Company: DARE
Filing Date: 2025-05-13
Form Type: 10-Q
Source: 0001401914-25-000022
Chunk: 57

Company: Dare Bioscience, Inc.
Filing Date: 2025-05-13
Form: 10-Q
Item: Part I, Item 1
Chunk 57
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 quarter of 2025, however, we do not expect the amount of such revenue, if any, to be material during 2025. We anticipate needing to invest no more than $1.0 million to support a 503B-registered outsourcing facility with technology-transfer activities specific to our Sildenafil Cream formulation, activate an awareness campaign, and facilitate access to our proprietary Sildenafil Cream formulation as an option for providers and women.

DARE-HRT1

We are also taking action to bring DARE-HRT1 to market under 503B. We are targeting to have DARE-HRT1 available, and we expect to begin recording revenue from sales thereof, by the end of 2026, however, we do not expect the amount of such revenue, if any, to be material during 2026. There are no FDA approved products that provide estradiol and progesterone together in a non-oral monthly form.

Consumer Health Products

We are also working to bring to market consumer health products. We have sourced vaginal probiotics from Europe that we aim to make available initially via a strategic partnership, and we expect to begin recording revenue from sales thereof, in the fourth quarter of 2025, however we do not expect the amount of such revenue, if any, to be material during 2025.

When we use the term "consumer health products," we refer to consumer health products that can be obtained without a physician's prescription, unless the context otherwise requires.

Similar to our plans with respect to our Section 503B business strategy, we do not plan to establish marketing, sales or distribution capabilities in order to bring our proprietary formulations to market as consumer health products, but rather we plan to identify and enter into strategic agreements and collaborations with telehealth platforms and other third parties with marketing, sales or distribution capabilities in the consumer health products market. 

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Nasdaq Listing

We have not been in compliance with the requirement in Nasdaq Listing Rule 5550(b) for continued listing on The Nasdaq Capital Market since August 2024. On March 25, 2025, we presented our multi-step plan for regaining compliance to the Nasdaq Hearing Panel, or the Panel. On April 9, 2025, we received a letter from Nasdaq informing us that the Panel determined to grant our request for an extension until August 12, 2025 to demonstrate compliance with Nasdaq Listing Rule 5550(b) by demonstrating compliance with either Nasdaq Listing Rule 5550(b)(