Dari Bioscience, Inc. (DARE): Business Model Canvas [Jan-2025 Mis à jour]

Daré Bioscience, Inc. (DARE) apparaît comme une force pionnière dans les soins de santé des femmes, naviguant stratégiquement dans le paysage pharmaceutique complexe grâce à un modèle commercial innovant qui transforme les besoins médicaux non satisfaits en solutions révolutionnaires. En tirant parti de l'expertise spécialisée dans la santé reproductive des femmes, l'entreprise élabore une proposition de valeur unique qui combine des technologies avancées d'administration de médicaments avec des approches thérapeutiques ciblées, se positionnant comme un acteur perturbateur dans un segment de marché traditionnellement mal desservi. Leur toile complète du modèle commercial révèle une stratégie méticuleusement conçue qui entrelace l'innovation scientifique, les partenariats stratégiques et le développement centré sur le patient pour révolutionner les solutions de soins de santé des femmes.

Dari Bioscience, Inc. (DARE) - Modèle commercial: partenariats clés

Collaboration stratégique avec les sociétés pharmaceutiques

Depuis 2024, Daré Bioscience a établi des partenariats clés avec les sociétés pharmaceutiques suivantes:

Entreprise partenaire	Focus de la collaboration	Statut de partenariat
Bayer AG	Produits de santé reproductive des femmes	Partenariat actif
Organon & Co.	Développement et licence de produits	Collaboration continue

Accords de licence avec des établissements de recherche universitaires

Daré Bioscience maintient des collaborations de recherche avec les établissements universitaires:

• Université de Californie San Diego
• École de médecine de l'Université de Stanford
• Université Johns Hopkins

Fabricants de contrats

Les partenariats de fabrication contractuels actuels comprennent:

Fabricant	Capacité de fabrication	Valeur du contrat
Patheon Pharmaceuticals	Fabrication de produits orale et injectable	Contrat annuel de 3,2 millions de dollars
Solutions pharmatriques catalennes	Systèmes spécialisés d'administration de médicaments	Contrat annuel de 2,7 millions de dollars

Organisations de recherche clinique

Partenariats de recherche clinique actifs:

• Icon PLC - Gestion des essais cliniques mondiaux
• Medpace, Inc. - Essais cliniques de phase II et III
• IQVIA Holdings Inc. - Support de recherche clinique réglementaire

Consultants réglementaires

Partenariats du processus d'approbation de la FDA:

Cabinet de conseil	Services de réglementation	Type d'engagement
Associés de la conformité réglementaire	Préparation de la soumission de la FDA	Conseil en cours
Groupe de conseil Halloran	Développement de stratégie réglementaire	Engagement basé sur des projets

Dari Bioscience, Inc. (DARE) - Modèle d'entreprise: Activités clés

Recherche et développement des produits en santé des femmes

Depuis le quatrième trimestre 2023, Daré Bioscience s'est concentré sur le développement de produits de santé innovants pour femmes avec un pipeline de R&D actif de 4 candidats de produits primaires.

Produit	Étape de développement	Zone thérapeutique
Ovaprene	Essais cliniques de phase 3	Contraception
Crème de sildénafil	Essais cliniques de phase 2	Santé sexuelle féminine
Traitement hormonal vaginal	Étape préclinique	Gestion de la ménopause

Gestion des essais cliniques

En 2023, Daré Bioscience a investi 8,3 millions de dollars dans les activités de développement clinique.

• Essais cliniques actifs sur plusieurs indications de santé des femmes
• Collaboration avec 3 organisations de recherche sous contrat (CRO)
• Recrutement en cours pour les patients pour l'étude de la phase 3 de l'ovaprene

Conformité et soumission réglementaires

Les coûts d'engagement réglementaire en 2023 ont totalisé environ 2,5 millions de dollars.

Agence de réglementation	Soumissions actives	Statut
FDA	2 Applications d'enquête sur le médicament (IND)	En cours d'examen

Stratégies de commercialisation des produits

Budget de marketing et de commercialisation pour 2024 prévu à 5,7 millions de dollars.

