Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s
health innovation, today reported financial results for the second
quarter ended June 30, 2019 and provided a Company update.
“Daré made tremendous progress during the second
quarter and remains on track to announce meaningful milestones
during the remainder of 2019 and 2020,” said Sabrina Martucci
Johnson, President and CEO of Daré. “In June, we were pleased to
announce the completion of enrollment for the Ovaprene postcoital
test clinical trial, an important milestone in the development of
this potential first-in-category, hormone-free contraceptive
candidate. As we enter the second half of the year, we believe we
are well positioned to deliver value across our entire portfolio of
clinical-stage product candidates, including reporting topline data
for the Ovaprene postcoital test clinical trial and initiating the
Phase 3 study for DARE-BV1 in the fourth quarter of 2019, and
continuing to advance the Sildenafil Cream, 3.6% program for Female
Sexual Arousal Disorder.”
Quarter Ended June 30, 2019 Financial
Results
- Cash and cash equivalents:
- As of June 30, 2019, cash and
cash equivalents were approximately $5.6 million, including the
$5.2 million of net proceeds the Company raised from the
underwritten offering it completed in April 2019.
- In March 2019, the Company received
a Notice of Award for an additional $982,851 of the anticipated
$1.9 million grant from the Eunice Kennedy Shriver National
Institute of Child Health and Human Development. During the second
quarter, the Company continued its activities under the Ovaprene
postcoital test clinical trial and to use the grant to offset
certain study expenses. As of June 30, 2019, the Company recorded a
receivable of $456,484 for expenses eligible for reimbursement
under the grant that were incurred through June 30th.
- General and administrative expenses
were $1.3 million for the second quarter of 2019, as compared
to $1.2 million for the same period in 2018. During the
second quarter of 2019, an increase in personnel costs due to staff
additions was partially offset by a decrease in expenses related to
outside professional services.
- Research and development expenses
were $2.5 million for the second quarter of 2019, as
compared to $2.2 million for the same period in 2018. The
increase reflects development activities of approximately $518,000
for two ongoing studies – the postcoital test clinical trial
of Ovaprene and the content validity study of Sildenafil Cream,
3.6% – and to a lesser extent, activities to prepare for the
clinical trials of DARE-BV1 (Phase 3) and DARE-HRT1 (Phase 1) that
the Company expects to initiate later this year. The research and
development expenses related to Ovaprene were partially offset by
grant funding of approximately $456,000. During the second quarter
of 2019, an increase in employees led to an increase in personnel
costs of $233,000 as compared with the same period in 2018.
- The Company reported a
comprehensive loss of $4.7 million for the second quarter of
2019, as compared to a loss of $3.6 million for the same
period in 2018. The loss incurred during the second quarter of 2019
included a non-cash deemed dividend of approximately $790,000 in
light of a reset in the exercise price of certain outstanding
warrants.
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,
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 is 2679339. 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 2679339. The call and webcast replay
will be available until August 21, 2019.
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; 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 the company'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 ability to announce meaningful
milestones during the remainder of 2019 and 2020, and to deliver
value across its entire portfolio of clinical-stage product
candidates, including the timing of reporting topline data for the
Ovaprene postcoital test clinical trial and the timing of
initiating the Phase 3 study for DARE-BV1. 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 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; 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
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
|
Daré Bioscience, Inc. and Subsidiaries |
Consolidated Statements of Operations and Comprehensive
Loss |
(Unaudited) |
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
Operating
expenses: |
|
|
|
|
|
|
|
General and administrative |
$ |
1,307,379 |
|
|
$ |
1,157,174 |
|
|
$ |
2,584,559 |
|
|
$ |
2,460,363 |
|
Research and development expenses |
|
2,512,572 |
|
|
|
2,217,622 |
|
|
|
4,205,963 |
|
|
|
3,304,275 |
|
License expenses |
|
162,500 |
|
|
|
250,000 |
|
|
|
275,000 |
|
|
|
350,000 |
|
Impairment of goodwill |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
5,187,519 |
|
Total operating expenses |
|
3,982,451 |
|
|
|
3,624,796 |
|
|
|
7,065,522 |
|
|
|
11,302,157 |
|
Loss from
operations |
|
(3,982,451 |
) |
|
|
(3,624,796 |
) |
|
|
(7,065,522 |
) |
|
|
(11,302,157 |
) |
Other income (expense) |
|
30,001 |
|
|
|
42,626 |
|
|
|
61,232 |
|
|
|
54,370 |
|
Net loss |
$ |
(3,952,450 |
) |
|
$ |
(3,582,170 |
) |
|
$ |
(7,004,290 |
) |
|
$ |
(11,247,787 |
) |
Deemed dividend from trigger
of down round provision feature |
$ |
(789,594 |
) |
|
$ |
- |
|
|
$ |
(789,594 |
) |
|
$ |
- |
|
Net loss to common
shareholders |
$ |
(4,742,044 |
) |
|
$ |
(3,582,170 |
) |
|
$ |
(7,793,884 |
) |
|
$ |
(11,247,787 |
) |
Foreign currency translation adjustments |
$ |
(7,917 |
) |
|
$ |
(27,485 |
) |
|
$ |
(296 |
) |
|
$ |
(41,231 |
) |
Comprehensive
loss |
$ |
(4,749,961 |
) |
|
$ |
(3,609,655 |
) |
|
$ |
(7,794,180 |
) |
|
$ |
(11,289,018 |
) |
Loss per common share - basic
and diluted |
$ |
(0.29 |
) |
|
$ |
(0.32 |
) |
|
$ |
(0.57 |
) |
|
$ |
(1.13 |
) |
Weighted average number of
common shares outstanding: |
|
|
|
|
|
|
|
Basic and diluted |
|
16,105,252 |
|
|
|
11,422,161 |
|
|
|
13,776,643 |
|
|
|
10,031,249 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Daré Bioscience, Inc. and Subsidiaries |
|
|
|
|
Consolidated Balance Sheets |
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,2019 |
|
December 31,2018 |
|
|
|
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents |
$ |
5,630,569 |
|
|
$ |
6,805,889 |
|
|
|
|
|
Working
capital |
$ |
4,587,617 |
|
|
$ |
6,148,967 |
|
|
|
|
|
Total
assets |
$ |
7,260,932 |
|
|
$ |
7,827,387 |
|
|
|
|
|
Total stockholders'
equity |
$ |
5,083,055 |
|
|
$ |
6,726,620 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Source: Daré Bioscience
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