Core Insights - DARE to PLAY™ Sildenafil Cream is a groundbreaking female arousal cream designed to enhance genital blood flow and arousal sensations, marking significant progress in women's sexual health [1][2][4] - The product is the first evidence-backed sildenafil cream formulation for women, manufactured under current Good Manufacturing Practice (cGMP) regulations [3][6] - Daré Bioscience aims to address the long-standing gap in women's sexual health solutions, providing a scientifically validated option for women experiencing arousal challenges [5][10] Product Overview - DARE to PLAY™ utilizes sildenafil, the same active ingredient in Viagra®, applied topically to improve genital blood flow without systemic effects [4][6] - The cream is available for prescription in select states, with plans for broader availability in the coming months [7][10] - The product is supported by multiple clinical trials and peer-reviewed research, ensuring its efficacy and safety [9][10] Market Opportunity - An estimated 20 million women in the U.S. face challenges related to genital arousal, highlighting a significant unmet need in the market [10] - The introduction of DARE to PLAY™ provides access to a clinically supported product for this underserved demographic [10] - Daré Bioscience is committed to closing the gap in women's health by advancing science-based solutions across various areas, including sexual health [12][13]

SAN DIEGO, Dec. 01, 2025 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a purpose-driven health biotech company solely focused on closing the gap in women’s health between promising science and real-world solutions, today announced that all rights to Ovaprene®, the company’s first-in-category, investigational, hormone-free monthly intravaginal contraceptive, will be returned to Daré by Bayer HealthCare LLC as a result of Bayer electing to terminate the license agreement between the parties as p ...

Grant funding will support continued progress on a preclinical research program to identify and develop a non-hormonal intravaginal contraceptive innovation aimed at addressing unmet global needsSAN DIEGO, Nov. 24, 2025 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a purpose-driven health biotech company solely focused on closing the gap in women’s health between promising science and real-world solutions, today announced that it has received an approximately $3.6 million payment under an exist ...

Core Viewpoint - The presentation focuses on the introduction of DARE to PLAY, a novel Sildenafil Cream formulation specifically designed for women, highlighting the company's commitment to addressing women's health needs [2]. Group 1: Company Overview - Dare Bioscience is led by CEO Sabrina Martucci Johnson, who emphasizes the company's mission to innovate in women's health [2]. - The company is excited to present DARE to PLAY, which is described as a first-of-its-kind product in the market [2]. Group 2: Product Introduction - DARE to PLAY is a Sildenafil Cream formulated specifically for women, indicating a targeted approach to addressing sexual health issues [2]. - The presentation features insights from Dr. Kingsberg and Dr. Simon, who will provide an overview of the product and its implications for women's health [3].

