DARÉ BIOSCIENCE, INC. Item 7.01 Regulation FD Disclosure.
On
The information contained in this Item 7.01, including in Exhibit 99.1 hereto,
is being "furnished" and shall not be deemed "filed" for the purposes of Section
18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to
the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities
Act of 1933, as amended. The information contained in this Item 7.01 and in
Exhibit 99.1 shall not be incorporated by reference into any filing with the
Item 8.01 Other Events.
On
The randomized, open-label, two-arm, parallel group Phase 1/2 study of DARE-HRT1 was designed to evaluate the PK of two versions of DARE-HRT1 (estradiol 80 µg/progesterone 4 mg IVR and estradiol 160 µg/progesterone 8 mg IVR) in approximately 20 healthy, post-menopausal women over approximately three consecutive months of use. The study also collected safety, usability, acceptability and symptom-relief data, including VMS as well as the vaginal symptoms of menopause.
Topline data from the study demonstrate that DARE-HRT1 successfully delivered estradiol and progesterone over the 12-week evaluation period. The baseline-corrected steady state release of estradiol and progesterone from both the lower (IVR1) and higher (IVR2) dose versions of DARE-HRT1 evaluated in the study demonstrated steady state release levels in month 3 of the 12-week study as shown in the table below:
Steady State Cavg
(standard deviation)
DARE-HRT1 IVR1 (n=11)
Estradiol 22.17 (4.47) pg/mL
Progesterone 1.25 (0.34) ng/mL
DARE-HRT1 IVR2 (n=10)
Estradiol 38.97 (10.79) pg/mL
Progesterone 1.80 (0.28) ng/mL
-2-
The levels of estradiol released from both the lower and higher dose formulation of DARE-HRT1 evaluated in the study achieved or exceeded the levels that were targeted for hormone therapy. Target levels of estradiol for hormone treatment for either the VMS or vaginal symptoms of menopause were established by reviewing PK levels published for FDA-approved products for both the treatment of VMS as well as the genitourinary symptoms of menopause. Based on the estradiol PK data in the DARE-HRT1 Phase 1/2 study, the results support the potential of DARE-HRT1 as an effective hormone therapy for both VMS and vaginal symptoms associated with menopause. The levels of progesterone released from both versions of DARE-HRT1 evaluated in the study met the objectives of releasing progesterone. Progesterone is used in hormone therapy to reduce the impact of estrogen on nontarget sites, such as the endometrium, to prevent estrogen-induced endometrial hyperplasia.
The levels of estradiol released from both the lower and higher dose formulation of DARE-HRT1 evaluated in the study achieved statistically significant improvement in VMS as well as the genitourinary symptoms of menopause, and vaginal pH and maturation index.
Menopausal symptoms, including hot flashes and night sweats, were reduced
compared with baseline in both DARE-HRT1 dose groups (p<0.01). Participants also
showed significant improvement from baseline in all measures surveyed on The
Menopausal Quality of
The study treatment was well tolerated with the types of most common adverse events consistent with other vaginal products. There were only two early discontinuations due to an adverse event, and no serious adverse events were reported.
DARE-HRT1 had a high level of acceptability in the study, with 100% of subjects reporting that the IVR was comfortable to wear, and there were no reports of the IVR being expelled from the vagina during use. Additionally, over 95% of subjects stated they would be either somewhat or very likely to use the IVR for a women's health condition or unrelated disease if needed.
Included as Exhibit 99.2 to this report is a presentation about Daré and its
product and product candidates, dated
-3- 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. Forward-looking statements include, but are
not limited to, statements relating to DARE-HRT1's potential as a safe and
effective hormone therapy for symptoms of menopause, DARE-HRT1's potential to be
the first FDA-approved monthly IVR product delivering both estrogen and
progestogen hormone therapy for symptoms of menopause, the importance of the
Phase 1/2 clinical study results to Daré and DARE-HRT1, the anticipated
regulatory approval pathway for DARE-HRT1, and the potential for FDA approval of
DARE-HRT1 for the treatment of moderate to severe VMS due to menopause in women
with intact uteri based on a single Phase 3 clinical trial together with study
data that establishes a scientific bridge to the selected listed drugs.
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 those expressed or implied by the
forward-looking statements, including, without limitation: 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; 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 development of a product candidate requires more clinical
or nonclinical studies than Daré anticipates, or that the duration of a study or
number of study subjects must be significantly greater than anticipated; 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
loss of, or inability to attract, key personnel; the effects of the COVID-19
pandemic, macroeconomic conditions such as inflation, rising interest rates and
geopolitical events on Daré's operations, financial results and condition, and
ability to achieve current plans and objectives, including the potential impact
of the pandemic on Daré's ability to timely commence, enroll, conduct and report
results of its clinical trials and on the ability of third parties on which Daré
relies to assist in the conduct of its business to fulfill their contractual
obligations to Daré; the impact of pharmaceutical industry regulation and health
care legislation in
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits Exhibit No. Description 99.1 Press release issued onJanuary 9, 2023 99.2 Corporate presentation, datedJanuary 9, 2023 104 Cover Page Interactive Data File (embedded within the Inline XBRL document) -4-
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