Core Viewpoint - Dare Bioscience, Inc. reported a quarterly loss of $0.50 per share, which was better than the Zacks Consensus Estimate of a loss of $0.63, indicating an earnings surprise of 20.63% [1] Financial Performance - The company posted revenues of $0.03 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 95.83%, compared to revenues of $0.01 million a year ago [2] - Over the last four quarters, the company has surpassed consensus EPS estimates four times but has not been able to beat consensus revenue estimates [2] Stock Performance - Dare Bioscience shares have lost about 7.7% since the beginning of the year, while the S&P 500 has declined by 0.6% [3] - The current consensus EPS estimate for the coming quarter is -$0.43 on $0.6 million in revenues, and for the current fiscal year, it is -$1.97 on $3.3 million in revenues [7] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Dare Bioscience belongs, is currently in the top 35% of over 250 Zacks industries, suggesting a favorable outlook [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact stock performance [5]

Financial Data and Key Metrics Changes - General and administrative expenses decreased by 14% to approximately $2.3 million compared to Q1 2024, primarily due to reduced stock-based compensation and headcount [13] - Research and development expenses decreased by 31% to approximately $2.3 million compared to Q1 2024 [13] - Comprehensive loss for the quarter was approximately $4.4 million, with cash and cash equivalents at approximately $10.3 million and a working capital deficit of approximately $9.4 million [13][14] Business Line Data and Key Metrics Changes - The company plans to commercialize three additional solutions for women, including two vaginal probiotics in 2025 and a proprietary monthly hormone therapy in 2026, targeting a $4.5 billion compounded hormone therapy market [5][19] - The company expects to start recording revenue in the fourth quarter of 2025 [6][67] Market Data and Key Metrics Changes - The women's health sector is described as underfunded and fragmented, presenting significant opportunities for returns [7][67] - The company is leveraging a dual path strategy to commercialize products via 503B compounding while seeking FDA approval [7][24] Company Strategy and Development Direction - The company is focused solely on women's health, aiming to provide evidence-based solutions through various channels, including telehealth and online platforms [8][21] - The strategy includes forming partnerships with telehealth providers and online retailers to enhance product accessibility [22][23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's unique position to deliver value amidst distractions in the healthcare and biotech sectors [6] - The company aims to meet the increasing demand for evidence-based treatments and is committed to rapid commercialization [16][17] Other Important Information - The company is actively evaluating the dual path approach for other proprietary formulations to expedite market access [24] - The company received a grant from the Gates Foundation to identify evidence-based formulations for vaginal probiotics [10][19] Q&A Session Summary Question: Will there be unique partnerships for each product or multiple partnerships for an individual product? - Management clarified that they intend to have multiple partnerships for individual products to ensure wide access [33] Question: Is there sufficient manufacturing capacity for Sildenafil Cream by year-end? - Management confirmed the need to support their 503B collaborator to ensure manufacturing readiness [35] Question: What additional information has the FDA requested for Sildenafil? - Management indicated that the FDA requested information regarding patient-reported outcomes and psychometrics, which is critical for the Phase III study [44][46] Question: Will the grant cover costs to add additional sites for Ovaprene? - Management confirmed that the grant is designed to cover costs associated with adding subjects to the study [56] Question: Should R&D expenses be expected to continue at the current lower level? - Management stated that the current trend reflects the absence of ongoing studies, and expenses may remain lower until new studies commence [58]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 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 Incor ...

● Four on-market products will accelerate revenue generation and provide path to profitability Exhibit 99.1 Daré Bioscience Reports First Quarter 2025 Financial Results and Provides Company Update In addition to its proprietary Sildenafil Cream formulation, Daré is taking action to make three other solutions for women available commercially, two vaginal probiotics in 2025 and its proprietary monthly hormone therapy in 2026 ● Creates commercial opportunity in the estimated up to $4.5 billion compounded hormo ...

Creates commercial opportunity in the estimated up to $4.5 billion compounded hormone therapy market, enabling women to access an evidence-based solutionFour on-market products will accelerate revenue generation and provide path to profitabilityDaré expects to start recording revenue in the 4th quarter of this year Conference call today at 4:30 p.m. ET to discuss the further expanded business strategy to commercialize multiple solutions in 2025 and 2026 2025 and 2026 Milestones Sildenafil Cream, 3.6% an inv ...

