Daré Bioscience Highlights Commercial Launch Readiness for DARE to PLAY™ Sildenafil Cream; November 17th Webinar to Feature Leading Clinicians Discussing Clinical Data and Potential Impact in Women’s Sexual Health

Rhea-AI Summary

Daré Bioscience (NASDAQ: DARE) will host a live webinar on November 17, 2025 to review clinical data and commercial launch readiness for DARE to PLAY™ Sildenafil Cream, a first-of-its-kind topical sildenafil formulation for women. Clinical results cited show increased genital blood flow within 10–15 minutes of application and improvements in arousal on clinically validated, FDA-reviewed endpoints. The company said commercial availability is anticipated via a 503B outsourcing facility, expected before year-end, and webinar attendees can join a product alert list to be notified when the prescription product becomes available.

Positive

• Genital blood flow increase within 10–15 minutes
• Improvements on clinically validated, FDA-reviewed arousal endpoints
• Anticipated commercial availability via 503B before year-end

Negative

• Commercial availability is anticipated, not yet realized
• Initial access expected through a 503B outsourcing facility, potentially limiting early distribution

Insights

Clinical-commercial analyst

Daré positions DARE to PLAY™ for near-term commercial availability via a 503B pathway, backed by clinical data showing rapid physiological and sensory signals.

DARE to PLAY™ is presented as a topical sildenafil cream formulated for women with clinical data reporting increased genital blood flow within 10 to 15 minutes and improvements on FDA‑reviewed arousal endpoints. The company plans a webinar on November 17, 2025 with leading clinicians and expects commercial access through a 503B outsourcing facility before year‑end, which would make a cGMP‑manufactured, evidence‑backed topical sildenafil available to prescribers.

The business mechanism is straightforward: publish clinical signals, engage clinician opinion leaders, and enable distribution via a 503B compounding/manufacturing route so prescribers can obtain a prescription product. Key dependencies and risks are explicit in the announcement: successful 503B manufacturing in accordance with cGMP, timely regulatory/compliance execution for that pathway, and clinician uptake despite prescriber education needs. Clinical claims are limited to the presented endpoints; no broader outcomes or market uptake figures are provided.

Concrete items to watch in the near term include the November 17, 2025 webinar for additional data context and clinician commentary, confirmation of 503B production readiness and shipment timing before year‑end, and the timing of the product alert list activation for prescription availability; these milestones over the next ~6 weeks determine whether the stated commercial readiness translates into actual patient access.

Event to Explore What Makes DARE to PLAY™ a First-of-Its-Kind Topical Sildenafil Cream for Women, Review Supporting Clinical Data, and Discuss 503B Pathway to Commercial Availability, Expected Before Year-End

SAN DIEGO, Nov. 11, 2025 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a purpose-driven health biotech company solely focused on closing the gap in women’s health between promising science and real-world solutions, today announced it will host a live webinar on Monday, November 17, 2025, on the DARE to PLAY™ difference with leading sexual health and menopause clinicians Dr. Sheryl Kingsberg and Dr. Jim Simon.

Event Details:

Title: The DARE to PLAY™ Difference
Date: Monday, November 17, 2025
Time: 12:00pm ET
Registration and Access: https://cvent.me/KO1obd

DARE to PLAY™ Sildenafil Cream is a first-of-its-kind topical sildenafil formulation designed specifically for women to enhance genital blood flow and arousal response. Supported by clinical data demonstrating increased genital blood flow within 10 to 15 minutes of application and improvements in arousal sensations based on clinically validated and FDA-reviewed endpoints, DARE to PLAY™ represents the first and only evidence-backed sildenafil cream formulation for women. Its anticipated upcoming commercial availability through a 503B outsourcing facility will mark the first time a topical sildenafil formulation manufactured in accordance with cGMP requirements and supported by clinical data will be accessible to healthcare providers and their patients.

The webinar will feature Dr. Sheryl Kingsberg and Dr. Jim Simon, distinguished clinicians and past presidents of both The Menopause Society and the International Society for the Study of Women’s Sexual Health (ISSWSH). Dr. Sheryl Kingsberg is the Division Chief of Behavioral Medicine at University Hospitals MacDonald Women’s Hospital and Professor in Reproductive Biology, Urology and Psychiatry at Case Western Reserve University. Her areas of clinical specialization include female sexual disorders, menopause, pregnancy and postpartum mood disorders, and psychological aspects of infertility. Dr. James Simon is Clinical Professor of Obstetrics, Gynecology and Reproductive Endocrinology at The George Washington University in Washington, DC. He has an active private practice, IntimMedicine Specialists®, in Washington, DC focused on complicated gynecology, sexual medicine for both men and women, and menopause, and has received numerous awards including: “Top Washington Physicians,” “America’s Top Obstetricians and Gynecologists” and “The Best Doctors in America.”

Webinar participants will also have the opportunity to join the product alert list, ensuring they are among the first to know when DARE to PLAY™ Sildenafil Cream becomes available by prescription, expected later this year. The event is open to clinicians, investors, and women seeking a trusted, science-based approach to improving sexual response.

