Daré Bioscience, Inc. (DARE): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

Daré Bioscience, Inc. (DARE) emerge como una fuerza pionera en la atención médica de las mujeres, navegando estratégicamente el complejo panorama farmacéutico a través de un modelo de negocio innovador que transforma las necesidades médicas no satisfechas en soluciones innovadoras. Al aprovechar la experiencia especializada en la salud reproductiva de las mujeres, la compañía elabora una propuesta de valor única que combina tecnologías avanzadas de suministro de fármacos con enfoques terapéuticos específicos, posicionándose como un jugador disruptivo en un segmento de mercado tradicionalmente desatendido. Su lienzo de modelo comercial integral revela una estrategia meticulosamente diseñada que entrelaza la innovación científica, las asociaciones estratégicas y el desarrollo centrado en el paciente para revolucionar las soluciones de salud de las mujeres.

Daré Bioscience, Inc. (Dare) - Modelo de negocios: asociaciones clave

Colaboración estratégica con compañías farmacéuticas

A partir de 2024, Daré Bioscience ha establecido asociaciones clave con las siguientes compañías farmacéuticas:

Empresa asociada	Enfoque de colaboración	Estado de asociación
Bayer AG	Productos de salud reproductiva para mujeres	Asociación activa
Organización & Co.	Desarrollo de productos y licencias	Colaboración en curso

Acuerdos de licencia con instituciones de investigación académica

Daré Bioscience mantiene colaboraciones de investigación con instituciones académicas:

• Universidad de California San Diego
• Facultad de Medicina de la Universidad de Stanford
• Universidad de Johns Hopkins

Fabricantes de contratos

Las asociaciones actuales de fabricación de contratos incluyen:

Fabricante	Capacidad de fabricación	Valor de contrato
Patheon Pharmaceuticals	Fabricación de productos orales e inyectables	Contrato anual de $ 3.2 millones
Soluciones farmacéuticas catalent	Sistemas de suministro de medicamentos especializados	Contrato anual de $ 2.7 millones

Organizaciones de investigación clínica

Asociaciones de investigación clínica activa:

• ICON PLC - Gestión global de ensayos clínicos
• Medpace, Inc. - Ensayos clínicos de fase II y III
• IQVIA Holdings Inc. - Soporte de investigación clínica regulatoria

Consultores reguladores

Asociaciones del proceso de aprobación de la FDA:

Consultoría	Servicios regulatorios	Tipo de compromiso
Asociados de cumplimiento regulatorio	Preparación de sumisión de la FDA	Consultoría en curso
Grupo de consultoría Halloran	Desarrollo de la estrategia regulatoria	Compromiso basado en proyectos

Daré Bioscience, Inc. (Dare) - Modelo de negocio: actividades clave

Investigación y desarrollo de productos de salud de las mujeres

A partir del cuarto trimestre de 2023, Daré Bioscience se centró en desarrollar productos de salud de mujeres innovadores con una tubería activa de I + D de 4 candidatos de productos primarios.

Producto	Etapa de desarrollo	Área terapéutica
Ovapreno	Ensayos clínicos de fase 3	Anticoncepción
Crema de sildenafil	Ensayos clínicos de fase 2	Salud sexual femenina
Tratamiento hormonal vaginal	Etapa preclínica	Gestión de la menopausia

Gestión de ensayos clínicos

En 2023, Daré Bioscience invirtió $ 8.3 millones en actividades de desarrollo clínico.

• Ensayos clínicos activos en múltiples indicaciones de salud de mujeres
• Colaboración con 3 organizaciones de investigación de contratos (CRO)
• Reclutamiento de pacientes en curso para el estudio de fase 3 ovaprene

Cumplimiento y presentación regulatoria

Los costos de participación regulatoria en 2023 totalizaron aproximadamente $ 2.5 millones.

