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Dare Bioscience, Inc. (DARE) Reports Q2 Loss, Lags Revenue Estimates
ZACKS· 2025-08-14 22:15
Company Performance - Dare Bioscience, Inc. reported a quarterly loss of $0.45 per share, which was better than the Zacks Consensus Estimate of a loss of $0.55, representing an earnings surprise of +18.18% [1] - The company has surpassed consensus EPS estimates for the last four quarters, but it reported revenues of -$0.02 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 103.68% [2] - The stock has lost approximately 32.4% since the beginning of the year, contrasting with the S&P 500's gain of 10% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.52 on revenues of $0.59 million, and for the current fiscal year, it is -$1.99 on revenues of $1.67 million [7] - The estimate revisions trend for Dare Bioscience was mixed ahead of the earnings release, resulting in a Zacks Rank 3 (Hold) for the stock, indicating expected performance in line with the market [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Dare Bioscience belongs, is currently ranked in the bottom 41% of over 250 Zacks industries, suggesting potential challenges for stock performance [8]
Daré Bioscience(DARE) - 2025 Q2 - Earnings Call Transcript
2025-08-14 21:30
Financial Data and Key Metrics Changes - The company ended the quarter with approximately $5 million in cash and cash equivalents and a working capital deficit of approximately $12.6 million [17] - General and administrative expenses were $2.4 million compared to $2.5 million in 2024, primarily due to decreases in personnel costs and stock-based compensation [18] - Research and development expenses were $1.4 million, a 71% decrease versus Q2 2024, mainly due to reductions in R&D expenses recognized from non-dilutive funding awards [18] Business Line Data and Key Metrics Changes - The company is on track to support the commercial availability of DARE2PLAY Sildenafil Cream through a 503B outsourcing facility in Q4 2025, representing a significant milestone in women's sexual health [5][6] - Ovaprene, a hormone-free contraceptive candidate, continues to progress with the Phase three trial, receiving a recommendation to continue from the Independent Data and Safety Monitoring Board [10] - DARE HRT1, an intravaginal ring for hormone therapy, is pursuing both FDA approval and a 503B compounding opportunity, targeting availability in late 2026 [12][13] Market Data and Key Metrics Changes - The company is addressing a significant unmet need in the contraceptive landscape with Ovaprene, which could transform the market for hormone-free birth control [11] - The compounded hormone therapy market is estimated at $4.5 billion, where DARE HRT1 is expected to generate meaningful revenue [12] Company Strategy and Development Direction - The company is executing a dual path strategy, focusing on commercializing proprietary formulations while pursuing FDA approval for innovative women's health solutions [2][5] - The strategy includes leveraging non-dilutive capital and a disciplined investment approach to unlock value efficiently [6] Management's Comments on Operating Environment and Future Outlook - Management highlighted the significant interest and unmet need in supporting women with arousal concerns, as evidenced by the feedback from the direct-to-patient awareness campaign [7] - The company remains optimistic about the potential of DARE2PLAY Sildenafil Cream as a near-term revenue driver and is excited about the ongoing clinical programs addressing women's health needs [9][15] Other Important Information - The company received approximately $17.6 million in net proceeds from sales of common stock and a $6 million grant payment after the quarter end, strengthening its balance sheet [17] - The company is preparing to launch two non-prescription vaginal probiotics designed to support vaginal microbiome health, complementing its prescription offerings [13] Summary of Q&A Session - Due to technical difficulties, there was no Q&A session held during the call [18]
Daré Bioscience(DARE) - 2025 Q2 - Quarterly Report
2025-08-14 20:04
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36395 DARÉ BIOSCIENCE, INC. (Exact Name of Registrant as Specified in its Charter) Delaware (State or Other Jurisdiction of Incorporation) 3655 Nobel Drive, Suite 260 San Diego, CA (Address of Principal Executive Offices) x QUARTERLY REPORT PURSUANT TO SECTION 13 O ...
Daré Bioscience(DARE) - 2025 Q2 - Quarterly Results
2025-08-14 20:01
Exhibit 99.1 Daré Bioscience Reports Second Quarter 2025 Financial Results and Provides Corporate Update DARE to PLAY™ Sildenafil Cream on Track for Q4 2025 Launch via 503B Compounding Pathway; Positioned for Product Revenue Beginning in Q4 2025 Positive Interim DSMB Outcome for Ovaprene® Phase 3 Study Supports Continued Enrollment Multiple Grant-Funded Programs Advance, Including to Address HPV and Long-Acting Contraception Four Commercially Available Solutions for Women on the Horizon Conference Call Toda ...
