Announcement • Jan 10

Daré Bioscience, Inc. Announces Positive Pharmacokinetic Results from the DARE-HRT1 Phase 1 / 2 Study

Daré Bioscience, Inc. announced topline PK results from its Phase 1 /2 clinical trial of DARE-HRT1 that support the potential of DARE-HRT1 as an effective hormone therapy (HT) based on the levels of hormones released. DARE-HRT1 is a novel, investigational intravaginal ring (IVR) designed to deliver bio-identical 17ß-estradiol and bio-identical progesterone continuously over a 28-day period as part of a HT regimen. HT is used to treat the vasomotor symptoms (VMS) and genitourinary syndrome associated with menopause. DARE-HRT1 has the 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. Daré plans to advance DARE-HRT1 into a single Phase 3 clinical trial to support a new drug application for DARE-HRT1 for the treatment of moderate to severe VMS due to menopause in women with intact uteri. Previously reported topline efficacy data from the Phase 1 /2 study demonstrated improvement in both VMS as well as vaginal symptoms of menopause. The North American Menopause Society’s (NAMS) guidance on hormone therapy states that dosing estrogen and progestogen in combination may offer important benefits to women, and NAMS observed that non-oral routes of administration may offer advantages over orally administered therapies. The IVR technology used in DARE-HRT1 was developed by Dr. Robert Langer from the Massachusetts Institute of Technology and Dr. William Crowley from Massachusetts General Hospital and Harvard Medical School. Unlike other IVR technologies, Daré’s IVR drug delivery technology is designed to release more than one active ingredient via a solid ethylene vinyl acetate polymer matrix without the need for a membrane or reservoir to contain the active drug or to control the release, allowing for sustained drug delivery. Data from a prior randomized, open-label, three-arm, parallel group Phase 1 study that evaluated the PK of DARE-HRT1 in approximately 30 healthy, post-menopausal women with intact uteri demonstrated that DARE-HRT1 successfully delivered both estradiol and progesterone over the 28-day evaluation period. The estradiol PK data in that prior DARE-HRT1 Phase 1 study support the potential of DARE-HRT1 as an effective hormone therapy for both VMS and vaginal symptoms associated with menopause. The randomized, open-label, two-arm, parallel group Phase 1/2 study was designed to evaluate DARE-HRT1’s safety, PK, and preliminary efficacy in improving the VMS as well as the vaginal symptoms of menopause in approximately 20 healthy, post-menopausal women (age range 51-65 years, mean 59 years) with intact uteri over approximately three consecutive months of use. The primary objective of the study was to describe the safety, tolerability, and PK of two different dose combinations (estradiol 80 µg/progesterone 4 mg IVR and estradiol 160 µg/progesterone 8 mg IVR) over 12 weeks of use. Secondary objectives of the study were to assess the usability, participant tolerability, and preliminary effectiveness of DARE-HRT1 for both the VMS and vaginal symptoms of menopause. The study was conducted by Daré’s wholly owned subsidiary in Australia. 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 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). 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. Daré plans to submit data from the Phase 1 /2 clinical study of DARE-HRT1 for publication in a peer-reviewed publication. Following clinical development, Daré intends to leverage the existing safety and efficacy data on the active ingredients in DARE-HRT1, estradiol and progesterone, to utilize the U.S. Food and Drug Administration’s (FDA) 505(b)(2) pathway to obtain marketing approval of DARE-HRT1 in the U.S. Daré intends to seek FDA approval of DARE-HRT1 for the treatment of moderate to severe VMS due to menopause in women with intact uteri.

Announcement • Nov 15

Daré Bioscience, Inc. Announces Positive Topline Results from DARE-VVA1 Phase 1/2 Clinical Study

