Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s
health innovation, today reported financial results for the first
quarter ended March 31, 2019 and provided a Company update.
“The first quarter was an active one for Daré
and positioned us well for the year ahead,” said Sabrina Martucci
Johnson, President and CEO of Daré. “We believe our differentiated
product candidate portfolio is well poised to drive value in 2019
and 2020 as we seek to execute against clinical and regulatory
milestones, particularly with our Phase 3 and Phase 2 candidates.
During the first quarter, we continued enrollment in the postcoital
test clinical trial of Ovaprene, our monthly, non-hormonal
contraceptive candidate, and we remain on track to report top-line
data in the second half of 2019. In addition, work continued on the
content validity patient reported outcome study of Sildenafil
Cream, 3.6%, positioning us to request a Type C meeting with the
FDA later this year at which we intend to obtain its guidance on
the endpoints for our Phase 2b and Phase 3 clinical trials for
female sexual arousal disorder. Finally, activities related to the
clinical supply and regulatory requirements of our single-dose
potential treatment for bacterial vaginosis, DARE-BV1, are underway
to support initiation of a Phase 3 trial later this year.”
Quarter Ended March 31, 2019 Financial
Results
- Cash and cash equivalents:○ As
of March 31, 2019, cash and cash equivalents were
approximately $3.5 million. ○ 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. The
Company will seek reimbursement for allowed expenses under this
grant throughout 2019 to cover a portion of the costs associated
with the ongoing Ovaprene postcoital test clinical trial.○ In
April 2019, the Company completed the sale of 5.26 million shares
of its common stock in an underwritten offering raising net
proceeds of approximately $5.2 million.
- General and administrative expenses
were $1.28 million for the first quarter of 2019, as compared
to $1.30 million for the same period in 2018. A reduction
in fees for legal and professional services during the first
quarter of 2019 was offset by higher personnel costs related to
staff additions during the prior six months.
- Research and development expenses
were $1.69 million for the first quarter of 2019, as
compared to $1.09 million for the same period in 2018.
The increase reflects development activities of approximately
$389,000 for two ongoing studies--the postcoital test clinical
study 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 Company reported a
comprehensive net loss of $3.04 million for the first quarter
of 2019, as compared to loss of $7.68 million for the same
period in 2018. The higher loss in the first quarter of 2018
included a non-cash charge of $5.2 million related to the
impairment of goodwill.
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 March 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 is 2297055. 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 2297055. The call and webcast replay
will be available until May 21, 2019.
About Daré Bioscience
Daré Bioscience is a clinical-stage
biopharmaceutical company committed to the advancement of
innovative products for women’s sexual health, vaginal health,
fertility, and contraception. The company’s mission is to identify,
develop and bring to market a portfolio of novel, differentiated
therapies that expand treatment options, improve outcomes and
facilitate convenience for women in these targeted areas.
Daré’s product portfolio includes potential
first-in-class candidates in clinical development: Ovaprene®, a
non-hormonal, monthly contraceptive vaginal 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 novel 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 the ability of Daré’s product candidate
portfolio to drive value in 2019 and 2020, the timing of reporting
top-line data from the postcoital test clinical trial of Ovaprene,
and the timing of future clinical trials for DARE-BV1 and
DARE-HRT1. 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.:
Alex GrayBurns
McClellanagray@burnsmc.com212-213-0006
OR
Media on behalf of Daré Bioscience, Inc.:
Jordann PhillipsCanale
CommunicationsJordann@canalecomm.com619-849-6009
|
Daré Bioscience, Inc.
and Subsidiaries |
Consolidated Statements
of Operations
and Comprehensive
Loss |
(Unaudited) |
|
|
Three months ended March 31, |
|
|
2019 |
|
|
|
2018 |
|
Operating
expenses |
|
|
|
General and administrative |
$ |
1,277,180 |
|
|
$ |
1,303,189 |
|
Research and development expenses |
$ |
1,693,391 |
|
|
$ |
1,086,653 |
|
License expenses |
$ |
112,500 |
|
|
$ |
100,000 |
|
Impairment of goodwill |
|
— |
|
|
$ |
5,187,519 |
|
Total operating expenses |
$ |
3,083,071 |
|
|
$ |
7,677,361 |
|
Loss from
operations |
$ |
(3,083,071 |
) |
|
$ |
(7,677,361 |
) |
Other income |
$ |
31,231 |
|
|
$ |
11,744 |
|
Net loss |
$ |
(3,051,840 |
) |
|
$ |
(7,665,617 |
) |
Foreign currency translation adjustments |
$ |
7,621 |
|
|
$ |
(13,746 |
) |
Comprehensive
loss |
$ |
(3,044,219 |
) |
|
$ |
(7,679,363 |
) |
Loss per common share - basic
and diluted |
$ |
(0.27 |
) |
|
$ |
(0.88 |
) |
Weighted average number of
common shares outstanding: |
|
|
|
Basic and diluted |
|
11,422,161 |
|
|
|
8,684,550 |
|
Daré Bioscience, Inc. and Subsidiaries |
Consolidated Balance Sheets |
|
|
|
|
|
March 31, |
|
December 31, |
|
|
2019 |
|
|
2018 |
|
|
(unaudited) |
|
|
|
|
|
|
Cash and cash equivalents |
$ |
3,505,026 |
|
|
$ |
6,805,889 |
|
Working
capital |
$ |
3,243,816 |
|
|
$ |
6,148,967 |
|
Total
assets |
$ |
5,019,855 |
|
|
$ |
7,827,387 |
|
Total stockholders'
equity |
$ |
3,780,369 |
|
|
$ |
6,726,620 |
|
|
|
|
|
|
|
|
|
In April 2019, the Company completed the sale of
5.26 million shares of its common stock in an underwritten offering
raising net proceeds of approximately $5.2 million. Such offering
occurred after the end of the first quarter of 2019, and hence,
such offering proceeds are not reflected in the March 31, 2019
balance sheet figures above.
Source: Daré Bioscience
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