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Positive Interim Phase 3 Results Highlight Potential of Ovaprene®, Novel Hormone-Free Contraceptive
Globenewswire· 2025-07-14 12:00
Core Insights - Daré Bioscience announced positive interim results from its Phase 3 clinical trial for Ovaprene, a hormone-free intravaginal contraceptive, highlighting its potential as a first-in-category product [1][3][5] Clinical Trial Results - The independent Data Safety Monitoring Board recommended the continuation of the trial without modifications after a planned interim analysis [2] - Approximately 9% of participants experienced pregnancy, aligning with pre-pivotal study expectations, indicating Ovaprene's effectiveness [3] - No new safety concerns were reported, with 17% of participants discontinuing due to vaginal odor, the most common adverse event [4] Market Potential - The CEO emphasized the significant unmet need for effective, hormone-free contraceptives in the U.S., suggesting Ovaprene could transform the contraceptive landscape [5] - The ongoing trial aims to enroll about 250 participants, assessing the typical use pregnancy rate over 13 menstrual cycles [6] Commercialization and Financials - Bayer holds the option to obtain exclusive U.S. commercialization rights for Ovaprene upon completion of the pivotal trial, contingent on a $20 million payment [7] - Daré could receive up to $310 million in milestone payments and tiered royalties on net sales, subject to third-party agreements [7] Company Overview - Daré Bioscience focuses on innovative solutions in women's health, aiming to address unmet needs in areas such as contraception and sexual health [8] - The company has previously launched XACIATO™, a vaginal gel for bacterial vaginosis, and is developing other first-in-category candidates [9]
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]
Dare Bioscience, Inc. (DARE) Reports Q1 Loss, Lags Revenue Estimates
ZACKS· 2025-05-13 22:10
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]
Daré Bioscience(DARE) - 2025 Q1 - Earnings Call Transcript
2025-05-13 21:32
Financial Data and Key Metrics Changes - General and administrative expenses decreased by 14% to approximately $2,300,000 compared to Q1 2024, primarily due to reduced stock-based compensation and headcount [12] - Research and development expenses decreased by 31% to approximately $2,300,000 compared to Q1 2024 [12] - Comprehensive loss for the quarter was approximately $4,400,000, with cash and cash equivalents at approximately $10,300,000 and a working capital deficit of approximately $9,400,000 [12][13] 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 $4,500,000,000 compounded hormone therapy market [4][17] - The company expects to start recording revenue in the fourth quarter of 2025 [5][65] Market Data and Key Metrics Changes - Women's health is identified as an underfunded and fragmented sector, presenting significant opportunities for returns [6][65] - The company is leveraging a dual path strategy to commercialize products via 503B compounding while seeking FDA approval [7][19] Company Strategy and Development Direction - The company is focused solely on women's health, developing therapeutic products for various conditions affecting women [8] - The strategy includes rapid commercialization of multiple products through various channels, including telehealth and online platforms [19][21] - The company aims to establish strategic partnerships to enhance access to its products [20] Management's Comments on Operating Environment and Future Outlook - The management acknowledges distractions in the healthcare and biotech sectors but believes the company is well-positioned to deliver value to stakeholders [5] - The management emphasizes the urgency for faster access to evidence-based treatments for women [14][15] - The company is committed to ensuring that women do not have to wait for needed medical treatment solutions while pursuing FDA approval [21] Other Important Information - The company is actively evaluating the dual path approach for other proprietary formulations to expedite market access [21] - The company received a grant from the Gates Foundation to identify evidence-based formulations for vaginal probiotics [10][18] Q&A Session Summary Question: Will there be unique partnerships for each product or multiple partnerships for an individual product? - The company intends to have multiple partnerships for individual products to ensure wide access [29] Question: Is there sufficient manufacturing capacity for Sildenafil Cream by year-end? - The company is working with a 503B collaborator to ensure the manufacturer is prepared for GMP production [31][32] Question: What additional information has the FDA requested for Sildenafil? - The FDA requested information regarding patient-reported outcomes psychometrics, which is crucial for the Phase III study [42] Question: Will there be an opportunity to increase the sample size for Ovaprene? - The upcoming Data Safety Monitoring Board meeting will focus on safety, with no opportunity for sample size changes [45] Question: Are all four products pursuing a dual path? - Sildenafil and hormone therapy are dual path products, while vaginal probiotics are consumer health brands without FDA approval plans [50] Question: Will the grant cover costs to add additional sites for Ovaprene? - The grant is designed to cover costs for adding subjects to the study, with flexibility to add more sites if needed [55] Question: Should R&D expenses be expected to continue at a lower level? - Current R&D expenses reflect the ongoing Ovaprene study, and trends are expected to continue until new studies are initiated [57] Question: Will there be additional costs for the hormone therapy product? - Additional costs will be associated with production activities and tech transfer for the hormone therapy product [59]
