<SEC-DOCUMENT>0001193125-18-335165.txt : 20181127
<SEC-HEADER>0001193125-18-335165.hdr.sgml : 20181127
<ACCEPTANCE-DATETIME>20181127160158
ACCESSION NUMBER:		0001193125-18-335165
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20181127
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20181127
DATE AS OF CHANGE:		20181127

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Dare Bioscience, Inc.
		CENTRAL INDEX KEY:			0001401914
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				204139823
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-36395
		FILM NUMBER:		181203134

	BUSINESS ADDRESS:	
		STREET 1:		3655 NOBEL DRIVE
		STREET 2:		SUITE 260
		CITY:			SAN DIEGO
		STATE:			CA
		ZIP:			92122
		BUSINESS PHONE:		858-926-7655

	MAIL ADDRESS:	
		STREET 1:		3655 NOBEL DRIVE
		STREET 2:		SUITE 260
		CITY:			SAN DIEGO
		STATE:			CA
		ZIP:			92122

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	Cerulean Pharma Inc.
		DATE OF NAME CHANGE:	20090714

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	Tempo Pharmaceuticals Inc
		DATE OF NAME CHANGE:	20070604
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>d650599d8k.htm
<DESCRIPTION>FORM 8-K
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<HTML><HEAD>
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 <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL" ALIGN="center"><B>UNITED STATES </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL" ALIGN="center"><B>SECURITIES AND EXCHANGE
COMMISSION </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL" ALIGN="center"><B>Washington, D.C. 20549 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:ARIAL" ALIGN="center"><B>FORM
<FONT STYLE="white-space:nowrap">8-K</FONT> </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P> <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL" ALIGN="center"><B>CURRENT REPORT </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL" ALIGN="center"><B>Pursuant to Section&nbsp;13
or 15(d) </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL" ALIGN="center"><B>of the Securities Exchange Act of 1934 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="center">Date of Report (Date of earliest event reported):<B> November</B><B></B><B>&nbsp;27, 2018</B> </P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P> <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:24pt; font-family:ARIAL" ALIGN="center"><B>DAR&Eacute; BIOSCIENCE, INC. </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="center">(Exact name of
registrant as specified in its charter) </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P> <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top" ALIGN="center"><B>Delaware</B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B><FONT STYLE="white-space:nowrap">001-36395</FONT></B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B><FONT STYLE="white-space:nowrap">20-4139823</FONT></B></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:ARIAL; font-size:8pt">
<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL" ALIGN="center">(State or other jurisdiction</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:ARIAL" ALIGN="center">of incorporation)</P></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL" ALIGN="center">(Commission</P> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:ARIAL" ALIGN="center">File
Number)</P></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL" ALIGN="center">(I.R.S. Employer</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:ARIAL" ALIGN="center">Identification No.)</P></TD></TR>
</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="center"><B>3655 Nobel Drive, Suite 260 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="center"><B>San Diego, CA 92122 </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL" ALIGN="center">(Address of Principal
Executive Offices and Zip Code) </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="center">Registrant&#146;s telephone number, including area code:
<B>(858)</B><B></B><B><FONT STYLE="white-space:nowrap">&nbsp;926-7655</FONT></B> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="center"><B>Not Applicable </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL" ALIGN="center">(Former name or former address, if changed since last report.) </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">Check the appropriate box below if the Form <FONT
STYLE="white-space:nowrap">8-K</FONT> filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below): </P>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:ARIAL; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><FONT STYLE="font-family:Times New Roman">&#9744;</FONT></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:ARIAL; " ALIGN="left">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) </P></TD></TR></TABLE>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:ARIAL; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><FONT STYLE="font-family:Times New Roman">&#9744;</FONT></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:ARIAL; " ALIGN="left">Soliciting material pursuant to Rule <FONT STYLE="white-space:nowrap">14a-12</FONT> under the Exchange Act (17 CFR <FONT
STYLE="white-space:nowrap">240.14a-12)</FONT> </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:ARIAL; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><FONT STYLE="font-family:Times New Roman">&#9744;</FONT></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:ARIAL; " ALIGN="left"><FONT STYLE="white-space:nowrap">Pre-commencement</FONT> communications pursuant to Rule
<FONT STYLE="white-space:nowrap">14d-2(b)</FONT> under the Exchange Act (17 CFR <FONT STYLE="white-space:nowrap">240.14d-2(b))</FONT> </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:ARIAL; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><FONT STYLE="font-family:Times New Roman">&#9744;</FONT></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:ARIAL; " ALIGN="left"><FONT STYLE="white-space:nowrap">Pre-commencement</FONT> communications pursuant to Rule
<FONT STYLE="white-space:nowrap">13e-4(c)</FONT> under the Exchange Act (17 CFR <FONT STYLE="white-space:nowrap">240.13e-4(c))</FONT> </P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">Indicate by
check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (&#167;230.405 of this chapter) or <FONT STYLE="white-space:nowrap">Rule&nbsp;12b-2&nbsp;of</FONT> the Securities Exchange Act of <FONT
STYLE="white-space:nowrap">1934&nbsp;(&#167;240.12b-2&nbsp;of</FONT> this chapter). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:ARIAL">Emerging growth company&nbsp;&nbsp;<FONT
STYLE="font-family:Times New Roman">&#9746;</FONT> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended
transition period for complying with any new or revised financial accounting standards provided pursuant to Section&nbsp;13(a) of the Exchange Act.&nbsp;&nbsp;<FONT STYLE="font-family:Times New Roman">&#9746;</FONT> </P>

