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 $2,300,000 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]

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]

[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 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)

Core Insights - Daré Bioscience is focused on women's health and aims to commercialize multiple solutions by 2025 and 2026, leveraging a dual path strategy for product approval and commercialization [1][3][5] Financial Performance - For the quarter ended March 31, 2025, total revenue was $25.4 million, a significant increase from $9.3 million in the same quarter of 2024 [21] - The company reported a net loss of $4.4 million for Q1 2025, compared to a net loss of $6.8 million in Q1 2024, indicating improved financial performance [21] - Cash and cash equivalents as of March 31, 2025, were approximately $10.3 million, down from $15.7 million at the end of 2024, with a working capital deficit of approximately $9.4 million [22] Product Development and Pipeline - The company is advancing several products, including Ovaprene®, a hormone-free contraceptive, and Sildenafil Cream, targeting female sexual arousal disorder, with expected revenue generation starting in Q4 2025 [4][5][6] - The ongoing pivotal Phase 3 study for Ovaprene® aims to assess its efficacy over 13 menstrual cycles, with interim data review scheduled for July 2025 [6][7] - Daré is also developing DARE-HRT1 for menopausal symptoms and vaginal probiotics, with plans to launch these as consumer health products [5][14] Strategic Positioning - Daré is uniquely positioned as a publicly traded company focused solely on women's health, addressing underfunded and fragmented areas such as contraception, sexual health, and menopause [3][13] - The company is leveraging multiple commercialization channels, including FDA-approved treatments, compounded products, and over-the-counter consumer health products [3][5] Market Opportunity - The compounded hormone therapy market is estimated to be up to $4.5 billion, presenting significant commercial opportunities for Daré's products [5] - The company anticipates that its innovative business model will allow for rapid commercialization and access to a broad range of women's health solutions [3][5]

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].