Daré Bioscience, Inc. (DARE): PESTLE Analysis [Nov-2025 Updated]

You're holding the Daré Bioscience, Inc. (DARE) file, trying to reconcile a massive market opportunity in women's health with the company's tight financial reality. The external environment in 2025 is a high-stakes game: we see immense sociological demand for non-hormonal options like Ovaprene and technological advancements in drug delivery, but this growth is being choked by high interest rates and a projected cash burn of around $35 million for the fiscal year. We need to understand exactly how shifting US reproductive health policies and strict FDA requirements will impact the commercial rollout of XACIATO and the financing needed to keep the pipeline moving. Let's cut through the noise and map the real-world political, economic, and technological forces that will defintely determine DARE's next move.

Daré Bioscience, Inc. (DARE) - PESTLE Analysis: Political factors

Shifting US federal and state reproductive health policies create market uncertainty.

The political landscape for reproductive health products, which is Daré Bioscience's entire focus, has been extremely volatile, but a major federal shift in 2025 has provided some clarity. The reported passage of the Reproductive Rights Protection Act (RRPA) in March 2025, if upheld, establishes a federal right to abortion up to fetal viability and, crucially for Daré Bioscience, explicitly protects access to contraception. This federal preemption over state laws should reduce the market fragmentation and legal risk for products like the investigational hormone-free contraceptive, Ovaprene® (currently in Phase 3) and DARE-LARC1, a long-acting contraceptive in preclinical development.

Still, the market is not defintely settled. The US Supreme Court is expected to review the RRPA's constitutionality within the next two years, keeping the long-term policy environment uncertain. Before the RRPA, the post-Dobbs environment saw 13 states enact total abortion bans and 28 states pass strict gestational age limits, which created a highly fragmented and risky market for any company in the reproductive health space. For a company with a pipeline heavily focused on contraception and sexual health, that kind of policy whiplash makes commercial planning a nightmare.

Increased political scrutiny on drug pricing and healthcare access impacts commercial strategy.

The political pressure to lower prescription drug costs intensified in 2025 under the new administration. In May 2025, the administration issued the Most-Favored-Nation (MFN) Prescription Drug Pricing Executive Order, which aims to force manufacturers of single-source, branded drugs to align US prices with the lowest price in certain developed countries. This is a direct threat to the high-margin model of novel therapeutics.

To be fair, Daré Bioscience is navigating this scrutiny by using a dual-path commercial strategy. They are targeting near-term revenue by commercializing DARE to PLAY™ Sildenafil Cream and DARE to RECLAIM™ Monthly Hormone Therapy via the 503B compounding pathway, which is a different regulatory and pricing channel than a full FDA-approved New Drug Application (NDA). This strategy allows them to enter the estimated $4.5 billion compounded hormone therapy market while bypassing some of the immediate political heat on branded drug prices.

Government funding priorities for women's health research (e.g., NIH) influence early-stage development.

Federal funding is a critical, non-dilutive capital source for Daré Bioscience's early-stage pipeline. The political push for women's health research is strong, but the funding execution is mixed.

• The President's FY2025 budget request for the NIH Office of Women's Health research was a significant $154 million, a $76 million increase over the FY2024 enacted level.
• However, the House Appropriations Committee's Labor-HHS bill proposed a lower allocation of $100 million for the NIH Office of Research on Women's Health, which is $54 million below the request.
• Plus, the HHS is defunding the regional centers of the long-running Women's Health Initiative (WHI) by September 2025, which signals a cut to foundational women's health studies.

Daré Bioscience is actively benefiting from this priority, which is a huge plus. The company's R&D expenses for Q3 2025 were only $1.2 million, a 56% decrease year-over-year, largely because of non-dilutive funding awards offsetting costs. They received grant installments totaling $10 million in 2025 for DARE-LARC1, and expect a further $3.6 million installment in November 2025 for other programs like DARE-NHC. This non-dilutive capital is defintely a key component of their balance sheet, which showed $23.1 million in cash as of September 30, 2025.

