Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s
health innovation, today reported financial results for the quarter
ended June 30, 2021 and provided a company update.
“This has been, and continues to be, an
incredibly productive year for Daré,” said Sabrina Martucci
Johnson, President and CEO of Daré Bioscience. “Consistent with our
guidance, we submitted our New Drug Application for DARE-BV1, a
potential new first-line treatment for bacterial vaginosis, to the
FDA in June. Our NDA was accepted for filing and received Priority
Review with a PDUFA target date of December 7, 2021. This year we
also commenced the Phase 2b RESPOND study of Sildenafil Cream,
3.6%, a potential first-in-category product in development to treat
female sexual arousal disorder, a physiological condition for which
there are no FDA approved products. In June, we announced positive
topline results from our Phase 1 study of DARE-HRT1, a novel
intravaginal ring designed to deliver bio-identical hormones which
is being developed to treat vasomotor symptoms and the
genitourinary syndrome commonly associated with menopause. And
finally, we reported two new sources of non-dilutive funding for
two of our programs – first, a grant intended to support the
continued development of DARE-LARC1 over more than five years
through the non-clinical proof of principle work, and second, a
collaboration with the National Institutes of
Health’s Eunice Kennedy Shriver National Institute of
Child Health and Human Development providing financial and
operational support for the conduct of a pivotal Phase 3 clinical
trial of Ovaprene®, an investigational hormone-free monthly
contraceptive whose U.S. commercial rights are under a license
agreement with Bayer.”
Portfolio Accomplishments and Management
Expectations for 2021-2022
-
DARE-BV1:
- Daré innovation:
Novel, investigational thermosetting bioadhesive hydrogel
formulated with clindamycin phosphate 2% as a first-line,
single-administration treatment for bacterial vaginosis.
- 4Q
2020: Successfully completed DARE-BVFREE Phase 3 clinical
study.
- June
2021: Submitted New Drug Application (NDA) to the U.S.
Food and Drug Administration (FDA).
- 2021
Prescription Drug User Fee Act (PDUFA) goal date: NDA
accepted and received Priority Review with a PDUFA target date of
December 7, 2021.
- 2021: Execute and
announce commercialization strategy for DARE-BV1 in the U.S. to
support a robust market introduction in 2022, if approved.
-
Sildenafil Cream, 3.6%:
- Daré innovation:
Proprietary, investigational cream formulation of sildenafil, the
active ingredient in Viagra®, for topical administration to treat
female sexual arousal disorder (FSAD).
- 1Q
2021: Commenced Phase 2b RESPOND clinical study.
-
2021: Ongoing enrollment in Phase 2b RESPOND
clinical study.
- FSAD is a
physiological condition characterized by the inability to attain or
maintain sufficient genital arousal during sexual activity and, of
the various types of female sexual dysfunction disorders, is most
analogous to erectile dysfunction in men.
- FSAD represents
a significant unmet need, with an estimated 10 million women in the
U.S. experiencing distress from symptoms of low or no sexual
arousal and actively seeking treatment.
-
DARE-HRT1:
- Daré innovation:
Unique, investigational 28-day intravaginal ring (IVR) containing
bio-identical estradiol and bio-identical progesterone for the
treatment of vasomotor symptoms and genitourinary syndrome
associated with menopause.
- June
2021: Reported positive topline data of Phase 1 clinical
study.
-
Ovaprene:
- Daré innovation:
Novel, investigational hormone-free monthly intravaginal
contraceptive whose U.S. commercial rights are under a
license agreement with Bayer.
- 3Q
2021:
- Announced a
Collaborative Research and Development Agreement (CRADA) for a
pivotal Phase 3 clinical study of Ovaprene in the U.S.
- The CRADA is
with the Eunice Kennedy Shriver National Institute of Child Health
and Human Development (NICHD), part of the National Institutes of
Health.
- The CRADA will
allow Daré to leverage the contraceptive clinical trial expertise
of NICHD while also sharing the costs of the Phase 3 clinical study
with NICHD. Daré agreed to contribute $5.5 million
toward the total estimated cost to conduct the study and to provide
clinical supplies of Ovaprene.
- 4Q
2021: Submit Investigational Device Exemption (IDE) to the
FDA for a pivotal Phase 3 clinical study in the U.S.
-
2022: Commence the pivotal Phase 3 clinical
study.
-
DARE-VVA1:
- Daré innovation:
Proprietary, investigational formulation of tamoxifen for vaginal
administration to treat vulvar and vaginal atrophy (VVA) in women
with or at risk for hormone-receptor positive breast cancer.
- 2H
2021: Initiate Phase 1 clinical study in Australia.
