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 primary endpoints of the study evaluated the safety and tolerability of DARE-VVA1 by vaginal administration and determined the plasma PK of DARE-VVA1 after intravaginal application. Secondary endpoints evaluated preliminary efficacy and PD of DARE-VVA1 in terms of most bothersome vaginal symptom and changes in vaginal cytology and pH.
Intravaginal administration of DARE-VVA1 was well tolerated in the study and all treatment emergent adverse events were mild or moderate and equally distributed between participants randomized to study drug treatment versus placebo. Concentration of tamoxifen in plasma samples collected over the course of the study did not exceed 10 ng/mL, even in participants in the highest dose group (20 mg tamoxifen).
Participants who received study drug treatment had improvements in the assessments and symptoms associated with VVA. Specifically, they had decreases in vaginal pH, increases in the percentage of vaginal superficial cells, significant decreases in the percentage of vaginal parabasal cells (p=0.04), and reduction in their self-assessed most bothersome vaginal symptom reported. Regarding the most bothersome vaginal symptom reported, of the participants randomized to receive study drug treatment, 39% (5/13) reported that vaginal dryness and 62% (8/13) reported that pain with intercourse (dyspareunia) was their most bothersome vaginal symptom at baseline. At the end of the treatment period, among the participants randomized to receive study drug treatment who reported vaginal dryness as their most bothersome symptom at baseline (n=5) (moderate or severe), all those who completed the study reported that vaginal dryness was either absent (n=1) or mild (n=3). Among the participants randomized to receive study drug treatment who reported dyspareunia as their most bothersome symptom at baseline (n=8) (moderate or severe), at the end of the treatment period, four reported no longer experiencing dyspareunia, one reported mild dyspareunia, two had no change in this symptom, and one did not complete the study. Of the four participants randomized to the placebo group, two reported vaginal dryness and two reported dyspareunia as their most bothersome symptom at baseline. At the end of the treatment period, the participants randomized to the placebo group who reported vaginal dryness as their most bothersome symptom at baseline (n=2) (moderate or severe), reported that vaginal dryness was either absent (n=1) or mild (n=1), and among the participants randomized to the placebo group who reported dyspareunia as their most bothersome symptom at baseline (n=2), one reported no longer experiencing dyspareunia and one did not complete the study.
Daré believes the topline results of the Phase 1/2 clinical study support
ongoing development of DARE-VVA1 as a treatment for moderate to severe VVA, and
that DARE-VVA1 has the potential to be the first therapeutic specifically
approved for the treatment of VVA in
-1- 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 DARE-VVA1's
potential as a safe and effective therapy for VVA, DARE-VVA1's potential to
become a new standard of care as the first FDA-approved product for the
treatment of VVA specifically in an HR+ breast cancer patient population, the
importance of the Phase 1/2 clinical study results to Daré and DARE-VVA1, and
the anticipated regulatory approval pathway for DARE-VVA1. 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; 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 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 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 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
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits Exhibit No. Description 99.1 Press release issued onNovember 14, 2022 104 Cover Page Interactive Data File (embedded within the Inline XBRL document) -2-
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