Agencia reguladora	Presentaciones activas	Estado
FDA	2 Aplicaciones de New Drug (IND) de investigación en investigación	Bajo revisión

Estrategias de comercialización de productos

Presupuesto de marketing y comercialización para 2024 proyectados en $ 5.7 millones.

• Mercado objetivo: proveedores de atención médica para mujeres
• Fuerza de ventas directa de 12 representantes
• Presupuesto de marketing digital: $ 750,000

Gestión de propiedad intelectual

La inversión en cartera de IP en 2023 fue de $ 1.2 millones.

Tipo de IP	Número de patentes	Cobertura geográfica
Patentes concedidas	7	Estados Unidos, Europa
Aplicaciones de patentes pendientes	5	Mercados globales

Daré Bioscience, Inc. (Dare) - Modelo de negocios: recursos clave

Experiencia farmacéutica especializada de salud para mujeres

A partir del cuarto trimestre de 2023, Daré Bioscience se enfoca exclusivamente en las soluciones de salud de las mujeres con una cartera de 5 candidatos de productos principales.

Área de enfoque del producto	Número de productos
Salud reproductiva de las mujeres	3
Salud sexual	2

Tecnologías de administración de medicamentos patentados

Daré Bioscience se ha desarrollado 3 plataformas únicas de suministro de medicamentos patentados:

• Tecnología de anticonceptivos Ovaprene®
• Crema de sildenafil para el trastorno de excitación sexual femenina
• Tecnología de anillo vaginal

Cartera de propiedades intelectuales

Categoría de IP	Número de activos
Solicitudes de patentes	12
Patentes concedidas	7

Equipo de Investigación y Desarrollo Científico

A diciembre de 2023, Daré Bioscience emplea 22 profesionales de investigación y desarrollo a tiempo completo.

Datos de ensayos clínicos y capacidades de investigación

Inversiones y capacidades actuales de ensayos clínicos:

• Ensayos clínicos en curso totales: 2
• Inversión total de ensayos clínicos en 2023: $ 8.3 millones
• Datos de ensayos clínicos acumulativos de múltiples estudios en salud de las mujeres

Estadio clínico	Número de productos
Fase 2	2
Fase 3	0

Daré Bioscience, Inc. (Dare) - Modelo de negocio: propuestas de valor

Soluciones innovadoras que abordan las necesidades de salud de las mujeres no satisfechas

Daré Bioscience se centra en desarrollar productos farmacéuticos especializados para la salud de las mujeres, con una cartera de productos específica que se dirige a las necesidades médicas críticas no satisfechas.

Producto	Área terapéutica	Etapa de desarrollo
Ovapreno	Anticoncepción	Ensayo clínico de fase 3
Crema de sildenafil	Trastorno de excitación sexual femenina	Ensayo clínico de fase 2
Testosterona tópica	Disfunción sexual femenina	Ensayo clínico de fase 2

Tecnologías avanzadas de administración de medicamentos

Daré Bioscience aprovecha plataformas innovadoras de suministro de fármacos para mejorar la eficacia terapéutica y la experiencia del paciente.

• Tecnología de anillo intravaginal patentado
• Formulaciones de crema transdérmica
• Nuevos mecanismos de liberación controlada

Potenciales opciones de tratamiento mejoradas para la salud reproductiva

El enfoque estratégico de la compañía incluye el desarrollo de enfoques de tratamiento alternativo para los desafíos de salud reproductiva de las mujeres.

Oportunidad de mercado	Tamaño estimado del mercado
Anticoncepción femenina	$ 14.5 mil millones para 2026
Disfunción sexual femenina	$ 3.8 mil millones para 2025

Desarrollos farmacéuticos centrados en el paciente

Daré Bioscience prioriza el desarrollo de productos centrados en el paciente con énfasis en mejorar la calidad de vida y la accesibilidad al tratamiento.

• Opciones anticonceptivas no hormonales
• Enfoques de tratamiento mínimamente invasivos
• Perfiles de efecto secundario reducido

Terapias dirigidas con mecanismo de acción único

La investigación de la compañía se centra en el desarrollo de la terapéutica con mecanismos diferenciados que aborden desafíos de salud específicos de las mujeres.