UPDATE - Daré Bioscience to Host August 6 Webinar: The DARE to PLAY™ Difference - The Sildenafil Cream That Raises the Bar
Globenewswire· 2025-07-21 17:47
Core Insights - Daré Bioscience, Inc. has developed a proprietary topical formulation of sildenafil, the active ingredient in Viagra, specifically for women, aimed at addressing female sexual arousal issues [1][2] - The product, named DARE to PLAY™, is expected to be available by prescription in the fourth quarter of 2025 [1][5] - A live webinar is scheduled for August 6, 2025, to discuss the clinical evidence supporting the product and its potential impact on women's sexual health [2][3] Company Overview - Daré Bioscience focuses on women's health, aiming to bridge the gap between scientific advancements and practical solutions [1][9] - The company is committed to developing innovative, evidence-based solutions for various women's health issues, including sexual health, contraception, and menopause [9][10] - Daré's first FDA-approved product is XACIATO™, a vaginal gel for bacterial vaginosis, indicating the company's capability in bringing women's health products to market [10] Product Details - DARE to PLAY™ is clinically shown to improve genital blood flow and sexual response in women, distinguishing it from untested compounded products [2][7] - The formulation is designed to deliver sildenafil effectively, addressing a long-standing gap in women's sexual health solutions [2][7] - The product aims to provide a credible, evidence-based option for women experiencing difficulties with sexual arousal, orgasm, and desire [7][9] Webinar Information - The webinar titled "The DARE to PLAY™ Difference: The Sildenafil Cream That Raises the Bar" will feature leading sexual health experts [3][6] - Participants will have the opportunity to join a product alert list to receive updates on the availability of DARE to PLAY™ [5][6] - The event is open to clinicians, investors, and women interested in science-based approaches to improving sexual response [6]
Crude Oil Moves Lower; Daré Bioscience Shares Jump
Benzinga· 2025-07-14 17:09
Group 1: U.S. Stock Market Performance - U.S. stocks traded higher with the Nasdaq Composite gaining around 0.4% on Monday [1] - The Dow increased by 0.05% to 44,393.18, while the S&P 500 rose by 0.11% to 6,266.78 [1] - Utilities shares jumped by 0.4%, while energy stocks dipped by 1.2% [1] Group 2: Company Earnings - Fastenal Company reported better-than-expected second-quarter earnings of 29 cents per share, beating the analyst consensus estimate of 28 cents [2] - The company also reported quarterly sales of $2.08 billion, surpassing the analyst consensus estimate of $2.07 billion [2] Group 3: Stock Movements - Sonnet BioTherapeutics Holdings, Inc. shares surged 157% to $13.32 after announcing a business combination to launch a Crypto treasury reserve strategy [8] - Daré Bioscience, Inc. shares increased by 141% to $6.05 following interim safety and efficacy results from a Phase 3 clinical trial [8] - Veritex Holdings, Inc. shares rose by 20% to $32.97 after announcing an acquisition by Huntington Bancshares for $1.9 billion [8] - Ruanyun Edai Technology Inc. shares dropped 59% to $8.27 [8] - Unusual Machines, Inc. shares fell 16% to $10.14 after announcing a $48.5 million registered direct offering [8] - Diginex Limited shares decreased by 13% to $58.00 after reporting FY25 financial results [8]
Daré Bioscience Receives $6 Million Non-Dilutive Grant Installment; $37.8M to Date of up to $49M Commitment Supporting Smart Drug Delivery Device for Contraception; Platform has Broader Application Potential in Obesity and Metabolic Disorders
Globenewswire· 2025-07-11 12:00
Core Insights - Daré Bioscience, Inc. has received a $6 million non-dilutive funding installment, increasing total funding to approximately $37.8 million out of a potential $49 million for the development of DARE-LARC1, a contraception-focused application of its intelligent drug delivery system [1][10] - DARE-LARC1 is a preclinical-stage long-acting reversible contraceptive utilizing a programmable drug delivery device to administer levonorgestrel, with broader applications in various chronic conditions [2][6] - The DARE-IDDS platform, originally developed at MIT, has been enhanced by Daré to improve its functionality and is capable of delivering multiple doses over extended periods without the need for recharging or surgical replacement [3][4] Funding and Development - The recent funding milestone will support the advancement of DARE-LARC1 and the development of a versatile drug delivery platform across high-value therapeutic areas [3][10] - Daré is eligible for additional non-dilutive funding of up to approximately $11.2 million, contingent on achieving specified technical milestones [10] Market Potential - The DARE-IDDS platform has potential applications beyond reproductive health, including obesity, diabetes, and other chronic conditions, which could significantly improve patient adherence and reduce healthcare costs [6][7] - The platform's features include precision dosing, extended duration of action, and remote programmability, making it suitable for various therapeutic areas [9] Strategic Partnerships - Daré is actively exploring strategic partnerships to expand the evaluation of the DARE-IDDS platform into additional therapeutic categories [2][10] - The company aims to leverage its innovative technology to address unmet needs in women's health and enhance treatment options [11]
