Daré Bioscience, Inc. (DARE): Business Model Canvas [Dec-2025 Updated]

You're looking at Daré Bioscience, Inc. (DARE) right now, and frankly, the late-2025 picture shows the company at a true inflection point, pivoting from pure R&D to a dual-path commercial reality. We're talking about a model underpinned by $\mathbf{\$23.1 \text{ million}}$ in cash as of September 30, 2025, where revenue is starting to flow from the Organon partnership for XACIATO™ alongside the immediate 503B launch of DARE to PLAY™. This Business Model Canvas maps out precisely how they intend to monetize differentiated assets like Ovaprene® and manage the costs of late-stage trials, so let's look under the hood at the nine building blocks driving this transition.

Daré Bioscience, Inc. (DARE) - Canvas Business Model: Key Partnerships

You're looking at the external relationships Daré Bioscience, Inc. relies on to execute its dual-path strategy-generating near-term revenue while advancing long-term innovation. These partnerships are crucial, especially given the company ended Q3 2025 with $23 million in cash and cash equivalents.

Organon: Global Commercialization Partner for XACIATO™

Organon holds the global license for XACIATO™, the FDA-approved treatment for Bacterial Vaginosis (BV) in females 12 and older. Daré Bioscience, Inc. received a $10 million upfront payment upon closing the agreement. Furthermore, Daré Bioscience, Inc. is eligible to receive potential milestone payments reaching up to $182.5 million, in addition to tiered double-digit royalties based on net sales.

Gates Foundation: Non-Dilutive Grant Funding

The Bill & Melinda Gates Foundation provides significant non-dilutive grant funding, which helps Daré Bioscience, Inc. advance its pipeline without equity dilution. This funding supports the Ovaprene® pivotal Phase 3 study and the development of a novel non-hormonal intravaginal contraceptive (DARE-NHC). The total grant agreement is worth up to approximately $10.7 million, announced in November 2024. Daré Bioscience, Inc. received the second tranche payment of approximately $3.6 million in November 2025, following an initial payment of approximately $5.4 million in 2024. This funding structure is key, as Research and Development expenses for Q3 2025 were $1.2 million.

503B Outsourcing Facilities: Near-Term Commercial Fulfillment

Critical partners for the near-term commercial strategy involve Section 503B-registered outsourcing facilities, which allow Daré Bioscience, Inc. to launch compounded products quickly. The company is targeting initial prescription fulfillment for DARE to PLAY™ Sildenafil Cream in select states in December 2025. This pathway is also planned for DARE to RECLAIM™ Monthly Hormone Therapy, targeted for early 2027, aiming to establish entry into the estimated $4.5 billion compounded hormone therapy market.

Rosy Wellness: Digital Health and Commercial Support

Daré Bioscience, Inc. formed a strategic collaboration with Rosy Wellness to support the marketing campaign for DARE to PLAY™ Sildenafil Cream, which is targeted for prescription availability in the fourth quarter of 2025. This partnership leverages Rosy Wellness's digital reach to a community of over 250,000 women, who are recommended by over 8,000+ healthcare professionals. Daré Bioscience, Inc. expects to start recording revenue from this product in Q4 2025.

Bayer: Rights Reversion for Ovaprene®

Bayer HealthCare LLC elected to terminate the license agreement for Ovaprene®, the investigational, hormone-free monthly intravaginal contraceptive. All rights will return to Daré Bioscience, Inc. by February 2026. Under the original agreement, if Bayer exercised its option after the pivotal trial, Daré Bioscience, Inc. was entitled to a $20 million payment and up to $310 million in commercial milestone payments, plus double-digit tiered royalties on net sales. The Phase 3 program for Ovaprene® continues, supported by the non-dilutive grant funding, and announced positive interim data in July 2025.

The structure of these external relationships dictates near-term revenue realization and long-term asset control. Finance: draft 13-week cash view by Friday.

Daré Bioscience, Inc. (DARE) - Canvas Business Model: Key Activities

You're looking at the core engine of Daré Bioscience, Inc. (DARE) right now-the day-to-day execution that bridges science to revenue. This isn't just about research; it's about a disciplined, multi-pronged approach to getting products to market, leveraging both regulatory pathways and non-dilutive capital.