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<TD WIDTH="12%" VALIGN="top" ALIGN="left"><B>Item&nbsp;8.01</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:ARIAL; " ALIGN="left"><B>Other Events. </B></P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">On November&nbsp;27, 2018, Dar&eacute; Bioscience, Inc. (&#147;Dar&eacute;&#148;), issued a press release regarding its product candidate, Sildenafil Cream, 3.6%, a
copy of which is filed as Exhibit 99.1 to this report and is incorporated herein by reference. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">By filing this report, including the information in Exhibit 99.1
attached hereto, Dar&eacute; makes no admission as to the materiality of any information in this report. Exhibit 99.1 contains information that is intended to be considered in the context of Dar&eacute;&#146;s filings with the U.S. Securities and
Exchange Commission (the &#147;SEC&#148;), including its Annual Report on Form <FONT STYLE="white-space:nowrap">10-K</FONT> filed on March&nbsp;28, 2018 (as amended by the Form <FONT STYLE="white-space:nowrap">10-K/A</FONT> filed on April&nbsp;30,
2018), Quarterly Reports on Form <FONT STYLE="white-space:nowrap">10-Q</FONT> filed on May&nbsp;14, 2018, August&nbsp;13, 2018 and November&nbsp;13, 2018, and other public announcements that Dar&eacute; makes, by press release or otherwise, from
time to time. Dar&eacute; undertakes no duty or obligation to publicly update or revise the information contained in this report, although it may do so from time to time as it believes is appropriate. Any such updating may be made through the filing
of other reports or documents with the SEC, through press releases, or through other public disclosure. </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:ARIAL; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="12%" VALIGN="top" ALIGN="left"><B>Item&nbsp;9.01</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:ARIAL; " ALIGN="left"><B>Financial Statements and Exhibits. </B></P></TD></TR></TABLE>
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<TD WIDTH="5%" VALIGN="top" ALIGN="left">(d)</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:ARIAL; " ALIGN="left">Exhibits. </P></TD></TR></TABLE> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom" NOWRAP STYLE="border-bottom:1.00pt solid #000000"> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:ARIAL"><B>Exhibit<BR>Number</B></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" STYLE="border-bottom:1.00pt solid #000000"> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:ARIAL"><B>Description</B></P></TD></TR>