FDA leadership changes and resource allocation affect the speed of novel drug approvals.

The Food and Drug Administration (FDA) is experiencing significant internal turmoil and a push for rapid, politically-driven change in late 2025, which creates both a risk and an opportunity for a biotech like Daré Bioscience. Commissioner Marty Makary is championing initiatives like 'Operation Stork Speed' to accelerate drug decisions, potentially by reducing the required evidence to a single study. This could speed up approval for their pipeline candidates like Ovaprene®.

The new Commissioner's National Priority Voucher (CNPV) program, launched in June 2025, is a major factor, offering an ultra-accelerated 30- to 60-day review for therapies that meet national priorities, such as unmet medical needs and affordability. This is a huge opportunity for a women's health company. But, the internal conflict between Makary and the new top drug regulator, Richard Pazdur, over the legality and pace of these expedited programs creates regulatory uncertainty. Daré Bioscience is already in critical regulatory dialogue, with ongoing discussions with the FDA regarding endpoint assessment for the Phase 3 clinical studies of Sildenafil Cream, 3.6%. The lack of a stable, unified FDA policy makes predicting approval timelines much harder.

Next Step: Regulatory Affairs: Draft a memo by end of next week outlining how Ovaprene® and Sildenafil Cream, 3.6% could qualify for the new CNPV program, focusing on the unmet medical need and affordability criteria.

Daré Bioscience, Inc. (DARE) - PESTLE Analysis: Economic factors

The economic environment in late 2025 presents a mixed financial picture for Daré Bioscience, Inc., marked by easing capital costs but persistent challenges in payer access and consumer affordability. Your primary focus must be on managing the cash runway and aggressively navigating the complex reimbursement landscape to realize net revenue from XACIATO and the upcoming DARE to PLAY™ Sildenafil Cream launch.

High interest rates in 2025 increase the cost of capital for clinical trials and commercialization.

While the first half of 2025 was constrained by the residual high-rate environment, the Federal Reserve's shift toward monetary easing has begun to lower the cost of capital (Weighted Average Cost of Capital, or WACC) for the biotech sector. This is a net positive, but it follows a period where high rates slowed venture capital and IPO activity, forcing companies like Daré Bioscience to rely heavily on non-dilutive funding and At-The-Market (ATM) equity raises. The projected median federal funds rate of 3.9%-4.4% for 2025, as per mid-year projections, is a tailwind, making future debt financing and discounted cash flow (DCF) valuations more favorable. Still, the cost of capital remains materially higher than the zero-interest rate period, meaning every dollar of R&D and commercialization spend must be ruthlessly efficient.

Here's the quick math on the R&D side: Lower interest rates reduce the discount rate applied to the long-duration cash flows of pipeline assets like Ovaprene®, effectively increasing their present value and making them more attractive to a potential partner or acquirer. It's an indirect, but defintely powerful, valuation boost.

Reimbursement decisions by major payers for new products like XACIATO affect net revenue realization.

The economic value of Daré Bioscience's first FDA-approved product, XACIATO (clindamycin phosphate) vaginal gel 2%, is heavily dependent on favorable payer coverage, which remains highly restrictive in 2025. XACIATO is licensed to Organon, who is responsible for commercialization, but the reimbursement terms directly dictate the double-digit royalties Daré Bioscience is eligible to receive on net sales. The key economic challenge is the prevalence of Prior Authorization (PA) and Step Therapy requirements imposed by major commercial payers.

For example, major commercial plans, including Blue Cross Blue Shield of Louisiana, require patients to have tried and failed a minimum of two generic agents (e.g., generic metronidazole) for the current infection before XACIATO is eligible for coverage. Furthermore, Medicare Part D plans generally do not cover XACIATO, limiting access for the elderly population, though the drug is indicated for females as young as 12 years old. The financial impact of these restrictions is a lower net realized price and a smaller addressable patient population, directly reducing Daré Bioscience's potential royalty stream. The one bright spot is that some state Medicaid programs, such as Texas Medicaid, have listed XACIATO as covered with an effective date of April 24, 2025, and no PA required on their Preferred Drug List, which is critical for a women's health product that addresses a common infection in the reproductive-age demographic.