Financial Data and Key Metrics Changes - The company ended Q3 2025 with approximately $23 million in cash and cash equivalents and working capital of approximately $3.8 million [21] - During Q3, the company received approximately $18.7 million in net proceeds from sales of common stock and a total of $7.3 million in grant payments, strengthening its balance sheet [21] - General and administrative (G&A) expenses were $2.5 million compared to $2 million in Q3 2024, primarily due to increases in professional services and commercial readiness expenses [22] - Research and development (R&D) expenses were $1.2 million compared to $2.7 million in Q3 2024, a 56% decrease, attributed to non-dilutive funding and reduced manufacturing costs [22] Business Line Data and Key Metrics Changes - The company is on track to support the commercial availability of Dare to Play Sildenafil Cream through a 503(b) outsourcing facility before the end of 2025, marking a significant milestone in women's sexual health [5][11] - The Dare to Restore product line, which includes proprietary vaginal probiotic products, is expected to be available in the U.S. in Q1 2026 [15] - The company is also pursuing a combination estradiol and progesterone intravaginal ring branded as Dare to Reclaim, targeting early 2027 for availability [16] Market Data and Key Metrics Changes - The company is addressing significant unmet needs in women's health, including contraception, HPV infection, and preterm birth, through its clinical pipeline [5][17] - The estimated market for compounded hormone therapy is $4.5 billion, with Dare to Reclaim positioned as a unique solution in this space [16] Company Strategy and Development Direction - The company employs a dual-path strategy, commercializing proprietary formulations while pursuing FDA approval and advancing select solutions as branded consumer health products [2][5] - The focus is on bridging the gap between promising science and real-world solutions for women, leveraging non-dilutive capital and disciplined investment strategies [6][17] - The company aims to create a self-reinforcing ecosystem for growth through its commercial initiatives, enhancing brand awareness and provider engagement [16][39] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the recent FDA guidance on hormone replacement therapy, which aligns with the company's development of Dare to Reclaim [24][28] - The company is excited about the potential of Dare to Play Sildenafil Cream as a near-term revenue driver and anticipates initial revenue recognition in Q4 2025 [39][40] - The management believes that the women's health market is ripe for value creation due to its historical underfunding and underserved status [40] Other Important Information - The company is actively recruiting for its pivotal phase III study of Oviprene, a contraceptive product, with completion anticipated in 2026 [17][18] - The company has received significant grant funding to support various programs, including DARE HPV and DARE LARK 1, demonstrating its ability to leverage strategic collaborations [20] Q&A Session Summary Question: Can you comment on FDA's recent reversal and guidance on hormone replacement therapy in menopause? - Management expressed excitement about the FDA's change and highlighted the development of Dare to Reclaim, a hormone therapy vaginal ring that combines estradiol and progesterone [24][25] Question: Will Dare to Reclaim be available through a compounder or is there a path for FDA approval? - Management confirmed that both paths are being pursued, similar to the strategy for Dare to Play Sildenafil Cream [29] Question: How is the company prioritizing R&D programs for FDA approval? - The focus is on advancing Dare to Play, Dare to Reclaim, and grant-funded programs like Oviprene and DARE HPV, prioritizing those with clear regulatory pathways [30][32] Question: What partnerships are being considered to increase awareness for Dare to Play? - Management mentioned plans for clinician awareness initiatives and online advertising, as well as partnerships with telehealth resources to facilitate prescription fulfillment [33][36] Question: Is there additional capacity left on the ATM? - Management indicated that the company is subject to baby shelf limitations, which restrict the amount available under the ATM [38]