Daré Bioscience, Inc. announced topline data from its Phase 1/2 clinical study of DARE-VVA1, a novel intravaginal proprietary formulation of tamoxifen being developed for the treatment of moderate to severe vulvar and vaginal atrophy. The randomized, double-blind, placebo-controlled study was designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of DARE-VVA1 in postmenopausal participants with moderate to severe VVA. The topline data from the study demonstrated safety and tolerability of DARE-VVA1, as well as improvement in the vaginal cytology parameters and the bothersome vaginal symptoms associated with VVA. DARE-VVA1 has the potential to be the first therapeutic specifically approved for the treatment of VVA in U.S. patients with HR+ breast cancer. There are currently no FDA-approved products labeled for VVA treatment in HR+ breast cancer patients. Globally, breast cancer is the most frequently diagnosed cancer type, accounting for over two million cases each year. Approximately 4 million U.S. women have a history of invasive breast cancer, and of all breast cancer diagnoses in U.S. women, it is estimated that more than 68% are HR+. VVA prevalence in postmenopausal breast cancer survivors is estimated at 42% to 70%. DARE-VVA1 Phase 1/2 Clinical Trial Study Design: The Phase 1/2 study evaluated different doses of DARE-VVA1, a tamoxifen vaginal insert, in 17 postmenopausal women with VVA. The study was a randomized, multi-center, double-blind, parallel-arm, placebo-controlled, dose-ranging study that evaluated the safety, tolerability, plasma pharmacokinetics (PK) and pharmacodynamics (PD) of DARE-VVA1. Eligible participants were randomly allocated to one of five treatment groups (approximately 4 participants per group) that evaluated four dose levels (1 mg, 5 mg, 10 mg, and 20 mg) and a placebo. Following a screening visit, DARE-VVA1 was self-administered intravaginally once a day for the first two weeks, and then twice a week for the following six weeks for a total treatment period of 56 days. In each treatment group, participants had serial blood sampling for PK analysis and underwent safety evaluations and preliminary assessments of effectiveness. Following the completion of the treatment period, participants attended a safety follow-up visit. 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. The study was conducted by the company’s wholly owned subsidiary in Australia. Topline Results of the Phase 1/2 Clinical Trial: The age of the 17 postmenopausal women with VVA who participated in the study ranged from 49 to 68 years (average age: 60.9). Fourteen women completed the study. The primary outcomes of this first-in-woman study were safety and plasma PK. Intravaginal administration of DARE-VVA1 was well tolerated 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), which is 1/10th of the average steady-state concentration of tamoxifen seen with daily dosing of orally administered tamoxifen citrate tablets (20 mg and 10 mg tamoxifen) for three months (average steady-state plasma concentrations of over 100 ng/mL). Secondary outcomes of the study were preliminary efficacy and PD of DARE-VVA1 in terms of most bothersome vaginal symptom and changes in vaginal cytology and pH. Participants who received study drug treatment (at 1 mg, 5 mg, 10 mg or 20 mg doses) 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 (p=0.04) decreases in the percentage of vaginal parabasal cells (despite the small sample size), and reduction in their self-assessed most bothersome vaginal symptom reported (either vaginal dryness or pain with intercourse). 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 plans to submit data from the Phase 1/2 clinical study of DARE-VVA1 for publication in a peer-reviewed publication. Following clinical development, Daré intends to leverage the existing safety and efficacy data on the active ingredient in DARE-VVA1, tamoxifen, to utilize the U.S. Food and Drug Administration’s (FDA) 505(b)(2) pathway to obtain marketing approval of DARE-VVA1 in the U.S.

Total Shareholder Yield	-49.4%
Future Dividend Yield	n/a
Dividend Growth	n/a
Next dividend pay date	n/a
Ex dividend date	n/a
Dividend per share	n/a
Payout ratio	n/a

Segment	Dividend Yield
Company (DARE)	n/a
Market Bottom 25% (US)	1.4%
Market Top 25% (US)	4.3%
Industry Average (Pharmaceuticals)	2.1%
Analyst forecast (DARE) (up to 3 years)	n/a

Data	Last Updated (UTC time)
Company Analysis	2026/05/15 03:04
End of Day Share Price	2026/05/15 00:00
Earnings	2026/03/31
Annual Earnings	2025/12/31

Package	Data	Timeframe	Example US Source ^*
Company Financials	10 years	Income statement Cash flow statement Balance sheet	SEC Form 10-K SEC Form 10-Q
Analyst Consensus Estimates	+3 years	Forecast financials Analyst price targets	Analyst Research Reports Blue Matrix
Market Prices	30 years	Stock prices Dividends, Splits and Actions	ICE Market Data SEC Form S-1
Ownership	10 years	Top shareholders Insider trading	SEC Form 4 SEC Form 13D
Management	10 years	Leadership team Board of directors	SEC Form 10-K SEC Form DEF 14A
Key Developments	10 years	Company announcements	SEC Form 8-K

