Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s
health innovation, today reported financial results for the quarter
ended September 30, 2021 and provided a company update.
“We’ve continued to make significant progress on
several key clinical and strategic corporate initiatives with our
portfolio during a rather challenging year,” said Sabrina Martucci
Johnson, President and CEO of Daré Bioscience. “The FDA accepted
our NDA for DARE-BV1 for priority review with a PDUFA target date
of December 7, 2021, and we entered into a CRADA under which a
pivotal Phase 3 clinical study of Ovaprene® will be supported by
the NICHD’s Contraceptive Development Program and conducted within
its Contraceptive Clinical Trial Network. We also initiated a Phase
1/2 clinical study of DARE-VVA1, our intravaginal tamoxifen
program. Additionally, we’re continuing to enroll patients in our
Phase 2b RESPOND study of Sildenafil Cream, 3.6%, and are scoping
the development strategy for DARE-HRT1 following the positive
topline results of our Phase 1 clinical study reported earlier this
year. On the heels of the important milestones achieved thus far in
2021, we are gearing up for an eventful next few months, and I look
forward to providing updates as we progress further.”
4Q 2021 Key Portfolio
Objectives
- DARE-BV1: PDUFA target action date
for the NDA of December 7, 2021
- DARE-BV1: Announce U.S.
commercialization strategy
- Ovaprene®: Submit Investigational
Device Exemption (IDE) to the FDA for pivotal clinical study
Portfolio Accomplishments and
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
- New Drug Application (NDA) accepted
for filing and granted priority review by the FDA in 3Q 2021
- PDUFA target action date of
December 7, 2021
- Announce U.S. commercialization
strategy in 4Q 2021
- Robust market introduction in 1H
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)
- Continue Phase 2b RESPOND clinical
study in 2021 and 2022
- Ovaprene®:
- Daré innovation: Novel,
investigational hormone-free monthly intravaginal contraceptive
whose U.S. commercial rights are under a license
agreement with Bayer
- Announced Collaborative Research
and Development Agreement (CRADA) for a pivotal Phase 3 study in
the U.S. with Eunice Kennedy Shriver National Institute of Child
Health and Human Development (NICHD), a division of the National
Institutes of Health (NIH), in 3Q 2021
- Submit IDE to the FDA for a pivotal
Phase 3 clinical study in the U.S. in 4Q 2021
- Commence the pivotal Phase 3
clinical study in 2022
- 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
- Submit data from the Phase 1
clinical study for publication in a peer-reviewed journal and scope
our development strategy for DARE-HRT1.
- DARE-VVA1:
- Daré innovation: Proprietary,
investigational formulation of tamoxifen for intravaginal
administration to treat vulvar and vaginal atrophy (VVA) in women
with or at risk for hormone-receptor positive breast cancer
- Initiated a Phase 1/2 clinical
study in Australia in 3Q 2021
- Report topline data of Phase 1/2
study in 2022
Financial Highlights for period ended September 30,
2021
- Cash and cash equivalents: $45.6
million at September 30, 2021, compared to $4.7 million at December
31, 2020.
- Net cash from financing activities
during the nine months ended September 30, 2021 was approximately
$59.8 million, primarily provided by net proceeds from sales of
common stock under the company’s at-the-market offering
programs.
- General and administrative expenses
were approximately $2.2 million in 3Q 2021, as compared to $1.4
million in 3Q 2020, with the increase primarily attributable to
higher costs and expenses in professional services, commercial
readiness, personnel, stock-based compensation and insurance.
- Research and development expenses
were approximately $10.4 million in 3Q 2021, as compared to
approximately $6.2 million in 3Q 2020. The $4.2 million increase
was primarily attributable to the ongoing Sildenafil Cream, 3.6%
Phase 2b RESPOND clinical trial and manufacturing and regulatory
affairs activities for Ovaprene®.
- Comprehensive loss for 3Q 2021 was
approximately $12.7 million, as compared to approximately $7.6
million for 3Q 2020.
Recent Financial Developments
- As of November 8, 2021,
approximately 76.6 million shares of Daré common stock were
outstanding.
Conference CallDaré will host a
conference call and live webcast today at 4:30 p.m. ET to
review the company's financial results for the quarter ended
September 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 8459303. 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 8459303. The call and webcast replay
will be available until November 24, 2021.
About Daré BioscienceDaré
Bioscience is a clinical-stage biopharmaceutical company committed
to advancing 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 prioritize women's
health and well-being, expand treatment options, and improve
outcomes, primarily in the areas of contraception, fertility, and
vaginal and sexual health.
