Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s
health innovation, today reported financial results for the quarter
ended March 31, 2022 and provided a company update.
“Our global license agreement with Organon to
commercialize XACIATO, an FDA-approved treatment for females 12
years of age and older with bacterial vaginosis, is expected to
close this quarter, the second quarter of 2022. Once effective,
Daré will receive a $10 million cash payment from Organon. XACIATO
is expected to be commercially available in the U.S. in the fourth
quarter of 2022. Since announcing our agreement with Organon on
March 31, 2022, I have been thrilled with the collaborative spirit
between our companies and we continue to believe that Organon’s
commercial capabilities will ensure that XACIATO reaches the women
most impacted by this condition.”
Bacterial vaginosis is the most common cause of
vaginitis worldwide and is estimated to affect approximately 21
million women.1 The condition results from an overgrowth of
bacteria, which upsets the balance of the natural vaginal
microbiome and can lead to symptoms of odor and discharge. In
addition to being the most common type of vaginal infection in
women of reproductive age and having bothersome symptoms, bacterial
vaginosis has been associated with certain increased health
risks.2
2022 Key Portfolio
Objectives
- XACIATO™—U.S.
commercial launch in 4Q-2022
-
Ovaprene®—Approval of Investigational Device Exemption (IDE)
submission by the FDA allowing commencement of pivotal Phase 3
clinical study in 2022
- DARE-VVA1—Phase 1/2 clinical study
topline data in 2H-2022
- Sildenafil Cream, 3.6%—Phase 2b
RESPOND clinical study interim analysis in 2022 and updated
timeframe for topline data
- DARE-HRT1—Phase
1/2 clinical study topline data in 4Q-2022
Portfolio Accomplishments and 2022
Management Expectations
-
XACIATO™ (clindamycin phosphate
vaginal gel, 2%):A clear, colorless, viscous gel to be
administered once intravaginally as a single dose for the treatment
of bacterial vaginosis in female patients 12 years of age and
older. Please click here for full Prescribing Information.
- Exclusive global license agreement
with Organon announced on March 31, 2022
- Transaction expected to close
2Q-2022
- U.S. commercial launch expected
4Q-2022
- Ovaprene®:A novel,
investigational hormone-free monthly intravaginal contraceptive
whose U.S. commercial rights are under a license
agreement with Bayer.
- 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) announced in 3Q-2021
- IDE review process with the U.S.
Food and Drug Administration (FDA) initiated in 1Q-2022
- Pivotal Phase 3 clinical study in
collaboration with NICHD expected to commence in 2022
- DARE-VVA1:A
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.
- Phase 1/2 clinical study in
Australia initiated in 3Q-2021
- Topline data expected during
2H-2022
- DARE-HRT1: A
unique, investigational intravaginal ring (IVR) designed to deliver
bio-identical estradiol and bio-identical progesterone continuously
over a 28-day period for the treatment of menopausal symptoms,
including vasomotor symptoms, as part of hormone therapy following
menopause.
- Phase 1/2 clinical study in
Australia initiated in 2Q-2022 to evaluate the pharmacokinetics
(PK) of lower and higher dose versions of DARE-HRT1 in
approximately 20 healthy, post-menopausal women over approximately
three consecutive months of use. The study will also collect
safety, usability, acceptability and symptom-relief data
- Topline data expected during
4Q-2022
- Sildenafil Cream,
3.6%: A proprietary, investigational cream formulation of
sildenafil, the active ingredient in Viagra®, for topical
administration to treat female sexual arousal disorder (FSAD).
- Ongoing enrollment in Phase 2b
RESPOND clinical study
- Interim analysis expected to be
conducted in 2022 followed by an update on the anticipated timing
for announcing topline data
Financial Highlights for the Quarter
ended March 31, 2022
- Cash and cash
equivalents: $39.3 million at March 31, 2022, compared to $51.7
million at December 31, 2021.
- General and
administrative expenses: $2.6 million in 1Q-2022, as compared to
$1.9 million in 1Q-2021, with the increase primarily attributable
to increases in professional services expenses, stock-based
compensation expense, personnel costs, and commercial-readiness
expenses.
- Research and
development expenses: $5.8 million in 1Q-2022, as compared to $5.7
million 1Q-2021, with expenses primarily related to the costs of
the ongoing Sildenafil Cream, 3.6% Phase 2b RESPOND clinical trial,
manufacturing and regulatory affairs activities related to
Ovaprene®, rent and facilities expenses, and expenses for personnel
and stock-based compensation.
- Comprehensive
loss: $8.4 million in 1Q-2022, as compared to $7.3 million in
1Q-2021.
- As of May 10, 2022: 84.7 million
shares of Daré common stock outstanding.