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<TD VALIGN="top" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:ARIAL">99.1</P></TD>
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<TD VALIGN="top"><A HREF="d650599dex991.htm">Press release issued on November&nbsp;27, 2018 </A></TD></TR>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="center"><B>SIGNATURES </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized. </P> <P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top" COLSPAN="3"><B>DAR&Eacute; BIOSCIENCE, INC.</B></TD></TR>
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<TD VALIGN="top">Dated: November&nbsp;27, 2018</TD>
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<TD VALIGN="top">By:</TD>
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<TD VALIGN="top"><U>/s/ Sabrina Martucci Johnson&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</U></TD></TR>
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<TD VALIGN="bottom">&nbsp;</TD>
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<TD VALIGN="top">Name: &nbsp;Sabrina Martucci Johnson</TD></TR>
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<TD VALIGN="top">Title:&nbsp; President and Chief Executive Officer</TD></TR>
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<TYPE>EX-99.1
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<DESCRIPTION>EX-99.1
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL" ALIGN="right"><B>Exhibit 99.1 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:14pt; font-family:ARIAL" ALIGN="center"><B>Dar&eacute; Bioscience, Inc. Announces Enrollment in Thermography Feasibility </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:14pt; font-family:ARIAL" ALIGN="center"><B>Study with Sildenafil Cream, 3.6%, a Potential Therapy for Female Sexual </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:14pt; font-family:ARIAL" ALIGN="center"><B>Arousal Disorder </B></P> <P STYLE="margin-top:14pt; margin-bottom:0pt; font-size:14pt; font-family:ARIAL" ALIGN="center"><B>Sildenafil Cream, 3.6% has
the Potential to Receive the First FDA Approval </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:14pt; font-family:ARIAL" ALIGN="center"><B>for Female Sexual Arousal Disorder </B></P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL">SAN DIEGO,&nbsp;Nov. 27, 2018&nbsp;(GLOBE NEWSWIRE) --<B>&nbsp;Dar</B><B>&eacute;</B><B></B><B>&nbsp;Bioscience, Inc</B><B>. </B>(NASDAQ: DARE), a leader in
clinical-stage women&#146;s health innovation, today announced that it is currently enrolling patients in an investigational study designed to evaluate the feasibility of using thermography technology to assess the pharmacodynamics of Sildenafil
Cream, 3.6% in normal healthy women. Sildenafil, the active ingredient in Sildenafil Cream, 3.6%, is marketed in an oral dosage form under the brand name Viagra<SUP STYLE="font-size:85%; vertical-align:top">&reg;</SUP> for the treatment of erectile
dysfunction in men. Dar&eacute;&nbsp;Bioscience, in partnership with Strategic Science&nbsp;&amp; Technologies, LLC (SST), is developing Sildenafil Cream, 3.6% as a potential treatment for female sexual arousal disorder (FSAD). During the
thermography study, genital temperature, a surrogate for genital blood flow, will be captured and recorded utilizing an infrared camera capable of detecting heat patterns from blood flow in body tissues. The study consists of the screening visit
(visit 1), the double-blind dosing of placebo or active cream (visits <FONT STYLE="white-space:nowrap">2-3)</FONT> and a safety <FONT STYLE="white-space:nowrap">follow-up.</FONT> </P>
<P STYLE="margin-top:8pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL">&#147;We are excited to announce that enrollment is underway in this thermography study,&#148; said Sabrina Martucci Johnson, President&nbsp;&amp; CEO of Dar&eacute;
Bioscience. &#147;This study is part of our larger FSAD development program, and reflects capital-efficient activities we are pursuing to enrich and enhance the Phase 2b program. This small exploratory study has the potential to provide greater
insight into the physiologic activity and time to effect resulting from the application of Sildenafil Cream, 3.6% externally to the vulva and internally in the vagina, which would further inform and support the design of our Phase 2b <FONT
STYLE="white-space:nowrap">at-home</FONT> study, anticipated to commence in 2019.&#148; </P> <P STYLE="margin-top:8pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL">Sildenafil Cream, 3.6% is a proprietary cream formulation specifically
designed to increase blood flow to the genital tissue in women, leading to a potential improvement in genital arousal response during sexual activity. If successful, Sildenafil Cream, 3.6% has the potential to be the first <FONT
STYLE="white-space:nowrap">FDA-approved</FONT> FSAD treatment option. </P> <P STYLE="margin-top:8pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL">&#147;The thermography study is part of a comprehensive clinical development and regulatory
strategy that includes an upcoming content validity study to support the implementation of FSAD specific patient reported outcome (PRO) instruments, as well as an <FONT STYLE="white-space:nowrap">at-home</FONT> dosing study which together constitute
our Phase 2b program,&#148; said Mary Jarosz, Global Head of Regulatory Affairs for Dar&eacute; Bioscience. </P> <P STYLE="margin-top:8pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL">The principal investigator for the thermography study is
Dr.&nbsp;Irwin Goldstein, a recognized leader in the treatment of both male and female sexual disorders and the 2009 recipient of the World Association for Sexual Health Gold Medal award in recognition of lifetime contributions to the field.
&#147;We are pleased to be working with SST and Dar&eacute; on the Sildenafil Cream, 3.6% program, leveraging the known therapeutic </P>

