SAN DIEGO - Dare Bioscience, Inc. (NASDAQ: DARE), a biopharmaceutical company focusing on women's health, has received a $10 million funding grant from the Advanced Research Projects Agency for Health (ARPA-H). The award is part of ARPA-H's Sprint for Women’s Health, aimed at addressing critical challenges in women's health and supporting transformative innovations.
The funding, to be received over two years, will support the development of DARE-HPV, Dare Bioscience's investigational treatment for human papillomavirus (HPV)-related cervical disease. HPV is a significant global health concern, as it is the primary cause of cervical cancer. In the United States alone, approximately 100,000 women are treated for cervical precancer annually, and about 4,000 women die from cervical cancer each year.
Current treatments for cervical precancer usually involve surgery, which carries risks such as preterm birth and sexual dysfunction. DARE-HPV aims to provide a non-surgical pharmaceutical alternative that could treat both late-stage cervical lesions and earlier stage HPV-related infections.
Sabrina Martucci Johnson, President and CEO of Dare Bioscience, expressed the company's enthusiasm for the potential of DARE-HPV to transform the management of HPV-related cervical diseases with an at-home strategy to control the virus responsible for cervical cancer.
Dare Bioscience will collaborate with an ARPA-H Program Manager and the Investor Catalyst Hub to develop DARE-HPV. The company will receive milestone-based payments aligned with research activities and performance objectives. As a launchpad performer, Dare Bioscience will also work with an Entrepreneur-in-Residence and participate in the Launchpad Accelerator program.
DARE-HPV is a proprietary fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert. If approved, it could become the first FDA-approved pharmaceutical intervention for the treatment of high-grade cervical lesions and other HPV-related cervical pathologies.
Dare Bioscience is committed to advancing innovative products for women's health and has a portfolio that includes the first FDA-approved product XACIATO (clindamycin phosphate) vaginal gel 2% for the treatment of bacterial vaginosis.
This development is based on a press release statement and represents a significant step in the pursuit of alternative treatments for HPV-related cervical diseases.
In other recent news, biopharmaceutical company Dare Bioscience has secured a $15 million funding agreement with Lincoln Park Capital Fund. This agreement allows Dare Bioscience to sell up to $15 million of its common stock to LPC over the next 24 months. The funds may support the company's portfolio, particularly the advancement of Sildenafil Cream, 3.6%, a potential treatment for female sexual arousal disorder.
The company's Sildenafil Cream has shown promise in recent Phase 2b clinical trials, demonstrating safety and tolerability without inducing typical side effects associated with similar treatments. The RESPOND study also suggested that both 1-month and 24-hour recall patient-reported outcome instruments could be effectively used to measure treatment efficacy in future clinical studies.
In financial developments, Dare Bioscience reported a decrease in general and administrative expenses and research and development expenses. The company has also secured additional funding through a royalty monetization transaction and a grant agreement, which will aid in the development of DARE-LARC1, an investigational contraceptive. These recent developments reflect Dare Bioscience's commitment to advancing their product candidates while managing capital responsibly.
InvestingPro Insights
The recent $10 million funding grant from ARPA-H to Dare Bioscience (NASDAQ: DARE) comes at a crucial time for the company, as revealed by InvestingPro data. With a market capitalization of $31.62 million, Dare is a small-cap player in the biopharmaceutical sector, making this grant particularly significant for its research and development efforts.
InvestingPro Tips highlight that Dare Bioscience is "quickly burning through cash" and "not profitable over the last twelve months." These insights underscore the importance of the ARPA-H funding, which could provide a vital financial lifeline for the company's DARE-HPV project. The company's focus on developing non-surgical treatments for HPV-related cervical diseases aligns with its strategy to address unmet needs in women's health, despite current financial challenges.
Another relevant InvestingPro Tip indicates that Dare "holds more cash than debt on its balance sheet." This financial position, combined with the new funding, may provide the company with the necessary runway to advance its promising DARE-HPV treatment through critical development stages.
It's worth noting that Dare's stock has shown a "strong return over the last month," with a 13.11% price increase. This positive momentum could reflect investor optimism about the company's potential, particularly in light of the recent ARPA-H grant.
For investors seeking a more comprehensive analysis, InvestingPro offers 8 additional tips for Dare Bioscience, providing a deeper understanding of the company's financial health and market position.
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