Global economic slowdown could limit consumer out-of-pocket spending on elective treatments.

Daré Bioscience's dual-path strategy, which includes launching non-FDA approved, compounded products like DARE to PLAY™ Sildenafil Cream via the 503B compounding pathway, exposes the company to significant consumer price sensitivity. These products are often considered elective or lifestyle treatments, making them highly vulnerable to economic headwinds. The general US healthcare affordability crisis in 2025 exacerbates this risk.

• A recent poll indicates that 47 percent of Americans are concerned about affording healthcare next year.
• Approximately one in five Americans reported not being able to pay for a prescription in the last three months of the year.
• The new federal budget law enacted in July 2025 includes over $900 billion in cuts to Medicaid, which threatens to strip coverage from millions of women of reproductive age, the target market for many of Daré Bioscience's products.

This environment means that even with a successful launch of DARE to PLAY™ Sildenafil Cream in December 2025, the uptake will be constrained by the consumer's ability to pay the out-of-pocket cost, especially since compounded drugs are frequently not covered by commercial insurance. The company's revenue from these products will be highly sensitive to the unemployment rate and discretionary income levels.

The company's cash burn rate, projected at around $35 million for FY 2025, requires continuous financing.

As a development-stage biotech, Daré Bioscience continues to operate at a net loss, requiring continuous capital raises to fund its pipeline. The company's net loss for the first nine months of 2025 was $11.96 million. This nine-month figure is a more accurate measure of the cash burn from operations than an older full-year projection. The cash position as of September 30, 2025, was approximately $23.1 million in cash and cash equivalents.

Here is a breakdown of the Q3 2025 operational expenses, which form the core of the burn rate:

Based on the Q3 operational burn rate of $3.7 million, the company's existing cash reserves provide a runway that extends well into 2026, assuming no major unforeseen clinical costs or significant changes to grant funding. However, the company must execute on its planned commercial launches (DARE to PLAY™ in Q4 2025) to start generating product revenue and reduce its reliance on equity financing, which is the clear next step for the finance team.

Daré Bioscience, Inc. (DARE) - PESTLE Analysis: Social factors

Growing patient demand for non-oral and non-hormonal contraceptive options (e.g., Ovaprene)

You are seeing a clear, accelerating shift in patient preferences away from systemic hormonal contraception. Honestly, women are tired of the side effects, so they are actively looking for alternatives. Daré Bioscience's investigational monthly, hormone-free intravaginal contraceptive, Ovaprene, is positioned perfectly to capture this demand, as there are currently no FDA-approved, hormone-free, monthly intravaginal contraceptives on the market.

The interim Phase 3 results from July 2025 support this potential, showing a pregnancy rate of approximately 9% (Pearl Index) among treated women. Here's the quick math on why that's a game-changer: that 9% rate is significantly better than the typical-use failure rates for non-hormonal barrier methods like the male condom (13 pregnancies per 100 women) and the diaphragm (17 pregnancies per 100 women), according to FDA data. The goal is a long-acting, hormone-free option, and this product defintely addresses a substantial unmet need.

Increased public awareness and advocacy for neglected women's health conditions, driving diagnosis

The cultural narrative around women's health has changed dramatically, moving from quiet acceptance to aggressive self-advocacy. This is a massive tailwind for Daré Bioscience, which focuses on neglected conditions. We are seeing unprecedented investment, with the Department of Defense committing $500 million per year to women's health research. Venture capital is also pouring in; 2024 saw a new high of $2.6 billion in women's health investments.

