |
|
$ |
(1.57 |
) |
|
Weighted
average number of common shares outstanding: |
|
|
|
|
Basic and diluted |
|
15,579 |
|
|
|
10,732 |
|
|
|
|
|
|
|
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