Fannie Mae, Freddie Mac shares tumble after conservatorship comments
SAN DIEGO - Daré Bioscience, Inc. (NASDAQ:DARE), a small-cap biotech with a market capitalization of $22.3 million and strong cash position relative to debt according to InvestingPro, announced Monday positive interim safety and efficacy results from its ongoing Phase 3 clinical trial of Ovaprene, a monthly hormone-free intravaginal contraceptive.
The trial’s independent Data Safety Monitoring Board recommended the study continue without modification after reviewing safety data. At the time of interim analysis, approximately 9% of women treated in the study had experienced a pregnancy, which the company stated is consistent with expectations based on previous studies. While the company shows promise in its clinical developments, InvestingPro data reveals challenging financials with weak gross profit margins and an expected decrease in net income for the current year.
No serious safety concerns were identified in the trial. Approximately 17% of participants discontinued due to vaginal odor, the most commonly reported product-related adverse event. Participants who completed the study reported they would be likely or very likely to use Ovaprene if it became available.
"We are encouraged by these interim results, which reinforce the potential of our hormone-free contraceptive candidate," said Sabrina Martucci Johnson, President and CEO of Daré Bioscience.
The ongoing pivotal Phase 3 trial is a multicenter, single-arm, open-label study enrolling women aged 18-40 across five sites. Approximately 115 participants were ongoing or had completed the study at the time of interim analysis, with target enrollment of about 250 participants completing approximately 12 months of use.
The primary objective is to assess the typical use pregnancy rate over 13 menstrual cycles. Secondary objectives include safety, acceptability, product fit, and vaginal health assessments.
Bayer holds the right to obtain exclusive U.S. commercialization rights following completion of the pivotal trial if it makes a $20 million payment to Daré. Daré may receive up to $310 million in commercial milestone payments, plus royalties on net sales. With current revenue of just $0.03 million in the last twelve months and an overall Financial Health Score of 2.05 (rated as "FAIR" by InvestingPro), such partnership payments could significantly impact the company’s financial outlook. Discover 10+ additional exclusive ProTips and comprehensive analysis in the Pro Research Report, available with an InvestingPro subscription.
There are currently no FDA-approved hormone-free monthly intravaginal contraceptives, according to the company’s press release statement.
In other recent news, Daré Bioscience has reported significant developments across various projects. The company announced positive interim results from its Phase 3 clinical trial of Ovaprene, a hormone-free monthly intravaginal contraceptive. The trial’s Data Safety Monitoring Board has recommended the study continue without modifications, noting no serious safety concerns. In addition, Daré Bioscience has received a $6 million installment for its contraceptive drug delivery system, part of a larger grant agreement, supporting the development of DARE-LARC1, a long-acting reversible contraceptive device. The company also held its annual meeting, where shareholders approved board nominees and an amendment to the 2022 Stock Incentive Plan, increasing available shares by 600,000.
Furthermore, Daré Bioscience has formed a strategic partnership with Rosy Wellness to promote its upcoming DARE to PLAY Sildenafil Cream, a topical treatment for female sexual arousal disorder. This collaboration aims to enhance awareness and education around the product, expected to be available by prescription in late 2025. Analysts at H.C. Wainwright have maintained a Buy rating for Daré Bioscience, citing confidence in the company’s strategic direction and market potential for the sildenafil cream. These recent developments highlight Daré Bioscience’s ongoing efforts to advance women’s health solutions through innovative partnerships and product development.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.