Daré Bioscience, Inc. (NASDAQ: DARE), a
clinical-stage, women’s biopharmaceutical company, today provided a
business update and announced financial results for the three and
nine months ended September 30, 2018.
Business Update
“We are actively enrolling couples in our
postcoital test clinical trial of Ovaprene®, our non-hormonal
monthly contraceptive, and are preparing to commence the Phase2b
program of Sildenafil Cream, 3.6%, our candidate for the treatment
of female sexual arousal disorder. We are also advancing our
development portfolio of other product candidates that we believe
have the potential to deliver a first-in-category product
addressing a persistent unmet need in women’s reproductive health,
such as our vaginal ring technologies for hormone replacement and
pregnancy maintenance and our vaginal tamoxifen for vulvar and
vaginal atrophy in women with hormone receptor positive breast
cancer,” said Sabrina Martucci Johnson, President and Chief
Executive Officer of Daré. “Our 2018 third quarter results were in
line with our expectations for advancing our novel portfolio of
clinical candidates in women’s health.”
Third Quarter Financial Results
At September 30, 2018, we had cash and cash
equivalents of $9.5 million. We believe our existing cash balance
is sufficient to fund our planned operations for at least the next
twelve months. For the three months ended September 30, 2018,
general and administrative expenses were $1.2 million and research
and development expenses were $1.4 million.
Our primary operations have consisted of, and
are expected to continue to consist of, product research and
development and advancing our portfolio of product candidates
through late-stage clinical development or regulatory approval.
Conference Call
Daré will host a conference call and live
webcast to discuss this announcement and recent developments
beginning at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) today.
To access the conference call via phone, dial (844) 831-3031
(domestic) or (443) 637-1284 (International). The conference ID
number for the call is 5463588. The live webcast can be accessed
under “Events & Presentations" in the Investor Relations
section of the Company's website at www.darebioscience.com.
Please log in approximately 5-10 minutes prior to the event 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 5463588. The telephone and webcast replay will be
available until November 20, 2018.
About Daré Bioscience
Daré Bioscience is a clinical-stage
biopharmaceutical company committed to the advancement of
innovative products for women’s reproductive and sexual health. The
company’s mission is to identify, develop and bring to market a
portfolio of novel, differentiated therapies that expand treatment
options, improve outcomes and facilitate convenience for women in
the areas of contraception, vaginal health, sexual health, and
fertility.
Daré’s product portfolio includes two potential
first-in-class candidates currently in clinical development:
Ovaprene®, a non-hormonal, monthly contraceptive vaginal ring, and
Sildenafil Cream, 3.6%, a potential treatment for female sexual
arousal disorder utilizing the same active ingredient as Viagra®.
To learn more about Daré’s full portfolio of women’s health
products, and mission to deliver novel therapies for women, please
visit www.darebioscience.com.
Daré may announce material information about its
finances, product candidates, clinical trials and other matters
using its investor relations website
(http://ir.darebioscience.com), SEC filings, press
releases, public conference calls and webcasts. Daré uses
these channels to communicate with its investors and the public
about the company and other company-related matters. The
information Daré posts on its investor relations website may be
deemed to be material information. Daré encourages investors, the
media, and others interested in the company to review the
information Daré posts on its investor relations 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,” “tend to,” or the negative version of these words and
similar expressions. Such statements include, but are not limited
to, statements relating to the potential of our product candidates
to deliver a first-in-category product addressing a persistent
unmet need in women’s reproductive health, our cash balance being
sufficient to fund our planned operations for at least the next
twelve months, and our expectation that are primary operations will
continue to consist of product research and development and
advancing our portfolio of product candidates through late-stage
clinical development or regulatory approval. Forward-looking
statements involve known and unknown risks, uncertainties and other
factors that may cause our actual results, performance or
achievements to be materially different from future results,
performance or achievements expressed or implied by the
forward-looking statements, including, without limitation, risk and
uncertainties related to: our ability to raise additional capital
when and as needed; our ability to develop and commercialize our
product candidates; the failure or delay in starting, conducting
and completing clinical trials or obtaining United States Food and
Drug Administration or foreign regulatory approval for our product
candidates in a timely manner; our ability to conduct and design
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 efficacy of our product candidates; our
ability to retain our licensed rights to develop and commercialize
a product candidate; our ability to satisfy the monetary
obligations and other requirements in connection with our
exclusive, in-license agreements covering the critical patents and
related intellectual property related to our product candidates;
developments by our competitors that make our product candidates
less competitive or obsolete; our dependence on third parties to
conduct clinical trials; our ability to adequately protect or
enforce our, or our licensor’s, intellectual property rights; the
lack of patent protection for the active ingredients in certain of
our product candidates which could expose our products to
competition from other formulations using the same active
ingredients; the risk of failure associated with product candidates
in preclinical stages of development that may lead investors to
assign them little to no value and make these assets difficult to
fund; and disputes or other developments concerning our
intellectual property rights. Our forward-looking statements are
based upon our 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 our risks and uncertainties, you are encouraged to review our
documents filed with the SEC including our 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 may be required by law.
Contacts:
Investors on behalf of Daré Bioscience, Inc.: Ami Bavishi
Burns McClellan abavishi@burnsmc.com 212-213-0006
OR
Media on behalf of Daré Bioscience, Inc.: Amanda Guisbond
Canale Communications amanda@canalecomm.com 781-405-8775
Source: Daré Bioscience, Inc.
