Daré Bioscience, Inc. (DARE): History, Ownership, Mission, How It Works & Makes Money

Daré Bioscience, Inc. (DARE): History, Ownership, Mission, How It Works & Makes Money

US | Healthcare | Biotechnology | NASDAQ

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How does Daré Bioscience, Inc. (DARE), a company singularly focused on women's health, manage to advance a deep pipeline while navigating the challenging biotech funding landscape?

You need to look closely at their dual-path strategy: they are on track to launch DARE to PLAY™ Sildenafil Cream for initial prescription fulfillment in December 2025, which is a near-term revenue generator.

Plus, their clinical progress, like the positive interim recommendation for the Ovaprene® Phase 3 study, is defintely de-risked by significant non-dilutive funding, including $10 million in grant installments received in 2025 alone for programs like DARE-LARC1.

Understanding this mix of commercialization and grant-funded research is key to valuing this unique player in a market hungry for innovation.

Daré Bioscience, Inc. (DARE) History

Daré Bioscience, Inc. is a biopharmaceutical company focused solely on women's health, a mission that took definitive shape after a pivotal corporate restructuring in 2017. The company's story is one of an initial corporate entity being repurposed to accelerate a diverse portfolio of differentiated therapies, moving from a pure research and development (R&D) model to a dual-path commercial strategy in 2025.

You're looking for the foundational data to understand the context of their current pipeline and financial moves, so let's cut straight to the origin and the numbers.

Given Company's Founding Timeline

Year established

The original Delaware corporation, Daré Bioscience, Inc., was formed on November 28, 2005.

Original location

San Diego, California, United States.

Founding team members

The company was founded by Sabrina Martucci Johnson, who serves as the President and Chief Executive Officer.

Initial capital/funding

The initial capital for the 2005 entity is undisclosed, but the first significant funding event was a Series A round in July 2017, which coincided with the corporate restructuring that brought the current women's health focus. The company has since relied heavily on non-dilutive capital, receiving approximately $37.8 million in total grant funding to date, with a potential commitment of up to $49 million for programs like DARE-LARC1.

Given Company's Evolution Milestones

Year Key Event Significance
2017 Business Combination with Cerulean Pharma Transformed the company into a publicly traded entity focused exclusively on women's health; secured initial product candidates.
2017 Licensed Ovaprene® Acquired the U.S. commercial rights to a novel, hormone-free monthly contraceptive, establishing a key Phase 3 asset.
2018 Licensed Sildenafil Cream, 3.6% Acquired the topical formulation of sildenafil (now DARE to PLAY™) for female sexual arousal disorder.
2021 FDA Approval of XACIATO™ Received FDA approval on December 7, 2021, for XACIATO (clindamycin phosphate) vaginal gel 2% for bacterial vaginosis, marking the company's first approved product.
2025 (Q3) Reported $23.1 million Cash and Working Capital of $3.8 million Demonstrated a strengthened balance sheet and improved liquidity, enabling the new commercial strategy.
2025 (Q4 Target) Launch of DARE to PLAY™ Sildenafil Cream Pivotal moment for the new dual-path strategy, targeting initial prescription fulfillment in December 2025 via a 503B compounding facility to generate near-term revenue.

Given Company's Transformative Moments

The most transformative decision for Daré Bioscience, Inc. was the adoption of a 'dual-path strategy' in 2025. This move acknowledged the long, costly timeline of traditional FDA-only development and pivoted to a more immediate revenue model.

This strategy is defintely a game-changer for a clinical-stage biotech.

  • The Reverse Merger and Focus Shift (2017): The business combination with Cerulean Pharma in July 2017 was the corporate reset. It provided a public listing and a clear, singular focus on women's health, moving away from the previous entity's broader, less-defined mandate.
  • Securing Non-Dilutive Capital: The consistent success in securing large, non-dilutive grants, totaling approximately $37.8 million to date, has been crucial. This funding, often from organizations like the NIH and the Bill & Melinda Gates Foundation, de-risks R&D for programs like DARE-LARC1, which is a preclinical long-acting reversible contraceptive.
  • The 503B Commercialization Pivot (2025): The decision to commercialize proprietary formulations like DARE to PLAY™ Sildenafil Cream through the 503B outsourcing facility pathway is the near-term revenue engine. This approach allows for rapid market access in select states by December 2025, bypassing the lengthy 505(b)(2) FDA approval process for certain formulations while still pursuing full FDA approval for long-term value. This dual approach is designed to create a path to profitability while advancing the clinical pipeline.