Executing a dual-path commercial strategy (FDA approval + 503B compounding)

The dual-path strategy is central to Daré Bioscience's near-term activity. You see them actively preparing for revenue generation outside of a full FDA approval timeline for certain assets. This means managing the logistics and regulatory requirements for the 503B compounding pathway simultaneously with the longer-term FDA approval track for key products.

Here's a snapshot of the near-term commercial focus:

• Preparing for initial prescription fulfillment of DARE to PLAY™ Sildenafil Cream in December 2025 via a 503B-registered outsourcing facility.
• Targeting commercialization of DARE to RESTORE™ Vaginal Probiotics to follow the DARE to PLAY™ launch.
• Advancing DARE to RECLAIM™ Monthly Hormone Therapy toward availability via the 503B Compounding Pathway in Early 2027.

This strategy is aimed at capturing a piece of the estimated $4.5 Billion Compounded Hormone Therapy Market while Daré Bioscience continues building toward the FDA-approval opportunity for DARE to RECLAIM™. Overall, the company expects four commercially available solutions for women over the next two years.

Managing and funding pivotal Phase 3 clinical trials for Ovaprene®

A major activity is keeping the pivotal Phase 3 trial for Ovaprene®, the investigational hormone-free intravaginal contraceptive, on track. This requires rigorous management of the study protocol and patient enrollment, all while securing non-dilutive funding to support the costs. You know the DSMB (Data Safety Monitoring Board) review is a key milestone; they had a positive interim outcome in July 2025, recommending the study continue without modification. The study itself is identified as ClinicalTrials.gov ID # NCT06127199.

The funding structure for this trial is heavily reliant on external support, which is a critical activity in itself:

Enrollment completion for the Phase 3 study is anticipated in 2026.

Advancing grant-funded R&D programs like DARE-HPV and DARE-NHC

Daré Bioscience is actively managing several grant-funded research and development programs, which directly impacts their operating expenses. You saw R&D Expenses drop to $1.2 million in Q3 2025, a 56% decrease year-over-year, partly due to these non-dilutive funding awards offsetting costs. This is smart capital allocation.

Key activities for these programs include:

• DARE-HPV: Conducting activities to enable submission of an Investigational New Drug (IND) application for a Phase 2 study, currently funded by an ARPA-H award and an NIH grant.
• DARE-NHC: Working on a novel non-hormonal intravaginal contraceptive product candidate; a $3.6 million installment under a November 2024 grant agreement was anticipated in November 2025.
• DARE-LARC1: Advancing preclinical development for the long-acting contraceptive using an intelligent drug delivery system, having received $6 million in July 2025 and $4 million in October 2025 installments.

The company received $7.3 million in total grant payments during the third quarter of 2025.

Commercial launch readiness for DARE to PLAY™ Sildenafil Cream in December 2025

The most immediate activity is the commercial launch readiness for DARE to PLAY™ Sildenafil Cream, which is targeted for initial prescription fulfillment in December 2025. This product is positioned as a near-term revenue driver, with first revenue recognition expected in Q4 2025. The plan involves broadening to 50-state fulfillment in early 2026.

Readiness activities include:

• Executing against the 503B pathway for initial availability.
• Engaging clinicians through educational webinars, such as the one scheduled for November 17, 2025.
• Highlighting clinical data showing increased genital blood flow within 10 to 15 minutes of application.

This commercial push is reflected in the General and Administrative Expenses, which rose to $2.5 million in Q3 2025, up from $2.0 million in Q3 2024, driven by commercial-readiness expenses.

Maintaining and expanding the intellectual property portfolio for women's health

Daré Bioscience must constantly manage and defend its intellectual property (IP) rights, which is a core operational activity, especially given the nature of its product candidates. The company notes risks related to the lack of patent protection for the active ingredients in certain product candidates, which exposes those products to competition from other formulations using the same active ingredients.

The IP portfolio is anchored by several key assets:

• Ovaprene®: U.S. commercial rights were under license with Bayer, but full control is consolidating in February 2026.
• Sildenafil Cream, 3.6%: Intends to leverage the existing safety and efficacy data to use the FDA's 505(b)(2) pathway.
• DARE-HRT1: A combination bio-identical estradiol and progesterone intravaginal ring.