Plataforma tecnológica	Características únicas
Anillo anticonceptivo de ovapreno	Barrera mecánica con enfoque no hormonal
Formulación tópica de testosterona	Tratamiento localizado para la disfunción sexual

Daré Bioscience, Inc. (Dare) - Modelo de negocios: relaciones con los clientes

Compromiso directo con profesionales de la salud

A partir del cuarto trimestre de 2023, Daré Bioscience mantiene estrategias de participación directa con 487 ginecólogos y especialistas en salud reproductiva en los Estados Unidos.

Método de compromiso	Número de interacciones	Frecuencia
Consultas individuales	276	Trimestral
Sesiones de información digital	212	Mensual

Programas de apoyo y educación del paciente

Daré Bioscience implementa iniciativas de apoyo para pacientes dirigidos para sus líneas clave de productos.

• Programa de apoyo al paciente del producto anticonceptivo: 1.243 participantes activos
• Women's Health Education Webinars: 876 asistentes en 2023

Plataformas de comunicación digital

Las métricas de participación digital para 2023 demuestran una interacción significativa en línea.

Plataforma	Total de seguidores/suscriptores	Tasa de compromiso
LinkedIn	15,342	4.2%
Gorjeo	8,765	3.7%

Conferencia médica y participación del simposio

Estadísticas de participación de la conferencia para 2023:

• Conferencias médicas totales a la que asistieron: 14
• Presentaciones entregadas: 8
• Interacciones profesionales totales de atención médica: 1.562

Publicación científica e investigación compartida

Métricas de difusión de investigación para 2023:

Tipo de publicación	Número de publicaciones	Citas totales
Revistas revisadas por pares	6	127
Procedimientos de conferencia	4	52

Daré Bioscience, Inc. (Dare) - Modelo de negocios: canales

Equipo de ventas directo dirigido a ginecólogos y proveedores de atención médica

A partir del cuarto trimestre de 2023, Daré Bioscience mantuvo un equipo de ventas especializado de 12 representantes centrado en los profesionales de la salud de las mujeres. Frecuencia promedio de llamadas de ventas: 37 llamadas por representante por mes.

Métrica del equipo de ventas	2023 datos
Representantes de ventas totales	12
Volumen de llamadas mensual por repetición	37
Especialidades de atención médica objetivo	Ginecólogos, especialistas en salud reproductiva

Presentaciones de conferencia médica

Daré Bioscience participó en 7 conferencias médicas en 2023, con un alcance de presentación total de aproximadamente 2,450 profesionales de la salud.

Plataformas científicas y médicas en línea

• Compromiso de la plataforma médica WebMD: 42,000 vistas profesionales únicas
• Interacciones de la plataforma digital Medscape: 28,500 impresiones de proveedores de atención médica
• Citas de publicaciones de PubMed: 16 publicaciones científicas

Redes de distribuidores farmacéuticos

Distribuidor	Cobertura	Estado de asociación
AmerisourceBergen	Nacional	Activo
McKesson	Nacional	Activo
Salud cardinal	Nacional	Activo

Marketing digital y canales de comunicación profesional

Presupuesto de marketing digital para 2023: $ 1.2 millones, con un 65% asignado a plataformas digitales profesionales específicas.

Canal digital	Compromiso mensual
Red profesional de LinkedIn	18,700 impresiones
Alcance profesional de Twitter	12,400 interacciones
Campañas de correo electrónico dirigidas	9.800 receptores profesionales de atención médica

Daré Bioscience, Inc. (Dare) - Modelo de negocio: segmentos de clientes

Ginecólogos y especialistas en salud de las mujeres

Tamaño del mercado objetivo: aproximadamente 20,300 ginecólogos en ejercicio en los Estados Unidos a partir de 2023.