For a deeper dive into who is backing this new strategy, you should read Exploring Daré Bioscience, Inc. (DARE) Investor Profile: Who's Buying and Why?

Daré Bioscience, Inc. (DARE) Ownership Structure

Daré Bioscience, Inc.'s ownership structure is heavily concentrated among institutional and strategic venture capital (VC) investors, which is typical for a clinical-stage biopharmaceutical company focused on women's health. This concentration means a small group of large stakeholders holds significant influence over the company's long-term strategy and governance.

Daré Bioscience, Inc.'s Current Status

Daré Bioscience, Inc. is a publicly traded company, listed on the NASDAQ Capital Market under the ticker symbol DARE. As of November 2025, the stock price was approximately $1.94 per share, reflecting a significant decline of 56.01% from its price one year prior. The company has been navigating compliance with Nasdaq's listing rules, specifically the requirement for a minimum stockholders' equity of $2.5 million or a market value of listed securities of $35.0 million.

The company is currently executing a dual-path strategy to generate revenue, including the commercialization of proprietary formulations through a 503B compounding pathway while simultaneously pursuing traditional FDA approvals for its pipeline.

Daré Bioscience, Inc.'s Ownership Breakdown

The ownership breakdown reflects a high level of control by professional investors and insiders, with a relatively small portion held by the general public. This structure aligns the interests of the largest shareholders, who are often focused on the long-term clinical development milestones, with the company's mission to deliver differentiated therapies for women. For a deeper dive into their goals, see Mission Statement, Vision, & Core Values of Daré Bioscience, Inc. (DARE).

Shareholder Type Ownership, % Notes
Institutional Investors (Funds) 10.12% Includes major funds like Vanguard Group Inc., State Street Corp, and BlackRock, Inc.
Individuals (Retail) 1.59% Represents the portion held by the general public and smaller individual investors.
Major Strategic/Venture Capital Holders & Other 88.02% This large category includes significant stakes held by early-stage investors and venture capital firms like Polaris Venture Management and Venrock Associates, who are often classified as insiders due to their influence.

Daré Bioscience, Inc.'s Leadership

The company is steered by a management team with extensive experience in the biopharmaceutical sector, particularly in women's health and corporate finance. Their average management tenure is approximately 9 years, suggesting a stable and experienced leadership core.

  • Sabrina Martucci Johnson: Chief Executive Officer (CEO), President, Principal Financial Officer, and Director. Ms. Johnson's total compensation for 2024 was approximately $898.38K, with a base salary component of $495.00K.
  • William H. Rastetter, Ph.D.: Independent Chairman of the Board.
  • MarDee Haring-Layton: Chief Accounting Officer.
  • Mark Walters: Vice President of Operations.
  • David Friend: Chief Scientific Officer.

This leadership, defintely female-led in the CEO role, has been recognized for its contributions to women's health innovation, which is a key part of the company's strategy as it moves toward commercialization of products like Sildenafil Cream and Ovaprene.

Daré Bioscience, Inc. (DARE) Mission and Values

Daré Bioscience is fundamentally a purpose-driven health biotech company, focused entirely on correcting the historical underfunding and neglect of women's health by prioritizing evidence-based scientific solutions and responsible commercialization. Their cultural DNA is built on challenging the status quo to deliver real-world impact for women's unmet medical needs.

If you are looking to dig deeper into the company's financial stability and execution of this mission, you can find a full breakdown here: Breaking Down Daré Bioscience, Inc. (DARE) Financial Health: Key Insights for Investors.

Daré Bioscience's Core Purpose

The company's core purpose goes beyond just developing drugs; it's about a systemic change in how women's health is approached and funded. They operate on the belief that innovation should be efficient and fiscally responsible, which is why they often look to repurpose or reformulate existing, clinically-validated active ingredients.

Official Mission Statement

The mission is centered on making women's health a priority and closing the significant gap between promising science and real-world solutions. It's a clear mandate to move past the decades of unmet needs in areas like contraception, sexual health, and menopause.

  • Challenge the status quo, making women's health a priority.
  • Bring innovative, evidence-based solutions to market as soon as practicable.
  • Address decades of unmet needs in contraception, sexual health, pelvic pain, fertility, and menopause.
  • Optimize access for women in a fiscally responsible manner.

That last point is key: they're not just chasing the next blockbuster drug, but practical, accessible solutions.

Vision Statement

The vision outlines the dual-track strategy to achieve their mission, focusing on both scientific integrity and speed to market. This is where the rubber meets the road for investors.