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benefit of Viagra&reg; to stimulate increased blood flow to the genital tissue,&#148; said Dr.&nbsp;Goldstein.&nbsp;&#147;There are no approved drugs for the treatment of FSAD and Sildenafil
Cream, 3.6% has the potential to be an <FONT STYLE="white-space:nowrap">on-demand</FONT> solution to prepare the body for a more pleasurable sexual experience.&#148; </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL"><B>About Sildenafil Cream, 3.6% and 3Q2018 Type C Meeting with the FDA </B></P>
<P STYLE="margin-top:8pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL">Sildenafil Cream, 3.6% has the potential to be the first <FONT STYLE="white-space:nowrap">FDA-approved</FONT> FSAD treatment option. Unlike other female sexual
disorders, FSAD is characterized primarily by an inability to attain or maintain sufficient physical sexual arousal that causes distress or interpersonal difficulty. It is the closest analog in women to erectile dysfunction in men. While increased
attention has been focused on female sexual dysfunction over the past several years, no pharmacologic options have yet been U.S. Food and Drug Administration (FDA) approved for FSAD. In a Phase 2a trial, Sildenafil Cream, 3.6% increased measurable
blood flow to the vaginal tissue in both <FONT STYLE="white-space:nowrap">pre-</FONT> and postmenopausal women with FSAD compared to placebo.</P> <P STYLE="margin-top:8pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL">During the third
quarter of 2018, we had a Type C meeting with the FDA regarding the Phase 2b program for Sildenafil Cream, 3.6%. The objective of this meeting was to align with the agency on key aspects of the Phase 2b and the overall clinical program to support
the planned New Drug Application, or NDA, including the screening assessments used to accurately diagnose FSAD, the PRO instruments to be used as primary efficacy endpoints for pivotal clinical studies, study duration, and the target patient
population to be studied. </P> <P STYLE="margin-top:8pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL">Based on the outcome of this meeting, in the fourth quarter of 2018, we will commence Phase 2b related activities for Sildenafil Cream,
3.6% with the initiation of a content validity PRO study to demonstrate that the FSAD symptoms we plan to assess in our Phase 2b and our pivotal studies are the most important and relevant to our target patient population and are also acceptable
efficacy endpoints for the FDA. After the content validity PRO study is completed and before the Phase 2b <FONT STYLE="white-space:nowrap">at-home</FONT> trial is initiated, we plan to request another Type C meeting to obtain the FDA&#146;s guidance
on whether it agrees that the PRO instruments are content valid for the target population. </P> <P STYLE="margin-top:8pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL"><B>About Dar&eacute; Bioscience </B></P>
<P STYLE="margin-top:8pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL">Dar&eacute; Bioscience is a clinical-stage biopharmaceutical company committed to the advancement of innovative products for women&#146;s reproductive and sexual health.
The company&#146;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. </P> <P STYLE="margin-top:8pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL">Dar&eacute;&#146;s product portfolio includes two potential
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">first-in-class</FONT></FONT> candidates in clinical development: Ovaprene<SUP STYLE="font-size:85%; vertical-align:top">&reg;</SUP>, a
<FONT STYLE="white-space:nowrap">non-hormonal,</FONT> monthly contraceptive vaginal ring, and Sildenafil Cream, 3.6%, a potential treatment for female sexual arousal disorder utilizing the same active ingredient as Viagra<SUP
STYLE="font-size:85%; vertical-align:top">&reg;</SUP>. To learn more about Dar&eacute;&#146;s full portfolio of women&#146;s health products, and mission to deliver novel therapies for women, please visit&nbsp;<FONT
STYLE="font-family:ARIAL" COLOR="#0000ff"><U>www.darebioscience.com</U></FONT><FONT STYLE="font-family:ARIAL">. </FONT></P>

