SAN DIEGO - Daré Bioscience, Inc. (NASDAQ: DARE) has announced that its topical Sildenafil Cream, 3.6%, intended for female sexual arousal disorder (FSAD), demonstrated safety and tolerability in a recent Phase 2b clinical trial. The study results, published in The Journal of Sexual Medicine, indicated that the cream did not induce typical side effects such as headaches and flushing, which are commonly associated with oral sildenafil treatments.
The RESPOND study evaluated the systemic and local genital safety of the cream among healthy premenopausal women and their sexual partners over a 12-week period. Safety assessments were based on 1,357 sexual experiences with the Sildenafil Cream and 1,160 with a placebo. According to Dr. Annie Thurman, lead author of the publication, the topical application did not show hypotensive side effects likely due to significantly lower systemic exposure compared to oral dosing.
Daré Bioscience's CEO, Sabrina Martucci Johnson, expressed satisfaction with the robust safety dataset, which included partner assessments. The company continues to engage with the FDA regarding the development of Sildenafil Cream as a treatment for FSAD while preparing for Phase 3 clinical studies.
FSAD, similar to erectile dysfunction in men, is characterized by a persistent inability to attain or maintain sufficient genital arousal, causing distress or interpersonal difficulty. Market research suggests that approximately 10 million women in the U.S. are actively seeking solutions for symptoms associated with FSAD.
Daré Bioscience is a biopharmaceutical company focused on women's health, with a portfolio that includes a range of product candidates such as contraceptives, vaginal health, reproductive health, menopause, sexual health, and fertility treatments. The company emphasizes its commitment to advancing innovative products for women's health and wellbeing.
This article is based on a press release statement from Daré Bioscience, Inc.
In other recent news, Daré Bioscience, a biopharmaceutical company, has made significant strides in women's health treatments. The company's RESPOND study of Sildenafil Cream, a potential treatment for female sexual arousal disorder, suggests that both 1-month and 24-hour recall patient-reported outcome instruments could be used effectively to measure treatment efficacy in future clinical studies. In addition, Daré Bioscience has reported a decrease in general and administrative expenses and research and development expenses. The company has secured funding through a royalty monetization transaction and a grant agreement, aiding in the development of DARE-LARC1, an investigational contraceptive. The company is also advancing menopause-related programs and is currently enrolling participants for a Phase 3 study of Ovaprene across 20 US sites. In the recent earnings call, CEO Sabrina Martucci Johnson expressed optimism for the rest of the year, with expected milestones and updates on various studies. These recent developments reflect Daré Bioscience's commitment to advancing their product candidates while managing capital responsibly.
InvestingPro Insights
As Daré Bioscience, Inc. (NASDAQ: DARE) continues to progress in its clinical trials for Sildenafil Cream, investors are closely monitoring the company's financial health and market performance. According to InvestingPro, Daré Bioscience holds more cash than debt on its balance sheet, which could provide some financial flexibility as it advances through the costly phases of clinical development. Nonetheless, the company is quickly burning through cash, which raises concerns about its ability to sustain long-term operations without seeking additional funding.
InvestingPro Data reveals a challenging financial picture for Daré Bioscience, with a market capitalization of $30.34 million and a negative Price/Earnings (P/E) ratio of -3.91, indicating the company is not currently profitable. Furthermore, the company's Price/Book ratio stands at a high 11.36, reflecting a premium market value compared to the company's book value. This valuation metric is particularly relevant as it may suggest that investors are expecting high growth or have confidence in the company's asset value despite the lack of current profitability.
InvestingPro Tips also highlight that Daré Bioscience suffers from weak gross profit margins, with a gross profit margin of -662.27% over the last twelve months as of Q2 2024. This could be a point of concern for investors looking at the company's ability to eventually turn a profit. Analysts do not anticipate the company will be profitable this year, and Daré has not been profitable over the last twelve months. Additionally, the company does not pay a dividend to shareholders, which may influence investment decisions for those seeking income-generating stocks.
For readers interested in a deeper analysis, InvestingPro offers additional tips on Daré Bioscience, providing a more comprehensive understanding of the company's investment potential. There are 7 additional InvestingPro Tips available, which can be found by visiting the InvestingPro platform at https://www.investing.com/pro/DARE.
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