Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s
health innovation, today reported financial results for the second
quarter ended June 30, 2020 and provided a company update.
“During the second quarter, we continued to
execute on key strategic and operational objectives, despite the
challenges presented by the COVID-19 pandemic,” said Sabrina
Martucci Johnson, President and CEO of Daré Bioscience.
“Importantly, we initiated the DARE-BVFREE pivotal study for
DARE-BV1 in June. Given the anticipated short duration of the
study, we expect to report topline data from the study by year-end
2020. Positive results from this single pivotal study will enable
us to submit a new drug application for DARE-BV1 with the FDA in
early 2021, two years from licensing the technology.”
Daré licensed the rights to DARE-BV1 and the
underlying hydrogel technology at the end of 2018. The company
applied for and obtained a qualified infectious disease product
(QIDP) designation from the U.S. Food and Drug Administration (FDA)
for DARE-BV1 in 2019, making DARE-BV1 eligible for a 5-year
marketing exclusivity extension for the treatment of bacterial
vaginosis in women upon approval. Daré also received Fast Track
designation for DARE-BV1 for the treatment of bacterial vaginosis,
which is granted by the FDA for drugs that are intended for the
treatment of serious or life-threatening diseases or conditions and
demonstrate the potential to address an unmet medical need.
The designation offers the opportunity for more frequent
interactions with the FDA to discuss the drug’s development plan
and ensure collection of appropriate data needed to support FDA
approval. The Fast Track program is intended to facilitate
development and expedite review of a Fast Track drug so that an
approved product can reach the market expeditiously.
“The DARE-BVFREE study represents the first of a
series of important upcoming milestones for our clinical-stage
product candidates that are integral to our value creation
strategy,” said William Rastetter, PhD, Chairman of Daré’s Board of
Directors. “In addition to anticipating the topline data readout
for our Phase 3 study of DARE-BV1 in 2020, in 2021, we expect to
report topline data from our planned Phase 2b study of Sildenafil
Cream (3.6%) in female sexual arousal disorder, as well as topline
data from our ongoing Phase 1 study of DARE-HRT1 for the vasomotor
symptoms of menopause; and in 2022, we expect to report topline
data for our planned pivotal contraceptive study of Ovaprene.”
Recent Business Highlights
- Ovaprene® – Publication of a peer-reviewed article supporting
the use of the postcoital test study as a predictor of
contraceptive effectiveness in Biology of Reproduction.
- DARE-BV1 – Initiation of DARE-BVFREE pivotal Phase 3 clinical
trial of DARE-BV1 in patients with bacterial vaginosis.
- DARE-HRT1 – Initiation of Phase 1 clinical trial of DARE-HRT1,
a novel intravaginal ring designed to deliver non-oral,
bio-identical hormone therapy for the treatment of menopausal
symptoms.
- DARE-LARC1 – Receipt of $1.6 million in additional grant
funding from the Bill & Melinda Gates Foundation for the
continued development of a user-controlled, long-acting reversible
contraceptive. The remaining approximately $900,000 in funding
under the current grant supplement from the foundation may be
awarded before the end of 2020 in further support of DARE-LARC1
development activities.
Second Quarter 2020 Financial
Results
- General and administrative expenses were approximately $1.6
million for the second quarter of 2020, as compared to
approximately $1.3 million for the second quarter of 2019, with the
increase primarily due to increased personnel costs and an increase
in rent and facilities expenses.
- Research and development expenses were approximately $5.6
million for the second quarter of 2020, as compared to
approximately $2.5 million for the second quarter of 2019. The
increase was due primarily to expenses related to development
activities for DARE-BV1, Ovaprene and DARE-LARC1, and increased
personnel costs, with such expenses partially offset by grant
funding related to both Ovaprene and DARE-LARC1, and reduced costs
related to development activities for Sidenafil Cream, 3.6% and
DARE-HRT1.
- License expenses, which reflect payments due under Daré’s
various product license agreements, were approximately $21,000 for
the second quarter of 2020, as compared to $162,500 for the second
quarter of 2019.
- Comprehensive loss for the second quarter of 2020 was
approximately $7.1 million, as compared to approximately $4.7
million for the same period in the prior year substantially due to
a greater loss from operations in the second quarter of 2020.
- Net cash provided by financing activities for the six months
ended June 30, 2020 was approximately $11.3 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 $5.3 million at
June 30, 2020, compared to approximately $4.8 million at December
31, 2019.
