Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s
health innovation, today reported financial results for the quarter
ended September 30, 2022 and provided a company update.
“During the third quarter, we received $18.0
million in non-dilutive cash to strengthen our balance sheet.
Approximately $8.0 million represented a payment under an existing
grant to fund the preclinical development of DARE-LARC1, a novel,
investigational long-acting, reversible personal contraceptive
system, and $10.0 million was the upfront payment under our license
agreement with Organon to commercialize XACIATO™, which was revenue
we recognized in the second quarter when the agreement became
effective. In addition, subsequent to quarter end, we received a
research and development cash rebate from the Australian government
of approximately $786,000 for clinical work performed in Australia
in 2021. Daré remains committed to exploring ways to operate our
business efficiently and to fund our portfolio in a manner we
believe will be favorable to our shareholders,” said Sabrina
Martucci Johnson, President and CEO of Daré Bioscience.
“During the past two months, we had several
positive developments related to our clinical-stage candidates. In
October, we announced the FDA’s approval of our Investigational
Device Exemption application allowing us to conduct a single arm,
open-label pivotal contraceptive efficacy study of Ovaprene. We are
currently reviewing and implementing additional FDA study design
considerations to further position the study to serve as the single
pivotal study necessary to support a premarket approval submission
to the FDA. In October, we also announced positive topline efficacy
data from our Phase 1/2 clinical study of DARE-HRT1, an
investigational intravaginal ring to provide bio-identical hormone
therapy for the treatment of menopausal symptoms with one IVR
delivering both bio-identical progesterone and bio-identical
estradiol together over 28 days. In November, we announced the
completion of subject screening for our exploratory Phase 2b
RESPOND clinical study of Sildenafil Cream, 3.6% for female sexual
arousal disorder and are targeting the second quarter of 2023 to
announce topline data.”
“Finally, the teams at Daré and Organon have
been diligently working toward a commercial launch of XACIATO in
the U.S. since our license agreement became effective. We are
confident in Organon’s go-to-market strategy, which will leverage
the knowledge and experience of its established NEXPLANON® sales
team to accelerate XACIATO uptake at launch, and we look forward to
the market introduction of this new medication for the treatment of
bacterial vaginosis in females 12 years of age and older. Bacterial
vaginosis is estimated to affect approximately 21 million women in
the U.S.1 We expect the first commercial sale in the first half of
2023 in the U.S. Our goal is to carry the strong momentum of the
final months of 2022 into 2023 so that we can start next year from
a position of strength.”
2H-2022 Portfolio Accomplishments and
1H-2023 Objectives
- Ovaprene: FDA
approved IDE application for pivotal study; investigator meeting
for pivotal study to be held in 4Q-2022; initiation of subject
recruitment targeted for mid-2023
- DARE-HRT1: Phase 1/2 clinical study
topline efficacy data announced 4Q-2022; topline pharmacokinetics
(PK) data expected later in 4Q-2022
- DARE-VVA1: Phase 1/2 clinical study
topline data expected in 4Q-2022
- Sildenafil Cream, 3.6%: Subject
screening completed for Phase 2b RESPOND clinical study in 4Q-2022;
topline data targeted for 2Q-2023
- XACIATO: Organon market access team is meeting with U.S.
customers now to review XACIATO and obtain competitive coverage in
the bacterial vaginosis marketplace; first commercial sale of
XACIATO expected in 1H-2023 in the U.S.
Portfolio Review
- 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.
- 3Q-2022: $10
million cash payment received under license agreement with Organon
to commercialize XACIATO
- 4Q-2022: Organon
market access team is meeting with U.S. customers now to review
XACIATO and obtain competitive coverage in the bacterial vaginosis
marketplace
-
1H-2023: First commercial sale expected
Bacterial vaginosis is the most common cause of
vaginitis worldwide. 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,
including pre-term labor and infertility.1, 2
A novel, investigational hormone-free monthly
intravaginal contraceptive whose U.S. commercial rights
are under a license agreement with Bayer HealthCare.
-
4Q-2022: FDA approved an Investigational Device
Exemption (IDE) application for a single arm, open-label pivotal
contraceptive efficacy study over 12-months (13 menstrual cycles)
and provided additional study design considerations
-
4Q-2022 (December): Investigator meeting for the
pivotal Phase 3 clinical study
-
Mid-year 2023: Initiation of subject recruitment
for the pivotal Phase 3 clinical study
The planned pivotal Phase 3 clinical study will
be conducted under a Collaborative Research and Development
Agreement with the U.S. Department of Health and Human Services, as
represented by the Eunice Kennedy Shriver National Institute of
Child Health and Human Development, or the NICHD, part of the
National Institutes of Health.
A proprietary, investigational cream formulation
of sildenafil, the active ingredient in Viagra®, for topical
administration to treat female sexual arousal disorder.
-
4Q-2022: Completed subject screening for Phase 2b
RESPOND clinical study
-
2Q-2023: Topline data announcement targeted for
Phase 2b clinical study
A unique, investigational intravaginal ring
(IVR) designed to deliver bio-identical estradiol and progesterone
continuously over a 28-day period for the treatment of menopausal
symptoms, including vasomotor symptoms, as part of hormone therapy
following menopause.
-
2Q-2022: Phase 1/2 clinical study initiated in
Australia to evaluate the pharmacokinetics of two versions of
DARE-HRT1 and to collect safety, usability, acceptability and
symptom-relief data
-
4Q-2022: Positive topline efficacy data reported
from Phase 1/2 clinical study; topline PK data expected later in
4Q-2022
A proprietary, investigational formulation of
tamoxifen for vaginal administration to treat vulvar and vaginal
atrophy in women with or at risk for hormone-receptor positive
breast cancer.