  • Meet the increasing demand for evidence-based treatments.
  • Combine uncompromising scientific rigor with rapid, responsible commercialization.

This vision is being executed right now through their dual-path strategy, which includes pursuing FDA approval while also using the 503B compounding pathway for products like DARE to PLAY™ Sildenafil Cream, which is on track for initial prescription fulfillment in December 2025.

Daré Bioscience Slogan/Tagline

While an official, short tagline isn't used in their corporate communications, the most consistent phrase that captures their ethos is their core purpose, which they use in nearly every corporate update:

  • Closing the gap in women's health between promising science and real-world solutions.

This commitment is backed by substantial non-dilutive funding, which helps de-risk their pipeline. For example, they received $10 million in grant installments in July and October 2025, with another $3.6 million anticipated in November 2025, specifically for advancing programs in HPV and long-acting contraception. This grant support is a defintely strong signal of external validation for their purpose-driven science.

Daré Bioscience, Inc. (DARE) How It Works

Daré Bioscience, Inc. operates by executing a dual-path strategy: generating near-term product revenue through accelerated commercialization via the 503B compounding pathway while simultaneously advancing a deep pipeline of innovative women's health therapeutics toward long-term FDA approval.

This model allows the company to address decades of unmet needs across contraception, sexual health, and menopause, using science-backed solutions that are often first-in-category, like its hormone-free contraceptive candidate. Honestly, it's a smart pivot from pure research and development (R&D) to a revenue-generating commercial entity.

Given Company's Product/Service Portfolio

Product/Service Target Market Key Features
DARE to PLAY™ Sildenafil Cream Women with Female Sexual Arousal Disorder (FSAD) Proprietary topical cream formulation of Sildenafil; near-term prescription availability via 503B compounding in December 2025.
Ovaprene® Women seeking a hormone-free, monthly contraceptive Novel, investigational, hormone-free intravaginal ring; currently in a pivotal Phase 3 clinical trial with a positive interim DSMB recommendation as of July 2025.
DARE to RESTORE™ Vaginal Probiotics Consumers focused on vaginal microbiome health Non-prescription consumer health product line; designed to support a healthy vaginal microbiome; targeted to launch in the first quarter of 2026.

Given Company's Operational Framework

The company's operational framework is built on a capital-efficient, multi-pronged value creation strategy that minimizes the time to market for proprietary formulations and leverages non-dilutive funding for its most innovative pipeline assets.

Here's the quick math on their current financial footing: as of September 30, 2025, Daré had approximately $23.1 million in cash and cash equivalents, plus a working capital of about $3.8 million. This is a defintely stronger position than earlier in the year, and it supports the shift to commercial operations.

  • Dual-Path Commercialization: Daré uses the Section 503B compounding pathway to bring select proprietary products, like DARE to PLAY™ Sildenafil Cream, to market quickly via prescription, bypassing the lengthy traditional FDA approval process to generate revenue starting in Q4 2025. This allows for market access while the company continues to pursue full FDA approval for long-term value.
  • Non-Dilutive R&D Funding: A significant portion of the pipeline is funded by grants. For example, the company received recent grant installments totaling $10 million and anticipates another $3.6 million installment in November 2025 to advance programs like DARE-HPV and DARE-LARC1. This reliance on grants drove R&D expenses down to just $1.2 million in Q3 2025.
  • Strategic Partnerships: Daré partners with larger entities for commercialization and development, such as the global license agreement with Organon for the FDA-approved XACIATO™ (clindamycin phosphate) vaginal gel 2% and the commercialization collaboration with Bayer for Ovaprene®.

If you're interested in the capital structure supporting this, you should be Exploring Daré Bioscience, Inc. (DARE) Investor Profile: Who's Buying and Why?

Given Company's Strategic Advantages

Daré's competitive edge isn't just in its products; it's in its ability to operate nimbly in a historically underserved market, which creates a significant first-mover advantage for novel delivery systems.

  • First-in-Category Focus: The pipeline targets areas with decades of unmet need, such as the hormone-free monthly contraceptive Ovaprene® and a topical treatment for female sexual arousal disorder, positioning them as potential market leaders in new segments.
  • Accelerated Market Access (503B Compounding): Leveraging the 503B pathway is a critical advantage, enabling the company to generate its first product revenue in Q4 2025 with DARE to PLAY™ Sildenafil Cream, which provides capital and market feedback ahead of competitors pursuing only the traditional FDA route.
  • Pipeline Breadth in Women's Health: The company has multiple shots on goal across key therapeutic areas-contraception, sexual health, and menopause-including DARE to RECLAIM™ (DARE-HRT1), which targets the estimated $4.5 billion compounded hormone therapy market.
  • Non-Dilutive Funding Expertise: Securing substantial non-dilutive grants from organizations like the NIH and foundations for programs like DARE-HPV and DARE-LARC1 significantly de-risks the R&D process and preserves shareholder capital.

