Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s
health innovation, today reported financial results for the third
quarter ended September 30, 2020 and provided a company update.
“We made great progress toward our strategic and
operational objectives during the third quarter. I’m proud to
report that despite this year’s challenging operating environment,
our team continued to execute efficiently, allowing us to maintain
our progress toward our anticipated milestones for 2020 and 2021,”
said Sabrina Martucci Johnson, President and CEO of Daré
Bioscience. “The completion of the DARE-BVFREE pivotal study of
DARE-BV1 for the treatment of bacterial vaginosis will be an
important milestone for Daré. We expect to report topline results
from this Phase 3 study before the end of 2020 and to submit a new
drug application to the FDA in the first half of 2021 if the study
is successful. It has been roughly two years since we licensed the
rights to the DARE-BV1 program, and the rapid pace at which we have
advanced its development is evidence of the strength of the entire
Daré team.”
“The DARE-BVFREE topline data read-out in Q4
2020 represents the first in a series of anticipated milestones for
our later-stage clinical-stage product candidates,” said David
Friend, PhD, Chief Scientific Officer of Daré Bioscience. “In 2021,
we are planning to initiate a Phase 2b study of Sildenafil Cream,
3.6%, our candidate for female sexual arousal disorder, the sexual
dysfunction condition in women most analogous to erectile
dysfunction in men, and look forward to reporting topline data from
this study by the end of 2021. FSAD is a highly pervasive condition
for which no FDA-approved product exists. A safe, effective and
convenient option for women is long overdue, and we hope to be able
to provide such a solution. In 2021, we also look forward to
advancing Ovaprene®, our investigational hormone-free, monthly
contraceptive, into a pivotal study that we expect, if successful,
to support a premarket approval submission to the FDA.”
U.S. commercial rights for Ovaprene are
subject to a license agreement with Bayer, which was announced
earlier this year.
Recent Business
Highlights
- DARE-LARC1: Received approximately
$0.9 million in funding that remained under a pre-existing grant
from the Bill & Melinda Gates Foundation in further support of
DARE-LARC1 development activities. Development of DARE-LARC1 has
been supported by a total of approximately $20.5 million in grant
funding from the foundation, including this recent
disbursement.
- DARE-FRT1: Received a Notice of
Award of a grant of approximately $0.3 million from the Eunice
Kennedy Shriver National Institute of Child Health and Human
Development (NICHD), a division of the National Institutes of
Health (NIH). NIH funding is awarded in phases and Daré may be
eligible to receive up to a total of approximately $2.3 million in
grant funding for the DARE-FRT1 program based on the grant
application it submitted to support the DARE-FRT1 Phase 1 human
clinical study. DARE-FRT1 is being developed for the prevention of
preterm birth and broader luteal phase support as part of an in
vitro fertilization regimen. The potential additional grant funding
of approximately $2.0 million is contingent upon satisfying
specified requirements and the availability of funds in the
future.
- Strategic CRO partnership: Entered
into an agreement with Avomeen, an accredited, independent contract
research, development, and manufacturing organization specializing
in chemical analysis and product development, under which Avomeen
will provide contract product development laboratory services with
a team specifically assembled to support the advancement of Daré’s
innovative pipeline.
Third Quarter
2020 Financial
Results
- General and administrative expenses
were approximately $1.4 million for the third quarter of 2020, a
modest increase over the approximately $1.3 million incurred in the
third quarter of 2019, with increased personnel costs, rent and
facilities expenses and stock-based compensation expense partially
offset by lower expenses for professional services.
- Research and development expenses
were approximately $6.2 million for the third quarter of 2020, as
compared to approximately $2.0 million for the third quarter of
2019. The increase was due primarily to increased expenses related
to development activities for DARE-BV1, Ovaprene and DARE-LARC1,
and higher personnel costs, with such expenses partially offset by
grant funding related to both Ovaprene and DARE-LARC1, and a
decrease in costs related to development activities for DARE-HRT1
and Sidenafil Cream, 3.6%.
- License expenses, which reflect
payments due under Daré’s various product license agreements, were
approximately $25,000 for the third quarter of 2020, as compared to
approximately $133,300 for the third quarter of 2019.
- Comprehensive loss for the third
quarter of 2020 was approximately $7.6 million, as compared to
approximately $3.4 million for the same period in the prior year,
substantially due to a greater loss from operations in the third
quarter of 2020.
- Net cash provided by financing
activities for the nine months ended September 30, 2020 was
approximately $16.7 million and consisted of net proceeds from
sales of common stock in “at-the-market” offerings and under the
company’s equity line, proceeds from exercises of warrants and
options and loan proceeds.
- Cash and cash equivalents were
approximately $5.4 million at September 30, 2020, compared to
approximately $4.8 million at December 31, 2019.
Recent
Developments
- Additional cash of approximately
$4.5 million (net of fees) was raised from sales of common stock in
“at-the-market” offerings and under the company’s equity line after
third quarter-end through November 11, 2020.
- As of November 11, 2020,
approximately 38 million shares of Daré common stock were
outstanding.
