SAN DIEGO - Daré Bioscience, Inc. (NASDAQ: DARE), a biopharmaceutical company, announced today that new data from its exploratory Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6%, suggests that both 1-month and 24-hour recall patient-reported outcome (PRO) instruments could be used effectively to measure treatment efficacy in future clinical studies.
The study, published in The Journal of Sexual Medicine, indicates that longer recall intervals for PRO assessments could reduce the burden on participants and potentially increase data collection compliance.
The RESPOND study, designed to identify the most meaningful patient population and outcome measures for Sildenafil Cream, a potential treatment for female sexual arousal disorder (FSAD), showed a strong correlation between the 24-hour recall eDiary and the 1-month recall instrument scores.
President and CEO of Daré Bioscience, Sabrina Martucci Johnson, expressed satisfaction with the consistent results from different recall periods, suggesting this could offer flexibility in clinical measurement of the cream's impact on FSAD patients.
Dr. Annie Thurman, MD, FACOG, Medical Director at Daré Bioscience, highlighted the importance of accurate data collection for a condition often dismissed and stigmatized. The less burdensome 1-month recall is seen as a significant advancement for patient manageability.
FSAD, characterized by a persistent inability to attain or maintain sufficient genital arousal, affects an estimated 10 million women in the U.S. Sildenafil Cream aims to increase genital blood flow and improve arousal response while minimizing systemic side effects common with oral sildenafil, known by its brand name Viagra® for treating erectile dysfunction in men.
Daré Bioscience has previously reported positive end-of-Phase 2 meeting outcomes with the FDA and continues to engage with the agency on the development program for Sildenafil Cream as an FSAD treatment. The company's portfolio also includes other women's health products, such as XACIATO™ for bacterial vaginosis and a hormone-free contraceptive, Ovaprene®.
This news is based on a press release statement and represents a subset analysis intended to enhance the understanding of patient-reported outcomes in clinical studies for FSAD treatment.
In other recent news, Daré Bioscience, a biopharmaceutical company, reported its financial results for the second quarter and provided updates on its product pipeline focused on women's health. The company noted a decrease in general and administrative expenses and research and development expenses, compared to the previous year. Funding was secured through a royalty monetization transaction and a grant agreement, which will aid in the development of DARE-LARC1, an investigational contraceptive.
Daré Bioscience is developing innovative treatments including XACIATO for bacterial vaginosis, Sildenafil Cream for female sexual arousal disorder, and Ovaprene for hormone-free contraception. The company is advancing menopause-related programs and is currently enrolling participants for a Phase 3 study of Ovaprene across 20 US sites.
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. The company anticipates providing more updates on their programs and is poised to make significant strides in the coming year.
InvestingPro Insights
As Daré Bioscience advances its clinical programs, particularly the Sildenafil Cream for FSAD, investors and industry observers are closely monitoring the company's financial health and market performance. According to InvestingPro data, Daré Bioscience has a market capitalization of approximately $29.49 million.
Despite the potential promise of its product pipeline, analysts have raised concerns about the company's financials, with an adjusted P/E ratio over the last twelve months as of Q1 2024 sitting at -1.03, and a significant revenue decline of -71.83% during the same period. This suggests that while Daré is making strides in its clinical developments, the financial picture is one of challenges and potential risks.
The company's gross profit margin presents another area of concern, with a figure of -668.35% for the last twelve months as of Q1 2024. This underscores the difficulties Daré faces in converting its revenues into gross profit, an issue reflected in one of the InvestingPro Tips that highlights the company's weak gross profit margins. Additionally, Daré does not pay a dividend to shareholders, which may be a consideration for investors seeking income in addition to capital gains.
On a more positive note, Daré Bioscience has seen a significant return over the last week, with a 1 Week Price Total Return of 8.7%. This could indicate investor optimism following recent company announcements or developments. However, it's important to consider the broader financial context, as the InvestingPro Tips suggest that analysts do not anticipate the company will be profitable this year, and short term obligations exceed liquid assets, indicating potential liquidity concerns.
For those interested in a more in-depth analysis, there are additional InvestingPro Tips available that provide further insights into Daré Bioscience's financial health and market performance. These tips could be especially valuable for investors considering the company's long-term potential amidst its current challenges.
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