Daré Bioscience, Inc. (DARE) How It Makes Money

Daré Bioscience, Inc. (DARE) currently generates its minimal revenue primarily through legacy royalty agreements, but its financial engine is in a critical transition, shifting to product sales from its emerging women's health portfolio and significant non-dilutive grant funding.

The company is executing a dual-path commercialization strategy to bring proprietary solutions to market quickly, aiming to generate initial product revenue from DARE to PLAY™ Sildenafil Cream via the 503B compounding pathway starting in December 2025, which will fundamentally change its revenue composition.

Daré Bioscience's Revenue Breakdown

As of the third quarter of 2025, Daré Bioscience's revenue is almost entirely from a single, legacy stream. This is typical for a biopharmaceutical company in the late-stage development phase, but it's a volatile stream. In Q3 2025, total revenue was only $2,262.

Revenue Stream % of Total (Q3 2025) Growth Trend
Royalty Revenue 100% Decreasing
Product Sales (DARE to PLAY™) 0% Increasing (Targeting Dec 2025 Launch)

The Q3 2025 revenue of $2,262 was a sharp decline of 94.6% from the $41,691 reported in Q3 2024. This volatility highlights why the company's focus is now on commercializing its pipeline. The real story here is the imminent shift to Product Sales, starting with DARE to PLAY™ Sildenafil Cream, which is on track for initial prescription fulfillment in December 2025.

Business Economics

You're looking at a development-stage biotech company that is actively building its commercial foundation. The core economic strategy is to de-risk and accelerate product launches using a dual-path approach: 503B compounding for near-term revenue and traditional FDA approval for long-term, high-margin value.

  • 503B Compounding Path: This strategy allows Daré to get products like DARE to PLAY™ Sildenafil Cream and the future DARE to RECLAIM™ Monthly Hormone Therapy to market faster than the full FDA New Drug Application (NDA) process. This means a quicker path to product revenue, which is critical for a company still posting net losses.
  • Grant Funding as Non-Dilutive Capital: Daré significantly offsets its Research & Development (R&D) costs with non-dilutive funding, meaning they get cash without issuing more stock. They received recent grant installments totaling $10 million for programs like DARE-LARC1 (long-acting contraception) and DARE-HPV. This is a massive economic advantage, directly reducing the cash burn from R&D expenses, which were only $1.2 million in Q3 2025, a 56% decrease year-over-year.
  • Targeting Large, Underserved Markets: The company is positioning DARE to RECLAIM™ to enter the compounded hormone therapy market, which is estimated to be up to $4.5 billion. This is a clear indicator of the potential for high-volume, high-value product sales once these solutions are fully commercialized.

The immediate economic goal is to validate the 503B compounding model with DARE to PLAY™ and then scale up with DARE to RECLAIM™ and non-prescription consumer products like DARE to RESTORE™ Vaginal Probiotics, which is targeted for Q1 2026. That's the quick math on how they plan to turn the corner.

Daré Bioscience's Financial Performance

As of the most recent reporting period (Q3 2025), Daré Bioscience shows the financial profile of a company aggressively investing in commercialization while managing its cash position tightly.

  • Net Loss: The company reported a net loss of $3.56 million for Q3 2025, which is an improvement from the net loss of $4.70 million in Q3 2024. While still a loss, the narrowing of the loss by about 24.2% year-over-year is a positive sign of expense management and pipeline progress.
  • Cash Position and Runway: Daré reported a cash and cash equivalents balance of approximately $23.1 million as of September 30, 2025. This cash balance is crucial, as it funds the continued Phase 3 study of Ovaprene® and the commercial launch of DARE to PLAY™ Sildenafil Cream.
  • Expense Trends: General and Administrative (G&A) expenses increased to $2.5 million in Q3 2025, up from $2.0 million in Q3 2024. This increase is a necessary, deliberate investment in commercial-readiness and professional services ahead of the December 2025 product launch, which is defintely a good use of capital. Meanwhile, R&D expenses dropped significantly to $1.2 million in Q3 2025, thanks to the non-dilutive grant funding offsetting costs.

