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

Daré Bioscience, Inc. (DARE) entwickelt sich zu einer Pionierkraft in der Gesundheitsversorgung von Frauen und navigiert strategisch durch die komplexe Pharmalandschaft durch ein innovatives Geschäftsmodell, das ungedeckte medizinische Bedürfnisse in bahnbrechende Lösungen umwandelt. Durch die Nutzung spezieller Fachkenntnisse im Bereich der reproduktiven Gesundheit von Frauen entwickelt das Unternehmen ein einzigartiges Wertversprechen, das fortschrittliche Arzneimittelverabreichungstechnologien mit gezielten Therapieansätzen kombiniert und sich so als disruptiver Akteur in einem traditionell unterversorgten Marktsegment positioniert. Ihr umfassender Business Model Canvas offenbart eine sorgfältig entworfene Strategie, die wissenschaftliche Innovation, strategische Partnerschaften und patientenzentrierte Entwicklung miteinander verknüpft, um Gesundheitslösungen für Frauen zu revolutionieren.

Daré Bioscience, Inc. (DARE) – Geschäftsmodell: Wichtige Partnerschaften

Strategische Zusammenarbeit mit Pharmaunternehmen

Seit 2024 hat Daré Bioscience wichtige Partnerschaften mit den folgenden Pharmaunternehmen aufgebaut:

Partnerunternehmen	Fokus auf Zusammenarbeit	Partnerschaftsstatus
Bayer AG	Produkte für die reproduktive Gesundheit von Frauen	Aktive Partnerschaft
Organon & Co.	Produktentwicklung und Lizenzierung	Laufende Zusammenarbeit

Lizenzvereinbarungen mit akademischen Forschungseinrichtungen

Daré Bioscience unterhält Forschungskooperationen mit akademischen Institutionen:

• Universität von Kalifornien San Diego
• Medizinische Fakultät der Stanford University
• Johns Hopkins Universität

Vertragshersteller

Zu den aktuellen Auftragsfertigungspartnerschaften gehören:

Hersteller	Fertigungskapazität	Vertragswert
Patheon Pharmaceuticals	Herstellung oraler und injizierbarer Produkte	Jahresvertrag über 3,2 Millionen US-Dollar
Catalent Pharma-Lösungen	Spezialisierte Arzneimittelverabreichungssysteme	Jahresvertrag über 2,7 Millionen US-Dollar

Klinische Forschungsorganisationen

Aktive klinische Forschungspartnerschaften:

• ICON plc – Globales Management klinischer Studien
• Medpace, Inc. – Klinische Studien der Phasen II und III
• IQVIA Holdings Inc. – Unterstützung bei der regulatorischen klinischen Forschung

Regulierungsberater

Partnerschaften im FDA-Zulassungsprozess:

Beratungsunternehmen	Regulierungsdienste	Engagement-Typ
Mitarbeiter zur Einhaltung gesetzlicher Vorschriften	Vorbereitung der FDA-Einreichung	Laufende Beratung
Halloran Consulting Group	Entwicklung einer Regulierungsstrategie	Projektbasiertes Engagement

Daré Bioscience, Inc. (DARE) – Geschäftsmodell: Hauptaktivitäten

Forschung und Entwicklung von Gesundheitsprodukten für Frauen

Ab dem vierten Quartal 2023 konzentrierte sich Daré Bioscience auf die Entwicklung innovativer Gesundheitsprodukte für Frauen mit einer aktiven Forschungs- und Entwicklungspipeline von vier Hauptproduktkandidaten.

Produkt	Entwicklungsphase	Therapeutischer Bereich
Ovaprene	Klinische Studien der Phase 3	Empfängnisverhütung
Sildenafil-Creme	Klinische Studien der Phase 2	Sexuelle Gesundheit von Frauen
Vaginale Hormonbehandlung	Vorklinisches Stadium	Management der Wechseljahre

Klinisches Studienmanagement

Im Jahr 2023 investierte Daré Bioscience 8,3 Millionen US-Dollar in klinische Entwicklungsaktivitäten.