Finance must ensure the balance sheet supports these activities; as of September 30, 2025, the company held approximately $23.1 million in cash and cash equivalents.

Daré Bioscience, Inc. (DARE) - Canvas Business Model: Key Resources

You're looking at the core assets Daré Bioscience, Inc. is relying on to execute its dual-path strategy-combining near-term revenue generation with clinical innovation. These resources are the foundation of their value proposition.

Financial Strength and Non-Dilutive Capital

The balance sheet strength comes from recent capital raises and significant non-dilutive funding awards, which directly offset Research and Development (R&D) expenses. As of September 30, 2025, Daré Bioscience, Inc. reported approximately $23.1 million in cash and cash equivalents. This cash position was bolstered by recent non-dilutive funding.

The company has secured substantial grant funding, notably from the Gates Foundation for a novel non-hormonal intravaginal contraceptive (DARE-NHC). This is part of an agreement originally announced in November 2024 for up to $10.7 million. Specifically, Daré Bioscience, Inc. received a $6.0 million grant installment in October 2025 and an additional $3.6 million payment in November 2025 under this agreement. Furthermore, the DARE-LARC1 program received a $6 million grant installment in July 2025 and a $4 million installment in October 2025.

The company's R&D expenses for the third quarter of 2025 were $1.2 million, reflecting a 56% decrease from the prior year, largely due to these non-dilutive funding awards offsetting costs.

Differentiated Pipeline Assets and Commercial Agreements

The pipeline represents intellectual property and clinical progress. The global license agreement for XACIATO™ (clindamycin phosphate) vaginal gel, 2% with Organon is a key revenue driver. Daré Bioscience, Inc. is eligible to receive potential future milestone payments of up to $180 million, in addition to tiered double-digit royalties on net sales. The first commercial sale already triggered a $1.8 million milestone payment.

The pipeline assets are a mix of near-term commercial opportunities and longer-term clinical candidates:

The company is also advancing other proprietary formulations and consumer health products. For instance, two non-prescription vaginal probiotics are targeted for commercial availability following the Sildenafil Cream launch.

The strategic use of non-dilutive funding is critical for advancing these assets:

• Gates Foundation Grant: Up to $10.7 million total commitment for DARE-NHC development.
• DARE-LARC1 Funding: Total of $10 million in grant installments received in 2025 ($6 million in July and $4 million in October).
• DARE-HPV Funding: Supported by an ARPA-H award and NIH grant.

These external funding sources help de-risk the development of several preclinical and clinical-stage programs.

Daré Bioscience, Inc. (DARE) - Canvas Business Model: Value Propositions

You're looking at the core reasons why a customer-whether a patient, provider, or partner-would choose Daré Bioscience, Inc. (DARE) solutions. It's about delivering what the market desperately needs, often years ahead of competitors.

First-in-category, hormone-free monthly contraceptive (Ovaprene®)

Ovaprene® is positioned as the first-in-category, investigational, hormone-free monthly intravaginal contraceptive. The pivotal Phase 3 multicenter, single-arm, open-label study (ClinicalTrials.gov ID # NCT06127199) is advancing, with enrollment anticipated to complete in 2026. Daré Bioscience, Inc. announced positive interim data from this trial in July 2025, showing consistent safety and tolerability, with no serious safety concerns identified. Furthermore, all commercialization rights will return to Daré Bioscience, Inc. from Bayer HealthCare LLC, effective February 2026, giving the company full control of this late-stage asset.

Accelerated market access via 503B compounding for sexual health and menopause treatments

Daré Bioscience, Inc. is executing a dual-path strategy to generate near-term revenue. The DARE to PLAY™ Sildenafil Cream is on track for initial prescription fulfillment in December 2025 through a 503B-registered outsourcing facility, with the company expecting to start recording revenue and cash flow in Q4 2025. This initial investment to support this 503B path was anticipated to be not more than $1 million. Separately, the DARE to RECLAIM™ Monthly Hormone Therapy via 503B Compounding Pathway is targeted for Early 2027, establishing entry into the estimated $4.5 Billion Compounded Hormone Therapy Market.