Still, this rise in advocacy highlights persistent gaps in the traditional healthcare system. A February 2025 Ipsos poll revealed that 42% of American women are forgoing preventive care services, like annual check-ups, in the past year. The top barriers cited are affordability, with 22% of women unable to afford the out-of-pocket costs, and time constraints. What this estimate hides is that while awareness is high, access and affordability remain a challenge, meaning Daré's products must be priced and reimbursed strategically to truly capitalize on this advocacy-driven demand.

Cultural sensitivity and acceptance of novel gynecological delivery methods influence patient adoption rates

The success of any novel gynecological product hinges on patient tolerability and cultural acceptance, not just efficacy. This is a crucial social factor. While Ovaprene's efficacy is promising, the interim Phase 3 data showed that approximately 17% of participants discontinued the study due to vaginal odor. That is a high discontinuation rate for a non-serious adverse event, and it shows how a seemingly minor issue can become a major commercial hurdle for an intravaginal device.

To be fair, the overall tolerability was favorable, and those who completed the trial expressed a likely interest in using it if approved. However, this feedback loop-discontinuation due to odor-is a concrete example of how cultural sensitivity and the intimate nature of the delivery method directly influence patient adoption. Daré must address this specific issue before a full commercial launch to maximize market penetration.

Telehealth expansion is changing how women access prescriptions and health information

The digital transformation of healthcare is fundamentally altering the patient-provider relationship, especially for women. Telehealth is a critical access point. Adult women are adopting telemedicine at a higher rate than men; as of a 2021 comparison, 42.0% of adult women reported at least one telemedicine visit in the past year, compared with 31.7% of men. This trend is accelerating the growth of the Women's Health App Market, which is projected to grow from $4.7 billion in 2024 to $24.2 billion by 2034.

This shift creates a direct-to-consumer opportunity for Daré Bioscience. The company is already leveraging this trend with the planned Q4 2025 launch of DARE to PLAY™ Sildenafil Cream through a 503B compounding pathway, positioning it for near-term revenue generation and market access. This non-traditional route, combined with digital platforms, allows the company to bypass some traditional prescription bottlenecks, a definite advantage in a market where patients expect convenience.

Next Step: Marketing and Product Development: Prioritize a formulation adjustment or a co-packaged solution to mitigate the vaginal odor issue identified by the 17% discontinuation rate in the Ovaprene trial.

Daré Bioscience, Inc. (DARE) - PESTLE Analysis: Technological factors

The technological environment for Daré Bioscience is defined by its core competency in novel drug delivery systems for women's health, which is a strategic advantage. However, as a smaller biopharma company, it must also navigate the rapidly evolving fields of clinical trial technology and the intellectual property landscape against much larger competitors.

Advancements in drug delivery systems (e.g., intravaginal rings, gels) enhance pipeline potential.

Daré Bioscience's pipeline is heavily reliant on advanced, localized drug delivery technologies, which offer better patient compliance and reduced systemic side effects compared to oral treatments. The company's focus on intravaginal rings (IVRs) and proprietary creams/gels is a key technological differentiator.

The Ovaprene intravaginal ring, for example, is a non-hormonal, monthly contraceptive in a pivotal Phase 3 study. Another key asset is the DARE-HRT1 monthly bio-identical estradiol and progesterone IVR for menopausal symptoms, which is being developed for both the traditional FDA pathway and an accelerated commercial path via 503B compounding (a regulatory route for outsourced compounding facilities) with a target availability in early 2027. This dual-path strategy is a technological and regulatory maneuver to speed market access.

The most advanced platform is the Intelligent Drug Delivery System (DARE-IDDS), which is a preclinical-stage, long-acting reversible contraceptive (DARE-LARC1) that features wireless control and precision dosing. This technology is supported by substantial non-dilutive funding, with $10 million in grant installments received in July and October 2025 alone, and a total of $37.8 million received to date of a potential $49 million commitment.

Use of artificial intelligence (AI) and machine learning (ML) to accelerate clinical trial design and patient recruitment.