Daré Bioscience(DARE) - 2025 Q1 - Earnings Call Transcript
2025-05-13 21:30
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]
Daré Bioscience(DARE) - 2025 Q1 - Quarterly Report
2025-05-13 20:04
[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Condensed Consolidated Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) This section presents Daré Bioscience's unaudited condensed consolidated financial statements, including balance sheets, statements of operations, stockholders' deficit, and cash flows, highlighting a going concern uncertainty, XACIATO royalty sale, and new 503B compounding strategy Condensed Consolidated Balance Sheet Data (Unaudited) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $10,329,967 | $15,698,174 | | Total current assets | $11,822,549 | $18,447,863 | | Total assets | $18,618,941 | $22,101,131 | | Total current liabilities | $21,188,074 | $21,609,013 | | Total liabilities | $28,182,642 | $28,113,220 | | Total stockholders' deficit | $(9,563,701) | $(6,012,089) | Condensed Consolidated Statements of Operations (Unaudited) | Account | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | Total revenue | $25,427 | $9,302 | | Total operating expenses | $4,606,545 | $6,031,775 | | Loss from operations | $(4,581,118) | $(6,022,473) | | Net loss | $(4,378,307) | $(6,755,356) | | Loss per common share - basic and diluted | $(0.50) | $(0.81) | Condensed Consolidated Statements of Cash Flows (Unaudited) | Cash Flow Activity | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(5,470,543) | $(6,812,962) | | Net cash used in investing activities | $(157,331) | $(7,296) | | Net cash provided by financing activities | $246,577 | $14,032 | | Net change in cash, cash equivalents and restricted cash | $(5,368,207) | $(6,845,453) | - The company's financial statements were prepared on a going concern basis, but a history of losses, negative cash flows, and insufficient cash to fund operations for the next 12 months raise substantial doubt about its ability to continue as a going concern. As of March 31, 2025, the company had an accumulated deficit of approximately **$179.7 million** and a working capital deficit of **$9.4 million**[33](index=33&type=chunk)[34](index=34&type=chunk)[35](index=35&type=chunk) - In March 2025, the company expanded its business strategy to include Section 503B compounding as a dual-path approach to bring certain proprietary formulations to market more quickly while continuing to pursue FDA approval for its product candidates[28](index=28&type=chunk) - In April 2024, the company sold its rights to all royalty and potential milestone payments from net sales of XACIATO to XOMA (US) LLC. After XOMA receives a specified return, the company will share equally in subsequent payments from Organon[30](index=30&type=chunk)[53](index=53&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=32&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's women's health strategy, including a new 503B compounding approach, Q1 2025 financial results showing decreased net loss and operating expenses, and the critical need for additional capital due to going concern doubts and Nasdaq compliance efforts [Business Overview and Recent Events](index=32&type=section&id=Business%20Overview%20and%20Recent%20Events) The biopharmaceutical company focuses on women's health with a pipeline including Ovaprene and Sildenafil Cream, recently expanded its strategy to include 503B compounding, and faces challenges with Ovaprene study recruitment and Nasdaq listing compliance - The company expanded its business strategy in March 2025 to include Section 503B compounding, aiming to bring proprietary formulations like Sildenafil Cream and DARE-HRT1 to market faster while continuing to pursue FDA approval[148](index=148&type=chunk)[156](index=156&type=chunk)[157](index=157&type=chunk) - Enrollment in the pivotal Phase 3 study of Ovaprene is ongoing but has been paused at NICHD-affiliated sites due to administrative issues, though recruitment continues at five company-funded sites[153](index=153&type=chunk) - The company is preparing for a Phase 3 study of Sildenafil Cream for female sexual arousal disorder (FSAD) but does not plan to conduct the study until additional capital is secured[154](index=154&type=chunk) - The company received an extension from Nasdaq until August 12, 2025, to regain compliance with listing requirements, specifically the Stockholders' Equity