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Daré Bioscience, Inc. (NASDAQ: DARE) is a clinical-stage biopharmaceutical company focused on the advancement of innovative products for women's reproductive health. The company's mission is to identify, develop, and bring to market a diverse portfolio of novel therapies that expand treatment options, improve outcomes, and facilitate convenience for women. Initially, the company's focus is on contraception, vaginal health, and fertility.
Daré's portfolio includes several product candidates in advanced clinical development. Their lead product, Ovaprene, is a non-hormonal monthly contraceptive ring currently undergoing clinical studies. The company's first FDA-approved product, XACIATO (clindamycin phosphate vaginal gel 2%), is a prescription gel for treating bacterial vaginosis in females aged 12 and older. Another prominent product candidate is Sildenafil Cream, 3.6%, a novel formulation intended to treat female sexual arousal disorder (FSAD).
Daré Bioscience has also engaged in significant partnerships to further its mission. For instance, the U.S. commercial rights for Ovaprene are licensed to Bayer, while XACIATO is under a global license agreement with Organon. This collaborative approach has enabled Daré to harness the clinical and market expertise of its partners while retaining control over development and regulatory approval processes.
Recently, Daré has aligned with the FDA on key elements of the Phase 3 program for Sildenafil Cream, setting the stage for a pivotal study to support a New Drug Application (NDA) filing. The company has also received grants, such as the $750,000 from the Bill & Melinda Gates Foundation, to support the development of bacteria-based biotherapeutic products. In addition, Daré is progressing with the clinical development of its hormonal therapy candidate, DARE-HRT1, a bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy.
Daré continues to build on its achievements from 2023, advancing its portfolio of novel investigational therapies, particularly those demonstrating proof of concept. The company actively engages in strategic processes to explore partnering opportunities for additional indications, such as GLP-1s for obesity and metabolic disorders.
Moreover, Daré received a $1 million payment as the latest installment under a grant agreement to advance its investigational contraceptive, DARE-LARC1. This product aims to address specific individual family planning goals with features like precision dosing and wireless control.
For the latest news and updates, investors and interested parties can visit Daré's investor relations website and follow their social media channels. The company remains committed to distributing material information through these channels and encourages stakeholders to stay informed about their developments and milestones.
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.
Daré Bioscience (NASDAQ: DARE) will implement a 1-for-12 reverse stock split of its common shares effective July 1, 2024. This action aims to elevate the stock's bid price to meet Nasdaq's $1.00 minimum bid price requirement. Authorized by shareholders on June 5, 2024, the reverse split will reduce the total number of outstanding shares from about 101.1 million to 8.4 million, while also adjusting the exercise prices and number of shares underlying stock options and warrants. No fractional shares will be issued; instead, fractional interests will be rounded up. The stock will continue trading under the symbol 'DARE' with a new CUSIP number 23666P200.
Daré Bioscience (NASDAQ: DARE) published the efficacy results of their Phase 2b study on topical Sildenafil Cream, 3.6% for treating Female Sexual Arousal Disorder (FSAD) in the journal Obstetrics & Gynecology. This double-blind, placebo-controlled study showed significant improvements in sexual arousal sensation, reduced sexual distress, and increased desire and orgasm, particularly in a subset of women with FSAD, with or without decreased desire. Currently, no FDA-approved therapies exist for FSAD. Daré had a positive end-of-Phase 2 meeting with the FDA and awaits feedback on proposed endpoints for Phase 3 trials, which is expected this quarter.
Daré Bioscience (NASDAQ: DARE) reported its Q1 2024 financials and company updates. Key developments include the ongoing Phase 3 study of Ovaprene®, a hormone-free contraceptive, and the successful end-of-Phase 2 meeting with the FDA for Sildenafil Cream, aimed at treating female sexual arousal disorder. Financial highlights show a decrease in Q1 2024 R&D expenses to $3.3 million from $5.0 million in Q1 2023, and a $22 million non-dilutive financing deal secured in April 2024. Cash reserves stood at $3.6 million as of March 31, 2024. The company's collaboration with Organon on XACIATO™ continues, with further milestones anticipated in 2024.
Daré Bioscience, Inc. will host a conference call and webcast on May 14, 2024, to discuss its financial results for Q1 2024. The company is a leader in women's health innovation, with details on how to access the call provided in the press release.
Daré Bioscience, Inc. (NASDAQ: DARE) has been chosen as a spoke member of the Investor Catalyst Hub, part of the nationwide ARPA-H network. This selection provides Daré with access to funding, networking opportunities, and the ability to influence research priorities in women's health.
Daré Bioscience secured $22 million in non-dilutive strategic royalty financing to advance Phase 3 first-in-category women’s health product candidates through key catalysts. The transaction with XOMA provides significant capital for Daré to focus on advancing Ovaprene® and Sildenafil Cream, 3.6%. This accelerates potential cash flows and shareholder value, showcasing the company's commitment to delivering value for all stakeholders.
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