Analyst	Institution
Brian Kemp Dolliver	Brookline Capital Markets
Douglas Tsao	H.C. Wainwright & Co.
Jason McCarthy	Maxim Group

Daré Bioscience Dividends and Buybacks

Dividend criteria checks 0/6

Key information

Recent dividend and buyback updates

Recent updates

Daré Bioscience Announces Positive Interim Phase 3 Results For Ovaprene

Daré Bioscience, Inc., Annual General Meeting, Jun 11, 2026

New major risk - Share price stability

Women’s Health Pipeline Risks Will Persist Yet Long Term Potential Will Eventually Emerge

Full year 2025 earnings: EPS and revenues exceed analyst expectations

Daré Bioscience, Inc. Announces DARE to PLAY Sildenafil Cream for Women

Women’s Health Pipeline And Dual 503B Pathway Will Transform Long Term Earnings Potential

Women’s Health Platform And 503B Launches Will Reshape Long-Term Outlook

Dare Bioscience Announces Fda Clearance of Ind for Phase 2 Clinical Study of Dare-Hpv, A Potential Treatment for Persistent High-Risk Hpv Infection, the Most Common Cause of Cervical Cancer

Daré Bioscience, Inc. Announces Telehealth Now Available for DARE to PLAY™ Sildenafil Cream: First Evidence-Based Topical Arousal Cream for Women

Price target decreased by 17% to US$10.75

Insufficient new directors

DARE to PLAY™ Sildenafil Cream Now Available for Pre-Order by Prescription: First Evidence-Based Topical Arousal Cream for Women Begins Commercial Rollout in Select States via 503B Outsourcing Facility

Dare Bioscience, Inc. Announces Return of Rights to Ovaprene; Phase 3 Program Ongoing; Positive Interim Data and Grant Funding Position Asset for Value-Maximization

Dare Bioscience and Rosy Wellness Launch First Phase of Patient-Focused Campaign to Support Dare to Play™? Sildenafil Cream

Daré Bioscience, Inc. Announces Positive Interim Safety and Efficacy Results from its Ongoing Phase 3 Clinical Trial Evaluating the Contraceptive

Daré Bioscience, Inc., Annual General Meeting, Jun 12, 2025

Daré Bioscience, Inc. Provides Non-Compliance Update

Daré Bioscience Announces Phase 3 Plans for Sildenafil Cream, 3.6%, in the Treatment of Female Sexual Arousal Disorder (FSAD)

Daré Bioscience, Inc. to Report Q3, 2024 Results on Nov 14, 2024

Daré Bioscience, Inc. announced that it expects to receive $15 million in funding from Lincoln Park Capital, LLC

Daré Bioscience, Inc. to Report Q2, 2024 Results on Aug 12, 2024

Dare Bioscience, Inc. Announces Publication in Obstetrics & Gynecology of Phase 2B Study Efficacy Results of Topical Sildenafil Cream, 3.6% for the Treatment of Female Sexual Arousal Disorder

Daré Bioscience, Inc. has filed a Follow-on Equity Offering in the amount of $18.08963 million.

Daré Bioscience, Inc., Annual General Meeting, Jun 05, 2024

Daré Bioscience, Inc. Announces Grant Funding Installment to Support Further Development of Novel Contraceptive Technology DARE-LARC1

Daré Bioscience, Inc. Announces Positive End-Of-Phase 2 Meeting with FDA on Development of Sildenafil Cream, 3.6% in Female Sexual Arousal Disorder and Provides Company Focus Areas for 2024

Daré Bioscience, Inc. Announces the Resignation of Lisa Walters-Hoffert as Chief Financial Officer

Daré Bioscience, Inc. Announces Executive Changes

Daré Bioscience's Common Stock to Be Delisted from Nasdaq Unless the Company Timely Requests A Hearing Before the Nasdaq Hearing Panel