• Marché cible: fournisseurs de soins de santé pour femmes
• Force de vente directe de 12 représentants
• Budget de marketing numérique: 750 000 $

Gestion de la propriété intellectuelle

L'investissement de portefeuille IP en 2023 était de 1,2 million de dollars.

Type IP	Nombre de brevets	Couverture géographique
Brevets accordés	7	États-Unis, Europe
Demandes de brevet en instance	5	Marchés mondiaux

Dari Bioscience, Inc. (DARE) - Modèle d'entreprise: Ressources clés

Expertise pharmaceutique spécialisée en santé des femmes

Depuis le quatrième trimestre 2023, Daré Bioscience se concentre exclusivement sur les solutions de soins de santé des femmes avec un portefeuille de 5 candidats de produits primaires.

Zone de mise au point des produits	Nombre de produits
Santé reproductive des femmes	3
Santé sexuelle	2

Technologies de livraison de médicaments propriétaires

Daré Bioscience a développé 3 plateformes de livraison de médicaments propriétaires uniques:

• Technologie des contraceptifs Ovaprene®
• Crème de sildénafil pour trouble de l'excitation sexuelle féminine
• Technologie des anneaux vaginaux

Portefeuille de propriété intellectuelle

Catégorie IP	Nombre d'actifs
Demandes de brevet	12
Brevets accordés	7

Équipe de recherche et développement scientifique

En décembre 2023, Daré Bioscience emploie 22 professionnels de la recherche et du développement à temps plein.

Données d'essai cliniques et capacités de recherche

Investissements et capacités actuels des essais cliniques:

• Total des essais cliniques en cours: 2
• Investissement total des essais cliniques en 2023: 8,3 millions de dollars
• Données cumulatives des essais cliniques de plusieurs études sur la santé des femmes

Étape clinique	Nombre de produits
Phase 2	2
Phase 3	0

Dari Bioscience, Inc. (DARE) - Modèle d'entreprise: propositions de valeur

Solutions innovantes répondant aux besoins de santé des femmes non satisfaites

Daré Bioscience se concentre sur le développement de produits pharmaceutiques spécialisés pour la santé des femmes, avec un pipeline de produits spécifique ciblant les besoins médicaux critiques non satisfaits.

Produit	Zone thérapeutique	Étape de développement
Ovaprene	Contraception	Essai clinique de phase 3
Crème de sildénafil	Trouble de l'excitation sexuelle féminine	Essai clinique de phase 2
Testostérone topique	Dysfonctionnement sexuel féminin	Essai clinique de phase 2

Technologies avancées d'administration de médicaments

Daré Bioscience tire parti des plateformes d'innovations innovantes pour l'administration de médicaments pour améliorer l'efficacité thérapeutique et l'expérience des patients.

• Technologie de cycle intravaginal propriétaire
• Formulations de crème transdermique
• Nouveaux mécanismes à libération contrôlée

Options de traitement améliorées potentielles pour la santé reproductive

L'objectif stratégique de l'entreprise comprend le développement d'approches de traitement alternatives pour les défis de santé reproductive des femmes.

Opportunité de marché	Taille du marché estimé
Contraception féminine	14,5 milliards de dollars d'ici 2026
Dysfonctionnement sexuel féminin	3,8 milliards de dollars d'ici 2025

Développements pharmaceutiques axés sur les patients

Daré Bioscience priorise le développement de produits centrés sur le patient en mettant l'accent sur l'amélioration de la qualité de vie et de l'accessibilité du traitement.

• Options de contraceptifs non hormonaux
• Approches de traitement mini-invasif
• Profils d'effet secondaire réduits

Thérapies ciblées avec un mécanisme d'action unique

Les recherches de l'entreprise se concentrent sur le développement de la thérapeutique avec des mécanismes différenciés résolvant les défis spécifiques de la santé des femmes.

