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UNITED STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT REPORT
Pursuant
to Section 13 or 15(d)
of
the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): November 1, 2023
DARÉ BIOSCIENCE, INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-36395 |
|
20-4139823 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(I.R.S.
Employer
Identification
No.) |
3655
Nobel Drive, Suite 260
San
Diego, CA 92122
(Address
of Principal Executive Offices and Zip Code)
Registrant’s
telephone number, including area code: (858) 926-7655
Not
Applicable
(Former
name or former address, if changed since last report.)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions (see General Instruction A.2. below):
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
stock |
|
DARE |
|
Nasdaq
Capital Market |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☐
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 13(a) of the Exchange Act. ☐
Item
7.01 |
Regulation
FD Disclosure. |
On
November 1, 2023, Daré Bioscience, Inc. (“Daré,” “we,” “us,” or “our”)
issued a press release announcing additional positive findings based on further analyses of data from the exploratory Phase 2b RESPOND
study that evaluated Sildenafil Cream, 3.6% (“Sildenafil Cream”) in women with female sexual arousal disorder (“FSAD”).
A copy of the press release is attached as Exhibit 99.1 to this report and is incorporated herein by reference.
The
information in Item 7.01 of this report, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of
the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to liability under that Section
or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The information contained in
this Item 7.01 and in Exhibit 99.1 shall not be incorporated by reference into any filing with the Securities and Exchange Commission
(the “SEC”) made by Daré, whether made before or after the date hereof, regardless of any general incorporation language
in such filing.
As
previously reported, in June 2023, we announced topline results from our exploratory Phase 2b RESPOND clinical study of Sildenafil Cream
in premenopausal women with FSAD. During the multi-center, double-blind, randomized, placebo-controlled study, subjects used Sildenafil
Cream and placebo cream in their home setting over 12 weeks following a 4-week non-drug run-in period and a 4-week, single-blind placebo
run-in period. The study was a first of its kind Phase 2b clinical study that included patient reported outcome instruments to screen
for eligible women with FSAD and measure efficacy endpoints. In July 2023 and on November 1, 2023, we announced additional findings based
on further analyses of data from the study. We believe data from the Phase 2b RESPOND study support advancing clinical development of
Sildenafil Cream into a Phase 3 pivotal study in women with FSAD and women with female sexual interest/arousal disorder (“FSIAD”)
whose primary complaint is arousal dysfunction using co-primary endpoints similar to those used in the Phase 2b RESPOND study to measure
Sildenafil Cream’s efficacy compared to placebo cream as a potential treatment for FSAD and FSIAD. Phase 3 clinical study design,
including primary and secondary efficacy endpoints, study duration, timing for efficacy endpoint assessment, use of endpoints that reduce
burden on study subjects (e.g., 28-day recall assessments as opposed to recall assessments within 24 hours after each sexual event),
and inclusion/exclusion criteria for study subjects, will be determined following discussions with the U.S. Food and Drug Administration
(“FDA”), including an end of Phase 2 meeting with the FDA, which we expect to occur before the end of 2023.
There
are no treatments approved by the FDA for FSAD, as described in the fourth edition of the Diagnostic and Statistical Manual (DSM), or
for FSIAD, as described in the fifth edition of the DSM, and thus, there are no efficacy endpoints that have been previously validated
in a Phase 3 pivotal study for potential treatments for FSAD or FSIAD.
Forward-Looking
Statements
Daré
cautions you that all statements, other than statements of historical facts, contained in this report, 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 Sildenafil
Cream’s potential as a safe and effective therapy for FSAD and/or FSIAD, Daré’s plans for continued clinical development
of Sildenafil Cream, the potential primary endpoints and patient population to be evaluated in a Phase 3 clinical study, the timing of
an end of Phase 2 meeting with the FDA related to Sildenafil Cream, the potential for Sildenafil Cream to be the first FDA-approved treatment
for any form of sexual arousal disorder in women, and the potential market opportunity for Sildenafil Cream. 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, risks and uncertainties related to: 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 risk
that data from the Phase 2b RESPOND study may not be predictive of positive results of any future clinical study; the risk that the FDA,
other regulatory authorities, members of the scientific or medical communities or investors may not accept or agree with Daré’s
interpretation of or conclusions regarding the study data; 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 development of a product candidate requires more clinical or nonclinical studies than Daré anticipates; 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; the loss of, or inability to attract, key personnel; the effects of macroeconomic conditions, geopolitical events, public health
emergencies, and major disruptions in government operations on Daré’s operations, financial results and condition, and ability
to achieve current plans and objectives; the impact of pharmaceutical industry regulation and health care legislation in the United States
and internationally; 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; cybersecurity incidents 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.
Item
9.01 |
Financial
Statements and Exhibits. |
(d)
Exhibits.
