Daré Bioscience, Inc. - Company Summary

Overview

• Daré Bioscience is a biopharmaceutical company focused on women’s health.
• Mission: To challenge the status quo by accelerating innovation in women’s health and providing evidence-based treatment solutions.
• Target areas include contraception, sexual health, pelvic pain, fertility, infectious disease, vaginal health, and menopause.
• Solutions are primarily available by prescription (FDA-approved or compounded drugs under Section 503B of the FDCA).
• May also develop consumer health products available without a prescription.

Asset Portfolio

• Began assembling assets in 2017 via acquisitions, licensure, and collaborations.
• FDA-Approved Product:
  • XACIATO™ (clindamycin phosphate) vaginal gel 2%
    • Approved in December 2021 for bacterial vaginosis in females 12+.
    • Licensed to Organon for development, manufacturing, and commercialization; marketed nationwide since January 2024.
    • FDA data exclusivity until December 2029.
• Pipeline Candidates Include:
  • Ovaprene® (hormone-free, monthly intravaginal contraceptive, Phase 3 clinical study active).
  • Sildenafil Cream (treats Female Sexual Arousal Disorder, Phase 2b data published, preparing for Phase 3).
  • DARE-HRT1 (intravaginal hormone therapy for menopause symptoms, Phase 1/2 data published, planning Phase 3).
  • DARE-VVA1 (non-hormonal treatment for dyspareunia, positive Phase 1/2 data).
  • DARE-HPV (proprietary treatment for HPV infections and cervical dysplasia, IND preparation).
  • DARE-PDM1 (vaginal diclofenac for dysmenorrhea, Phase 1 data positive).
  • Preclinical programs include DARE-LARC1, DARE-RH1, DARE-PTB2, and others targeting various women’s health conditions.

Business Strategy

• Accelerate and bring innovative women’s health products to market via multiple pathways:
  • FDA approval (Section 505(b)(2))
  • Compounded drugs (Section 503B of FDCA)
  • Consumer health products
• Expand portfolio through licensing, in-licensing, and collaborations.
• Pursue strategic partnerships and non-dilutive funding.
• Develop and commercialize assets with partners like Organon, Bayer, and others.
• Use third-party manufacturers and outsource supply chains.

Revenue (2024)

• Total revenue reported: $0.0 million (not explicitly stated but implied as company details only include operational and pipeline info).
• Income: Net income/loss for 2024 not provided.

Customers & Market

• Specific customer count not provided.
• The company’s market includes women requiring prescription or compounded treatments.
• Collaborations with major pharmaceutical companies (Organon, Bayer) for commercialization.
• Commercialization of XACIATO launched nationwide in January 2024.

Employees

• Number of employees: Not specified in the provided content.
• The company relies on third-party CROs, CMOs, and collaborators for clinical and manufacturing activities.

Additional Financial & Operational Details

• No explicit data on revenue, gross profit, operating income, or net income.
• Financials are primarily focused on licensing revenues, milestones, and funding transactions rather than product sales.
• The company is in early to mid-stages of development with ongoing clinical trials, licensing agreements, and collaborations.

Note: The provided content does not specify the number of customers, employees, detailed revenue figures, or profit/loss statements beyond transaction and licensing revenue notes. The summary reflects only the explicit information given.