Daré Bioscience to Present at the Jones Healthcare and Technology Innovation Conference on Expanded Business Strategy Including Action to Make its Proprietary Sildenafil Cream Formulation Available via Prescription This Year

Rhea-AI Summary

Daré Bioscience (NASDAQ: DARE) has announced its expanded business strategy featuring a dual-path approach for its proprietary Sildenafil Cream formulation, with plans to make it available via prescription in Q4 2025. The company's President and CEO, Sabrina Martucci Johnson, will present these developments at the Jones Healthcare and Technology Innovation Conference on April 9th, 2025.

The strategy includes utilizing Section 503B compounding to expedite market access for select Daré proprietary formulations. The company is also exploring bringing consumer health products to market without prescription requirements. Additional strategic partnerships and timing updates are expected this quarter.

The presentation will be accessible via webcast at 1:00 p.m. PT, with a replay available until April 23, 2025, through the company's investor relations website.

• Daré unveiled its new dual-path approach for its proprietary Sildenafil Cream formulation after urging on the part of the healthcare community and hearing the demand from women
• Daré is targeting availability of its proprietary Sildenafil Cream formulation via prescription in Q4 2025

SAN DIEGO, April 07, 2025 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a biopharmaceutical company driven by a mission to challenge the status quo, making women's health a priority, today announced that Sabrina Martucci Johnson, the company’s President and CEO, will present at the Jones Healthcare and Technology Innovation Conference on the company’s expanded business strategy to integrate 503B compounding as part of a dual-path approach to bring select Daré proprietary formulations to market as soon as practicable, starting with its proprietary Sildenafil Cream formulation this year. There are other proprietary formulations in the Daré portfolio that could also be provided via a prescription through the Section 503B of the FDCA framework.

“We are actively evaluating a dual-path approach for some of the other proprietary formulations as part of our responsibility to women, to the healthcare community, and to our shareholders. In addition, we may also bring to market consumer health products that can be obtained without a physician’s prescription. We are targeting this quarter to provide an update on timing and strategic partnerships to achieve these objectives, and I look forward to discussing our previously announced expanded business strategy this Wednesday, April 9^th,” said Ms. Johnson.

The live presentation may be accessed via webcast. Details for the presentation are as follows:

Event:	Jones Healthcare and Technology Innovation Conference
Date / Time:	Wednesday, April 9, 2025, 1:00 p.m. PT
Webcast Link:	https://wsw.com/webcast/jones2/dare/1859132
A replay of the presentation will be available in the Investors section of the company's website at http://ir.darebioscience.com under “Presentations, Events & Webcasts” until April 23, 2025.

About Daré Bioscience
Daré Bioscience is a biopharmaceutical company driven by a mission to challenge the status quo, making women's health a priority. We believe that innovation does not have to start from scratch. Our goal is to bring to market as soon as practicable innovative evidence-based solutions that address decades of unmet needs in women’s health and enhance outcomes and convenience, primarily in the areas of contraception, sexual health, pelvic pain, fertility, infectious disease, vaginal health and menopause. The potential products we identify, in many cases, already have clinical proof of concept or existing safety data for the active ingredient that we leverage. This gives us optionality and flexibility, in many cases, in how we seek to bring solutions to market in ways designed to optimize access for women in a fiscally responsible manner.

The first FDA-approved product to emerge from Daré’s portfolio of women’s health product candidates is XACIATO™ (clindamycin phosphate) vaginal gel 2%, a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older, which is under a global license agreement with Organon. Visit www.xaciato.com for information about XACIATO. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene^®, a novel, hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil, the active ingredient in Viagra^®, to treat female sexual arousal disorder (FSAD); and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy. To learn more about Daré’s full portfolio of women’s health product candidates and mission to deliver differentiated therapies for women, please visit www.darebioscience.com.

Daré Bioscience leadership has been named on the Medicine Maker’s Power List and Endpoints News’ Women in Biopharma and Daré's CEO has been honored as one of Fierce Pharma’s Most Influential People in Biopharma for Daré’s contributions to innovation and advocacy in the women’s health space.

Daré may announce material information about its finances, product and product candidates, clinical trials and other matters using the Investors section of its website (http://ir.darebioscience.com), SEC filings, press releases, public conference calls and webcasts. Daré will use these channels to distribute material information about the company and may also use social media to communicate important information about the company, its finances, product and product candidates, clinical trials and other matters. The information Daré posts on its investor relations website or through social media channels may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré posts in the Investors section of its website and to follow these X (formerly Twitter) accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the list of social media channels the company may use to communicate information will be posted in the Investors section of Daré’s website.