About Daré Bioscience
Daré Bioscience is a purpose-driven health biotech company solely focused on closing the gap in women's health between promising science and real-world solutions. Every innovation Daré advances is based in advanced science and backed by rigorous, peer-reviewed research. From contraception to menopause, pelvic pain to fertility, vaginal health to infectious disease, Daré is working to close critical gaps in care using science that serves her needs.

For decades, women have been told to “wait it out” or “live with it,” while innovations that could improve their quality of life languish in the regulatory or funding pipeline. With growing awareness around menopause, sexual health, and vaginal health, the conversation is shifting. However, access to real, evidence-based solutions continues to lag. Daré was founded to change that. As a female-led health biotech company, Daré is accelerating the development of credible, science-based solutions that meet the high standards of clinical rigor – randomized, controlled trials; validated endpoints; peer-reviewed publications; and current Good Manufacturing Practice (cGMP) requirements.

To learn more about Daré’s mission to deliver differentiated therapies for women and its innovation pipeline, 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, products 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, products 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,” “seek,” “should,” “would,” “project,” “target,” “explore” “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 timing for commercial availability of DARE to PLAY™ Sildenafil Cream in the U.S., production of the compounded drug product in accordance with cGMP requirements, the ability of the product to provide a solution for women seeking improvements in genital arousal response, the market opportunity for the product, its market position, and its ability to gain market acceptance. 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 reliance on a Section 503B-registered outsourcing facility and other third parties to bring DARE to PLAY™ Sildenafil Cream to market and facilitate access to the product and the risk that those third parties do not perform as expected; difficulties in establishing and sustaining relationships with third-party collaborators; the risk that the U.S. Food and Drug Administration (FDA) could stop permitting Section 503B-registered outsourcing facilities to manufacture and fulfill orders for compounded sildenafil products or change the conditions under which sildenafil may used in compounding or compounded sildenafil products may be distributed; the ability of Daré’s outsourcing facility partner to maintain its registration with the FDA under Section 503B of the Federal Food, Drug, and Cosmetic Act; the timing of establishing, and ability to maintain, state-required licensure or registration to enable fulfillment of prescriptions for DARE to PLAY™ Sildenafil Cream; Daré’s inexperience, as a company, in and lack of infrastructure for commercializing products; the degree of market demand and acceptance for DARE to PLAY™ Sildenafil Cream; competitive product launches; greater than expected costs to bring compounded drug products to market and marketing costs; shifts in consumer spending or behavior; Daré’s ability to raise additional capital when and as needed to execute its business strategy and continue as a going concern; Daré’s dependence on grants and other financial awards from governmental entities and a private foundation; limitations on Daré’s ability to raise additional capital through sales of its common stock or other equity securities due to restrictions under SEC and Nasdaq rules and regulations or contractual limitation; 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 products and product candidates; Daré’s ability to adequately protect or enforce its, or its licensor’s, intellectual property rights; disputes or other developments concerning Daré’s intellectual property rights; product liability claims; governmental investigations or actions relating to Daré’s products or product candidates or the business activities of Daré, its commercial collaborators or other third parties on which Daré relies; changes in healthcare, pharmaceutical, consumer protection or privacy laws and regulatory policies; increased scrutiny from regulators; 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, completing or conducting clinical trials of a product candidate and the inherent uncertainty of outcomes of clinical trials; the risks 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 and that interim data or results from a particular clinical study do not necessarily predict the final results for that study; 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 effects of macroeconomic conditions, geopolitical events, and major changes and disruptions in U.S. government policies and operations on Daré’s ability to raise additional capital or on Daré’s operations, financial results and condition, and ability to achieve current plans and objectives; Daré’s ability to maintain compliance with Nasdaq’s continued listing requirements and continue to have its common stock listed on The Nasdaq Capital Market; and cybersecurity incidents or similar events that compromise Daré’s technology systems and/or significantly disrupt Daré’s business or those of third parties on which Daré relies. 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 is Daré Bioscience (DARE) hosting the DARE to PLAY webinar?

The live webinar is scheduled for November 17, 2025 at 12:00pm ET.

What clinical effects did DARE to PLAY sildenafil cream show in trials?

Clinical data reported increased genital blood flow within 10–15 minutes and improved arousal on validated, FDA-reviewed endpoints.

How and when will DARE to PLAY (DARE) be commercially available?

Daré said commercial availability is planned via a 503B outsourcing facility and is expected before year-end 2025.

Can clinicians and patients sign up to be notified when DARE to PLAY (DARE) is available?

Yes — webinar participants can join a product alert list to receive availability notifications.

Will DARE to PLAY (DARE) be a prescription product?

The company indicated DARE to PLAY will be available by prescription when released.

Who are the clinicians presenting at the DARE to PLAY (DARE) webinar?

Presenters include Dr. Sheryl Kingsberg and Dr. Jim Simon, leading sexual health and menopause clinicians.