Company: DARE
Filing Date: 2025-08-14
Form Type: 10-Q
Source: 0001401914-25-000044
Chunk: 67

Company: Dare Bioscience, Inc.
Filing Date: 2025-08-14
Form: 10-Q
Item: Part I, Item 1
Chunk 67
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 the anticipated study, and activities necessary to enable submission of an IND application to the FDA for a Phase 2 clinical study of DARE-HPV in the United States.

Section 503B Business Strategy Update

DARE to PLAY™ Sildenafil Cream 

As announced in March 2025, we are taking action to bring our proprietary topical cream formulation of sildenafil to market under Section 503B. The compounded drug will be branded as DARE to PLAY Sildenafil Cream. We are targeting to have DARE to PLAY Sildenafil Cream available by prescription in the U.S., 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. 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 to begin recording revenue from sales thereof, in late 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 are targeting to make available as consumer health products in the U.S. after DARE to PLAY Sildenafil Cream is available by prescription in the U.S.

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 third parties with marketing, sales or distribution capabilities in the consumer health products market.

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Nasdaq Listing 

On July 24, 2025, we received a letter from the Nasdaq Office of General Counsel confirming that we had demonstrated compliance with the