Dare Bioscience Investor Presentation Deck
DARE-HRT1*
Completed Phase 1 STUDY
A Phase 1, Open-Label, 3-arm Parallel Group Study to Evaluate the Pharmacokinetics (PK) and Safety of DARE-HRT1 (80 μg and 160 µg Estradiol/ 4 mg
and 8 mg Progesterone Intravaginal Rings) in Healthy Post-Menopausal Women.
The topline data from the study support DARE-HRT1's potential to be the first FDA-approved product to offer vaginal delivery of combination bio-
identical estradiol and bio-identical progesterone hormone therapy in a convenient monthly format to treat both VMS as well as vaginal symptoms of
menopause.
Completed Phase 1/2 STUDY
The open-label study evaluated the PK of the two dose versions of DARE-HRT1 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.
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 Life Survey (MENQOL), which surveys not only parameters of VMS,
but also physical, psychosocial and sexual symptoms (p<0.01 on all domains). With DARE-HRT1 use, vaginal pH significantly decreased compared to
baseline (p<0.01) and cytologic tests of the vaginal epithelium (vaginal maturation index) showed significant normalization (all p values <0.01 for
increases in superficial cells, increases in intermediate cells and decreases in parabasal cells from baseline) among all participants. Finally, the most
common genitourinary symptom, vaginal dryness, which was reported by 70% of participants at baseline, showed significant improvement in both
DARE-HRT1 groups (p<0.01) and this subset also experienced significant decreases in vaginal pain with DARE-HRT1 use (p<0.01).
*505(b)(2) candidate³.
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