-
3Q-2021: Phase 1/2 clinical study initiated in
Australia
-
4Q-2022: Topline data from Phase 1/2 clinical
study anticipated
Financial Highlights for the Quarter
ended September 30, 2022
- Cash and cash
equivalents: $40.4 million at September 30, 2022, compared to $51.7
million at December 31, 2021.
- General and
administrative expenses: $2.7 million in 3Q-2022, as compared to
$2.2 million in 3Q-2021, with the current quarter’s increase
primarily attributable to an increase in professional services
expense.
- Research and
development expenses: $4.5 million in 3Q-2022, as compared to $10.4
million 3Q-2021, with the current quarter’s decrease primarily
attributable to decreases in expenses related to the ongoing
Sildenafil Cream, 3.6% Phase 2b RESPOND clinical trial,
manufacturing and regulatory affairs activities related to
Ovaprene, costs related to development activities for XACIATO as a
result of the completion of the Phase 3 clinical trial for XACIATO
in December 2020, and costs related to development activities for
our preclinical programs and Phase 1 and Phase 1-ready
programs.
- As of November 9, 2022: 84.8
million shares of common stock outstanding.
1 https://www.cdc.gov/std/bv/stats.htm2
https://www.mayoclinic.org/diseases-conditions/bacterial-vaginosis/symptoms-causes/syc-2035227
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 September 30, 2022 and to
provide a company update.
To access the conference call via phone, dial
(800) 715-9871 (U.S.) or (646) 307-1963 (international). The
conference ID number for the call is 8044477. 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. The webcast will be archived under
“Presentations, Events & Webcasts" in the Investors section of
the Company's website at http://ir.darebioscience.com and available
for replay until November 24, 2022.
About Daré Bioscience
Daré 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 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®; 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 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,” “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
sources of funding the Company’s operations, 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 and the potential for FDA approval of a product
candidate based on a single pivotal clinical study, and
expectations regarding the commercial launch of XACIATO in the
U.S., including the strategy, efforts and capabilities of Daré’s
commercial collaborator and the timing of the first commercial sale
of XACIATO. 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 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; difficulties
establishing and sustaining relationships with development and/or
commercial collaborators; 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; 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 or product candidates or the business activities
of Daré, its commercial collaborators or other third parties on
which Daré relies; the impact of pharmaceutical industry regulation
and health care legislation in the United States and
internationally; global trends toward health care cost containment;
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 RobisonEvoke
Canale jake.robison@evokegroup.com 619.849.5383
Source: Daré Bioscience, Inc.
|
Daré
Bioscience, Inc. and Subsidiaries |
Consolidated
Statements of Operations and Comprehensive Loss |
(Unaudited) |
|
|
Three months endedSeptember 30, |
|
Nine months endedSeptember 30, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Revenue |
|
|
|
|
|
|
|
License fee revenue |
$ |
— |
|
|
$ |
— |
|
|
$ |
10,000,000 |
|
|
$ |
— |
|
Total revenue |
|
— |
|
|
|
— |
|
|
|
10,000,000 |
|
|
|
— |
|
Operating
expenses |
|
|
|
|
|
|
|
General and administrative |
$ |
2,651,543 |
|
|
$ |
2,211,334 |
|
|
$ |
8,014,424 |
|
|
$ |
5,949,299 |
|
Research and development |
|
4,462,250 |
|
|
|
10,432,603 |
|
|
|
17,065,497 |
|
|
|
23,501,098 |
|
License fee expense |
|
25,000 |
|
|
|
25,000 |
|
|
|
75,000 |
|
|
|
75,000 |
|
Total operating expenses |
|
7,138,793 |
|
|
|
12,668,937 |
|
|
|
25,154,921 |
|
|
|
29,525,397 |
|
Loss from
operations |
|
(7,138,793 |
) |
|
|
(12,668,937 |
) |
|
|
(15,154,921 |
) |
|
|
(29,525,397 |
) |
Other
income |
|
118,950 |
|
|
|
1,508 |
|
|
|
150,406 |
|
|
|
1,686 |
|
Gain on
extinguishment of note payable |
$ |
0 |
|
|
$ |
0 |
|
|
|
0 |
|
|
|
369,887 |
|
Net
loss |
$ |
(7,019,843 |
) |
|
$ |
(12,667,429 |
) |
|
$ |
(15,004,515 |
) |
|
$ |
(29,153,824 |
) |
Foreign currency translation adjustments |
$ |
(230,748 |
) |
|
$ |
(63,281 |
) |
|
$ |
(375,767 |
) |
|
$ |
(79,002 |
) |
Comprehensive loss |
$ |
(7,250,591 |
) |
|
$ |
(12,730,710 |
) |
|
$ |
(15,380,282 |
) |
|
$ |
(29,232,826 |
) |
Loss per
common share - basic and diluted |
$ |
(0.08 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.45 |
) |
Weighted
average number of shares outstanding: |
|
|
|
|
|
|
|
Basic and diluted |
|
84,822,516 |
|
|
|
70,775,508 |
|
|
|
85,553,134 |
|
|
|
64,196,162 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Daré
Bioscience, Inc. and Subsidiaries |
Condensed
Consolidated Balance Sheets Data |
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2022 |
|
December 31, 2021 |
|
|
|
|
|
(unaudited) |
|
|
Cash and
cash equivalents |
|
|
|
|
$ |
40,389,546 |
|
|
$ |
51,674,087 |
|
Working
capital |
|
|
|
|
$ |
26,759,012 |
|
|
$ |
39,243,160 |
|
Total
assets |
|
|
|
|
$ |
50,376,432 |
|
|
$ |
55,807,177 |
|
Total
stockholders' equity |
|
|
|
|
$ |
26,343,772 |
|
|
$ |
38,754,321 |
|
|
|
|
|
|
|
|
|
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