Rule or the Minimum Market Value of Listed Securities Rule[161](index=161&type=chunk) [Results of Operations](index=40&type=section&id=Results%20of%20Operations) For Q1 2025, the company reported a net loss of $4.4 million, a 35% decrease from Q1 2024, driven by a 24% reduction in total operating expenses, primarily from lower R&D and G&A costs Comparison of Operations for Three Months Ended March 31 | Item | 2025 | 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $25,427 | $9,302 | $16,125 | 173% | | General and administrative | $2,309,164 | $2,670,581 | $(361,417) | (14)% | | Research and development | $2,297,381 | $3,353,520 | $(1,056,139) | (31)% | | Loss from operations | $(4,581,118) | $(6,022,473) | $1,441,355 | (24)% | | Net loss | $(4,378,307) | $(6,755,356) | $2,377,049 | (35)% | - General and administrative expenses decreased by approximately **$0.4 million**, mainly due to lower stock-based compensation, professional services, and personnel costs[181](index=181&type=chunk) - Research and development expenses decreased by approximately **$1.1 million**, primarily due to reduced manufacturing costs for Ovaprene and lower development activity costs for Sildenafil Cream and preclinical programs[185](index=185&type=chunk) [Liquidity and Capital Resources](index=42&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company had $10.3 million cash and a $9.4 million working capital deficit, raising substantial doubt about its going concern ability, necessitating additional capital, which it is actively pursuing through various options - The company has a history of losses and negative cash flows, leading to substantial doubt about its ability to continue as a going concern. Additional capital is required to fund operations into Q3 2025[188](index=188&type=chunk)[189](index=189&type=chunk) - The company is pursuing capital through various means, including an equity line agreement with Lincoln Park, under which it sold **150,000 shares** for net proceeds of approximately **$0.4 million** in Q1 2025[190](index=190&type=chunk)[196](index=196&type=chunk) - If additional capital cannot be raised, the company may need to delay, scale back, or eliminate development programs, reduce expenses, or cease operations[191](index=191&type=chunk) Summary of Cash Flows | Cash Flow Activity | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(5,470,543) | $(6,812,962) | | Net cash used in investing activities | $(157,331) | $(7,296) | | Net cash provided by financing activities | $246,577 | $14,032 | [Quantitative and Qualitative Disclosures About Market Risk](index=47&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Daré Bioscience is not required to provide the information for this item - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[218](index=218&type=chunk) [Controls and Procedures](index=47&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - Based on an evaluation, the principal executive and financial officer concluded that the company's disclosure controls and procedures were effective as of March 31, 2025[220](index=220&type=chunk) - No change in internal control over financial reporting occurred during the fiscal quarter that has materially affected, or is reasonably likely to materially affect, internal controls[221](index=221&type=chunk) [PART II. OTHER INFORMATION](index=48&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=48&type=section&id=Item%201.%20Legal%20Proceedings) As of the filing date, the company is not a party to any material pending legal proceedings, nor is management aware of any contemplated governmental proceedings - There are no material pending legal proceedings to which the company is a party[223](index=223&type=chunk) [Risk Factors](index=48&type=section&id=Item%201A.%20Risk%20Factors) This section highlights the significant risk of the company's common stock being delisted from Nasdaq due to non-compliance with listing requirements, which could severely impair capital raising and negatively affect stock price - The company is not in compliance with Nasdaq's continued listing requirement for minimum market value of listed securities (**$35.0 million**)[225](index=225&type=chunk) - Nasdaq has granted an extension until August 12, 2025, for the company to regain compliance with either the market value rule or the stockholders' equity rule (at least **$2.5 million**)[228](index=228&type=chunk) - Failure to regain compliance could lead to the delisting of the company's common stock, which would substantially impair its ability to raise capital, harm investor confidence, and adversely affect the stock's market price and trading efficiency[232](index=232&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=49&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item is marked as "None" [Defaults Upon Senior Securities](index=49&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[233](index=233&type=chunk) [Mine Safety Disclosures](index=49&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[234](index=234&type=chunk) [Other Information](index=49&type=section&id=Item%205.%20Other%20Information) During the first quarter of 2025, none of the company's directors or officers adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements - From January 1, 2025, to March 31, 2025, no directors or officers adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements[235](index=235&type=chunk) [Exhibits](index=50&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, which include the Amended and Restated Non-Employee Director Compensation Policy, certifications by the Principal Executive Officer and Principal Financial Officer, and XBRL data files