Financial Performance - Total revenue for the three months ended September 30, 2025, was $2,262, a decrease of 94.6% compared to $41,691 for the same period in 2024[19] - Loss from operations for the three months ended September 30, 2025, was $3,672,148, compared to a loss of $4,681,349 for the same period in 2024[19] - Net loss for the nine months ended September 30, 2025, was $11,957,556, compared to a net income of $1,452,799 for the same period in 2024[19] - Total revenue for the nine months ended September 30, 2025, was $6,517, down from $73,431 in 2024, indicating a decrease of about 91.1%[144] - The company reported a comprehensive loss of $3,555,906 for the three months ended September 30, 2025, compared to a loss of $4,679,566 for the same period in 2024[19] Operating Expenses - Operating expenses for the three months ended September 30, 2025, were $3,674,410, down 22.2% from $4,723,040 in the prior year[19] - Segment operating expenses for the three months ended September 30, 2025, were $3,674,410, compared to $4,723,040 in 2024, a reduction of approximately 22.2%[144] - Research and development direct program costs for the three months ended September 30, 2025, totaled $641,668, down from $1,539,276 in 2024, a decrease of approximately 58.3%[144] - Personnel-related costs, including stock-based compensation, for the three months ended September 30, 2025, were $1,168,085, compared to $1,429,180 in 2024, a decline of about 18.2%[144] Cash and Assets - Cash and cash equivalents increased to $23,075,261 as of September 30, 2025, from $15,698,174 as of December 31, 2024, representing a growth of 47.1%[18] - Total assets as of September 30, 2025, were $30,748,574, an increase of 39.5% from $22,101,131 as of December 31, 2024[18] - The company had unrestricted cash and cash equivalents of approximately $23.1 million and working capital of approximately $3.8 million as of September 30, 2025[37] - Cash equivalents increased from approximately $15.3 million as of December 31, 2024, to approximately $22.7 million as of September 30, 2025[48] Liabilities and Equity - Total liabilities decreased slightly to $27,890,671 as of September 30, 2025, from $28,113,220 as of December 31, 2024[18] - The company had a total stockholders' equity of $2,857,903 as of September 30, 2025, compared to a deficit of $(6,012,089) as of December 31, 2024[18] - The company’s accumulated deficit increased to $(187,247,186) as of September 30, 2025, from $(169,783,232) as of September 30, 2024[25] - The company’s total stockholders' equity as of September 30, 2025, was $2,857,903, compared to a deficit of $(1,484,483) as of September 30, 2024[25] Cash Flow - The company reported net cash used in operating activities of $(11,330,134) for the nine months ended September 30, 2025, compared to net cash provided of $167,637 for the same period in 2024[28] - The Company reported negative cash flow from operations of approximately $11.3 million for the nine months ended September 30, 2025[39] Funding and Grants - The Company has received a total of $12.8 million in non-refundable payments from Organon, recorded as license fee revenue[52] - The Company is entitled to receive up to $180.0 million in tiered commercial sales and regulatory milestones from Organon[53] - The Company received a $1.0 million grant from NIAID for DARE-HPV development, with an additional $1.0 million recommended for the subsequent project year[128] - The Company was awarded approximately $2.0 million from NICHD to support the development of DARE-PTB1, with recorded expenses of approximately $0.2 million and $0.5 million for the three and nine months ended September 30, 2025, respectively[129] Stock and Financing - The Company has the right to sell up to $15.0 million of shares of its common stock to Lincoln Park Capital Fund, LLC over a 24-month period starting November 27, 2024[87] - During the nine months ended September 30, 2025, the Company sold 900,000 shares of common stock under the Lincoln Park agreement for net proceeds of approximately $2.0 million[89] - The Company sold 4,329,116 shares of common stock under the ATM sales agreement for aggregate gross proceeds of approximately $18.0 million, resulting in net proceeds of approximately $17.6 million after expenses[90] Development and Licensing Agreements - The company announced a dual-path approach to market new products, pursuing both traditional FDA approval and earlier market access via Section 503B outsourcing facilities[32] - The company entered into a co-development and licensing agreement with Theramex for a biodegradable contraceptive implant, Casea S, receiving a royalty-free, exclusive license in exchange for 50% of the purchase price paid by Theramex[64] - Under the Douglas License Agreement, the company may make future payments of up to $5.25 million for development milestones and up to $64.0 million for commercial sales milestones, with no payments made as of September 30, 2025[66] - The Hennepin License Agreement allows for potential payments of up to $6.25 million for development milestones and up to $45.0 million for commercial sales milestones, with no payments made as of September 30, 2025[68] Concerns and Future Outlook - There is substantial doubt about the Company's ability to continue as a going concern within the next 12 months[39] - The Company updated its forecast of Net Royalty Payments, resulting in an estimated Financing Term extending through 2037, with an effective interest rate of 12.8%[114]

