Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 79

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 79
---
 currently planned Phase 3 study will have co-primary efficacy endpoints- one assessing arousal sensations and one assessing associated distress, which will be the same co-primary endpoints for arousal sensations and associated distress used in the Phase 2b RESPOND study. In addition, secondary efficacy endpoints to assess improvement in orgasm, desire, and distress and interpersonal difficulties will be included in the Phase 3 study, as they were in the Phase 2b RESPOND study.

We plan to submit the protocol and statistical analysis plan for an adequate and well-controlled Phase 3 clinical study, reflecting the FDA’s recommendations, to the FDA in the second quarter of 2025, pending review of additional forthcoming recommendations from the FDA that impact our statistical analysis plan. We are targeting 2025 for commencement of the Phase 3 study pending the forthcoming FDA recommendations. We do not plan to conduct the Phase 3 study until after we secure additional capital.

A second confirmatory Phase 3 study will be required to support the NDA submission. We anticipate that each 

11

Phase 3 study will be approximately $15.0 million in direct R&D costs (as defined below). 

We are developing Sildenafil Cream with Strategic Science & Technologies-D LLC and Strategic Science & Technologies, LLC (which we refer to collectively as SST) under our license and collaboration agreement announced in February 2018. See “Strategic Agreements for Pipeline Development” below for discussion of the terms of this collaboration.

DARE-HRT1

DARE-HRT1 is a unique intravaginal ring, or IVR, designed to deliver bio-identical 17β-estradiol and bio-identical progesterone continuously over a 28-day period as part of a menopausal hormone therapy regimen. The IVR technology used in DARE-HRT1 was developed by Dr. Robert Langer from the Massachusetts Institute of Technology and Dr. William Crowley from Massachusetts General Hospital and Harvard Medical School. Unlike other vaginal ring technologies, ours is designed to release drugs via a solid ethylene vinyl acetate polymer matrix without the need for a membrane or reservoir to contain the active drug or control the release, allowing for sustained drug delivery over time periods ranging from weeks to months. Hormone therapy is considered the most effective treatment for vasomotor symptoms, or VMS, commonly referred to as hot flashes, and the genitourinary syndrome of menopause, or GSM, and it has been shown to prevent bone loss and fracture. 

Following clinical development, we intend to leverage