Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s
health innovation, today reported financial results for the quarter
ended March 31, 2021 and provided a company update.
“The strong momentum of 2020 continued during
the first quarter of 2021 for Daré. Having completed the
DARE-BVFREE Phase 3 study in late 2020, we are preparing to file a
New Drug Application with the FDA for DARE-BV1 for the treatment of
bacterial vaginosis during the second quarter. This will be Daré’s
first NDA submission and represents a meaningful milestone for our
company,” said Sabrina Martucci Johnson, President and CEO of Daré
Bioscience. “In March of 2021, we initiated the Phase 2b RESPOND
study of Sildenafil Cream, 3.6% for the treatment of female sexual
arousal disorder, and our clinical sites are actively recruiting.
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. Daré’s
strategy is to identify and advance candidates that address
persistent unmet needs in women’s health, and Sildenafil Cream,
3.6% falls squarely within our mission.”
2021 Key Portfolio Objectives
- DARE-BV1: NDA submission and strategic commercialization
agreement.
- Sildenafil Cream, 3.6%: Phase 2b clinical study topline
data.
- Ovaprene: Investigational Device Exemption (IDE)
submission.
- DARE-HRT1: Phase 1 clinical study topline data.
- DARE-VVA1: Initiation of Phase 1 clinical study.
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: Successful completion of the DARE-BVFREE Phase 3
clinical study.
- 2Q
2021: Submit NDA to the U.S. Food and Drug Administration
(FDA).
- 2021
PDUFA goal date: Fast track and Qualified Infectious
Disease Product (QIDP) designations allow for a priority review
request at the time of NDA submission, which, if granted, could
lead to FDA approval in the current year.
- 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.
- Year-end
2021: Topline data readout of RESPOND clinical study
targeted for 4Q.
- No FDA-approved
products exist today to treat FSAD.
- 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.
-
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.
- 2Q
2021: Topline data readout of Phase 1 clinical study
targeted for 2Q.
-
Ovaprene:
- Daré innovation:
Novel, investigational hormone-free monthly intravaginal
contraceptive whose U.S. commercial rights are under a
license agreement with Bayer.
- 4Q
2021: Submit IDE to the FDA for a pivotal contraceptive
clinical study in the U.S.
- 1Q
2022: Commence pivotal Phase 3 clinical study.
- Year-end 2022:
6-month safety and efficacy data readout targeted for 4Q 2022.
-
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 to be conducted in
Australia.
Financial Highlights for Quarter ended
March 31, 2021
- Cash and cash
equivalents: $7.7 million at March 31, 2021, compared to $4.7
million at December 31, 2020.
- Net cash from
financing activities during 1Q 2021 was approximately $11.4 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 $1.94 million in 1Q
2021, as compared with $1.86 million in 1Q 2020, with the increase
reflecting higher personnel costs and stock-based compensation
expense.
- Research and
development expenses were approximately $5.7 million in 1Q 2021, as
compared to approximately $2.4 million in 1Q 2020. The $3.3 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 1Q 2021 was approximately $7.3 million, as compared to
approximately $4.3 million for 1Q 2020.
Recent Financial
Developments
- Between April
1, 2021 and May 10, 2021, Daré received additional cash of
approximately $2.6 million (net of fees) from sales of common stock
under the company’s at-the-market offering program and equity
line.
- As of May 10,
2021, approximately 49.4 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 March 31, 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 7857813. 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 7857813. The call and webcast replay
will be available until May 27, 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, investigational hormone-free monthly intravaginal
contraceptive 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, NDA and IDE submissions, potential FDA review and
approval, and a potential commercial partnership for and 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:
Investors on behalf of Daré Bioscience, Inc.:Tom
MastersonAllele Capital
Partnerstmasterson@allelecapital.com646.573.3216
Source: Daré Bioscience, Inc.
Daré
Bioscience, Inc. and Subsidiaries |
Condensed
Consolidated Statements of Operations and Comprehensive
Loss |
(Unaudited) |
|
Three months ended March 31, |
|
|
2021 |
|
|
|
2020 |
|
Operating expenses |
|
|
|
General and administrative |
$ |
1,940,328 |
|
|
$ |
1,861,765 |
|
Research and development |
|
5,728,206 |
|
|
|
2,379,804 |
|
License fees |
|
25,000 |
|
|
|
12,500 |
|
Total operating expenses |
|
7,693,534 |
|
|
|
4,254,069 |
|
Loss
from operations |
|
(7,693,534 |
) |
|
|
(4,254,069 |
) |
Other
income |
|
3 |
|
|
|
1,821 |
|
Gain on
extinguishment of note payable |
|
369,887 |
|
|
|
- |
|
Net
loss |
$ |
(7,323,644 |
) |
|
$ |
(4,252,248 |
) |
Foreign
currency translation adjustments |
|
(6,841 |
) |
|
|
(22,944 |
) |
Comprehensive loss |
$ |
(7,330,485 |
) |
|
$ |
(4,275,192 |
) |
Loss per
common share - basic and diluted |
$ |
(0.16 |
) |
|
$ |
(0.18 |
) |
Weighted
average number of common shares outstanding: |
|
|
|
Basic and diluted |
|
44,502,582 |
|
|
|
23,799,396 |
|
|
|
|
|
|
|
|
|
Daré
Bioscience, Inc. and Subsidiaries |
Condensed
Consolidated Balance Sheet Data |
|
|
|
|
|
March 31, 2021 |
|
December 31, 2020 |
|
(unaudited) |
|
|
|
|
|
|
Cash and cash equivalents |
$ |
7,660,151 |
|
|
$ |
4,669,467 |
|
Working capital (deficit) |
$ |
3,490,641 |
|
|
$ |
(676,689 |
) |
Total assets |
$ |
10,518,453 |
|
|
$ |
7,550,712 |
|
Total stockholders' equity (deficit) |
$ |
3,258,233 |
|
|
$ |
(1,151,733 |
) |
|
|
|
|
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