SIGNATURES
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.
|
DARÉ
BIOSCIENCE, INC. |
|
|
Dated:
November 1, 2023 |
By: |
/s/
Sabrina Martucci Johnson |
|
Name: |
Sabrina
Martucci Johnson |
|
Title: |
President
and Chief Executive Officer |
Exhibit 99.1
Daré
Bioscience Announces Additional Positive Data from Phase 2b RESPOND Study of Sildenafil Cream, 3.6% in Women and Proposed Endpoints and
Patient Population for Phase 3 Program
Additional
Analyses of Phase 2b Data Conducted in Population of Study Participants with Female Sexual Interest/Arousal Disorder (FSIAD), With Primary
Complaint of Arousal Dysfunction
Achieved
Statistical Significance and Clinically Meaningful Improvement in Phase 2b Co-Primary Endpoint Assessing Arousal Sensation, and Statistical
Significance in Items from Phase 2b Co-Primary Endpoint Scale Evaluating Concern Related to Difficulties with Sexual Arousal in Subset
Analyses
Data
Support Advancing Co-Primary Endpoints and Selected Patient Population from Phase 2b to Proposed Phase 3 Program
Company
is On Track for End of Phase 2 Meeting with FDA This Year
Sildenafil
Cream Has Potential to Be First FDA-Approved Treatment for Any Form of Sexual Arousal Disorder in Women
SAN
DIEGO, November 1, 2023 (GLOBE NEWSWIRE) – Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health innovation,
and its collaborator Strategic Science & Technologies, LLC (SST), a Cambridge, MA based novel topical drug delivery company, today
announced additional positive findings based on further analyses of data from the exploratory Phase 2b RESPOND study that evaluated Sildenafil
Cream, 3.6% (Sildenafil Cream) in women with female sexual arousal disorder (FSAD).
The
Phase 2b RESPOND study enrolled women with FSAD and included women who had sexual dysfunctions in addition to FSAD. Further analyses
of Phase 2b RESPOND study data identified a subset of study participants—women with FSAD as well as women with FSIAD whose primary
complaint was arousal dysfunction—that achieved statistically significant and clinically meaningful improvement in the Phase 2b
co-primary endpoint of evaluating the efficacy of Sildenafil Cream versus placebo cream as measured by change from baseline to the end
of the 12-week double-blind dosing period in the Arousal-Sensation Domain of the Sexual Function Questionnaire (p=0.04). In addition,
only the Sildenafil Cream treatment group in this subset, and not the placebo group, demonstrated clinically meaningful improvement at
the end of the 12-week period.
The
other co-primary objective of the Phase 2b RESPOND study was to evaluate the efficacy of Sildenafil Cream compared to placebo cream as
measured by the change from baseline to the end of the 12-week double-blind dosing period in the score for feeling concerned by difficulties
with sexual arousal utilizing the Female Sexual Distress Scale – Desire, Arousal, Orgasm (FSDS-DAO). Analyses of the same subset
of women in the Phase 2b RESPOND study (women with FSAD and women with FSIAD whose primary complaint was arousal dysfunction) demonstrated
that the Sildenafil Cream treatment group achieved statistically significant improvement in several FSDS-DAO questions, including regarding
guilt, stress, inadequacy, and embarrassment due to their sexual problems (p=0.02 to 0.05).
“After
showing improvements in multiple aspects of the sexual experience, we believe that the further analyses of the Phase 2b RESPOND study
data support advancing the Phase 2b co-primary endpoints to our Phase 3 program and evaluating the efficacy of Sildenafil Cream in a
broader population of women—women with FSAD and FSIAD,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience.
“The further analyses bolster our belief that Sildenafil Cream has the potential to successfully address the significant unmet
need of arousal disorder. We remain on track for an end of Phase 2 meeting to discuss these exciting findings with the FDA this year,
and look forward to potentially initiating the first ever Phase 3 pivotal study for the treatment of arousal disorder in women. We also
look forward to presenting these additional positive analyses at the upcoming meeting of the Sexual Medicine Society of North America
in San Diego later this month.”
Based
on data from the exploratory Phase 2b RESPOND study, demonstrating improvement in multiple facets of female sexual dysfunction, and because
there is no FDA-approved product for FSAD, as described in the fourth edition of the Diagnostic and Statistical Manual (DSM-IV), or for
FSIAD, as described in the fifth edition of the Diagnostic and Statistical Manual (DSM-5), Sildenafil Cream has the potential to be a
first-in-category product.