1 https://www.cdc.gov/std/bv/stats.htm22
https://www.mayoclinic.org/diseases-conditions/bacterial-vaginosis/symptoms-causes/syc-20352279
Conference Call
Daré will host a conference call and live
webcast today at 4:30 p.m. Eastern Time to review
financial results for the quarter ended March 31, 2022 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 7961884. 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 7961884. The call and webcast replay
will be available until May 26, 2022.
About Daré BioscienceDaré
Bioscience is a 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 first FDA-approved product,
XACIATO™ (clindamycin phosphate vaginal gel, 2%), is a
lincosamide antibacterial indicated for the treatment of bacterial
vaginosis in female patients 12 years of age and older, which is
under a global license agreement with Organon. XACIATO is a clear,
colorless, viscous gel, to be administered once intravaginally as a
single dose. Daré’s portfolio also 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®; and DARE-HRT1, a
combination bio-identical estradiol and progesterone intravaginal
ring for hormone therapy following menopause. To learn more about
XACIATO™, Daré’s full portfolio of women’s health product
candidates, and Daré’s mission to deliver differentiated therapies
for women, please visit www.darebioscience.com.
Daré may announce material information about its
finances, product and 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 and 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 in
the Investors section of Daré’s website.
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,” “objective,” 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 expectations regarding the closing of
the transactions under the exclusive license agreement with Organon
(the “XACIATO Agreement”) and the payment to Daré in connection
therewith, the timing of when XACIATO will be commercially
available in the U.S., plans and expectations with respect to
Daré’s product candidates, including anticipated timing for
commencement and conduct of clinical trials and clinical trial data
readouts for Daré’s product candidates. 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: the risks that the XACIATO Agreement may
not become fully effective, may be terminated early and that
payments to Daré under the agreement may not occur or be
significantly less than the anticipated or potential amounts;
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 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 and supply clinical trial material
and 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 loss of, or
inability to attract, key personnel; the effects of the COVID-19
pandemic, macroeconomic conditions and geopolitical events 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 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 or
product candidates less competitive or obsolete; failure to timely
establish or maintain third-party partnerships or collaborations to
develop and/or commercialize Daré’s product candidates, if
approved; failure of Daré’s product or product candidates, if
approved, to gain market acceptance or obtain adequate coverage or
reimbursement from third-party payers; Daré’s ability to retain its
licensed rights to develop and commercialize a product or 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 and 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; product
liability claims; governmental investigations or actions relating
to Daré’s product, product candidates or business activities; 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 |
|
Condensed
Consolidated Statements of Operations and Comprehensive
Loss |
|
(Unaudited) |
|
|
Three Months Ended March 31, |
|
|
|
2022 |
|
|
2021 |
|
|
Operating expenses |
|
|
|
General and administrative |
$ |
2,569,987 |
|
$ |
1,940,328 |
|
|
Research and development |
|
5,805,462 |
|
|
5,728,206 |
|
|
License fees |
|
25,000 |
|
|
25,000 |
|
|
Total operating expenses |
|
8,400,449 |
|
|
7,693,534 |
|
|
Loss
from operations |
|
(8,400,449 |
) |
|
(7,693,534 |
) |
|
Other
income |
|
1,779 |
|
|
3 |
|
|
Gain on loan
extinguishment of note payable |
|
- |
|
|
369,887 |
|
|
Net
loss |
$ |
(8,398,670 |
) |
$ |
(7,323,644 |
) |
|
Net
loss to common shareholders |
$ |
(8,398,670 |
) |
$ |
(7,323,644 |
) |
|
Foreign currency translation adjustments |
$ |
(9,150 |
) |
$ |
(6,841 |
) |
|
Comprehensive loss |
$ |
(8,407,820 |
) |
$ |
(7,330,485 |
) |
|
Loss per
common share - basic and diluted |
$ |
(0.10 |
) |
$ |
(0.16 |
) |
|
Weighted
average number of common shares outstanding: |
|
|
|
Basic and diluted |
|
83,944,119 |
|
|
44,502,582 |
|
|
|
|
|
|
|
|
|
|
Daré Bioscience, Inc. and Subsidiaries |
|
Condensed
Consolidated Balance Sheets Data |
|
|
|
|
|
|
Three months
ended March 31, |
|
|
|
2022 |
|
|
2021 |
|
|
|
(unaudited) |
|
|
Cash and
cash equivalents |
$ |
39,316,911 |
|
$ |
51,674,087 |
|
|
Working
capital |
$ |
31,422,629 |
|
$ |
39,243,160 |
|
|
Total
assets |
$ |
49,186,582 |
|
$ |
55,807,177 |
|
|
Total
stockholders' equity |
$ |
30,878,910 |
|
$ |
38,754,321 |
|
|
|
|
|
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