Business Context and Reporting Period
Company: Daré Bioscience, Inc.
Filing Type: Form 8-K (Current Report)
Date of Report: July 8, 2021
Reporting Period: Event-based report regarding a specific agreement entered into on July 8, 2021.
Key Financial Metrics
This filing does not report standard financial performance metrics such as revenue, profit, cash flow, or margins. The primary financial disclosure relates to a specific contractual obligation:
- Total Commitment: $5.5 million payable to the U.S. Department of Health and Human Services (NICHD).
- Payment Schedule:
- Payment 1: $250,000 (Due within 30 days of effective date).
- Payment 2: $1.25 million (Due Q4 2021).
- Payment 3: $3.5 million (Due Q1 2022).
- Payment 4: $500,000 (Due Q2 2023).
Material Changes
The material change reported is the entry into a Cooperative Research and Development Agreement (CRADA) with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Key terms include:
- Objective: Conduct a multi-center, non-comparative, pivotal Phase 3 clinical study for the contraceptive device Ovaprene.
- Timeline: Daré anticipates submitting an Investigational Device Exemption (IDE) to the FDA in Q4 2021, with study commencement expected in 2022.
- Roles: Daré provides clinical supplies, regulatory coordination, and funding. NICHD manages the study network, clinical coordination, and data collection.
- Intellectual Property: Daré retains an exclusive option to negotiate a license for inventions jointly or independently invented by NICHD employees related to the research plan.
Outlook, Risks, and Contingencies
Management Commentary and Outlook: The company expects to file the IDE in late 2021 to begin the Phase 3 study in 2022. The CRADA expires five years from its effective date.
Risks and Contingencies:
- Termination: Either party may terminate the CRADA for any reason with 30 days' prior written notice.
- Financial Risk: Risks include Daré's ability to raise additional capital to meet payment obligations and continue as a going concern.
- Operational Risk: Risks inherent in R&D of investigational products and the ability to timely meet regulatory milestones.
- Data Transfer: If terminated before completion, NICHD must cooperate to transfer data and study conduct to Daré.
Investor Verification Checklist
- Verify the company's current cash position and ability to fund the $5.5 million payment schedule, particularly the $3.5 million due in Q1 2022.
- Monitor the status of the Investigational Device Exemption (IDE) filing with the FDA, targeted for Q4 2021.
- Review the full text of the CRADA agreement when filed in the Form 10-Q for the period ending September 30, 2021.
- Assess the risk of early termination by NICHD, which could impact the timeline for Ovaprene commercialization.