Daré Bioscience(DARE) - 2025 Q1 - Quarterly Results
2025-05-13 20:01
[Daré Bioscience First Quarter 2025 Update](index=1&type=section&id=Dar%C3%A9%20Bioscience%20Reports%20First%20Quarter%202025%20Financial%20Results%20and%20Provides%20Company%20Update) [Expanded Business Strategy and 2025/2026 Milestones](index=1&type=section&id=Expanded%20Business%20Strategy%20and%202025%2F2026%20Milestones) The company is pursuing a dual commercialization strategy to accelerate revenue generation starting in Q4 2025 - The company is implementing a dual-path strategy, commercializing products via 503B compounding for near-term revenue while simultaneously seeking full FDA approval[3](index=3&type=chunk) - Daré expects to begin recording revenue in the **fourth quarter of 2025**[2](index=2&type=chunk) - Key commercialization targets include **Sildenafil Cream and vaginal probiotics in 2025**, followed by **DARE-HRT1 in 2026**[1](index=1&type=chunk)[2](index=2&type=chunk) - The company is targeting the compounded hormone therapy market, which is estimated to be up to **$4.5 billion**[1](index=1&type=chunk) [Therapeutic Development Pipeline Highlights](index=2&type=section&id=Therapeutic%20Development%20Pipeline%20Highlights) The company is advancing its clinical pipeline, with a key data review for Ovaprene® scheduled for July 2025 - **Ovaprene®:** Enrollment is ongoing in the pivotal Phase 3 contraceptive efficacy study, with a data safety monitoring board scheduled to review interim data in July 2025[2](index=2&type=chunk)[5](index=5&type=chunk)[9](index=9&type=chunk) - **Sildenafil Cream, 3.6%:** The company continues interactions with the FDA regarding the planned Phase 3 study and expects to submit the protocol by the end of Q2 2025[6](index=6&type=chunk)[9](index=9&type=chunk) - **DARE-HPV:** Daré is preparing to submit an IND application for a Phase 2 clinical study for the clearance of high-risk HPV, supported by a non-dilutive award of up to $10 million[7](index=7&type=chunk)[9](index=9&type=chunk) [First Quarter 2025 Financial Results](index=2&type=section&id=Financial%20Highlights%20for%20the%20Quarter%20ended%20March%2031%2C%202025) The company reported a reduced net loss and ended the quarter with $10.3 million in cash and cash equivalents [Financial Highlights Summary](index=2&type=section&id=Financial%20Highlights%20Summary) Daré demonstrated fiscal discipline by significantly reducing operating expenses compared to the prior-year period Key Financial Position & Expense Changes (Q1 2025 vs Q1 2024) | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | $10.3 million | N/A | - | | Research and development expenses | $2.3 million | $3.4 million | -31% | | General and administrative expenses | $2.3 million | $2.7 million | -15% | [Consolidated Statements of Operations](index=6&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The net loss for Q1 2025 improved to $4.4 million, down from a $6.8 million loss in Q1 2024 Consolidated Statements of Operations (Three Months Ended March 31) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Total revenue | $25,427 | $9,302 | | Total operating expenses | $4,606,545 | $6,031,775 | | Loss from operations | ($4,581,118) | ($6,022,473) | | **Net loss** | **($4,378,307)** | **($6,755,356)** | | Loss per common share | ($0.50) | ($0.81) | [Condensed Consolidated Balance Sheet Data](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20Data) The balance sheet showed $10.3 million in cash and a working capital deficit of $9.4 million as of March 31, 2025 Condensed Consolidated Balance Sheet Data | Metric | March 31, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $10,329,967 | $15,698,174 | | Working capital deficit | ($9,365,525) | ($3,161,150) | | Total assets | $18,618,941 | $22,101,131 | | Total stockholders' deficit | ($9,563,701) | ($6,012,089) | [Company Information and Forward-Looking Statements](index=3&type=section&id=Company%20Information%20and%20Forward-Looking%20Statements) This section outlines Daré's business focus, investor call details, and significant risks and uncertainties - A conference call to discuss the financial results and company update was scheduled for May 13, 2025, at 4:30 p.m. Eastern Time[11](index=11&type=chunk) - Daré Bioscience is a biopharmaceutical company focused on advancing innovative products for women's health in areas like contraception, sexual health, and menopause[13](index=13&type=chunk)[14](index=14&type=chunk) - The report contains extensive forward-looking statements concerning go-to-market strategies, product timelines, and clinical development, which are subject to significant risks[17](index=17&type=chunk)