COVID-19 Update: Daré continues to monitor the
pandemic, its associated restrictions and their potential effects
on the company’s business, financial condition and results of
operations, including the potential impacts on the company’s
ongoing and planned clinical trials and the company’s ability to
raise additional capital when needed. Due to the high level of
uncertainty regarding the duration and impact of the COVID-19
pandemic on the U.S. and global economies, workplace environments
and capital markets, Daré is unable to predict with any reasonable
accuracy the full extent to which the pandemic will impact its
business, financial condition or results of operations at this
time.
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 quarter ended September 30,
2020 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 6519434. The live webcast can be
accessed under “Presentations, Events & Webcasts" in the
Investors section of the company's website
at http://ir.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 6519434. The call and
webcast replay will be available until November 19, 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 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
topline results of the DARE-BVFREE study and submission of an NDA
for DARE-BV1 to the FDA, the potential for NDA filing and
regulatory approval to market DARE-BV1 based on a single successful
Phase 3 study, commencement and announcement of topline results of
clinical studies of Sildenafil Cream, 3.6% and Ovaprene, the
potential for Sildenafil Cream, 3.6% to be the first FDA-approved
product to treat female sexual arousal dysfunction, the potential
for a premarket application filing and regulatory approval to
market Ovaprene based on a single successful contraceptive efficacy
study, and potential additional grant funding from the NICHD for
development of DARE-FRT1. 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 and
continue as a going concern; the effects of the COVID-19 pandemic
on Daré’s operations, financial results and condition, and ability
to achieve current plans and objectives, including the potential
impact of the pandemic on Daré’s ability to timely enroll, conduct
and report results of its clinical trials and on the ability of
third parties on which Daré relies to assist in the conduct of its
business, including its clinical trials, to fulfill their
contractual obligations to Daré; 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 and/or nonclinical
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; cyber attacks,
security breaches or similar events that compromise Daré’s
technology systems or those of third parties on which it relies
and/or significantly disrupt Daré’s business; 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.
Contact:
Investors on behalf of Daré Bioscience, Inc.:Lee
RothBurns McClellanlroth@burnsmc.com212.213.0006
Source: Daré Bioscience, Inc.
|
Daré Bioscience, Inc. and
Subsidiaries |
Consolidated Statements of Operations and Comprehensive
Loss |
(Unaudited) |
|
|
|
|
|
|
|
|
|
Three months ended |
|
Nine months ended |
|
September 30, |
|
September 30, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Operating expenses |
|
|
|
|
|
|
|
General and administrative |
$ |
1,353,069 |
|
|
$ |
1,318,986 |
|
|
$ |
4,772,382 |
|
|
$ |
3,903,545 |
|
Research and development expenses |
|
6,203,753 |
|
|
|
1,966,230 |
|
|
|
14,131,007 |
|
|
|
6,172,192 |
|
License expenses |
|
25,000 |
|
|
|
133,333 |
|
|
|
58,333 |
|
|
|
408,333 |
|
Total operating expenses |
|
7,581,822 |
|
|
|
3,418,549 |
|
|
|
18,961,722 |
|
|
|
10,484,070 |
|
Loss from operations |
|
(7,581,822 |
) |
|
|
(3,418,549 |
) |
|
|
(18,961,722 |
) |
|
|
(10,484,070 |
) |
Other income |
|
(986 |
) |
|
|
25,471 |
|
|
|
2,454 |
|
|
|
86,703 |
|
Net loss |
$ |
(7,582,808 |
) |
|
$ |
(3,393,078 |
) |
|
$ |
(18,959,268 |
) |
|
$ |
(10,397,367 |
) |
Deemed dividend from trigger of down round provision feature |
$ |
(6,864 |
) |
|
$ |
- |
|
|
$ |
(6,864 |
) |
|
$ |
(789,594 |
) |
Net loss to common shareholders |
$ |
(7,589,672 |
) |
|
$ |
(3,393,078 |
) |
|
$ |
(18,966,132 |
) |
|
$ |
(11,186,961 |
) |
Foreign currency translation adjustments |
$ |
672 |
|
|
$ |
(15,378 |
) |
|
$ |
(10,182 |
) |
|
$ |
(15,674 |
) |
Comprehensive loss |
$ |
(7,589,000 |
) |
|
$ |
(3,408,456 |
) |
|
$ |
(18,976,314 |
) |
|
$ |
(11,202,635 |
) |
Loss per common share - basic and diluted |
$ |
(0.24 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.69 |
) |
|
$ |
(0.76 |
) |
Weighted average number of common shares outstanding: |
|
|
|
|
|
|
|
Basic and diluted |
|
31,588,152 |
|
|
|
16,683,411 |
|
|
|
27,381,508 |
|
|
|
14,756,213 |
|
|
|
|
|
|
|
|
|
Daré Bioscience, Inc. and Subsidiaries |
Condensed Consolidated Balance Sheets |
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
2020 |
|
2019 |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
5,389,414 |
|
|
$ |
4,780,107 |
|
Working capital (deficit) |
$ |
(980,230 |
) |
|
$ |
831,526 |
|
Total assets |
$ |
7,661,742 |
|
|
$ |
7,442,788 |
|
Total liabilities |
$ |
9,047,630 |
|
|
$ |
7,001,962 |
|
Total stockholders' equity (deficit) |
$ |
(1,385,888 |
) |
|
$ |
440,826 |
|
|
|
|
|
|
|
|
|
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