Forward-Looking Statements
Daré cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “objective,” “on track,” or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to plans and expectations with respect to Daré’s product candidates; Daré’s plans and timing for making its proprietary formulation of Sildenafil Cream available by prescription in the U.S. as a compounded drug via Section 503B of Federal Food, Drug, and Cosmetic Act (FDCA); its anticipated market acceptance and potential market demand; the potential for Daré to take action to make other proprietary formulations in the Daré portfolio available as compounded drugs via Section 503B of the FDCA; the potential for Daré to bring to market consumer health products; and potential third-party collaborations. As used in this press release, “first-in-category” is a forward-looking statement relating to the potential of a product candidate to represent a new category of product if it were to receive marketing approval for the indication for which it is being developed because Daré believes it would address a need in women’s health that is not being met by existing FDA-approved products. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Daré’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, without limitation, risks and uncertainties related to: Daré’s ability to raise additional capital when and as needed to execute its business strategy and continue as a going concern; the risk of delisting of Daré’s common stock from Nasdaq; developments impacting U.S. federal government contracting and funding of research and development activities; the degree of market demand and acceptance for Daré’s proprietary formulation of Sildenafil Cream provided as a compounded drug; the performance of Section 503B-registered outsourcing facilities on which Daré will rely; the risk that the FDA could stop permitting Section 503B-registered outsourcing facilities to compound sildenafil citrate or other active pharmaceutical ingredients in the company’s proprietary formulations that it is evaluating making available via Section 503B of the FDCA; Daré’s ability to achieve the product development and other milestones required for it to receive payments under its subaward and grant agreements; the limits on Daré’s ability to sell stock under its equity line arrangement at times it may desire to raise additional capital; Daré’s ability to develop, obtain FDA or foreign regulatory approval for, and commercialize its product candidates and to do so on communicated timelines; failure or delay in starting, conducting and completing clinical trials of a product candidate and the inherent uncertainty of outcomes of clinical trials; Daré’s ability to design and conduct successful clinical trials, to enroll a sufficient number of patients, to meet established clinical endpoints, to avoid undesirable side effects and other safety concerns, and to demonstrate sufficient safety and efficacy of its product candidates; Daré’s dependence on third parties to conduct clinical trials and manufacture and supply clinical trial material and commercial product; the risk that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; the risk that the FDA, other regulatory authorities, members of the scientific or medical communities or investors may not accept or agree with Daré’s interpretation of or conclusions regarding data from clinical studies of its product candidates; the risk that development of a product candidate requires more clinical or nonclinical studies than Daré anticipates; the risk that the current regulatory pathway known as the FDA’s 505(b)(2) pathway for drug product approval in the U.S. is not available for a product candidate as Daré anticipates; the loss of, or inability to attract, key personnel; the effects of macroeconomic conditions, geopolitical events, public health emergencies, and major disruptions in government operations on Daré’s operations, financial results and condition, and ability to achieve current plans and objectives; the risk that developments by competitors make Daré’s product or product candidates less competitive or obsolete; difficulties establishing and sustaining relationships with development and/or commercial collaborators; failure of Daré’s product or product candidates, if approved, to gain market acceptance or obtain adequate coverage, pricing and reimbursement from third-party payors; Daré’s ability to retain its licensed rights to develop and commercialize a product or product candidate; Daré’s ability to satisfy the monetary obligations and other requirements in connection with its exclusive, in-license agreements covering the critical patents and related intellectual property related to its product and product candidates; Daré’s or its licensors’ failure to obtain and maintain sufficient intellectual property protection; the lack of patent protection for the active ingredients in certain of Daré’s product candidates which could expose its products to competition from other formulations using the same active ingredients; product liability claims; governmental investigations or actions relating to Daré’s product or product candidates or the business activities of Daré, its commercial collaborators or other third parties on which Daré relies; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; cybersecurity incidents or similar events that compromise Daré’s technology systems or those of third parties on which it relies and/or significantly disrupt Daré’s business; and disputes or other developments concerning Daré’s intellectual property rights. Daré’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of Daré’s risks and uncertainties, you are encouraged to review its documents filed with the SEC including Daré’s recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Daré undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Contacts:

Daré Bioscience Investor Relations
innovations@darebioscience.com

Source: Daré Bioscience, Inc.

FAQ

When will Daré Bioscience's Sildenafil Cream be available by prescription?

Daré Bioscience plans to make its Sildenafil Cream formulation available via prescription in Q4 2025.

What is the dual-path approach announced by DARE for their product launches?

DARE's dual-path approach combines 503B compounding with traditional product launches, allowing select proprietary formulations to reach the market faster while pursuing standard regulatory pathways.

When is Daré Bioscience presenting at the Jones Healthcare Conference 2025?

The presentation is scheduled for Wednesday, April 9th, 2025, at 1:00 p.m. PT.

What new product strategies is DARE implementing beyond prescription medications?

DARE is exploring the launch of consumer health products that can be obtained without a physician's prescription, alongside their prescription medications.

How long will the Jones Healthcare Conference presentation replay be available for DARE investors?

The presentation replay will be available in the Investors section of Daré's website until April 23, 2025.