• Aktive klinische Studien zu verschiedenen Indikationen für die Frauengesundheit
• Zusammenarbeit mit 3 Auftragsforschungsorganisationen (CROs)
• Laufende Patientenrekrutierung für die Ovaprene-Phase-3-Studie

Einhaltung gesetzlicher Vorschriften und Einreichung

Die Kosten für den regulatorischen Eingriff beliefen sich im Jahr 2023 auf etwa 2,5 Millionen US-Dollar.

Regulierungsbehörde	Aktive Einreichungen	Status
FDA	2 Investigational New Drug (IND)-Anträge	Wird überprüft

Strategien zur Produktkommerzialisierung

Das Marketing- und Vermarktungsbudget für 2024 wird voraussichtlich 5,7 Millionen US-Dollar betragen.

• Zielmarkt: Gesundheitsdienstleister für Frauen
• Direktvertriebsteam von 12 Vertretern
• Budget für digitales Marketing: 750.000 US-Dollar

Geistiges Eigentumsmanagement

Die Investitionen in das IP-Portfolio beliefen sich im Jahr 2023 auf 1,2 Millionen US-Dollar.

IP-Typ	Anzahl der Patente	Geografische Abdeckung
Erteilte Patente	7	Vereinigte Staaten, Europa
Ausstehende Patentanmeldungen	5	Globale Märkte

Daré Bioscience, Inc. (DARE) – Geschäftsmodell: Schlüsselressourcen

Spezialisierte pharmazeutische Expertise für die Frauengesundheit

Ab dem vierten Quartal 2023 konzentriert sich Daré Bioscience ausschließlich auf Gesundheitslösungen für Frauen mit einem Portfolio von fünf Hauptproduktkandidaten.

Produktschwerpunktbereich	Anzahl der Produkte
Reproduktive Gesundheit von Frauen	3
Sexuelle Gesundheit	2

Proprietäre Arzneimittelverabreichungstechnologien

Daré Bioscience hat sich entwickelt 3 einzigartige proprietäre Plattformen zur Medikamentenverabreichung:

• Ovaprene®-Verhütungstechnologie
• Sildenafil-Creme gegen weibliche sexuelle Erregungsstörung
• Vaginalring-Technologie

Portfolio für geistiges Eigentum

IP-Kategorie	Anzahl der Vermögenswerte
Patentanmeldungen	12
Erteilte Patente	7

Wissenschaftliches Forschungs- und Entwicklungsteam

Ab Dezember 2023 beschäftigt Daré Bioscience 22 Vollzeit-Forschungs- und Entwicklungsexperten.

Klinische Studiendaten und Forschungskapazitäten

Aktuelle Investitionen und Kapazitäten für klinische Studien:

• Gesamtzahl der laufenden klinischen Studien: 2
• Gesamtinvestition in klinische Studien im Jahr 2023: 8,3 Millionen US-Dollar
• Kumulative klinische Studiendaten aus mehreren Studien zur Frauengesundheit

Klinisches Stadium	Anzahl der Produkte
Phase 2	2
Phase 3	0

Daré Bioscience, Inc. (DARE) – Geschäftsmodell: Wertversprechen

Innovative Lösungen für ungedeckte Gesundheitsbedürfnisse von Frauen

Daré Bioscience konzentriert sich auf die Entwicklung spezialisierter pharmazeutischer Produkte für die Gesundheit von Frauen und verfügt über eine spezifische Produktpipeline, die auf kritische ungedeckte medizinische Bedürfnisse abzielt.

Produkt	Therapeutischer Bereich	Entwicklungsphase
Ovaprene	Empfängnisverhütung	Klinische Phase-3-Studie
Sildenafil-Creme	Weibliche sexuelle Erregungsstörung	Klinische Phase-2-Studie
Topisches Testosteron	Weibliche sexuelle Dysfunktion	Klinische Phase-2-Studie

Fortschrittliche Technologien zur Arzneimittelverabreichung

Daré Bioscience nutzt innovative Plattformen zur Arzneimittelverabreichung, um die therapeutische Wirksamkeit und das Patientenerlebnis zu verbessern.