Addressing significant unmet needs in women's health (e.g., FSAD, BV, non-oral hormone therapy)

The focus is on closing gaps in a market that represents over $200 Billion in annual spending. For instance, the World Health Organization indicated that among 1.9 billion women of reproductive age in 2021, 164 million still had unmet needs for family planning. Daré Bioscience, Inc. has a solution for Bacterial Vaginosis (BV), XACIATO™ (clindamycin phosphate) vaginal gel 2%, which is indicated for treatment in female patients 12 and older. The company is also advancing DARE-NHC, a preclinical program for a novel non-hormonal intravaginal contraceptive, which is anticipated to receive a $3.6 million grant installment in November 2025.

The value propositions are tied directly to the pipeline assets and their market potential:

Evidence-based, differentiated therapies backed by clinical rigor

Clinical validation is central to the value proposition. The interim data for Ovaprene® in July 2025 confirmed that the rate of pregnancy in treated women was consistent with the company's expectations based on the pre-pivotal postcoital test clinical study. For DARE to PLAY™ Sildenafil Cream, clinical data was published in 2024 supporting its use as an 'on demand' solution. Financially, the company is demonstrating capital efficiency to support these rigorous programs; Research and Development (R&D) Expenses decreased by 56% in Q3 2025 compared to Q3 2024, partially due to non-dilutive funding awards.

Daré Bioscience, Inc. (DARE) - Canvas Business Model: Customer Relationships

You're looking at how Daré Bioscience, Inc. (DARE) connects with the market, especially now that they're accelerating their dual-path strategy. It's a mix of relying on established partners and building direct channels for their new 503B products.

Indirect, through Organon's established commercial sales force for XACIATO™

The relationship here is primarily passive for Daré Bioscience, Inc., relying on Organon's existing infrastructure for the FDA-approved product, XACIATO™ (clindamycin phosphate) vaginal gel, 2%.

The financial structure of this relationship involves significant potential upside for Daré Bioscience, Inc. based on Organon's sales performance:

Organon is leveraging its commercial expertise to deliver XACIATO™ to women treating bacterial vaginosis, a condition estimated to affect approximately 21 million women of reproductive age in the United States.

Direct engagement with healthcare providers (HCPs) to drive 503B prescriptions

This is where Daré Bioscience, Inc. is building its near-term revenue engine by making proprietary formulations available via Section 503B compounding, which bypasses full FDA approval timelines for immediate patient access.

Key products driving this direct HCP engagement include:

• DARE to PLAY™ Sildenafil Cream: Targeted for initial prescription fulfillment in December 2025 via a 503B-registered outsourcing facility.
• DARE to RECLAIM™ Monthly Hormone Therapy: Targeted for 503B availability in early 2027.

The DARE to RECLAIM™ launch is positioned to enter the estimated up to $4.5 billion compounded hormone therapy market. The investment in this strategy is visible in operational costs; General and Administrative Expenses for Q3 2025 were $2.5 million, compared to $2.0 million in Q3 2024, with commercial-readiness expenses tied to this expanded strategy noted as a driver.

Digital and direct-to-consumer (DTC) marketing for non-prescription products

For products not requiring a prescription, Daré Bioscience, Inc. is focusing on a consumer health launch, which necessitates direct-to-consumer (DTC) relationship building.

The non-prescription pipeline includes:

• DARE to RESTORE™ Vaginal Probiotics: Targeted for commercialization following the DARE to PLAY Sildenafil Cream availability in 2025.

For DARE to PLAY Sildenafil Cream, a direct-to-patient awareness campaign was launched in partnership with Rosy Wellness. While Daré Bioscience, Inc.'s specific DTC spend isn't itemized, the broader US pharmaceutical sector saw prescription drug TV ad spending hit approximately $1.25 billion in Q3 2025, with the global industry expected to spend about $10 billion on DTC advertising in 2025.

Investor relations and grant reporting for non-dilutive funding sources

The relationship with investors and funding bodies is managed to secure capital without diluting existing shareholders, which directly impacts operational capacity.

Key financial and funding metrics as of late 2025:

• Cash and cash equivalents were $23.1 million as of September 30, 2025.
• This followed a Q2 2025 cash position of $5.0 million, which was bolstered by a subsequent capital raise of $17.6 million.
• Research and Development (R&D) Expenses in Q3 2025 were $1.2 million, a 56% decrease from $2.7 million in Q3 2024, partly due to contra-R&D expenses recognized from non-dilutive funding.

