<SEC-DOCUMENT>0001193125-18-338016.txt : 20181129
<SEC-HEADER>0001193125-18-338016.hdr.sgml : 20181129
<ACCEPTANCE-DATETIME>20181129160207
ACCESSION NUMBER:		0001193125-18-338016
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20181129
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20181129
DATE AS OF CHANGE:		20181129

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:		181208515

	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>d649259d8k.htm
<DESCRIPTION>FORM 8-K
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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="margin-top:4pt; margin-bottom:0pt; font-size:16pt; font-family:Times New Roman" ALIGN="center"><B>UNITED STATES </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:16pt; font-family:Times New Roman" ALIGN="center"><B>SECURITIES AND EXCHANGE COMMISSION </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Washington, D.C. 20549 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" 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><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>CURRENT
REPORT </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" 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:Times New Roman" 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:Times New Roman" ALIGN="center">Date of Report (Date of earliest event reported):<B> November</B><B></B><B>&nbsp;29, 2018</B> </P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:24pt; font-family:Times New Roman" ALIGN="center"><B>DAR&Eacute; BIOSCIENCE, INC. </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(Exact name of registrant as specified in its charter) </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE CELLSPACING="0" CELLPADDING="0" WIDTH="100%" BORDER="0" STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:8pt" ALIGN="center">


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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:Times New Roman; font-size:8pt">
<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(State or other jurisdiction</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>of incorporation)</B></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:Times New Roman" ALIGN="center"><B>(Commission</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>File Number)</B></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:Times New Roman" ALIGN="center"><B>(I.R.S. Employer</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>Identification No.)</B></P></TD></TR>
</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>3655 Nobel Drive, Suite 260 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>San Diego, CA 92122 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Address of Principal Executive Offices and Zip Code) </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" 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:Times New Roman" ALIGN="center"><B>Not Applicable </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Former
name or former address, if changed since last report.) </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">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:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " 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:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " 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:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " 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:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " 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:Times New Roman">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:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Emerging growth company&nbsp;&#9746; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">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;&#9746; </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:0pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P>
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<TD WIDTH="9%" 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:Times New Roman; " ALIGN="left"><B>Other Events. </B></P></TD></TR></TABLE>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">On November&nbsp;29, 2018, Dar&eacute; Bioscience, Inc. (&#147;Dar&eacute;&#148;), issued a press release regarding the initiation of the content validity
study for 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:Times New Roman">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:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TR style = "page-break-inside:avoid">
<TD WIDTH="9%" 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:Times New Roman; " ALIGN="left"><B>Financial Statements and Exhibits. </B></P></TD></TR></TABLE>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">(d)&nbsp;&nbsp;&nbsp;&nbsp;Exhibits. </P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom" NOWRAP ALIGN="center"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; border-bottom:1.00pt solid #000000; display:table-cell; font-size:8pt; font-family:Times New Roman; " ALIGN="center"><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:Times New Roman"><B>Description</B></P></TD></TR>