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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL">Dar&eacute; 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. Dar&eacute; uses these channels to communicate with its investors and the public about the company and other
company-related matters. The information Dar&eacute; posts on its investor relations website may be deemed to be material information. Dar&eacute; encourages investors, the media, and others interested in the company to review the information
Dar&eacute; posts on its investor relations website. </P> <P STYLE="margin-top:8pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL"><B>Forward-Looking Statements </B></P>
<P STYLE="margin-top:8pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL"><I>Dar&eacute; 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 &#147;believe,&#148; &#147;may,&#148; &#147;will,&#148; &#147;estimate,&#148; &#147;continue,&#148; &#147;anticipate,&#148; &#147;design,&#148; &#147;intend,&#148;
&#147;expect,&#148; &#147;could,&#148; &#147;plan,&#148; &#147;potential,&#148; &#147;predict,&#148; &#147;seek,&#148; &#147;should,&#148; &#147;would,&#148; &#147;contemplate,&#148; project,&#148; &#147;target,&#148; &#147;tend to,&#148; or the
negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to the potential of Sildenafil Cream, 3.6% to be the first <FONT STYLE="white-space:nowrap">FDA-approved</FONT> FSAD
treatment option, the usefulness of the thermography study to clinical development and potential regulatory approval of Sildenafil Cream, 3.6% for FSAD, the timing of initiation or completion of the company&#146;s clinical studies, and the
company&#146;s ability to advance its product candidates through clinical development and regulatory approval. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Dar&eacute;&#146;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: 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 FDA 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, <FONT STYLE="white-space:nowrap">in-license</FONT> 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&#146;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 </I></P>

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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 <FONT STYLE="white-space:nowrap">8-K,</FONT> Form <FONT STYLE="white-space:nowrap">10-K</FONT> and Form <FONT STYLE="white-space:nowrap">10-Q.</FONT> You are cautioned
not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Dar&eacute; 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. </I></P> <P STYLE="margin-top:8pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL"><B><I>Contacts: </I></B></P>
<P STYLE="margin-top:8pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL">Investors on behalf of Dar&eacute;&nbsp;Bioscience, Inc.: </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL">Ami Bavishi </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL">Burns McClellan </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL"><FONT STYLE="font-family:ARIAL" COLOR="#0000ff"><U>abavishi@burnsmc.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL"><FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">212-213-0006</FONT></FONT> </P>
<P STYLE="margin-top:8pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL">OR </P> <P STYLE="margin-top:8pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL">Media on behalf of Dar&eacute;&nbsp;Bioscience, Inc.: </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL">Amanda Guisbond </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL">Canale Communications </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL"><FONT STYLE="font-family:ARIAL" COLOR="#0000ff"><U>amanda@canalecomm.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL"><FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">781-405-8775</FONT></FONT> </P>
<P STYLE="margin-top:8pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL">Source: Dar&eacute;&nbsp;Bioscience, Inc. </P>
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