Specific grant-funded programs demonstrate this non-dilutive relationship:

Investor relations communications confirm the receipt of a $4 million grant installment in November 2025 for DARE-LARC1, reinforcing the reliance on non-dilutive capital.

Daré Bioscience, Inc. (DARE) - Canvas Business Model: Channels

You're looking at how Daré Bioscience, Inc. (DARE) gets its products and pipeline assets to market as of late 2025. The strategy is clearly a dual path: near-term revenue via compounding/consumer health and long-term value through clinical development.

Organon's global commercial distribution network for XACIATO™.

The channel for XACIATO™ (clindamycin phosphate vaginal gel, 2%) relies on Organon's established global women's healthcare sales force. Daré Bioscience is eligible for tiered double-digit royalties based on net sales from this channel. The potential financial upside from this distribution channel includes up to $180.0 million in future milestone payments, in addition to the $10.0 million upfront payment received in 2022 and the $1.8 million milestone triggered by the first U.S. commercial sale in late 2023. Bacterial vaginosis, the indication for XACIATO, is estimated to impact between 23% to 29% of all women worldwide.

503B-registered outsourcing facilities for compounded products (e.g., DARE to PLAY™).

This channel is the primary near-term revenue driver, leveraging Section 503B of the FDCA to accelerate patient access. Daré Bioscience is on track for initial prescription fulfillment of DARE to PLAY Sildenafil Cream through a 503B-registered outsourcing facility in select states in December 2025, with national fulfillment targeted for early 2026. The company reported $2.5 million in General and Administrative Expenses in Q3 2025, which included commercial-readiness costs driven by this expanded strategy. Another product, DARE to RECLAIM, is targeted for availability via this compounding pathway in early 2027, aiming to enter the estimated $4.5 Billion Compounded Hormone Therapy Market. The company expects four commercially available solutions over the next two years using this approach.

Here's a quick look at the near-term commercialization channel targets:

Direct-to-consumer e-commerce platforms for non-prescription consumer health products.

The channel for non-prescription consumer health products, specifically the DARE to RESTORE vaginal probiotic line, is targeted to follow the DARE to PLAY launch. Commercialization of these probiotics is targeted for the first quarter of 2026. For DARE to PLAY, a direct-to-patient awareness campaign was launched in partnership with Rosy Wellness in Q2 2025, indicating an early digital marketing component to support prescription uptake.

Clinical trial sites and academic collaborators for pipeline development.

The development pipeline utilizes clinical trial sites and academic/grant funding as key channels for advancement. The pivotal Phase 3 trial for Ovaprene continues, with enrollment expected to complete in 2026. This program is being advanced using non-dilutive funding, including a grant from the Gates Foundation. Daré Bioscience received $7.3 million in grant payments during the third quarter of 2025, which supported R&D activities, including clinical and preclinical programs like DARE-HPV and DARE-LARC1. Furthermore, the company is pursuing a PMA (Premarket Approval) regulatory strategy with the FDA CDRH for Ovaprene. The Ovaprene Phase 3 study is supported by grant funding, with a $3.6 million installment under a November 2024 grant agreement anticipated in November 2025. Enrollment in the Ovaprene study is proceeding at five study sites initiated in 2025, funded by a 2024 grant, following a previous count of 15 active sites from the NICHD's network.

Pipeline advancement is heavily supported by external funding sources:

• Grant funding supports Ovaprene Phase 3 completion.
• $7.3 million in grant payments received in Q3 2025.
• $3.6 million installment anticipated in November 2025.
• Bayer's termination of Ovaprene rights is effective February 2026.

Finance: draft 13-week cash view by Friday.

Daré Bioscience, Inc. (DARE) - Canvas Business Model: Customer Segments

You're looking at the core patient populations Daré Bioscience, Inc. (DARE) is targeting with its near-term commercial efforts and late-stage pipeline assets as of late 2025. This isn't just about drug development; it's about capturing specific, underserved segments of the women's health market.

