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News about Daré Bioscience, Inc. (NASDAQ: DARE) centers on its efforts to advance and commercialize women’s health products across contraception, sexual health, vaginal health and menopause. Company press releases highlight progress on clinical programs, grant-funded research, regulatory interactions and commercialization plans for both prescription and consumer health offerings.
Recent news has focused on DARE to PLAY Sildenafil Cream, a proprietary topical arousal cream designed specifically for women. Daré reports that this first-of-its-kind topical sildenafil formulation for women has been evaluated in multiple clinical studies and is being introduced via a Section 503B outsourcing facility as an evidence-backed option to enhance genital blood flow and arousal response. Updates describe pre-order availability in select U.S. states, webinar events with sexual health clinicians and the role of DARE to PLAY in the company’s broader 503B compounding strategy.
Another major news theme is Ovaprene, Daré’s investigational hormone-free monthly intravaginal contraceptive. Releases discuss interim Phase 3 results, data safety monitoring board recommendations to continue the pivotal study without modification, and the return of commercialization rights to Daré from a prior license partner. These items provide context on clinical progress, safety and tolerability findings, and the company’s plans to maximize the asset’s value.
Daré’s news flow also covers non-dilutive grant funding and collaborations, including multi-year support for DARE-LARC1, a long-acting contraceptive based on the DARE-IDDS programmable drug delivery platform, and grants for non-hormonal intravaginal contraceptive research and HPV-related programs. Corporate updates detail quarterly financial results, Nasdaq listing matters, and strategic initiatives that combine near-term revenue opportunities with long-term pipeline development. Investors and observers can use the DARE news page to follow these developments and track how clinical, commercial and funding milestones evolve over time.
Daré Bioscience (DARE) reported Q3 2024 financial results with cash and equivalents of $11.2 million. Research and development expenses decreased 60% to $2.7 million compared to Q3 2023, while general and administrative expenses declined to $2.0 million from $2.7 million. The company received significant funding, including a $10.7 million foundation grant, a $10 million ARPA-H award, and established a $15 million equity line. Key developments include ongoing recruitment for Ovaprene's Phase 3 study, progress toward Sildenafil Cream's Phase 3 trial, and advancement of other pipeline candidates including DARE-HPV, DARE-VVA1, and DARE-PTB1.
Daré Bioscience (NASDAQ: DARE) has secured a grant of up to $10.7 million from the Bill & Melinda Gates Foundation. The funding will support two key initiatives: the development of a novel non-hormonal intravaginal contraceptive product candidate and the expansion of clinical sites for the ongoing Ovaprene® pivotal study. The company will receive an initial payment of $5.4 million in 2024, with additional payments contingent upon achieving specific development milestones during the 24-month grant period. The new contraceptive product aims to serve women in low- and middle-income countries.
Daré Bioscience (NASDAQ: DARE), a women's health innovation company, has announced it will host a conference call and webcast on November 14, 2024, at 4:30 p.m. Eastern Time to discuss its third quarter 2024 financial results and provide a company update. The financial results will be released after market close on the same day. Participants can join via phone at (646) 307-1963 (U.S.) or (800) 715-9871 (international) using conference ID 6400145. A webcast will be available on the company's investor relations website and archived until November 28, 2024.
Daré Bioscience has been selected to receive a $10 million award from ARPA-H's Sprint for Women's Health program for the development of DARE-HPV, a potential first-in-category treatment for HPV-related cervical disease. The funding will be distributed over two years through the launchpad track for later-stage health solutions. DARE-HPV aims to provide an alternative to current surgical treatments, which can increase risks of preterm birth and sexual dysfunction. The treatment could potentially address both late-stage cervical lesions and earlier stage HPV-related cervical infections, potentially transforming clinical HPV management with an at-home strategy.