Financial Highlights for period ended
June 30, 2021
- Cash and cash
equivalents: $9.1 million at June 30, 2021, compared to $4.7
million at December 31, 2020.
- Net cash from
financing activities during the six months ending June 30, 2021 was
approximately $24.6 million and included net proceeds from sales of
common stock under the company’s at-the-market offering program and
equity line and warrant exercises.
- General and
administrative expenses were approximately $1.8 million in 2Q 2021,
as compared with $1.6 million in 2Q 2020, with the increase
reflecting higher personnel costs and stock-based compensation
expense.
- Research and
development expenses were approximately $7.3 million in 2Q 2021, as
compared to approximately $5.5 million in 2Q 2020. The $1.8 million
increase was due primarily to increases in expenses related to
clinical trial and other development and regulatory affairs
activities for Sildenafil Cream, 3.6%, DARE-BV1, Ovaprene and
DARE-HRT1.
- Comprehensive
loss for 2Q 2021 was approximately $9.2 million, as compared to
approximately $7.1 million for 2Q 2020.
Recent Financial
Developments
- Between July 1,
2021 and August 10, 2021, Daré received additional cash of
approximately $25.4 million (net of fees) from sales of common
stock under the company’s at-the-market offering program.
- In July 2021, Daré received an
initial cash payment of $11.45 million in non-dilutive grant
funding to support the non-clinical development of DARE-LARC1. The
entire grant award is for up to $48.95 million and future payments
are contingent upon the DARE-LARC1 program’s achievement of
specified development and reporting milestones.
- As of August
10, 2021, approximately 70.5 million shares of Daré common stock
were outstanding.
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, 2021 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 5286254. 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 5286254. The call and webcast replay
will be available until August 26, 2021.
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
novel, hormone-free monthly contraceptive candidate
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 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 the Investors section of its 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 in the Investors section of its 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. In this press release, forward-looking
statements include, but are not limited to, statements relating to
the market opportunity and commercial potential for Daré’s product
candidates and management’s expectations for Daré’s product
candidates in 2021 and 2022, including anticipated timing for the
conduct of clinical trials, topline and other clinical trial data
readouts, IDE submissions, potential FDA review and approval, and a
potential commercial launch of 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 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
design and conduct 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; the risk that developments by
competitors make Daré’s product candidates less competitive or
obsolete; failure of Daré’s product candidates, if approved, to
gain market acceptance or obtain adequate coverage from third-party
payers; 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; Daré’s failure to timely
establish or leverage third-party partnerships or collaborations to
commercialize its product candidates, if approved; 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; 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
Lisa Walters-Hoffert, Chief Financial Officer
Daré Bioscience, Inc.lwalters@darebioscience.com858.926.7655
Source: Daré Bioscience, Inc.
Daré
Bioscience, Inc. and Subsidiaries |
Consolidated
Statements of Operations and Comprehensive Loss |
(Unaudited) |
|
Three Months EndedJune 30,
2021 |
|
|
2021 |
|
|
|
2020 |
|
Operating expenses: |
|
|
|
General and administrative |
$ |
1,797,637 |
|
|
$ |
1,557,548 |
|
Research and development expenses |
|
7,340,289 |
|
|
|
5,547,450 |
|
License fees |
|
25,000 |
|
|
|
20,833 |
|
Total operating expenses |
|
9,162,926 |
|
|
|
7,125,831 |
|
Loss
from operations |
|
(9,162,926 |
) |
|
|
(7,125,831 |
) |
Other
income |
|
175 |
|
|
|
1,618 |
|
Net
loss |
$ |
(9,162,751 |
) |
|
$ |
(7,124,213 |
) |
Foreign currency translation adjustments |
$ |
(8,880 |
) |
|
$ |
12,090 |
|
Comprehensive loss |
$ |
(9,171,631 |
) |
|
$ |
(7,112,123 |
) |
Loss per
common share - basic and diluted |
$ |
(0.18 |
) |
|
$ |
(0.27 |
) |
Weighted
average number of common shares outstanding: |
|
|
|
Basic and diluted |
|
50,436,593 |
|
|
|
26,710,750 |
|
Daré
Bioscience, Inc. and Subsidiaries |
Condensed
Consolidated Balance Sheet Data |
|
|
|
|
|
June 30, 2021 |
|
December 30, 2021 |
|
(unaudited) |
|
|
|
|
|
|
Cash and cash equivalents |
$ |
9,111,741 |
|
|
$ |
4,669,467 |
|
Working
capital (deficit) |
$ |
8,054,330 |
|
|
$ |
(676,689 |
) |
Total
assets |
$ |
14,822,410 |
|
|
$ |
7,550,712 |
|
Total
stockholders' equity (deficit) |
$ |
7,744,004 |
|
|
$ |
(1,151,733 |
) |
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