Women with Bacterial Vaginosis (BV) (via XACIATO™)

This segment is already being served, as XACIATO™ (clindamycin phosphate) vaginal gel 2% is an on-market product, licensed to Organon for U.S. commercialization. This represents a non-dilutive revenue stream for Daré Bioscience, Inc. (DARE).

• Bacterial vaginosis (BV) is the most common cause of vaginitis globally.
• The condition is estimated to affect approximately 21 million women in the U.S..
• Daré Bioscience, Inc. (DARE) is eligible to receive tiered double-digit royalties on net sales from Organon.
• The company is also eligible for up to $180 million in potential milestone payments related to XACIATO™.
• In 2023, Daré Bioscience, Inc. (DARE) recognized total revenue of approximately $2.8 million, which included a $1.8 million milestone payment from Organon related to XACIATO™'s launch.

Women seeking non-hormonal, user-controlled contraception (Ovaprene®)

Ovaprene® is positioned as a first-in-category, investigational, hormone-free monthly intravaginal contraceptive. The pivotal Phase 3 study is progressing, and Daré Bioscience, Inc. (DARE) is set to regain full control of this late-stage asset.

• The pivotal Phase 3 study (NCT06127199) is ongoing, with an Independent Data Safety Monitoring Board (DSMB) recommending continuation without modification after an interim review in July 2025.
• Enrollment is anticipated to complete in 2026.
• The development is supported by non-dilutive funding, including an up to $10.7 million foundation grant announced in November 2024.
• Bayer HealthCare elected to terminate the license agreement, with all rights returning to Daré Bioscience, Inc. (DARE) effective in February 2026.

Women with Female Sexual Arousal/Interest Disorder (FSAD/FSIAD)

This segment is targeted by DARE to PLAY™ Sildenafil Cream (Sildenafil Cream, 3.6%), which has the potential to be the first FDA-approved pharmacological treatment for FSAD. You can expect near-term revenue from this product via an alternative pathway.

• Market research suggests approximately 10 million women in the U.S. aged 21 to 60 are distressed by FSAD symptoms and actively seeking solutions.
• Initial prescription fulfillment via a 503B-registered outsourcing facility is on track for December 2025.
• The company is targeting full 50-state availability by early 2026.

Women experiencing perimenopause and menopause symptoms (DARE to RECLAIM™)

DARE to RECLAIM™ (DARE-HRT1) is Daré Bioscience, Inc. (DARE)'s investigational monthly intravaginal hormone therapy aimed at vasomotor symptoms. This product targets a significant market opportunity through the compounded route first.

• The target market for compounded hormone therapy is estimated at up to $4.5 billion.
• Availability via the 503B Compounding Pathway is targeted for Early 2027.
• Vasomotor Symptoms (VMS), which DARE to RECLAIM™ addresses, are experienced by almost 75% of women reaching menopause.
• The broader global menopause market size was estimated at USD 17.79 billion in 2024 and projected to reach USD 18.71 billion in 2025.

Here's a quick look at how these pipeline assets map to the customer segments and their near-term commercialization status as of the Q3 2025 update:

The company's balance sheet as of September 30, 2025, showed approximately $23.1 million in cash and cash equivalents, which supports the execution across these segments. Also, General and Administrative Expenses were $2.5 million in Q3 2025, reflecting commercial-readiness spending for these launches.

Finance: review the Q4 2025 cash burn projection based on the December 2025 Sildenafil Cream launch.

Daré Bioscience, Inc. (DARE) - Canvas Business Model: Cost Structure

You're looking at the cost side of Daré Bioscience, Inc. (DARE) operations as of the third quarter of 2025, which gives us the clearest picture leading into the end of the year. The cost structure is heavily influenced by ongoing clinical programs and the ramp-up for near-term commercialization efforts.

High fixed costs in Research and Development (R&D) are typical for a biotech, but grant funding is significantly offsetting these expenses right now. For the quarter ended September 30, 2025, Research and Development (R&D) Expenses were reported at $1.2 million. This represents a substantial 56% decrease compared to the $2.7 million in R&D expenses reported in Q3 2024. This reduction is primarily driven by an increase in contra R&D expenses, which are reductions to R&D expenses due to non-dilutive funding awards received.