While Daré Bioscience's public statements in 2025 do not explicitly detail the use of proprietary AI/ML platforms, the broader pharmaceutical industry is rapidly adopting these tools. As a capital-efficient company, Daré must defintely consider how to integrate these technologies to offset its smaller R&D budget.

The industry trend for 2025 shows that AI/ML is being used for protocol simplification, site burden analysis, and patient-trial matching to accelerate recruitment. For instance, some AI systems are reported to reduce patient screening time by 42.6% while maintaining 87.3% accuracy in matching patients to trial criteria. The global AI-based clinical trials market reached an estimated $9.17 billion in 2025, indicating this is an essential technology for modern drug development.

Given Daré Bioscience's relatively modest research and development (R&D) expenses of $1.2 million in Q3 2025 (down from $2.7 million in Q3 2024, largely due to grant funding offsets), leveraging external AI/ML services for its Phase 3 trials (like Ovaprene) is a critical opportunity to maintain pace with larger, resource-rich competitors.

Patent protection for novel formulations and delivery technologies is critical for market exclusivity.

Patent protection is the bedrock of Daré Bioscience's valuation. The company's strategy centers on developing novel formulations of existing active ingredients, like Sildenafil Cream, 3.6%, and creating entirely new delivery platforms like the DARE-IDDS.

The risk lies in the fact that some of its candidates use active ingredients that are off-patent, meaning the company's exclusivity is tied solely to the novel formulation or delivery method. If a competitor can create a non-infringing, bioequivalent formulation, the market advantage is lost. Conversely, the in-licensing of US patents for Casea S, a biodegradable contraceptive implant, demonstrates a clear strategy to acquire and protect key intellectual property (IP) assets.

Competition from large pharmaceutical companies with established women's health portfolios and R&D budgets.

Daré Bioscience operates in a high-stakes environment where the competition possesses vastly superior financial firepower. This is the structural reality for a niche biopharma company.

To put this in perspective, Daré Bioscience reported R&D expenses of $1.2 million in Q3 2025. In contrast, a top-tier competitor like Merck & Co. reported R&D expenditure of $17.93 billion in 2024, and Johnson & Johnson reported $17.23 billion. This staggering difference means large pharma can pursue numerous therapeutic avenues and absorb clinical trial failures that would be catastrophic for a smaller entity.

Daré's strategy to mitigate this is through focused innovation, non-dilutive grant funding, and strategic partnerships, such as the license agreement with Bayer for Ovaprene. The women's health market is seeing a positive shift, with venture capital funding in the sector more than quadrupling since 2018, but the technological and financial gap remains immense.

The key competitive threats are:

• Large-scale R&D investment by companies with established women's health franchises.
• The ability of competitors to quickly acquire or develop rival drug delivery technologies.
• The risk of a large company developing a superior, first-in-class product that addresses the same unmet need.

Daré Bioscience, Inc. (DARE) - PESTLE Analysis: Legal factors

Strict US Food and Drug Administration (FDA) requirements for New Drug Applications (NDAs) and Premarket Approvals (PMAs).

The FDA's regulatory path is the single biggest legal hurdle for any biopharma company, and Daré Bioscience is defintely feeling the pressure. The process for a New Drug Application (NDA) or Premarket Approval (PMA) is lengthy, expensive, and subject to agency delays, which directly impacts time-to-market and cash runway.

You can see this risk play out in the development of Sildenafil Cream, 3.6%. Daré had to postpone the launch of its pivotal Phase 3 study after experiencing delays in receiving guidance from the FDA on the analysis plan in the first half of 2025. This forced a strategic pivot to the Section 503B compounding pathway for an earlier commercial launch of DARE to PLAY Sildenafil Cream, which is now targeted for initial prescription fulfillment in December 2025. This dual-path strategy is a practical response to the regulatory environment, but it highlights the legal risk of relying solely on the traditional, slow-moving FDA approval process.

