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2023-12-20
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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): December 20, 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
December 20, 2023, Daré Bioscience, Inc. (“Daré,” “we,” “us,” or “our”)
issued a press release announcing topline results from the Phase 1 clinical study of DARE-PDM1 discussed in Item 8.01 below. 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.
On
December 20, 2023, Daré announced topline results from its Phase 1 clinical study of DARE-PDM1, an investigational, proprietary
hydrogel formulation of diclofenac, a nonsteroidal anti-inflammatory drug, for vaginal administration as a treatment for primary dysmenorrhea.
The DARE-PDM1 Phase 1 study, DARE-PDM1-001, was a multi-center, randomized, placebo-controlled, double-blind, three-arm parallel group
study among approximately 42 healthy, premenopausal women with symptomatic primary dysmenorrhea. The study was designed to assess the
systemic (plasma) and local mucosal (vaginal fluid) diclofenac pharmacokinetics (PK) and safety after a single dose and during three
daily doses of vaginally administered DARE-PDM1, given in two different strengths (1% or 3% diclofenac in 2.5 mL of hydrogel) versus
placebo (vaginal hydrogel, no active ingredient). The study also assessed, as an exploratory endpoint, the preliminary dysmenorrhea treatment
efficacy of DARE-PDM1, when dosed in three daily doses at the onset of dysmenorrhea symptoms, compared to a no-treatment, baseline, control
cycle. The study observation period encompassed approximately three menstrual cycles.
The
topline data indicate that the study treatment was well-tolerated, and treatment emergent adverse events profiles were comparable between
the DARE-PDM1 treatment groups and the placebo group. All adverse events were mild or moderate; most adverse events (85%) were mild.
There were no early discontinuations due to an adverse event, and no serious adverse events were reported.
The
vaginal fluid PK results exhibited dose proportionality for the 1% and 3% diclofenac strengths of the DARE-PDM1 study treatment. Additionally,
the vaginal fluid PK results demonstrated that the product was retained in the vaginal canal through 24 hours. The plasma PK results
are forthcoming.
The
exploratory endpoint that evaluated the efficacy of DARE-PDM1 versus placebo in reducing dysmenorrhea-associated pain showed a promising
signal, with a statistically significant decrease in pelvic/vaginal and lower back pain scores in the 1% diclofenac DARE-PDM1 treatment
group compared to the placebo group, as well as a decrease in pain scores in the 3% diclofenac DARE-PDM1 treatment group. Additionally,
while most participants used at least one non-pharmacologic pain relief method (e.g., heating pad) for dysmenorrhea-associated pain during
the no-treatment, baseline, control cycle, the proportion of participants who used at least one non-pharmacologic pain relief method
for dysmenorrhea-associated pain decreased significantly in the DARE-PDM1 treatment groups during the dosing period, but not in the placebo
group. There was no difference in the exploratory assessment of frequency
of use of rescue medications in the treatment phase between the three groups.
Pending
the plasma PK data, the topline results of the Phase 1 study support continued clinical development of DARE-PDM1 as a treatment for primary
dysmenorrhea.
The
DARE-PDM1-001 study was conducted in Australia by the company’s wholly-owned subsidiary, DARE Bioscience Australia Pty Ltd.
Cautionary
Statement Regarding 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 report, forward-looking statements include, but are not limited to, statements relating to DARE-PDM1’s
potential as a safe and effective treatment for primary dysmenorrhea and Daré’s clinical development plans for DARE-PDM1.
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 report, including, without limitation, risks and uncertainties related to: the risk that topline
results from a clinical trial, including the Phase 1 study of DARE-PDM1, are based on Daré’s preliminary analysis of key
data and, following a comprehensive review of study data, including the forthcoming plasma PK data from the Phase 1 study of DARE-PDM1,
such results may change and topline results may not accurately reflect the complete results from the clinical trial; 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; 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 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
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 data from clinical studies of its product candidates; the risk that development of a product
candidate requires more clinical or nonclinical studies than Daré anticipates; 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 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:
December 20, 2023 |
By: |
/s/
Sabrina Martucci Johnson |
| |
Name: |
Sabrina
Martucci Johnson |
| |
Title: |
President
and Chief Executive Officer |
Exhibit
99.1
Daré
Bioscience Announces Positive Topline Pharmacokinetic and Exploratory Efficacy Results from the DARE-PDM1 Phase 1 Clinical Study
Data
Support Continued Clinical Development of DARE-PDM1 and its Potential as a First-in-Category Treatment for Primary Dysmenorrhea
SAN
DIEGO, December 20, 2023 (GLOBE NEWSWIRE) — Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation,
today announced positive topline results from the Phase 1 study evaluating the pharmacokinetics (PK), safety, and exploratory efficacy
of DARE-PDM1. DARE-PDM1 is an investigational product designed to deliver diclofenac, a nonsteroidal anti-inflammatory drug (NSAID),
vaginally via the company’s proprietary hydrogel to treat primary dysmenorrhea, which is defined as painful menstruation in women
with normal pelvic anatomy. DARE-PDM1 has the potential to be a first-in-category product, delivering diclofenac in a convenient vaginal
format that may extend the duration of pain relief and reduce the risks associated with the oral delivery of NSAIDs.
The
DARE-PDM1 Phase 1 study, DARE-PDM1-001, was a multi-center, randomized, placebo-controlled, double-blind, 3-arm parallel group study
among approximately 42 healthy, premenopausal women with symptomatic primary dysmenorrhea. This study was designed to assess the systemic
(plasma) and local mucosal (vaginal fluid) diclofenac PK and safety after a single dose and during three daily doses of vaginally administered
DARE-PDM1, given in two different strengths (1% or 3% diclofenac in 2.5 mL of hydrogel) versus placebo (vaginal hydrogel, no active ingredient).
