-Conference Call and Webcast Today, April
2nd, at 4:30 PM Eastern Time-
Daré Bioscience, Inc. (NASDAQ:DARE), a clinical-stage, women’s
biopharmaceutical company, today announced financial results for
the full year ended December 31, 2017.
Company Highlights and 2018
Milestones
- Completed stock purchase transaction between Daré Bioscience,
Inc. (formerly known as Cerulean Pharma Inc.) and Daré Bioscience
Operations, Inc. in July 2017.
- Entered into a worldwide license and development agreement for
a clinical Phase 2b stage asset, Topical Sildenafil, for the
treatment of Female Sexual Arousal Disorder in February 2018.
-
- The Company intends to communicate
with the U.S. Food and Drug Administration in mid-2018 regarding
the Phase 2b study of Topical Sildenafil.
- Pending these discussions, the
Company anticipates commencing a Phase 2b study of Topical
Sildenafil in the fourth quarter of 2018.
- Entered into a worldwide development and option agreement for
novel injectable formulations of etonogestrel seeking to provide
contraceptive protection for periods of six and 12 months in March
2018.
- The Company expects to commence enrollment in the OvapreneTM
postcoital test clinical trial in the second quarter of 2018.
“2017 was a year of transformative growth for
Daré Bioscience as we established a strong foundation for our goal
of building a preeminent company in women’s reproductive health. We
expect that our year end cash balance of approximately $7.56
million will enable us to fully fund an important clinical study
evaluating Ovaprene, which, if approved, has the potential to fill
a significant gap in the marketplace as the first woman-initiated
non-hormonal contraceptive providing protection over the course of
several weeks,” stated Sabrina Martucci Johnson, Chief Executive
Officer at Daré. “Additionally, in the first quarter of 2018, we
announced the addition of Topical Sildenafil, a product with the
potential to be the first product approved for Female Sexual
Arousal Disorder, and raised approximately $10.4 million in net
proceeds through the sale of equity securities to continue its
development into Phase 2b. Each of our two lead development
programs has the potential to deliver a first-in-category product
addressing unmet need in women’s reproductive health, and, together
with our pre-clinical injectable contraceptive program, constitute
a differentiated portfolio that we believe is well positioned to
drive significant value in both the short and long term.”
Full Year 2017 Financial
Summary
As of December 31, 2017, Daré had cash of $7.56
million. The Company believes existing cash balances plus
approximately $10.4 million of net proceeds received from the sale
of equity securities in February 2018 will be sufficient for Daré
to commence and complete a postcoital test clinical trial of
Ovaprene and advance Topical Sildenafil into Phase 2b.
General and administrative expenses for the full
year ended December 31, 2017 were $2.7 million, increased from
$157,925 in the prior year primarily due to increased legal,
accounting and other expenses incurred in connection with the July
19, 2017 stock purchase transaction, increased personnel costs
following the stock purchase transaction, and costs related to
being a public company.
Research and development expenses for the full
year ended December 31, 2017 were $984,749, increased from $72,666
in the prior year due to Ovaprene development costs during the
current period.
The Company incurred a non-cash impairment
charge of $7.49 million in 2017. Based upon our annual
impairment test conducted as of December 31, 2017, the book value
of our net assets exceeded the fair value of our company,
determined based upon our average market capitalization during the
month of December 2017 as well as a discounted cash flow method. A
charge to goodwill is a balance sheet adjustment that does not
affect Daré Bioscience’s cash position or cash flow from operating
activities and that will not have any impact on future
operations.
The net loss for the full year ended December
31, 2017 was $11,527,721 (or $3.57 per share),
compared to the net loss of $672,687 (or $0.81 per
share) for the full year ended December 31, 2016. The 2017
financial statements represent Daré’s operations as a public
company following the completion of a stock purchase transaction on
July 19, 2017. The financial statements presented for 2016
represent Daré operations when the Company was private, making a
comparison between periods difficult.
Conference Call and
Webcast
Daré Bioscience will host a live conference call
and webcast 4:30 p.m. Eastern Time / 1:30 p.m.
Pacific Time to discuss Daré’s financial results and provide a
general business update.
The live webcast and a replay may be accessed by
visiting the investor relations section of Daré’s website at
http://www.darebioscience.com. Please connect to the Company's
website at least 15 minutes prior to the live webcast to ensure
adequate time for any software download that may be needed to
access the webcast.
Alternatively, please call (844) 831-3031 (U.S.)
or (443) 637-1284 (international) to listen to the live conference
call. The conference ID number for the live call is 7696698. Please
dial in approximately 10 minutes prior to the call.
About Daré Bioscience
Daré Bioscience is a clinical-stage
biopharmaceutical company committed to the advancement of
innovative products for women’s reproductive health that address
clear therapeutic gaps. The company is driven by a mission to
identify, develop and bring to market a diverse portfolio of novel
and 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 currently has two product candidates in clinical
development. The first is Ovaprene™, a non-hormonal monthly
contraceptive ring intended to provide protection over multiple
weeks between menses. The second is SST-6007 (5% Topical Sildenafil
Citrate Cream), a potential treatment for Female Sexual Arousal
Disorder. SST-6007 incorporates sildenafil, the same active
ingredient in Viagra®, in a proprietary cream formulation that is
specifically designed to locally increase blood flow to the
vulvar-vaginal tissue in women, leading to a potential improvement
in genital arousal response and overall sexual experience. Daré
also has an option to enter into a license agreement for ORB-204
and ORB-214, preclinical stage injectable etonogestrel
contraceptives with target 6- and 12-month durations.
Forward-Looking Statements
This press release contains "forward-looking
statements" within the meaning of The Private Securities Litigation
Reform Act of 1995 regarding matters that are not historical facts,
including statements relating to Daré's ability to develop Ovaprene
and Topical Sildenafil at the cost and in accordance with the
targeted timelines and milestones set forth herein, expectations
regarding the anticipated market demands for its products, the
safety and effectiveness of its products, market acceptance of
Daré's products and the qualifications and expertise of Daré's
management team. Because such statements are subject to risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements as a result
of various important factors, including the uncertainties inherent
in the initiation and completion of clinical trials; availability
and timing of data from ongoing and future clinical trials and the
results of such trials; whether preliminary results from a clinical
trial will be predictive of the final results of that trial or
whether results of early clinical trials will be indicative of the
results of later clinical trials, expectations for regulatory
approvals; claims of infringement and other risks relating to
Daré's owned and licensed intellectual property rights, and other
factors discussed in the "Risk Factors" section of Daré's Report on
Form 10-K filed with the Securities and Exchange Commission on
March 28, 2018. Additional information concerning factors that
could cause actual results to materially differ from those in the
forward-looking statements is contained in Daré's reports to the
Securities and Exchange Commission, including Daré's reports on
Forms 10-Q, 8-K and 10-K. In addition, any forward-looking
statements included in this press release represent our views only
as of the date of this release and should not be relied upon as
representing our views as of any subsequent date. Daré specifically
disclaims any obligation to update any forward-looking statements
included in this press release.
Contacts:
Investors on behalf of Daré Bioscience, Inc.:Ami
BavishiBurns McClellanabavishi@burnsmc.com212-213-0006
OR
Media on behalf of Daré Bioscience, Inc.:Amanda
GuisbondCanale Communicationsamanda@canalecomm.com781-405-8775
Source: Daré Bioscience
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