Daré Bioscience (DARE) Earnings Call Presentation
2025-07-03 14:11
Company Overview - Daré Bioscience's mission is to challenge the status quo and prioritize women's health [3] - The company aims to meet the increasing demand for evidence-based treatments with scientific rigor and rapid commercialization [4] Product Pipeline and Market Opportunity - Sildenafil Cream (Rx) is designed for her sexual experience, addressing an $11 billion erectile dysfunction market opportunity [17] - Vaginal probiotic suppositories (non-Rx) are designed to maintain a healthy vaginal microbiome, capitalizing on the growing vaginal health awareness [17] - Monthly estradiol + progesterone vaginal ring (Rx) is designed to support her through menopause, targeting a $25-45 billion U S compounded hormone therapy market [17] Investment Thesis - Only approximately 1% of healthcare research spending is invested in non-oncologic female conditions [25] - Women's health products make up 27% of total blockbuster products while contributing to 35% of total blockbuster sales [26] - Women control 80% of U S healthcare purchasing decisions [27] Key Products and Milestones - Targeting availability of DARE to PLAY Sildenafil Cream by prescription in Q4 2025 via 503B-registered partner [98] - Ovaprene® Phase 3 study enrollment is ongoing, with an interim data review scheduled for July 2025 [98] - XACIATO (clindamycin phosphate) vaginal gel 2% is Daré's first FDA-approved product [86]
Daré Bioscience Announces Adjournment of Annual Meeting of Stockholders
Globenewswire· 2025-06-12 21:00
Core Points - Daré Bioscience, Inc. convened its 2025 annual meeting of stockholders but adjourned it due to a lack of quorum, with plans to reconvene on July 9, 2025 [1][2] - Stockholders who have already submitted proxies or voted do not need to vote again, as their submissions will remain valid [3] - The company emphasizes the importance of voting for stockholders who have not yet participated, providing instructions for online and telephone voting [4] Company Overview - Daré Bioscience is a biopharmaceutical company focused on women's health, aiming to address unmet needs through innovative solutions [8] - The company has developed products such as XACIATO™, a vaginal gel for bacterial vaginosis, and is working on other candidates like Ovaprene® and Sildenafil Cream for various women's health issues [9][10] - Daré's leadership has received recognition for contributions to innovation and advocacy in women's health [11]
Daré Bioscience and Rosy Wellness Announce Strategic Collaboration to Educate and Market Daré’s DARE to PLAY Sildenafil Cream
Globenewswire· 2025-06-04 12:00
Core Insights - Daré Bioscience, Inc. has announced a strategic collaboration with Rosy Wellness to support the marketing and awareness campaign for its DARE to PLAY Sildenafil Cream, aimed at enhancing women's sexual health [1][3][4] Company Overview - Daré Bioscience is a biopharmaceutical company focused on women's health, aiming to address unmet needs through innovative solutions [10] - The company is set to start recording revenue in the fourth quarter of 2025 with the launch of DARE to PLAY Sildenafil Cream, a topical formulation of sildenafil citrate [1][2] Product Details - DARE to PLAY Sildenafil Cream is designed to increase local blood flow to genital tissues, addressing female sexual arousal disorder [2][11] - The product is expected to be available by prescription in the U.S. as a compounded drug under Section 503B of the FDCA [2] Collaboration Highlights - The partnership combines Daré's clinical expertise with Rosy's extensive digital reach and community engagement, which includes over 250,000 women [1][3] - The collaboration will focus on educational outreach and destigmatizing conversations around female sexual health [3][5] Market Context - Female sexual health is identified as a significantly underserved area, with 65% of women reporting concerns with arousal [3][4] - The partnership aims to enhance sexual wellness education and access for women, addressing a historically stigmatized topic [5][8]