On November 9, 2023, Daré Bioscience Inc (DARE, Financial), a leader in women's health innovation, announced its financial results for the third quarter ended September 30, 2023, and provided a company update. The company reported significant progress, including the U.S. launch of XACIATO™ and advancements in several product candidates, positioning Daré for long-term success.
Financial and Operational Highlights
Daré Bioscience Inc (DARE, Financial) has made substantial progress in the third quarter of 2023, marked by the U.S. launch of XACIATO™, which triggered a $1.8 million milestone payment from Organon. The company is also gearing up for the pivotal Phase 3 contraceptive efficacy study of Ovaprene® and is preparing for an end-of-Phase 2 meeting with the FDA regarding Sildenafil Cream, 3.6%. Additionally, Daré is expecting topline data from the Phase 1 clinical study of DARE-PDM1.
President and CEO Sabrina Martucci Johnson expressed satisfaction with the company's progress and the execution of their mission to bring innovative treatments to market. She stated,
The fourth quarter is also proving to be a busy one for Daré, and we remain on track to have multiple meaningful milestones by the end of 2023 as we execute on our mission to accelerate development of and bring to market innovative treatments that women want and need."
Product Pipeline and Development Programs
Daré Bioscience Inc (DARE, Financial) boasts a diverse portfolio, including one FDA-approved product, XACIATOTM, and 13 development programs across 9 distinct indications. Three products are in or nearing Phase 3 clinical development, with multiple significant product development milestones anticipated by the end of 2023.
XACIATOTM, a treatment for bacterial vaginosis, has already generated a $10.0 million cash payment in the third quarter of 2022 and a $1.0 million cash payment in the second half of 2023, along with the $1.8 million milestone payment. Ovaprene®, a hormone-free monthly intravaginal contraceptive, is expected to initiate subject enrollment in its pivotal Phase 3 clinical study soon. Sildenafil Cream, 3.6%, is moving towards a Phase 3 study design confirmation with the FDA.
Financial Performance
The financial highlights for the quarter ended September 30, 2023, include the receipt of significant milestone payments and progress in the development of the company's product candidates. The company's financial position is supported by these developments, along with its strategic partnerships and license agreements.
Daré Bioscience Inc (DARE, Financial) will host a conference call and live webcast to review the financial results for the quarter and provide a company update. The webcast will be available for replay until November 23, 2023.
In conclusion, Daré Bioscience Inc (DARE, Financial) has demonstrated a strong commitment to advancing women's health, with multiple product candidates progressing through the pipeline and the successful launch of XACIATO™. The company's financial results reflect the achievement of key milestones and the potential for continued growth as it moves towards pivotal clinical studies and further engagement with the FDA.
For more detailed information on Daré Bioscience Inc (DARE, Financial)'s financial results, product pipeline, and upcoming milestones, please visit the Investors section of the company's website at http://ir.darebioscience.com.
Explore the complete 8-K earnings release (here) from Dare Bioscience Inc for further details.