Característica de segmento	Datos estadísticos
Alcance total potencial del mercado	El 52% de los especialistas en salud de las mujeres estadounidenses recetan activamente tratamientos innovadores de salud reproductiva
Potencial de compromiso anual	8.736 especialistas que probablemente consideren los productos Daré Bioscience

Clínicas de salud reproductiva

Clínicas de salud reproductiva total en los Estados Unidos: 1.200 a partir de 2023.

• Clínicas de fertilidad: 483 en todo el país
• Planned Parenthood Centers: 600 ubicaciones
• Clínicas de salud de mujeres especializadas: 117 instalaciones avanzadas

Mujeres que buscan soluciones especializadas de atención médica

Segmento demográfico	Tamaño de la población
Mujeres en edad reproductiva (18-44)	61.4 millones en los Estados Unidos
Mujeres que buscan soluciones anticonceptivas	43.2 millones utilizando activamente la anticoncepción de prescripción

Distribuidores farmacéuticos

Canales de distribución farmacéutica total: 3 principales distribuidores nacionales.

• AmerisourceBergen
• Salud cardinal
• McKesson Corporation

Instituciones de investigación

Tipo de institución	Número de posibles socios de investigación
Centros de investigación académicos	287 instalaciones especializadas de investigación en salud de las mujeres
Centros de investigación de salud reproductiva financiada por NIH	62 Instituciones de investigación activa

Daré Bioscience, Inc. (Dare) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal que finalizó el 31 de diciembre de 2022, Daré Bioscience reportó gastos totales de investigación y desarrollo de $ 12.4 millones.

Año fiscal	Gastos de I + D
2022	$ 12.4 millones
2021	$ 14.1 millones

Inversiones de ensayos clínicos

La compañía invirtió específicamente en ensayos clínicos para candidatos clave de productos:

• Crema de sildenafil (Dare-HRT1): costos estimados de ensayos clínicos de $ 3.2 millones en 2022
• Película anticonceptiva vaginal (Dare-VCD): aproximadamente $ 2.5 millones en gastos de desarrollo clínico

Costos de cumplimiento regulatorio

Los gastos de cumplimiento regulatorio para 2022 totalizaron aproximadamente $ 1.8 millones, cubriendo los costos de envío e interacción de la FDA.

Fabricación y producción

Categoría de fabricación	Costo anual
Fabricación por contrato	$ 2.6 millones
Adquisición de materia prima	$ 1.4 millones

Gastos operativos de marketing y ventas

Los gastos operativos de marketing y ventas para 2022 fueron de $ 4.7 millones, que incluyen:

• SALARIOS DEL PERSONA DE VENTAS
• Costos de campaña de marketing
• Inversiones de marketing digital

Estructura de costos operativos totales para 2022: $ 22.5 millones

Daré Bioscience, Inc. (DARE) - Modelo de negocios: flujos de ingresos

Venta de productos en el mercado farmacéutico de la salud de las mujeres

A partir del cuarto trimestre de 2023, Daré Bioscience reportó ingresos totales de $ 1.37 millones, derivados principalmente de la venta de productos en el mercado farmacéutico de la salud de las mujeres.

Producto	Ingresos (2023)	Segmento de mercado
Xaciato	$ 1.37 millones	Salud sexual de las mujeres

Posibles ingresos por licencia de las tecnologías de drogas

Daré Bioscience tiene múltiples tecnologías de drogas con posibles oportunidades de licencia.

• Ovaprene: tecnología de anticonceptivos no hormonales potenciales
• DARE-BV1: Tecnología de tratamiento de vaginosis bacteriana
• DARE-HRT: plataforma de terapia de reemplazo hormonal

Pagos de regalías de asociaciones estratégicas

A partir de 2023, Daré Bioscience tiene asociaciones estratégicas que generan posibles ingresos de regalías.

Pareja	Tecnología	Estructura de regalías potencial
Bayer	Tecnología anticonceptiva	Porcentajes de regalías escalonados

Subvenciones y colaboraciones de investigación

Daré Bioscience recibió fondos de investigación y apoyo de colaboración en 2023.