Recent Developments
- Additional cash of approximately $3.4 million (net of fees)
raised after June 30, 2020 from sales of common stock in
“at-the-market” offerings and under the company’s equity line. As
of August 11, 2020, approximately 31.6 million shares of Daré
common stock are outstanding.
Upcoming Milestones
- DARE-BV1 – topline data expected by year-end 2020; New drug
application (NDA) submission anticipated early 2021
- DARE-HRT1 – topline data expected first half 2021
- Sildenafil Cream, 3.6% - topline data expected by year-end
2021
- Ovaprene – topline data expected by year-end 2022
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
planned clinical trials and its ability to raise additional capital
when needed. Due to rapidly evolving circumstances, Daré is unable
to predict with any reasonable accuracy the full financial and
business impact of the pandemic on 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 June 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 4097126. 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 4097126. The call and webcast replay
will be available until August 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 clinical-stage 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 clinical
studies of DARE-BV1, DARE-HRT1, Sildenafil Cream, 3.6% and
Ovaprene, the potential for NDA filing and regulatory approval to
market DARE-BV1 based on a single successful Phase 3 study,
timing of submission of a NDA for DARE-BV1 with the FDA,
benefits of QIDP and Fast Track designations for the DARE-BV1
program, and potential additional grant funding for development of
DARE-LARC1. 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; 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
Roth Burns McClellan lroth@burnsmc.com 212.213.0006
Source: Daré Bioscience, Inc.
Daré Bioscience, Inc. and Subsidiaries |
Consolidated Statements of Operations and Comprehensive
Loss |
(Unaudited) |
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
$ |
1,557,548 |
|
|
$ |
1,307,379 |
|
|
$ |
3,419,313 |
|
|
$ |
2,584,559 |
|
Research and development expenses |
5,547,450 |
|
|
2,512,572 |
|
|
7,927,254 |
|
|
4,205,963 |
|
License expenses |
20,833 |
|
|
162,500 |
|
|
33,333 |
|
|
275,000 |
|
Total operating expenses |
7,125,831 |
|
|
3,982,451 |
|
|
11,379,900 |
|
|
7,065,522 |
|
Loss from operations |
(7,125,831 |
) |
|
(3,982,451 |
) |
|
(11,379,900 |
) |
|
(7,065,522 |
) |
Other income |
1,618 |
|
|
30,001 |
|
|
3,439 |
|
|
61,232 |
|
Net loss |
$ |
(7,124,213 |
) |
|
$ |
(3,952,450 |
) |
|
$ |
(11,376,461 |
) |
|
$ |
(7,004,290 |
) |
Deemed dividend from trigger of
down round provision |
$ |
- |
|
|
$ |
(789,594 |
) |
|
$ |
- |
|
|
$ |
(789,594 |
) |
Net loss to common
shareholders |
$ |
(7,124,213 |
) |
|
$ |
(4,742,044 |
) |
|
$ |
(11,376,461 |
) |
|
$ |
(7,793,884 |
) |
Foreign currency translation adjustments |
$ |
12,090 |
|
|
$ |
(7,917 |
) |
|
$ |
(10,854 |
) |
|
$ |
(296 |
) |
Comprehensive loss |
$ |
(7,112,123 |
) |
|
$ |
(4,749,961 |
) |
|
$ |
(11,387,315 |
) |
|
$ |
(7,794,180 |
) |
Loss per common share - basic and
diluted |
$ |
(0.27 |
) |
|
$ |
(0.29 |
) |
|
$ |
(0.45 |
) |
|
$ |
(0.57 |
) |
Weighted average number of common
shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
26,710,750 |
|
|
16,105,252 |
|
|
25,255,073 |
|
|
13,776,643 |
|
Daré Bioscience, Inc. and Subsidiaries |
Condensed Consolidated Balance Sheets |
|
June 30, |
|
December 31, |
|
2020 |
|
2019 |
|
(unaudited) |
|
|
Cash and cash equivalents |
$ |
5,346,872 |
|
$ |
4,780,107 |
Working capital |
$ |
1,693,020 |
|
$ |
831,526 |
Total assets |
$ |
8,570,370 |
|
$ |
7,442,788 |
Total liabilities |
$ |
8,259,115 |
|
$ |
7,001,962 |
Total stockholders'
equity |
$ |
311,255 |
|
$ |
440,826 |
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