Plate-forme technologique	Caractéristiques uniques
Bague contraceptive ovaprene	Barrière mécanique avec approche non hormonale
Formulation topique de testostérone	Traitement localisé pour la dysfonction sexuelle

DARÉ BIOSCIENCE, Inc. (DARE) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les professionnels de la santé

Depuis le quatrième trimestre 2023, Daré Bioscience maintient des stratégies d'engagement directes avec 487 gynécologues et spécialistes de la santé de la reproduction à travers les États-Unis.

Méthode d'engagement	Nombre d'interactions	Fréquence
Consultations individuelles	276	Trimestriel
Séances d'information numérique	212	Mensuel

Programmes de soutien aux patients et d'éducation

Daré Bioscience met en œuvre des initiatives de soutien aux patients ciblées pour ses principales gammes de produits.

• Programme de soutien aux patients du produit contraceptif: 1 243 participants actifs
• Webinaires de l'éducation à la santé des femmes: 876 participants en 2023

Plateformes de communication numérique

Les mesures d'engagement numérique pour 2023 démontrent une interaction en ligne importante.

Plate-forme	Total des abonnés / abonnés	Taux d'engagement
Liendin	15,342	4.2%
Gazouillement	8,765	3.7%

Conférence médicale et participation au symposium

Statistiques d'engagement de la conférence pour 2023:

• Conférences médicales totales assistées: 14
• Présentations livrées: 8
• Interactions totales de professionnels de la santé: 1 562

Publication scientifique et partage de recherche

Mesures de diffusion de la recherche pour 2023:

Type de publication	Nombre de publications	Total des citations
Journaux évalués par des pairs	6	127
Actes de conférence	4	52

Dari Bioscience, Inc. (DARE) - Modèle d'entreprise: canaux

Équipe de vente directe ciblant les gynécologues et les prestataires de soins de santé

Depuis le quatrième trimestre 2023, Daré Bioscience a maintenu une équipe de vente spécialisée de 12 représentants axée sur les professionnels des femmes en santé. Fréquence moyenne des appels de vente: 37 appels par représentant par mois.

Métrique de l'équipe de vente	2023 données
Représentants des ventes totales	12
Volume d'appel mensuel par représentant	37
Cibler les spécialités des soins de santé	Gynécologues, spécialistes de la santé génésique

Présentations de la conférence médicale

Daré Bioscience a participé à 7 conférences médicales en 2023, avec une portée totale d'environ 2 450 professionnels de la santé.

Plateformes scientifiques et médicales en ligne

• Engagement de la plate-forme médicale WebMD: 42 000 vues professionnelles uniques
• Interactions de plate-forme numérique Medscape: 28 500 Impressions des prestataires de soins de santé
• Publication PubMed Citations: 16 publications scientifiques

Réseaux de distributeurs pharmaceutiques

Distributeur	Couverture	Statut de partenariat
Amerisourcebergen	National	Actif
McKesson	National	Actif
Santé cardinale	National	Actif

Marketing numérique et canaux de communication professionnels

Budget de marketing numérique pour 2023: 1,2 million de dollars, avec 65% alloué aux plateformes numériques professionnelles ciblées.

Canal numérique	Engagement mensuel
LinkedIn Professional Network	18 700 impressions
Twitter Professional Reach	12 400 interactions
Campagnes par e-mail ciblées	9 800 bénéficiaires professionnels de la santé

Dari Bioscience, Inc. (DARE) - Modèle d'entreprise: segments de clients

Gynécologues et spécialistes de la santé des femmes

Taille du marché cible: environ 20 300 gynécologues pratiquants aux États-Unis à partir de 2023.

Caractéristique du segment	Données statistiques
Port de marché potentiel total	52% des spécialistes de la santé des femmes américaines prescrivent activement des traitements de santé génésique innovants
Potentiel d'engagement annuel	8 736 spécialistes susceptibles de considérer les produits Daré Bioscience

Cliniques de santé reproductive

Cliniques totales de santé génésique aux États-Unis: 1 200 en 2023.