The shift in focus toward commercial readiness is clearly visible in the General and Administrative (G&A) line. G&A costs for Q3 2025 were $2.5 million, an increase from the $2.0 million reported in Q3 2024. This year-over-year change is directly attributable to increased spending on professional services and commercial-readiness expenses as the company executes its expanded business strategy, including the 503B compounding pathway for select solutions.

Here's a quick look at the key operating expenses for the third quarter of 2025:

Clinical trial expenses for late-stage assets like Ovaprene® are being managed through grant funding, which acts as a significant offset. The Ovaprene® pivotal Phase 3 contraceptive efficacy study continued enrollment following a positive interim Data Safety Monitoring Board (DSMB) recommendation. Furthermore, the R&D decrease in Q3 2025 specifically cited decreases in manufacturing costs related to Ovaprene.

For the near-term commercial products, specific start-up costs are being incurred to enable the 503B compounding pathway. The cost to enable the launch of DARE to PLAY™ Sildenafil Cream via the 503B outsourcing facility was approximately $1 million for start-up and tech transfer activities. For the DARE to RESTORE™ Vaginal Probiotics and DARE to RECLAIM™ Monthly Hormone Therapy (HRT1), which are targeted for 2026 and early 2027, respectively, the HRT1 503B start-up is expected to be in a similar single-digit millions range.

The structure shows a clear trade-off: R&D costs are temporarily lower due to non-dilutive funding awards and reduced Ovaprene manufacturing, while G&A is intentionally increasing to support the commercial launch of DARE to PLAY™ Sildenafil Cream in December 2025. The company also received a total of $7.3 million in grant payments during Q3 2025, which directly helps offset operating expenditures.

Key components influencing the R&D cost base include:

• Decreases in manufacturing costs related to Ovaprene.
• Increases in costs for development activities for DARE-HPV and DARE-LARC1 programs.
• Start-up costs for DARE to PLAY Sildenafil Cream development activities.

Finance: draft 13-week cash view by Friday.

Daré Bioscience, Inc. (DARE) - Canvas Business Model: Revenue Streams

You're looking at the revenue streams for Daré Bioscience, Inc. (DARE) as we close out 2025. It's a mix of partnership income and the very beginning of proprietary product sales, which is exactly what a dual-path strategy looks like right now.

The most immediate, non-dilutive cash flow comes from strategic partnerships and grants. You see this clearly with the recent Gates Foundation funding. This cash helps keep the lights on and advances non-commercial assets without issuing more stock.

Also, don't forget the existing commercial product, XACIATO™, licensed to Organon. This is a steady, albeit currently small, stream based on their net sales. Daré Bioscience is eligible to receive double digit royalties based on those net sales, plus up to $180 million in potential future milestone payments from Organon. For context on past milestone activity, Daré recognized total revenue of approximately $2.8 million in 2023, which included a $1.0 million payment and an additional $1.8 million milestone payment in October 2023 related to XACIATO™'s U.S. launch.

The big near-term inflection point is the start of initial product sales from DARE to PLAY™ Sildenafil Cream. Management reiterated the targeted Q4 2025 launch through a 503B outsourcing facility, with initial prescription fulfillment targeted for December. This marks the start of commercial revenue generation from their own efforts, which is a major proof point for their 503B compounding strategy. Honestly, getting that first dollar of product revenue is huge for credibility.

When you look at what the market expects for the full year, it reflects this transition period where grant money is still significant, but product sales are just beginning. Analyst consensus from 6 Wall Street analysts forecasts Daré Bioscience's full-year 2025 revenue to be approximately $5,625,955. This figure is bracketed by a low forecast of $0 and a high forecast of $21,505,290.

Here is a quick look at the expected revenue components as of late 2025:

• Milestone/Royalty Income: From Organon's net sales of XACIATO™, eligible for double digit royalties.
• Non-Dilutive Funding: Includes the $3.6 million tranche received in November 2025 from the Gates Foundation.
• Initial Product Sales: Expected to begin late 2025 (targeted December fulfillment) for DARE to PLAY™ Sildenafil Cream via the 503B pathway.
• Analyst Consensus 2025 Revenue: Averaging $5,625,955 across reporting analysts.

Finance: draft 13-week cash view by Friday.