Business
Daré Bioscience Reports Third Quarter 2022 Financial Results and Provides a Company Update
September 30, 2022: $40.4 million in cash and cash equivalentsOvaprene®: IDE approval from FDA for pivotal Phase 3 study; additional study design
About this update from Dare Bioscience, Inc.
[{"type":"text","content":"September 30, 2022: $40.4 million in cash and cash equivalentsOvaprene®: IDE approval from FDA for pivotal Phase 3 study; additional study design considerations being reviewed and implemented to further position the study as the single pivotal study for marketing approvalDARE-HRT1: Positive topline efficacy data from Phase 1/2 clinical studySildenafil Cream, 3.6%: Completion of subject screening for Phase 2b RESPOND clinical study Conference Call and Webcast Today at 4:30 p.m. ET SAN DIEGO, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today reported financial results for the quarter ended September 30, 2022 and provided a company update. “During the third quarter, we received $18.0 million in non-dilutive cash to strengthen our balance sheet. Approximately $8.0 million represented a payment under an existing grant to fund the preclinical development of DARE-LARC1, a novel, investigational long-acting, reversible personal contraceptive system, and $10.0 million was the upfront payment under our license agreement with Organon to commercialize XACIATO™, which was revenue we recognized in the second quarter when the agreement became effective. In addition, subsequent to quarter end, we received a research and development cash rebate from the Australian government of approximately $786,000 for clinical work performed in Australia in 2021. Daré remains committed to exploring ways to operate our business efficiently and to fund our portfolio in a manner we believe will be favorable to our shareholders,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “During the past two months, we had several positive developments related to our clinical-stage candidates. In October, we announced the FDA’s approval of our Investigational Device Exemption application allowing us to conduct a single arm, open-label pivotal contraceptive efficacy study of Ovaprene. We are currently reviewing and implementing additional FDA study design considerations to further position the study to serve as the single pivotal study necessary to support a premarket approval submission to the FDA. In October, we also announced positive topline efficacy data from our Phase 1/2 clinical study of DARE-HRT1, an investigational intravaginal ring to provide bio-identical hormone therapy for t...