• Proprietäre intravaginale Ringtechnologie
• Transdermale Cremeformulierungen
• Neuartige Mechanismen zur kontrollierten Freisetzung

Potenziell verbesserte Behandlungsmöglichkeiten für die reproduktive Gesundheit

Der strategische Schwerpunkt des Unternehmens umfasst die Entwicklung alternativer Behandlungsansätze für die Probleme der reproduktiven Gesundheit von Frauen.

Marktchance	Geschätzte Marktgröße
Empfängnisverhütung für Frauen	14,5 Milliarden US-Dollar bis 2026
Weibliche sexuelle Dysfunktion	3,8 Milliarden US-Dollar bis 2025

Patientenorientierte pharmazeutische Entwicklungen

Daré Bioscience legt Wert auf eine patientenzentrierte Produktentwicklung mit Schwerpunkt auf der Verbesserung der Lebensqualität und der Zugänglichkeit von Behandlungen.

• Nicht-hormonelle Verhütungsmittel
• Minimalinvasive Behandlungsansätze
• Reduzierte Nebenwirkungsprofile

Gezielte Therapien mit einzigartigem Wirkmechanismus

Die Forschung des Unternehmens konzentriert sich auf die Entwicklung von Therapeutika mit differenzierten Wirkmechanismen, die speziell auf die gesundheitlichen Herausforderungen von Frauen zugeschnitten sind.

Technologieplattform	Einzigartige Eigenschaften
Ovaprene-Verhütungsring	Mechanische Barriere mit nicht-hormonellem Ansatz
Topische Testosteronformulierung	Lokalisierte Behandlung sexueller Dysfunktion

Daré Bioscience, Inc. (DARE) – Geschäftsmodell: Kundenbeziehungen

Direkter Kontakt mit medizinischem Fachpersonal

Seit dem vierten Quartal 2023 unterhält Daré Bioscience Strategien zur direkten Zusammenarbeit mit 487 Gynäkologen und Spezialisten für reproduktive Gesundheit in den Vereinigten Staaten.

Engagement-Methode	Anzahl der Interaktionen	Häufigkeit
Einzelberatungen	276	Vierteljährlich
Digitale Informationsveranstaltungen	212	Monatlich

Patientenunterstützungs- und Aufklärungsprogramme

Daré Bioscience implementiert gezielte Initiativen zur Patientenunterstützung für seine wichtigsten Produktlinien.

• Patientenunterstützungsprogramm für Verhütungsmittel: 1.243 aktive Teilnehmer
• Webinare zur Gesundheitserziehung für Frauen: 876 Teilnehmer im Jahr 2023

Digitale Kommunikationsplattformen

Die Kennzahlen zum digitalen Engagement für 2023 zeigen eine signifikante Online-Interaktion.

Plattform	Gesamtzahl der Follower/Abonnenten	Engagement-Rate
LinkedIn	15,342	4.2%
Twitter	8,765	3.7%

Teilnahme an medizinischen Konferenzen und Symposien

Statistiken zum Konferenzengagement für 2023:

• Gesamtzahl der besuchten medizinischen Konferenzen: 14
• Vorträge gehalten: 8
• Gesamtzahl der Interaktionen mit medizinischem Fachpersonal: 1.562

Wissenschaftliche Veröffentlichung und Forschungsaustausch

Kennzahlen zur Forschungsverbreitung für 2023:

Veröffentlichungstyp	Anzahl der Veröffentlichungen	Gesamtzahl der Zitate
Von Experten begutachtete Zeitschriften	6	127
Konferenzbeiträge	4	52

Daré Bioscience, Inc. (DARE) – Geschäftsmodell: Kanäle

Direktvertriebsteam für Gynäkologen und Gesundheitsdienstleister

Ab dem vierten Quartal 2023 unterhielt Daré Bioscience ein spezialisiertes Vertriebsteam von 12 Vertretern, die sich auf Fachkräfte im Gesundheitswesen von Frauen konzentrieren. Durchschnittliche Verkaufsanrufhäufigkeit: 37 Anrufe pro Vertreter und Monat.