The study also assessed, as an exploratory endpoint, the preliminary dysmenorrhea treatment efficacy of DARE-PDM1, when dosed in three
daily doses at the onset of dysmenorrhea symptoms, compared to a no-treatment, baseline, control cycle. The study observation period
encompassed approximately three menstrual cycles. The plasma PK results are forthcoming.
“We
are encouraged by these data which indicate that our candidate, DARE-PDM1, was well-tolerated and safe for premenopausal women in both
treatment groups,” said Dr. Annie Thurman, Medical Director of Daré Bioscience. “The most common interventions for
primary dysmenorrhea include oral NSAIDs and hormonal contraceptives, which often can produce undesirable side effects such as an increased
risk of gastrointestinal adverse events, including nausea, vomiting, bloating, or ulcerations. These topline Phase 1 data indicate that
by leveraging a vaginal route of administration, we can provide a more convenient and accessible treatment option for women that addresses
the pain-related symptoms of the condition while minimizing side effects commonly seen with the use of oral medications.”
“DARE-PDM1
utilizes a well-known and well-characterized active pharmaceutical ingredient for primary dysmenorrhea delivered by our novel hydrogel
technology, which is designed to keep the product from leaking out of the vagina and may increase the vaginal residence time,”
said David Friend, PhD, Chief Scientific Officer for Daré Bioscience. “The PK findings support that the product is retained
in the vagina for a prolonged period, which we believe will contribute to the efficacy of the treatment.”
DARE-PDM1
Phase 1 Topline Results
The
Phase 1 study results indicate that the study treatment was well-tolerated, and treatment emergent adverse events profiles were comparable
between the DARE-PDM1 treatment groups and the placebo group. All adverse events were mild or moderate; most adverse events (85%) were
mild. There were no early discontinuations due to an adverse event, and no serious adverse events were reported.
The
vaginal fluid PK results exhibited dose proportionality for the 1% and 3% diclofenac strengths of the DARE-PDM1 study treatment. Additionally,
the vaginal fluid PK results demonstrated that the product was retained in the vaginal canal through 24 hours, which is similar to the
vaginal retention demonstrated in the PK study of Daré’s FDA-approved vaginal gel product, which uses the same proprietary
hydrogel technology.
The
exploratory endpoint that evaluated the efficacy of DARE-PDM1 versus placebo in reducing dysmenorrhea-associated pain showed a promising
signal, with a statistically significant decrease in pelvic/vaginal and lower back pain scores in the 1% diclofenac DARE-PDM1 treatment
group compared to the placebo group, as well as a decrease in pain scores in the 3% diclofenac DARE-PDM1 treatment group. Additionally,
while most participants used at least one non-pharmacologic pain relief method (e.g., heating pad) for dysmenorrhea-associated pain during
the no-treatment, baseline, control cycle, the proportion of participants who used at least one non-pharmacologic pain relief method
for dysmenorrhea-associated pain decreased significantly in the DARE-PDM1 treatment groups during the dosing period, but not in the placebo
group. There was no difference in the exploratory assessment of frequency of use of rescue medications in the treatment phase between the three groups.
Pending
the plasma PK data, the topline results of this Phase 1 study support continued clinical development of DARE-PDM1 for primary dysmenorrhea.
The
DARE-PDM1-001 study was conducted in Australia by the company’s subsidiary, DARE Bioscience Australia Pty Ltd.
At
the conclusion of the development program, if successful, Daré intends to leverage the existing safety and efficacy data for diclofenac
to utilize the U.S. Food and Drug Administration’s (FDA) 505(b)(2) pathway to obtain marketing approval of DARE-PDM1 in the U.S.
About
Primary Dysmenorrhea
Primary
dysmenorrhea is defined as painful menstruation in women with normal pelvic anatomy, typically described as cramping pain in the lower
abdomen before or during the menstrual period. Recent market research suggests that the global market for dysmenorrhea treatment was
estimated to be valued at USD $13 billion in 2022 and that the size of this market is expected to increase to USD $28.5 billion by 2029.
Oral NSAIDs, such as oral diclofenac products, are often recommended for temporary relief from the painful symptoms of primary dysmenorrhea.
Because there are currently no FDA-approved vaginal diclofenac treatment options for primary dysmenorrhea, DARE-PDM1 has the potential
to be a first-in-category product, delivering diclofenac in a convenient vaginal format that may extend the duration of pain relief and
reduce the risks associated with the oral delivery of NSAIDs.
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, XACIATOTM (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 DARE-PDM1’s
potential as a safe and effective treatment for primary dysmenorrhea, DARE-PDM1’s potential to demonstrate better safety and tolerability
compared with oral NSAID medications and/or hormonal contraceptives commonly used to treat primary dysmenorrhea, Daré’s
clinical development plans and anticipated FDA approval pathway for DARE-PDM1, and the potential market opportunity for DARE-PDM1, if
approved. 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: the
risk that topline results from a clinical trial, including the Phase 1 study of DARE-PDM1, are based on Daré’s preliminary
analysis of key data and, following a comprehensive review of study data, including the forthcoming plasma PK data from the Phase 1 study
of DARE-PDM1, such results may change and topline results may not accurately reflect the complete results from the clinical trial; 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; 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 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
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 data from clinical studies of its product candidates; the risk that development of a product
candidate requires more clinical or nonclinical studies than Daré anticipates; 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 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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