Daré’s product portfolio includes potential
first-in-category candidates in clinical development: Ovaprene®, a
novel, hormone-free monthly 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 StatementsDaré
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,” 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 belief that current clinical development
activities and work being done with strategic partners will
maximize the value of Daré’s product candidates, expectations for
Daré’s product candidates in 2021 and 2022, including potential FDA
approval of the DARE-BV1 NDA, anticipated timing of announcing the
commercial strategy for and the commercial launch of DARE-BV1 in
the U.S., if approved, anticipated timing for the Ovaprene IDE
submission, commencement and conduct of clinical trials, and
clinical trial data readouts. 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 develop, obtain FDA or
foreign regulatory approval for, and commercialize its product
candidates and to do so on communicated timelines; failure to
timely establish or leverage third-party partnerships or
collaborations to commercialize Daré’s product candidates, if
approved; failure or delay in starting, conducting and completing
clinical trials of a product candidate; 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; Daré’s dependence on third parties to conduct clinical
trials and manufacture clinical trial material, and if any of its
product candidates are approved, to manufacture commercial product;
Daré’s ability to raise additional capital when and as needed to
advance its product candidates, execute its business strategy 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; 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 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.
Contacts:Investors on behalf of Daré
Bioscience, Inc.:Lee Roth Burns
McClellanlroth@burnsmc.com212.213.0006
OR
Media on behalf of Daré Bioscience, Inc.:Jake RobisonCanale
Communicationsjake.robison@canalecomm.com 619.849.5383
Source: Daré Bioscience, Inc.
|
Daré
Bioscience, Inc. and Subsidiaries |
Consolidated
Statements of Operations and Comprehensive Loss |
(Unaudited) |
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Operating expenses |
|
|
|
|
|
|
|
General and administrative |
$ |
2,211,334 |
|
|
$ |
1,353,069 |
|
|
$ |
5,949,299 |
|
|
$ |
4,772,382 |
|
Research and development expenses |
|
10,432,603 |
|
|
|
6,203,753 |
|
|
|
23,501,098 |
|
|
|
14,131,007 |
|
License expenses |
|
25,000 |
|
|
|
25,000 |
|
|
|
75,000 |
|
|
|
58,333 |
|
Total operating expenses |
|
12,668,937 |
|
|
|
7,581,822 |
|
|
|
29,525,397 |
|
|
|
18,961,722 |
|
Loss
from operations |
|
(12,668,937 |
) |
|
|
(7,581,822 |
) |
|
|
(29,525,397 |
) |
|
|
(18,961,722 |
) |
Other income
(expense) |
|
1,508 |
|
|
|
(986 |
) |
|
|
1,686 |
|
|
|
2,454 |
|
Gain on loan
extinguishment of note payable |
|
- |
|
|
|
- |
|
|
|
369,887 |
|
|
|
- |
|
Net
loss |
$ |
(12,667,429 |
) |
|
$ |
(7,582,808 |
) |
|
$ |
(29,153,824 |
) |
|
$ |
(18,959,268 |
) |
Deemed
dividend from trigger of down round provision feature |
|
- |
|
|
|
(6,863 |
) |
|
|
- |
|
|
|
(6,863 |
) |
Net
loss to common shareholders |
$ |
(12,667,429 |
) |
|
$ |
(7,589,671 |
) |
|
$ |
(29,153,824 |
) |
|
$ |
(18,966,131 |
) |
Foreign currency translation adjustments |
|
(63,281 |
) |
|
|
672 |
|
|
|
(79,002 |
) |
|
|
(10,182 |
) |
Comprehensive loss |
$ |
(12,730,710 |
) |
|
$ |
(7,582,136 |
) |
|
$ |
(29,232,826 |
) |
|
$ |
(18,976,313 |
) |
Loss per
common share - basic and diluted |
$ |
(0.18 |
) |
|
$ |
(0.24 |
) |
|
$ |
(0.45 |
) |
|
$ |
(0.69 |
) |
Weighted
average number of common shares outstanding: |
|
|
|
|
|
|
|
Basic and diluted |
|
70,775,508 |
|
|
|
31,588,152 |
|
|
|
64,196,162 |
|
|
|
27,381,508 |
|
|
|
|
|
|
|
|
|
Daré Bioscience, Inc. and Subsidiaries |
Condensed Consolidated Balance Sheet Data |
|
|
|
|
|
September 30, 2021 |
|
December 31, 2020 |
|
(unaudited) |
|
|
Cash and cash equivalents |
$ |
45,570,781 |
|
|
$ |
4,669,467 |
|
Working capital (deficit) |
$ |
32,336,068 |
|
|
$ |
(676,689 |
) |
Total assets |
$ |
48,811,476 |
|
|
$ |
7,550,712 |
|
Total stockholders' equity (deficit) |
$ |
31,888,591 |
|
|
$ |
(1,151,733 |
) |
|
|
|
|
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