Vertriebsteam-Metrik	Daten für 2023
Gesamtzahl der Vertriebsmitarbeiter	12
Monatliches Anrufvolumen pro Mitarbeiter	37
Zielgerichtete Gesundheitsspezialitäten	Gynäkologen, Spezialisten für reproduktive Gesundheit

Präsentationen auf medizinischen Konferenzen

Daré Bioscience nahm im Jahr 2023 an sieben medizinischen Konferenzen teil, mit einer Gesamtpräsentationsreichweite von rund 2.450 medizinischen Fachkräften.

Online-Plattformen für Wissenschaft und Medizin

• Engagement auf der medizinischen Plattform WebMD: 42.000 einzigartige professionelle Ansichten
• Interaktionen mit der digitalen Plattform Medscape: 28.500 Impressionen von Gesundheitsdienstleistern
• PubMed-Publikationszitate: 16 wissenschaftliche Publikationen

Pharmazeutische Vertriebsnetzwerke

Händler	Abdeckung	Partnerschaftsstatus
AmerisourceBergen	National	Aktiv
McKesson	National	Aktiv
Kardinalgesundheit	National	Aktiv

Digitales Marketing und professionelle Kommunikationskanäle

Budget für digitales Marketing für 2023: 1,2 Millionen US-Dollar, davon 65 % für gezielte professionelle digitale Plattformen.

Digitaler Kanal	Monatliches Engagement
LinkedIn Professional Network	18.700 Impressionen
Professionelle Twitter-Reichweite	12.400 Interaktionen
Gezielte E-Mail-Kampagnen	9.800 Empfänger medizinischer Fachkräfte

Daré Bioscience, Inc. (DARE) – Geschäftsmodell: Kundensegmente

Gynäkologen und Frauengesundheitsspezialisten

Zielmarktgröße: Ungefähr 20.300 praktizierende Gynäkologen in den Vereinigten Staaten im Jahr 2023.

Segmentcharakteristik	Statistische Daten
Gesamte potenzielle Marktreichweite	52 % der US-amerikanischen Frauengesundheitsspezialisten verschreiben aktiv innovative Behandlungen für die reproduktive Gesundheit
Jährliches Engagement-Potenzial	8.736 Spezialisten werden wahrscheinlich die Produkte von Daré Bioscience in Betracht ziehen

Kliniken für reproduktive Gesundheit

Gesamtzahl der Kliniken für reproduktive Gesundheit in den Vereinigten Staaten: 1.200 (Stand 2023).

• Fruchtbarkeitskliniken: 483 landesweit
• Geplante Elternschaftszentren: 600 Standorte
• Spezialisierte Frauenkliniken: 117 moderne Einrichtungen

Frauen auf der Suche nach spezialisierten Gesundheitslösungen

Demografisches Segment	Bevölkerungsgröße
Frauen im gebärfähigen Alter (18–44)	61,4 Millionen in den Vereinigten Staaten
Frauen auf der Suche nach Verhütungslösungen	43,2 Millionen nutzen aktiv verschreibungspflichtige Verhütungsmittel

Pharmazeutische Vertriebshändler

Gesamtzahl der pharmazeutischen Vertriebskanäle: 3 große nationale Vertriebshändler.

• AmerisourceBergen
• Kardinalgesundheit
• McKesson Corporation

Forschungseinrichtungen

Institutionstyp	Anzahl potenzieller Forschungspartner
Akademische Forschungszentren	287 spezialisierte Forschungseinrichtungen für Frauengesundheit
Vom NIH finanzierte Forschungszentren für reproduktive Gesundheit	62 aktive Forschungseinrichtungen

Daré Bioscience, Inc. (DARE) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das am 31. Dezember 2022 endende Geschäftsjahr meldete Daré Bioscience Forschungs- und Entwicklungskosten in Höhe von insgesamt 12,4 Millionen US-Dollar.