Daré Bioscience has entered into a $15 million common stock purchase agreement with Lincoln Park Capital Fund, (LPC). This 24-month agreement allows Daré to sell up to $15 million of its stock to LPC at its discretion, subject to SEC approval and other conditions. Daré will control the timing and amount of sales, with LPC purchasing at prevailing market prices. The agreement provides Daré with access to capital to fund portfolio advancement, particularly the Phase 3 program for Sildenafil Cream, 3.6%, a potential first-in-category treatment for female sexual arousal disorder. The agreement includes no warrants, short selling restrictions, or limitations on use of proceeds. Daré can terminate the agreement at any time without penalty.
Daré Bioscience (NASDAQ: DARE) announced the publication of safety data from its Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6% in The Journal of Sexual Medicine. The study, involving 1,357 sexual experiences, showed that the topical cream was safe and well-tolerated by women with female sexual arousal disorder (FSAD) and their partners. Notably, the cream did not produce common side effects associated with oral sildenafil, such as headache and flushing. This is likely due to the hundred-fold lower systemic exposure compared to oral dosing. The study was designed to identify the most responsive patient population and appropriate patient-reported outcome measures for future Phase 3 trials. Daré is currently in discussions with the FDA regarding the development program for Sildenafil Cream as an FSAD treatment.
Daré Bioscience (NASDAQ: DARE) announced the publication of additional data from its Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6% in The Journal of Sexual Medicine. The study, focusing on female sexual arousal disorder (FSAD), revealed that 1-month and 24-hour recall patient reported outcome (PRO) instruments yielded similar responses. This finding supports the use of either method for assessing treatment efficacy in future clinical studies, with longer recall intervals being less burdensome for participants and potentially improving data collection compliance.
The company previously announced a positive end-of-Phase 2 meeting with the FDA, supporting the advancement of Sildenafil Cream for FSAD treatment. Daré continues to interact with the FDA on the development program. Efficacy data from the Phase 2b RESPOND study were also published in Obstetrics & Gynecology.
Daré Bioscience (NASDAQ: DARE) reported Q2 2024 financial results and provided a company update. Key highlights include:
1. Ongoing enrollment in the Ovaprene Phase 3 contraceptive efficacy study across the U.S.
2. Progress on Sildenafil Cream, 3.6% for female sexual arousal disorder, awaiting FDA feedback on Phase 3 study design.
3. Cash and cash equivalents of $16.4 million as of June 30, 2024.
4. Q2 2024 R&D expenses decreased 19% to $4.9 million, while G&A expenses decreased to $2.4 million.
5. Received $22 million in April 2024 from a non-dilutive royalty monetization transaction.
The company continues to focus on advancing its late-stage candidates, all representing first-in-category opportunities in women's health.
Daré Bioscience (NASDAQ: DARE), a leader in women's health innovation, has announced its upcoming second quarter 2024 financial results conference call and webcast. The event is scheduled for August 12, 2024, at 4:30 p.m. Eastern Time. The company will release its financial results for the quarter ended June 30, 2024, after market close on the same day. Investors can access the call via phone or live webcast, with dial-in numbers provided for both U.S. and international participants. The conference ID is 6756565. The webcast will be available under the Investors section of Daré's website and will remain accessible for replay until August 26, 2024.
Daré Bioscience (NASDAQ: DARE) has regained compliance with Nasdaq's minimum bid price rule, as announced on July 19, 2024. The company's stock closed at $1.00 or higher for 10 consecutive trading sessions, meeting the Nasdaq Listing Rule 5550(a)(2) requirement. CEO Sabrina Martucci Johnson expressed enthusiasm about this development, stating it strengthens the company's market position and enhances its ability to advance its vision.
Johnson also provided updates on key programs in Daré's portfolio:
- Ongoing enrollment in the pivotal Phase 3 study of Ovaprene®, a potential first-in-category hormone-free monthly intravaginal contraceptive
- Continued activities supporting progression toward a Phase 3 trial of Sildenafil Cream, 3.6% for female sexual arousal disorder, an area with no current FDA-approved treatments
The company remains focused on accelerating the development of innovative treatments for women's health, with an emphasis on first-in-category opportunities.