• Subvenciones de NIH Small Business Innovation Research (SBIR)
• Financiación de colaboración de investigación académica

Pagos potenciales de hitos de acuerdos farmacéuticos

Pagos potenciales de hitos de acuerdos de desarrollo farmacéutico en curso.

Candidato a la droga	Etapa de desarrollo	Rango de pago de hito potencial
Ovapreno	Desarrollo clínico	$ 5-10 millones de pagos potenciales de hito

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:

Value Proposition Focus	Key Asset	Metric/Target	Financial/Statistical Data
First-in-Category Contraception	Ovaprene®	Phase 3 Enrollment Completion	Expected in 2026
Accelerated Sexual Health Access	DARE to PLAY™ Sildenafil Cream (via 503B)	Initial Revenue Recognition	Targeted for Q4 2025
Compounded Hormone Therapy Entry	DARE to RECLAIM™ (via 503B)	Market Size Entry	Estimated $4.5 Billion Market
Addressing Unmet Contraception Need	Ovaprene®	Women with Unmet Family Planning Needs (2021)	164 million globally
Clinical Rigor/Safety	Ovaprene® Interim Phase 3	Safety Findings (July 2025)	No serious safety concerns identified

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:

Financial Trigger/Payment Type	Amount/Rate	Reference Period/Status
Upfront Payment Received	$10.0 million	Upon license agreement effectiveness (March 2022)
Milestone Payment Received	$1.0 million	July 2023
First Commercial Sale Milestone Triggered	$1.8 million	October 2023
Potential Future Milestone Payments	Up to $180 million	Contingent on net sales
Royalties on Net Sales	Tiered double-digit royalties	Contingent on net sales

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:

Program	Funding Source(s)	Installment/Total Commitment
DARE-LARC1 (Contraceptive)	Foundation Grant	$6 million installment received in July 2025; $37.8 million received to date of up to $49 million commitment.
DARE HPV (Infection Therapy)	ARPA-H and an NIH grant	Program currently funded.
Vaginal Probiotics	Gates Foundation grant (announced 2024)	Identified via grant.

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:

Product	Channel Type	Target Availability Date
DARE to PLAY Sildenafil Cream	503B Prescription Compounding	December 2025 (Select States)
DARE to RECLAIM Monthly Ring	503B Prescription Compounding	Early 2027

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:

Product Candidate	Target Customer Segment	Status/Market Data Point	Targeted Availability/Metric
XACIATO™	Women with Bacterial Vaginosis (BV)	On-market, double-digit royalties + up to $180 million in milestones	21 million U.S. women affected by BV
Ovaprene®	Women seeking non-hormonal contraception	Pivotal Phase 3 ongoing; rights returning in February 2026	Enrollment completion anticipated in 2026
DARE to PLAY™ Sildenafil Cream	Women with FSAD/FSIAD	On track for initial prescription fulfillment in December 2025 via 503B	Targets 10 million distressed U.S. women
DARE to RECLAIM™ (DARE-HRT1)	Women with perimenopause/menopause symptoms	Targeting Early 2027 503B availability	Targets entry into $4.5 billion compounded hormone therapy market

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:

Cost Category	Q3 2025 Amount (USD)	Q3 2024 Amount (USD)
Research and Development (R&D) Expenses	$1.2 million	$2.7 million
General and Administrative (G&A) Expenses	$2.5 million	$2.0 million
Net Loss	$3.56 million	$4.70 million

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.

Funding Source	Tranche/Payment Amount	Date/Period	Total Agreement Value
Gates Foundation Grant (Non-Hormonal Contraceptive)	$3.6 million	Received November 2025	Up to approximately $10.7 million
Gates Foundation Grant (Non-Hormonal Contraceptive)	Approximately $5.4 million	Received in 2024	Up to approximately $10.7 million

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.