Geschäftsjahr	F&E-Ausgaben
2022	12,4 Millionen US-Dollar
2021	14,1 Millionen US-Dollar

Investitionen in klinische Studien

Das Unternehmen investierte gezielt in klinische Studien für wichtige Produktkandidaten:

• Sildenafil-Creme (DARE-HRT1): Geschätzte Kosten für klinische Studien belaufen sich im Jahr 2022 auf 3,2 Millionen US-Dollar
• Vaginaler Verhütungsfilm (DARE-VCD): Ungefähr 2,5 Millionen US-Dollar an klinischen Entwicklungskosten

Kosten für die Einhaltung gesetzlicher Vorschriften

Die Ausgaben für die Einhaltung gesetzlicher Vorschriften beliefen sich im Jahr 2022 auf insgesamt etwa 1,8 Millionen US-Dollar und deckten die Einreichungs- und Interaktionskosten bei der FDA ab.

Herstellung und Produktion

Kategorie „Fertigung“.	Jährliche Kosten
Auftragsfertigung	2,6 Millionen US-Dollar
Rohstoffbeschaffung	1,4 Millionen US-Dollar

Betriebskosten für Marketing und Vertrieb

Die Betriebskosten für Marketing und Vertrieb beliefen sich im Jahr 2022 auf 4,7 Millionen US-Dollar, darunter:

• Gehälter des Vertriebspersonals
• Kosten für Marketingkampagnen
• Investitionen in digitales Marketing

Gesamtbetriebskostenstruktur für 2022: 22,5 Millionen US-Dollar

Daré Bioscience, Inc. (DARE) – Geschäftsmodell: Einnahmequellen

Produktverkäufe im Arzneimittelmarkt für Frauengesundheit

Im vierten Quartal 2023 meldete Daré Bioscience einen Gesamtumsatz von 1,37 Millionen US-Dollar, der hauptsächlich aus Produktverkäufen im Markt für Frauengesundheitspharmazeutika stammte.

Produkt	Umsatz (2023)	Marktsegment
Xaciato	1,37 Millionen US-Dollar	Sexuelle Gesundheit von Frauen

Potenzielle Lizenzeinnahmen aus Arzneimitteltechnologien

Daré Bioscience verfügt über mehrere Arzneimitteltechnologien mit potenziellen Lizenzmöglichkeiten.

• Ovaprene: Mögliche nicht-hormonelle Verhütungstechnologie
• DARE-BV1: Technologie zur Behandlung bakterieller Vaginose
• DARE-HRT: Plattform für Hormonersatztherapie

Lizenzgebühren aus strategischen Partnerschaften

Ab 2023 verfügt Daré Bioscience über strategische Partnerschaften, die potenzielle Lizenzeinnahmen generieren.

Partner	Technologie	Mögliche Lizenzgebührenstruktur
Bayer	Verhütungstechnologie	Gestaffelte Lizenzgebührenprozentsätze

Forschungsstipendien und Kooperationen

Daré Bioscience erhielt im Jahr 2023 Forschungsgelder und Kooperationsunterstützung.

• Zuschüsse des NIH Small Business Innovation Research (SBIR).
• Finanzierung der akademischen Forschungszusammenarbeit

Potenzielle Meilensteinzahlungen aus Arzneimittelverträgen

Mögliche Meilensteinzahlungen aus laufenden pharmazeutischen Entwicklungsvereinbarungen.

Arzneimittelkandidat	Entwicklungsphase	Möglicher Meilensteinzahlungsbereich
Ovaprene	Klinische Entwicklung	Potenzielle Meilensteinzahlungen in Höhe von 5 bis 10 Millionen US-Dollar

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.