Daré Bioscience, Inc. and
Subsidiaries |
Consolidated Balance Sheets |
|
|
|
|
|
September 30, 2018 |
|
December 31, 2017 |
Assets |
(Unaudited) |
|
|
Current assets |
|
|
|
Cash and
cash equivalents |
$ |
9,537,463 |
|
|
$ |
7,559,846 |
|
Other
receivables |
|
80,278 |
|
|
|
284,206 |
|
Prepaid
expenses |
|
549,949 |
|
|
|
311,571 |
|
Other
current assets |
|
— |
|
|
|
193,495 |
|
Total
current assets |
|
10,167,690 |
|
|
|
8,349,118 |
|
Property and equipment,
net |
|
10,572 |
|
|
|
— |
|
Goodwill |
|
— |
|
|
|
5,187,519 |
|
Other non-current
assets |
|
617,499 |
|
|
|
723,191 |
|
Total
assets |
$ |
10,795,761 |
|
|
$ |
14,259,828 |
|
Liabilities and
stockholders’ equity |
|
|
|
Current
liabilities |
|
|
|
Accounts
payable and accrued expenses |
$ |
1,202,912 |
|
|
$ |
966,653 |
|
Convertible promissory notes |
|
— |
|
|
|
— |
|
Interest
payable |
|
— |
|
|
|
— |
|
Total
current liabilities |
|
1,202,912 |
|
|
|
966,653 |
|
Deferred rent |
|
9,292 |
|
|
|
392 |
|
Total
liabilities |
|
1,212,204 |
|
|
|
967,045 |
|
Commitments and
contingencies (Note 8) |
|
|
|
Stockholders' equity
(deficit) |
|
|
|
Preferred
stock, $0.01 par value, 5,000,000 shares authorized |
|
|
|
None
issued and outstanding |
|
— |
|
|
|
— |
|
Common
stock: $0.0001 par value, 120,000,000 shares authorized, 11,422,161
and 6,047,161 shares issued and outstanding at September 30, 2018
and December 31, 2017, respectively |
|
1,142 |
|
|
|
605 |
|
Accumulated other comprehensive loss |
|
(78,032 |
) |
|
|
(18,080 |
) |
Additional paid-in capital |
|
35,713,662 |
|
|
|
25,541,210 |
|
Accumulated deficit |
|
(26,053,215 |
) |
|
|
(12,230,952 |
) |
Total
stockholders' equity |
|
9,583,557 |
|
|
|
13,292,783 |
|
Total
liabilities and stockholders' equity |
$ |
10,795,761 |
|
|
$ |
14,259,828 |
|
|
Daré Bioscience, Inc. and
Subsidiaries |
Consolidated Statement of
Operations |
(in thousands, except share and per share
data) |
|
|
|
|
|
|
|
|
|
|
|
Three months ended September 30, |
|
Nine months ended September 30, |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
Operating
expenses: |
|
|
|
|
|
|
|
|
General
and administrative |
|
$ |
1,175,049 |
|
|
$ |
1,052,628 |
|
|
$ |
3,635,413 |
|
|
$ |
1,729,338 |
|
Research
and development expenses |
|
|
1,446,548 |
|
|
|
280,793 |
|
|
|
4,750,823 |
|
|
|
312,169 |
|
License
expenses |
|
|
— |
|
|
|
— |
|
|
|
350,000 |
|
|
|
— |
|
Impairment of goodwill |
|
|
— |
|
|
|
— |
|
|
|
5,187,519 |
|
|
|
— |
|
Total operating expenses |
|
|
2,621,597 |
|
|
|
1,333,421 |
|
|
|
13,923,755 |
|
|
|
2,041,507 |
|
Loss from
operations |
|
|
(2,621,597 |
) |
|
|
(1,333,421 |
) |
|
|
(13,923,755 |
) |
|
|
(2,041,507 |
) |
Other income
(expense) |
|
|
47,122 |
|
|
|
(296,262 |
) |
|
|
101,492 |
|
|
|
(330,233 |
) |
Net
loss |
|
$ |
(2,574,475 |
) |
|
$ |
(1,629,683 |
) |
|
$ |
(13,822,263 |
) |
|
$ |
(2,371,740 |
) |
Foreign
currency translation adjustments |
|
$ |
(18,721 |
) |
|
$ |
(9,774 |
) |
|
$ |
(59,952 |
) |
|
$ |
(9,774 |
) |
Comprehensive
loss |
|
$ |
(2,593,196 |
) |
|
$ |
(1,639,457 |
) |
|
$ |
(13,882,215 |
) |
|
$ |
(2,381,514 |
) |
Loss per common share -
basic and diluted |
|
$ |
(0.23 |
) |
|
$ |
(0.33 |
) |
|
$ |
(1.32 |
) |
|
$ |
(1.04 |
) |
Weighted average number
of common shares outstanding: |
|
|
|
|
|
|
|
|
Basic and
diluted |
|
|
11,422,161 |
|
|
|
4,986,226 |
|
|
|
10,499,982 |
|
|
|
2,283,673 |
|
The operations presented in the interim
consolidated financial statements (A) for the three and nine months
ended September 30, 2018 and that include the period from July 19,
2017 to September 30, 2017 represent the operations of the Company
following the Cerulean/Private Daré stock purchase transaction, and
(B) that include the period from January 1, 2017 to July 18, 2017
represent the operations of the Company when it was private, making
a comparison between periods difficult.
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