The
Phase 2b RESPOND study was a first of its kind Phase 2b clinical study that included patient reported outcome (PRO) instruments to screen
eligible women and a number of primary, secondary, and exploratory PRO assessments to measure improvement in localized genital sensations
of arousal and reduction in the distress that women experience with FSAD. There are no FDA-approved treatments for FSAD or FSIAD and
thus there are no efficacy endpoints that have been previously validated in Phase 3 pivotal studies for potential treatments for FSAD
or FSIAD. The Phase 3 study design for Sildenafil Cream, including primary and secondary efficacy endpoints and inclusion/exclusion criteria
for study participants, will be determined following discussions with the U.S. Food and Drug Administration (FDA), including the company’s
end of Phase 2 meeting with the FDA.
About
FSAD, FSIAD and Sildenafil Cream, 3.6%
FSAD,
as described in the DSM-IV, is a condition characterized as primarily by a persistent or recurrent inability to attain or maintain sufficient
genital arousal (an adequate lubrication-swelling response) during sexual activity, frequently resulting in distress or interpersonal
difficulty, and, of the various types of female sexual dysfunction disorders, FSAD is most analogous to erectile dysfunction (ED) in
men. As with ED in men, FSAD is associated with insufficient blood flow to the genitalia.
FSIAD
is characterized in the DSM-5 as lack of, or significantly reduced, sexual interest and/or arousal for at least six months and the symptoms
must be severe enough to cause clinically significant distress. A woman must have three of the following six symptoms in order to receive
an FSIAD diagnosis: absent or reduced interest in sexual activity; absent or reduced sexual thoughts or fantasies; no or reduced initiation
of sexual activity, and typically unreceptive to a partner’s attempts to initiate; absent or reduced sexual excitement or pleasure
in almost all or all sexual encounters; absent or reduced sexual interest/arousal in response to any internal or external sexual cues;
and absent or reduced genital or non-genital sensations during sexual activity in all or almost all sexual encounters. FSIAD can be lifelong
or acquired, range from mild to severe, and may be generalized or situational.
Sildenafil,
a phosphodiesterase-5 (PDE-5) inhibitor, is the active ingredient in a tablet for oral administration currently marketed under the brand
name Viagra® for the treatment of ED in men. Sildenafil Cream is an investigational, proprietary cream formulation of
sildenafil designed for topical administration to the vulvar-vaginal tissue on demand to increase genital blood flow and provide improvements
in the female genital arousal response, while avoiding systemic side effects observed with oral formulations of sildenafil.
Market
research suggests that 16% of women in the U.S. ages 21 to 60, or approximately 10 million women, are distressed from experiencing symptoms
associated with FSAD, including lack of or low sexual arousal, and are actively seeking solutions to improve their condition. In comparison,
the prevalence of complete ED in men is estimated to be about 5% of men at age 40, increasing to about 15% at age 70.
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, vaginal health, reproductive health,
menopause, sexual health and fertility.
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. 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 (FSAD) and/or female sexual interest/arousal disorder (FSIAD)
utilizing the active ingredient in Viagra®; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal
ring for menopausal hormone therapy. 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
Bioscience leadership has been named on the Medicine Maker’s Power List and Endpoints News’ Women in Biopharma 2022. In 2023,
Daré’s CEO was honored as one of Fierce Pharma’s Most Influential People in Biopharma for Daré’s contributions
to innovation and advocacy in the women’s health space. Daré Bioscience placed #1 in the Small Company category of the San
Diego Business Journal’s 2023 Best Places to Work Awards.
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 X (formerly 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 Sildenafil
Cream’s potential as a safe and effective therapy for FSAD and/or FSIAD, Daré’s plans for continued clinical development
of Sildenafil Cream, the potential primary endpoints and patient population to be evaluated in a Phase 3 clinical study, the timing of
an end of Phase 2 meeting with the FDA related to Sildenafil Cream, the potential for Sildenafil Cream to be the first FDA-approved treatment
for any form of sexual arousal disorder in women, and the potential market opportunity for Sildenafil Cream. 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, risks and uncertainties related to: 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 risk
that data from the Phase 2b RESPOND study may not be predictive of positive results of any future clinical study; the risk that the FDA,
other regulatory authorities, members of the scientific or medical communities or investors may not accept or agree with Daré’s
interpretation of or conclusions regarding the study data; 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 development of a product candidate requires more clinical or nonclinical studies than Daré anticipates; 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; the loss of, or inability to attract, key personnel; the effects of macroeconomic conditions, geopolitical events, public health
emergencies, and major disruptions in government operations on Daré’s operations, financial results and condition, and ability
to achieve current plans and objectives; the impact of pharmaceutical industry regulation and health care legislation in the United States
and internationally; 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; cybersecurity incidents 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:
Media
and Investors on behalf of Daré Bioscience, Inc:
Camilla
White / Simona Kormanikova
Dentons
Global Advisors
DareBioscience@dentonsglobaladvisors.com
/ 1.212.466.6450
Source:
Daré Bioscience, Inc.
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Dare Bioscience (NASDAQ:DARE)
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Dare Bioscience (NASDAQ:DARE)
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From Jan 2024 to Jan 2025