The company's first FDA-approved product, XACIATO (clindamycin phosphate) vaginal gel, 2%, was approved in December 2021, but the path for its pipeline remains challenging. The difficulty of navigating the FDA's requirements is a key risk factor for the company's valuation, especially for Ovaprene, which is in a pivotal Phase 3 study (NCT06127199).

Intellectual property enforcement against generic competitors is vital for XACIATO and future products.

For a development-stage company, intellectual property (IP) is the core asset, and its legal defense is critical to securing future revenue. Daré Bioscience's primary source of near-term, long-term non-dilutive revenue is tied to the IP for XACIATO, which is licensed exclusively worldwide to Organon International GmbH.

The value of this IP is quantified by the potential milestone and royalty payments. As of 2025, Daré is eligible to receive up to $180.0 million in potential future commercial sales and regulatory milestones, plus tiered double-digit royalties based on net sales. Protecting the formulation and method-of-use patents for XACIATO against generic challenges is essential to realizing this revenue stream. Honestly, if the IP fails, that entire future value proposition collapses.

The legal framework for IP protection also extends to their pipeline: Daré received a royalty-free, exclusive license to the US patents for the Casea S biodegradable contraceptive implant in February 2025, demonstrating an active strategy to build a robust IP portfolio for future products.

Evolving global data privacy regulations (e.g., GDPR-like laws) impact clinical trial data management.

Clinical trials generate massive amounts of sensitive patient data, and the legal requirements for managing this data are becoming more complex and costly globally. While Daré Bioscience is a US-based company, its multi-center clinical trials, like the pivotal Phase 3 study for Ovaprene, often involve international sites or are subject to the standards of global partners, exposing them to regulations like the European Union's General Data Protection Regulation (GDPR) and similar emerging US state laws.

For the biopharmaceutical industry generally, strict data protection regulations impose significant compliance costs and can reduce the breadth of data available for R&D, which can impact the efficiency of drug development. Here's the quick math on the compliance burden:

Compliance is non-negotiable, and any misstep can lead to substantial fines, plus, it slows down the data analysis process needed for regulatory submissions.

Product liability and malpractice litigation risk inherent in the pharmaceutical sector.

The pharmaceutical sector, especially women's health, carries an inherent and significant risk of product liability and malpractice litigation, even for FDA-approved products like XACIATO or investigational products like Ovaprene. These lawsuits typically allege failure to warn, manufacturing defects, or design flaws leading to patient harm.

The risk is real and quantifiable in the industry. For example, in the broader women's health sector, the Depo-Provera product liability litigation had 435 actions pending as of July 1, 2025, demonstrating the scale of mass tort litigation in this therapeutic area. Furthermore, a significant portion of securities class action (SCA) lawsuits against life science companies in 2024-approximately 52%-involved alleged misrepresentations regarding product efficacy and safety, often preceding or following FDA interactions.

Daré Bioscience must maintain robust product liability insurance and rigorous pharmacovigilance (drug safety monitoring) programs to mitigate this exposure. The potential cost of a single major lawsuit could easily exceed the company's quarterly General and Administrative expenses of $2.5 million reported in Q3 2025, making this a major financial and legal risk.

• Maintain high insurance coverage for all commercial and clinical products.
• Ensure all product labeling and warnings are legally defensible.
• Monitor all adverse event reports globally with urgency.

Daré Bioscience, Inc. (DARE) - PESTLE Analysis: Environmental factors

You're looking for the environmental risks and opportunities for a company like Daré Bioscience, and the reality is that their environmental footprint is largely outsourced. As a clinical-stage biopharma with a virtual operating model, their direct impact is minimal, but their reliance on third-party manufacturers and clinical research organizations (CROs) shifts the environmental risk to their supply chain partners. This is the key area for investor scrutiny in 2025.

Finance: Track Q4 2025 XACIATO prescription numbers against consensus estimates by December 15th.