Dare Bioscience, Inc. Announces Positive Topline Pharmacokinetic and Exploratory Efficacy Results from the Dare-Pdm1 Phase 1 Clinical Study

Dare Bioscience, Inc. Announces FDA Clearance of Investigational New Drug (IND) Application for DARE-VVA1

Dare Bioscience, Inc. Announces Commencement of Phase 3 Study of Ovaprene, an Investigational Hormone-Free Monthly Intravaginal Contraceptive

New major risk - Revenue and earnings growth

We're A Little Worried About Daré Bioscience's (NASDAQ:DARE) Cash Burn Rate

Daré Bioscience, Inc. to Report Q3, 2023 Results on Nov 09, 2023

Price target decreased by 11% to US$5.33

New major risk - Financial position

New major risk - Revenue size

Daré Bioscience, Inc. Announces Grant Award Supporting Development of Potential New Therapeutic Intervention for the Prevention of Idiopathic Preterm Birth

Daré Bioscience Receives Notice from Nasdaq Regarding Non-Compliance with the Minimum Bid Price Requirement

We Think Daré Bioscience (NASDAQ:DARE) Needs To Drive Business Growth Carefully

Dare Bioscience, Inc. Announces Additional Positive Data from Exploratory Phase 2b Response Study of Sildenafil Cream, 3.6% in Women

New minor risk - Profitability

Consensus revenue estimates decrease by 18%

Daré Bioscience, Inc. Provides Update on Activities to Support Commercial Launch of XACIATO

Daré Bioscience Announces Publication in Menopause: The Journal of The North American Menopause Society of Data from Phase 1/2 Open-Label Safety and Pharmacokinetics Study of DARE-HRT1 in Healthy Postmenopausal Women

Dare Bioscience, Inc. Announces Positive Topline Data from the Exploratory Phase 2b Response Study of Sildenafil Cream, 3.6% in Women with Female Sexual Arousal Disorder

Consensus revenue estimates increase by 29%, EPS downgraded

No longer forecast to breakeven

Is Daré Bioscience (NASDAQ:DARE) In A Good Position To Invest In Growth?

Price target increased by 13% to US$6.00

Daré Bioscience Announces Publication in Menopause: The Journal of The North American Menopause Society of Data from Phase 1 Trial of DARE-HRT1 that Support the Potential of DARE-HRT1 as an Effective Hormone Therapy for both Vasomotor and Vaginal Symptoms of Menopause

Daré Bioscience, Inc. Announces Positive Pharmacokinetic Results from the DARE-HRT1 Phase 1 / 2 Study

Forecast to breakeven in 2025

Daré Bioscience Receives Non-Compliance Notice From Nasdaq

Consensus revenue estimates fall by 38%

Consensus forecasts updated

Price target decreased to US$5.33

Daré Bioscience, Inc. Announces Positive Topline Results from DARE-VVA1 Phase 1/2 Clinical Study

Daré Bioscience Announces Subject Screening for Phase 2B Respond Study of Sildenafil Cream, 3.6% in Women with Female Sexual Arousal Disorder Complete

Daré Announces Topline Results of Its Phase 1/2 Clinical Study of Dare-HRT1

Daré rises on positive data from early-to-mid-stage trial of intravaginal ring to treat menopause symptoms

Daré Bioscience, Inc. Announces IDE Approval for a Single Arm, Open-Label Pivotal Contraceptive Efficacy Study of Ovaprene, an Investigational Hormone-Free Monthly Intravaginal Contraceptive

Daré Bioscience rises as company submits application to begin trial of non-hormonal contraceptive

Daré Bioscience Announces Interim Analysis of Phase 2B Respond Study of Sildenafil Cream, 3.6% in Women with Female Sexual Arousal Disorder

Dare Bioscience reports positive progress for cream for female sexual arousal disorder

Consensus revenue estimates increase by 24%

No longer forecast to breakeven

Daré Bioscience signs agreement with Organon for bacterial vaginosis therapy

Daré Bioscience, Inc., Annual General Meeting, Jul 14, 2022

Consensus revenue estimates increase by 11%

Daré Bioscience, Inc., Annual General Meeting, Jun 23, 2022

Price target increased to US$8.25

Forecast to breakeven in 2024