The financial picture is one of controlled burn, strategically moving capital from R&D (offset by grants) to G&A (for commercial launch). The entire financial health of the business hinges on the successful execution and revenue generation from the December 2025 launch of DARE to PLAY™ Sildenafil Cream. For a deeper dive into who is betting on this transition, consider Exploring Daré Bioscience, Inc. (DARE) Investor Profile: Who's Buying and Why?

Daré Bioscience, Inc. (DARE) Market Position & Future Outlook

Daré Bioscience is positioned at a critical inflection point, transitioning from a pure-play research and development (R&D) entity to a commercial-stage company by the close of 2025, a move designed to unlock both near-term revenue and long-term value. This dual-path strategy, leveraging the 503B compounding pathway for rapid market entry while simultaneously pursuing full Food and Drug Administration (FDA) approvals, is key to capturing a larger piece of the $200+ billion women's health market.

The company's strategic focus on addressing decades of unmet needs in contraception, sexual health, and menopause positions it for a projected revenue growth of 64.3% per year, according to analyst forecasts, with an expectation of becoming profitable within the next three years.

Competitive Landscape

Daré Bioscience operates in a highly fragmented but rapidly growing women's health market, competing against both major pharmaceutical giants and smaller, focused biotechs. Its competitive advantage lies in developing first-in-category products like DARE to PLAY™ Sildenafil Cream and the investigational Ovaprene®, which target specific gaps in care-a strategy that bypasses direct, head-to-head competition with the market leaders in their established product lines. The table below illustrates the scale of the established players in the therapeutic areas Daré is entering.

Company Market Share, % Key Advantage
Daré Bioscience <0.1% (Initial Entry) Dual-Path Strategy (503B & FDA), Non-Hormonal/Topical Innovation
Bayer AG 18% (Compound Contraceptives) Global Dominance in Hormonal Contraceptives (e.g., IUDs, Pills), Extensive Distribution
Pfizer Inc. 12.5% (Global HRT Market) Established Brand Recognition (e.g., Premarin), Broad HRT Portfolio

Opportunities & Challenges

You should view Daré's immediate future through the lens of execution risk versus market opportunity. The launch of DARE to PLAY™ Sildenafil Cream in December 2025 is the first real test of its commercial model, and success here provides the financial runway for the rest of the pipeline. The non-dilutive grant funding is a defintely a huge advantage.

Opportunities Risks
Near-term revenue from DARE to PLAY™ Sildenafil Cream launch in Q4 2025 via 503B compounding pathway. Significant working capital deficit of $12.6 million as of June 30, 2025, requiring continued financing.
Targeting the estimated $4.5 billion compounded hormone therapy market with DARE to RECLAIM™ (targeted early 2027). Regulatory risk and uncertainty regarding long-term reimbursement for products commercialized solely through the 503B compounding pathway.
Non-dilutive funding from NIH and ARPA-H, including a $4 million grant installment received in October 2025 for DARE-LARC1. Clinical trial risk, particularly the pivotal Phase 3 study for Ovaprene®, where a negative outcome would jeopardize the $330 million milestone payment opportunity from Bayer.

Industry Position

Daré Bioscience is establishing itself as a specialized innovation engine within the women's health sector, focusing on novel delivery systems and non-hormonal options where large pharma has historically underinvested. Its position is less about market share right now and more about pipeline differentiation.

  • Contraception: Ovaprene® is a first-in-category, investigational hormone-free monthly intravaginal contraceptive, offering a distinct alternative to the hormonal pills and IUDs that dominate the $10.57 billion contraceptive market.
  • Sexual Health: The December 2025 launch of DARE to PLAY™ Sildenafil Cream positions the company to be the first to offer an evidence-backed, topical sildenafil formulation specifically for women's sexual arousal disorder.
  • Financial Efficiency: The company's Q3 2025 R&D expenses dropped to $1.2 million, a 56% decrease year-over-year, largely due to leveraging non-dilutive grant funding, which is a sign of fiscal discipline in a high-cost industry.

The strategic use of the 503B compounding route for DARE to PLAY™ and DARE to RECLAIM™ is a smart, tactical maneuver to generate early cash flow while the company pursues the much slower, more valuable FDA approval path for its core assets. This is a classic biotech move to bridge the funding gap between R&D and major commercialization. For a deeper dive into the capital structure supporting this strategy, you should read Exploring Daré Bioscience, Inc. (DARE) Investor Profile: Who's Buying and Why?

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