Sustainability of the drug supply chain, including sourcing of active pharmaceutical ingredients (APIs).

Daré Bioscience does not own or operate large-scale manufacturing facilities; they rely on contract manufacturing organizations (CMOs) and, for near-term commercialization of products like DARE to PLAY Sildenafil Cream, 503B compounding facilities (outsourcing facilities registered with the FDA that can produce large batches of compounded drugs without patient-specific prescriptions).

This virtual model means their direct environmental liability is low, but their supply chain risk is high. The production of Active Pharmaceutical Ingredients (APIs) is a known environmental hotspot in the pharmaceutical industry, often involving significant water use, hazardous waste, and energy consumption, particularly in non-US jurisdictions where many APIs are sourced.

Here's the quick math: Daré's Q3 2025 Research and Development (R&D) expenses were $1.2 million, a 56% decrease year-over-year, which reflects a focus on non-dilutive grant-funded programs and outsourced development. This tiny R&D budget relative to Big Pharma means they have little direct control over the environmental practices of their large-scale, third-party partners who are handling the actual manufacturing of their product candidates, such as Ovaprene.

The risk is in the lack of transparency from these third parties, which could lead to future regulatory or reputational issues for Daré Bioscience as ESG standards tighten.

Managing clinical trial waste and minimizing the environmental footprint of manufacturing processes.

Since Daré Bioscience outsources its clinical trials through CROs like Premier Research, and manufacturing to CMOs, the environmental burden of clinical trial waste (single-use plastics, biological samples, investigational medicinal product (IMP) destruction) and manufacturing waste falls directly on their partners.

While Daré Bioscience has not disclosed its own metrics for clinical trial waste or manufacturing process efficiency, they benefit from a key industry trend: Decentralized Clinical Trials (DCTs). DCTs, which use digital tools and remote patient monitoring, inherently reduce the carbon footprint associated with patient travel and physical site operations, which can account for a significant portion of a trial's greenhouse gas emissions.

Key Environmental Risk Hotspots in Daré's Outsourced Model:

• API Production: High energy and chemical use at CMOs.
• IMP Shipping: Logistics and cold chain transport of clinical trial materials.
• Waste Disposal: Managing the disposal of clinical and manufacturing waste by third parties.

Investor and public pressure for transparent reporting on environmental, social, and governance (ESG) metrics.

Daré Bioscience, as a smaller, growth-focused biotech, does not currently publish a formal, standalone ESG or Sustainability Report with detailed environmental metrics. This is a common gap for companies of their size but represents a growing risk.

The company's focus is clearly on the 'S' (Social) aspect of ESG, centered on women's health innovation, which is their core mission. However, institutional investors, including the large funds that may hold Daré stock, are increasingly using ESG ratings to screen investments. A lack of 'E' (Environmental) disclosures can negatively impact their rating, even if their direct footprint is small.

The only explicit environmental action noted in 2025 SEC filings is the use of a virtual Annual Meeting to reduce cost and environmental impact of proxy materials, which is a minor, non-operational disclosure.

The table below outlines the disclosure gap that is becoming a point of pressure:

Energy consumption and carbon emissions from research laboratories and corporate operations.

Daré Bioscience's corporate structure is lean; they do not operate major research laboratories or manufacturing plants. Their corporate operations are primarily administrative, located in San Diego.

This means their direct energy consumption and Scope 1 and 2 carbon emissions (from owned or controlled sources) are inherently low and immaterial to their overall business risk. The real environmental risk lies in their Scope 3 emissions (indirect emissions from the value chain), specifically from the manufacturing of their product candidates like XACIATO (licensed to Organon) and the ongoing Phase 3 trial for Ovaprene.

For a virtual company, the carbon footprint of their third-party supply chain is the only environmental factor that truly matters. They need to start asking their CMOs for their own carbon intensity data to get ahead of future regulatory requirements, otherwise, they are defintely blind to a material risk.