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<TD VALIGN="top" NOWRAP ALIGN="center">99.1</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d649259dex991.htm">Press release issued on November&nbsp;29, 2018 </A></TD></TR>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>SIGNATURES </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">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:12pt;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;29, 2018</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top">By:</TD>
<TD VALIGN="bottom" STYLE=" BORDER-BOTTOM:1px solid #000000">&nbsp;</TD>
<TD VALIGN="top" STYLE="BORDER-BOTTOM:1px solid #000000">/s/ Sabrina Martucci Johnson</TD></TR>
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<TD VALIGN="top">Name: Sabrina Martucci Johnson</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top"></TD>
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<TD VALIGN="bottom">Title: President and Chief Executive Officer</TD></TR>
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<TYPE>EX-99.1
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<FILENAME>d649259dex991.htm
<DESCRIPTION>EX-99.1
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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="right"><B>Exhibit 99.1 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:14pt; font-family:Times New Roman" ALIGN="center"><B>Dar&eacute; Bioscience, Inc. Announces Initiation of Content Validity Study for Sildenafil Cream, 3.6%, a Potential Therapy for Female
Sexual Arousal Disorder </B></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:14pt; font-family:Times New Roman" ALIGN="center"><B>Sildenafil Cream, 3.6% has the Potential to Receive the First FDA Approval for Female Sexual Arousal
Disorder </B></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">SAN DIEGO,&nbsp;Nov. 29, 2018&nbsp;(GLOBE NEWSWIRE) &#151;<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, and Strategic Science&nbsp;&amp; Technologies, LLC (SST), a Cambridge, MA based novel topical drug delivery company, today announced the initiation of a content validity
study intended to support the use of specific patient reported outcome (PRO) measures to assess efficacy in female sexual arousal disorder (FSAD) patients in the Phase 2b and Phase 3 program for Sildenafil Cream, 3.6%. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">This <FONT STYLE="white-space:nowrap">non-interventional</FONT> study is designed to explore the experience of FSAD and evaluate the relevance of the selected
PRO measures based on patients&#146; own experiences and determine patients&#146; understanding of the items, instructions, and response options of the selected PRO measures. Subjects that meet the inclusion criteria will participate in <FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">one-on-one,</FONT></FONT> <FONT STYLE="white-space:nowrap">in-depth</FONT> interviews conducted by subject matter experts in the field of clinical outcome assessments and female sexual
medicine, which include thought leaders in the field of sexual medicine that are a subset of the sites that are expected to enroll subjects into the Phase 2b <FONT STYLE="white-space:nowrap">at-home</FONT> interventional study. This <FONT
STYLE="white-space:nowrap">non-interventional</FONT> content validity study provides a unique opportunity to pilot the methods intended to be used, subject to U.S. Food and Drug Administration (FDA) approval, to identify, screen and diagnose women
with FSAD in the Phase 2b <FONT STYLE="white-space:nowrap">at-home</FONT> interventional study. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">&#147;We&#146;re excited to announce that we have reached
this milestone with the initiation of the content validity study for our Sildenafil Cream, 3.6% program,&#148; said Sabrina Martucci Johnson, President and CEO of Dar&eacute; Bioscience. &#147;Although numerous pharmaceutical products have been
developed, tested and approved to treat erectile dysfunction (ED) in men, women continue to lack effective options for FSAD, an analogous condition. Sildenafil 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 ED in men, and we plan to leverage the existing data and safety profile of the Viagra<SUP STYLE="font-size:85%; vertical-align:top">&reg;</SUP> brand for our Sildenafil
Cream, 3.6% program. Correct selection and implementation of a validated PRO to assess efficacy is a critical component of our successful Phase 2b and Phase 3 program. The goal of the study is to demonstrate that women both understand the PRO items
and agree that they capture their most important and relevant symptoms and impacts of FSAD. We believe that establishing a content valid and well-understood PRO tool will help us provide confidence in the efficacy endpoints selected for the Phase 2b
study.&#148; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">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:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">&#147;The content validation study is part of a robust clinical development program designed to support this innovative application of sildenafil for the
treatment of FSAD,&#148; said Steven Brugger, President and Chief Operating Officer of SST. &#147;Working in concert with the FDA we look forward to advancing the program towards important near-term value inflection milestones in the Phase 2b
program, beginning with the content validity study.&#148; </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>About FSAD </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">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 ED in men. While increased attention has been focused on female sexual dysfunction over the past several years, no pharmacologic options have yet been 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>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>About Dar&eacute; Bioscience </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">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:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">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;<U>www.darebioscience.com</U>. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">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:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Forward-Looking Statements </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><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 ability to demonstrate content validity of the proposed PRO instrument for Phase 2b and Phase 3
studies of Sildenafil Cream, 3.6% for FSAD, the ability to leverage existing safety and efficacy data of the Viagra<SUP STYLE="font-size:85%; vertical-align:top">&reg;</SUP> product for the Sildenafil Cream, 3.6% program, and the company&#146;s
ability to advance its product candidates, including Sildenafil Cream, 3.6%, 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 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:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><I>Contacts: </I></B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Investors on behalf of Dar&eacute;&nbsp;Bioscience, Inc.: </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Ami
Bavishi </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Burns McClellan </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>abavishi@burnsmc.com</U> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">212-213-0006</FONT></FONT> </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">OR </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Media on behalf of Dar&eacute;&nbsp;Bioscience, Inc.: </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Amanda Guisbond </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Canale Communications </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>amanda@canalecomm.com</U> </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap">781-405-8775</FONT></FONT> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Source: Dar&eacute;&nbsp;Bioscience, Inc. </P>
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