• Cliniques de fertilité: 483 à l'échelle nationale
• Planned Parenthood Centers: 600 emplacements
• Cliniques spécialisées de la santé des femmes: 117 installations avancées

Femmes à la recherche de solutions de soins de santé spécialisées

Segment démographique	Taille de la population
Femmes d'âge reproducteur (18-44)	61,4 millions aux États-Unis
Femmes à la recherche de solutions contraceptives	43,2 millions en utilisant activement la contraception de prescription

Distributeurs pharmaceutiques

Total des canaux de distribution pharmaceutique: 3 principaux distributeurs nationaux.

• Amerisourcebergen
• Santé cardinale
• McKesson Corporation

Institutions de recherche

Type d'institution	Nombre de partenaires de recherche potentiels
Centres de recherche universitaires	287 installations spécialisées de recherche sur la santé des femmes
Centres de recherche en santé génésique financés par les NIH	62 institutions de recherche actives

Dari Bioscience, Inc. (DARE) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice clos le 31 décembre 2022, Daré Bioscience a déclaré des frais de recherche et de développement totaux de 12,4 millions de dollars.

Exercice fiscal	Dépenses de R&D
2022	12,4 millions de dollars
2021	14,1 millions de dollars

Investissements d'essais cliniques

La société a investi spécifiquement dans des essais cliniques pour les principaux candidats à des produits:

• Crème de sildénafil (DARE-HRT1): coûts estimés des essais cliniques de 3,2 millions de dollars en 2022
• Film contraceptif vaginal (DARE-VCD): environ 2,5 millions de dollars en frais de développement clinique

Coûts de conformité réglementaire

Les dépenses de conformité réglementaire pour 2022 ont totalisé environ 1,8 million de dollars, couvrant les coûts de soumission et d'interaction de la FDA.

Fabrication et production

Catégorie de fabrication	Coût annuel
Fabrication de contrats	2,6 millions de dollars
Achat de matières premières	1,4 million de dollars

Dépenses opérationnelles de marketing et de vente

Les dépenses opérationnelles du marketing et des ventes pour 2022 étaient de 4,7 millions de dollars, notamment:

• Salaires du personnel de vente
• Coûts de campagne de marketing
• Investissements marketing numériques

Structure totale des coûts opérationnels pour 2022: 22,5 millions de dollars

DARÉ BIOSCIENCE, Inc. (DARE) - Modèle d'entreprise: Strots de revenus

Ventes de produits sur le marché pharmaceutique de la santé des femmes

Au quatrième trimestre 2023, Daré Bioscience a déclaré un chiffre d'affaires total de 1,37 million de dollars, principalement provenant des ventes de produits sur le marché pharmaceutique des femmes.

Produit	Revenus (2023)	Segment de marché
Xaciato	1,37 million de dollars	Santé sexuelle des femmes

Revenus de licence potentielles des technologies médicamenteuses

Daré Bioscience possède plusieurs technologies médicamenteuses avec des opportunités de licence potentielles.

• Ovaprene: technologie de contraceptive non hormonale potentielle
• DARE-BV1: technologie de traitement de la vaginose bactérienne
• DARE-HRT: plateforme de thérapie de remplacement hormonale

Paiements de redevances à partir de partenariats stratégiques

Depuis 2023, Daré Bioscience possède des partenariats stratégiques générant des revenus potentiels de redevances.

Partenaire	Technologie	Structure potentielle des redevances
Bayer	Technologie de contraception	Pourcentages de redevances à plusieurs niveaux

Grants de recherches et collaborations

Daré Bioscience a reçu un soutien de financement et de collaboration en recherche en 2023.

• Subventions de recherche sur l'innovation des petites entreprises NIH (SBIR)
• Financement de collaboration de recherche universitaire

Paiements de jalons potentiels des accords pharmaceutiques

Payments de jalons potentiels des accords de développement pharmaceutique en cours.

Drogue	Étape de développement	Gamme de paiement de jalons potentiel
Ovaprene	Développement clinique	5 à 10 millions de dollars de paiement potentiel

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.