Core Viewpoint - Daré Bioscience is expanding its business strategy to integrate 503B compounding for bringing proprietary formulations to market, starting with Sildenafil Cream in 2025 [1][7]. Company Strategy - The company is adopting a dual-path approach for its proprietary formulations, which includes both prescription and over-the-counter consumer health products [2]. - An update on the timing and strategic partnerships for these objectives is expected in the current quarter [2]. Product Development - Daré's first FDA-approved product is XACIATO™, a vaginal gel for bacterial vaginosis, and it has several candidates in clinical development, including Ovaprene® and Sildenafil Cream [5]. - The proprietary Sildenafil Cream formulation is targeted for prescription availability in Q4 2025 [7]. Company Mission - Daré Bioscience focuses on addressing unmet needs in women's health, with a commitment to innovation and evidence-based solutions [4]. - The company aims to enhance outcomes and convenience in areas such as contraception, sexual health, and menopause [4]. Leadership Recognition - Daré's leadership has received accolades for contributions to innovation and advocacy in women's health, highlighting the company's influence in the biopharmaceutical sector [6].

Dare Bioscience, Inc. (DARE) came out with a quarterly loss of $0.64 per share versus the Zacks Consensus Estimate of a loss of $0.66. This compares to loss of $0.72 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 3.03%. A quarter ago, it was expected that this company would post a loss of $0.60 per share when it actually produced a loss of $0.55, delivering a surprise of 8.33%. Over the last four quarters, the company has su ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________________________ FORM 10-K ___________________________________________________ ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 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 No. 001-36395 DARÉ BIOSCIENCE, INC. (Exa ...

Financial Performance - Total revenue for 2024 was $9,784, compared to $2,807,885 in 2023, indicating a significant decrease[28]. - The net loss for 2024 was $4,053,299, a substantial improvement from the net loss of $30,161,391 in 2023[28]. - The company reported a comprehensive loss of $4,121,212 in 2024, down from $30,170,976 in 2023, marking a notable decrease[28]. - The loss per common share improved to $0.48 in 2024 from $4.15 in 2023, indicating a significant reduction in per-share losses[28]. - Cash and cash equivalents increased to $15,698,174 in 2024 from $10,476,056 in 2023, reflecting a growth of approximately 50.5%[30]. - Total assets rose to $22,101,131 in 2024, up from $21,282,215 in 2023, showing an increase of about 3.8%[30]. - Total liabilities increased to $28,113,220 in 2024 from $26,329,855 in 2023, representing a rise of approximately 6.8%[30]. - Working capital deficit slightly worsened to $(3,161,150) in 2024 from $(2,936,897) in 2023[30]. - The weighted average number of common shares outstanding increased to 8,497,459 in 2024 from 7,275,308 in 2023, reflecting a growth of approximately 16.7%[28]. Expenses - General and administrative expenses decreased by 24% to approximately $9.2 million in 2024, primarily due to reduced commercial readiness expenses and headcount[24]. - Research and development expenses were approximately $14.2 million in 2024, reflecting a 34% decrease compared to the prior year, mainly due to manufacturing activities and ongoing enrollment in the Phase 3 study of Ovaprene[24]. - Research and development expenses decreased to $14,205,208 in 2024 from $21,538,074 in 2023, a reduction of approximately 34.4%[28]. Clinical Development - Daré is conducting a pivotal Phase 3 contraceptive efficacy study for Ovaprene, with a non-dilutive grant of up to $10.7 million announced in November 2024 to support the addition of 5 new investigator sites[7]. - The company anticipates that approximately 125 women will complete six months of Ovaprene use by the end of the second quarter of 2025, which is a designated checkpoint for interim data review[7]. - Daré plans to submit the protocol and statistical analysis plan for a Phase 3 clinical study of Sildenafil Cream to the FDA in the second quarter of 2025[11]. Strategic Outlook - Daré expects to start recording revenue and cash flow from its proprietary Sildenafil Cream formulation in the 4th quarter of 2025[1]. - The company is targeting the second quarter of 2025 to provide updates on strategic partnerships and the timing for bringing other proprietary formulations to market[5]. - The company is evaluating a dual-path approach for some proprietary formulations to optimize access for women in a fiscally responsible manner[5]. Leadership and Recognition - Daré's leadership has been recognized for contributions to innovation and advocacy in women's health, highlighting the company's commitment to addressing unmet needs[22].

Conference call today at 4:30 p.m. ET to discuss the expanded business strategy to integrate 503B compounding as part of a dual-path approach to bring select Daré proprietary formulations to market as soon as practicable SAN DIEGO, March 31, 2025 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a biopharmaceutical company driven by a mission to challenge the status quo, making women's health a priority, today reported financial results for the year ended December 31, 2024 and provided a company upda ...