Financial Performance - Total revenue for Q3 2025 was $2,262, a significant decrease from $41,691 in Q3 2024, representing a decline of approximately 94.6%[22] - Operating expenses for Q3 2025 totaled $3,674,410, down from $4,723,040 in Q3 2024, indicating a reduction of about 22.2%[22] - The net loss for Q3 2025 was $3,562,766, compared to a net loss of $4,702,501 in Q3 2024, reflecting an improvement of approximately 23.9%[22] - The company reported a loss per common share of $0.28 for Q3 2025, an improvement from a loss of $0.55 per share in Q3 2024[22] - General and administrative expenses for Q3 2025 were $2,499,242, up from $2,041,268 in Q3 2024, reflecting an increase of about 22.4%[22] - Research and development expenses decreased to $1,175,168 in Q3 2025 from $2,681,772 in Q3 2024, a reduction of approximately 56.2%[22] Cash and Assets - The company reported a cash position of approximately $23.1 million and working capital of approximately $3.8 million as of September 30, 2025[17] - Cash and cash equivalents increased to $23,075,261 as of September 30, 2025, up from $15,698,174 at the end of 2024, marking a growth of about 47.0%[24] - Total assets rose to $30,748,574 as of September 30, 2025, compared to $22,101,131 at the end of 2024, representing an increase of approximately 38.9%[24] - The company's total stockholders' equity improved to $2,857,903 as of September 30, 2025, compared to a deficit of $6,012,089 at the end of 2024[24] Product Development and Strategy - Daré Bioscience is on track to launch DARE to PLAY™ Sildenafil Cream by December 2025, representing a near-term revenue generation opportunity[2] - DARE to RECLAIM™ Monthly Hormone Therapy is targeted for early 2027, establishing entry into the estimated $4.5 billion compounded hormone therapy market[2] - The independent data safety monitoring board (DSMB) recommended the continuation of the Phase 3 study for Ovaprene without modification, indicating positive interim results[8] - Daré expects four women's health products to be commercially available over the next two years, enhancing its market presence[8] - The company is advancing multiple grant-funded programs, including DARE-HPV, DARE-LARC1, and DARE-NHC, with significant funding received in 2025[8] - Daré is focused on creating value for shareholders through a disciplined, multi-pronged strategy that includes both clinical innovation and near-term commercial solutions[7] Upcoming Events - The company is preparing for a webinar on November 17, 2025, to discuss clinical data related to DARE to PLAY™ Sildenafil Cream[2]

DARE to PLAY™ Sildenafil Cream on Track to Launch Before Year End via 503B Pathway, Paving the Way for Near-Term Product RevenuePositive Interim DSMB Outcome for Ovaprene® Phase 3 Study Supports Continued EnrollmentMultiple Grant-Funded Programs Advance, Including to Address HPV and Long-Acting as well as Non-Hormonal ContraceptionFour Commercially Available Solutions for Women Expected Over the Next Two Years In addition to DARE to PLAY™ Sildenafil Cream, Commercialization of DARE to RESTORE™ Vaginal Probi ...

Core Insights - Daré Bioscience is hosting a webinar on November 17, 2025, to discuss its innovative product DARE to PLAY™, a topical sildenafil cream designed specifically for women [1][2] - DARE to PLAY™ is the first evidence-backed sildenafil cream for women, showing increased genital blood flow within 10 to 15 minutes of application and improvements in arousal sensations [2][3] - The product is expected to be commercially available through a 503B outsourcing facility by the end of 2025, marking a significant advancement in women's sexual health solutions [2][3] Company Overview - Daré Bioscience focuses on addressing gaps in women's health through science-based solutions, with a commitment to rigorous clinical research and development [4][5] - The company aims to provide credible, evidence-based therapies for various women's health issues, including sexual health, menopause, and fertility [4][5] - Daré is a female-led organization recognized for its contributions to innovation and advocacy in women's health, with leadership acknowledged in industry publications [6] Product Details - DARE to PLAY™ is a unique formulation that enhances genital blood flow and arousal response, supported by FDA-reviewed clinical data [2][3] - The product's anticipated launch will be the first time a topical sildenafil formulation manufactured under cGMP requirements is available to healthcare providers [2][3] - The webinar will feature expert clinicians discussing the product's benefits and clinical data, providing an opportunity for participants to join a product alert list [3]

Core Insights - Daré Bioscience, Inc. is focused on addressing women's health issues by bridging the gap between scientific advancements and practical solutions [3][4] - The company will host a conference call on November 13, 2025, to discuss its financial results for Q3 2025 and provide updates [1] Company Overview - Daré Bioscience is dedicated to developing innovative solutions in women's health, including areas such as contraception, menopause, pelvic pain, fertility, vaginal health, and infectious diseases [3] - The company emphasizes the importance of rigorous scientific research and clinical validation in its product development [4] Industry Context - Historically, women's health innovations have been underfunded and delayed, with many women advised to "wait it out" regarding health issues [4] - There is a growing awareness and conversation around women's health topics, but access to evidence-based solutions remains insufficient [4] Leadership and Recognition - Daré Bioscience's leadership has received accolades for their contributions to women's health innovation, including recognition on Medicine Maker's Power List and Endpoints News' Women in Biopharma [5] - The CEO has been honored as one of Fierce Pharma's Most Influential People in Biopharma [5]