Release Details

First Product Revenue Expected This Month, Opening New Commercial Chapter for Women's Health Innovator

Limited-Time Launch Offer: 30% Off + Free Shipping 

SAN DIEGO, June 04, 2026 (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 the upcoming commercial launch of Flora Sync LF5™, a vaginal probiotic capsule formulated specifically to restore microbiome balance and support lasting vaginal comfort. The launch represents a milestone for Daré, as the company expects to generate its first direct consumer product revenue in June 2026, marking the company's transition from a pure development-stage biotech to a women's health company with a revenue-generating product.

Flora Sync LF5™ will be marketed under the brand family DARE to RESTORE™ and manufactured by Probiotical S.p.A., a global leader in probiotic development and manufacturing.

"Flora Sync LF5 was developed specifically for vaginal health, not gut health," said Sabrina Martucci Johnson, President and Chief Executive Officer of Daré Bioscience. "By delivering a vagina-specific probiotic strain directly to the vaginal environment, Flora Sync LF5 represents a targeted approach to supporting vaginal wellness. This upcoming launch marks an important milestone for Daré as it represents the company’s first consumer health product launch. We continue to work to bring women other innovative, science-backed products they can access directly, without a prescription. We look forward to making Flora Sync LF5 available to women across the country and sharing our first commercial results with investors and our community."

ABOUT FLORA SYNC LF5™ (DARE TO RESTORE™)

Flora Sync LF5 is a targeted, non-hormonal probiotic vaginal capsule formulated with Limosilactobacillus fermentum LF5, a clinically studied probiotic strain originally isolated from the vaginal microbiome of healthy women with no reported history of yeast infections and backed by over 30 years of research.

Unlike most probiotics marketed for vaginal health, which rely on gut strains taken orally, Flora Sync LF5 delivers a vagina-specific probiotic strain directly to the vaginal environment, where imbalance occurs. This targeted approach is designed to support a healthy vaginal microbiome, natural moisture balance, and overall vaginal wellness at the source.

Flora Sync LF5 is manufactured by Probiotical S.p.A., a leader in probiotic science and manufacturing, under current Good Manufacturing Practices (cGMP) standards. Probiotical oversees every step of the process, from strain selection and scientific validation through manufacturing and quality control, helping ensure product quality, consistency, purity, and performance.

Upon launch, Flora Sync LF5 will be available without a prescription, for $49 per box (6 capsules), and offers a simple three-day routine designed for noticeable benefits. It is intended for women experiencing:

• Vaginal dryness leading to irritation or itching
• Unwanted odor or excess discharge
• Disruption following intimacy, hormonal shifts, or antibiotic use
• Routine changes such as travel, new products, or elevated stress

CLINICALLY STUDIED. BACKED BY OVER 30 YEARS OF PROBIOTIC RESEARCH.

Flora Sync LF5 is manufactured by Probiotical S.p.A., an Italian pioneer in probiotic science with roots in lactic acid bacteria research dating back nearly a century. From strain discovery and scientific validation to manufacturing under current Good Manufacturing Practices (cGMP) standards, Probiotical maintains oversight of the entire process to deliver a high quality, clinically studied probiotic designed specifically for vaginal health.

Flora Sync LF5 is supported by clinical research published in Frontiers in Microbiology (2024). In a single-blind, randomized controlled clinical trial of 100 women:

• 96% of women achieved vaginal microbiome balance within 3 days*
• 90% maintained a balanced vaginal microbiome at 2 weeks*

*Based on a single-blind, randomized controlled clinical trial of 100 women published in Frontiers in Microbiology (2024). Flora Sync LF5 is not intended to treat, cure, or prevent any disease or medical condition.

LIMITED-TIME LAUNCH OFFER: GET 30% OFF + FREE SHIPPING

To celebrate the upcoming launch of Flora Sync LF5, Daré Bioscience is offering a limited-time promotion for women who sign up to receive launch updates. Women who register will receive a discount code for 30% off plus free shipping, redeemable when Flora Sync LF5 becomes available through the DARE Health Hub. This exclusive launch offer is designed to help more women experience a science-backed approach to vaginal wellness and to thank early supporters who have followed the product's development journey.

A COMMERCIAL MILESTONE IN A PIPELINE BUILT FOR WOMEN

The upcoming launch of Flora Sync LF5 marks the beginning of direct product revenue for Daré Bioscience, and arrives alongside significant momentum across the Company's broader pipeline.

On May 18, 2026, Daré announced the initiation of its Phase 2 clinical study of DARE-HPV, a novel pharmacologic treatment for persistent high-risk human papillomavirus (HPV) infection — the leading cause of cervical cancer cases in the U.S. — with no currently U.S. Food and Drug Administration (FDA)-approved treatments. The Phase 2 study is a randomized, placebo-controlled, double-blind trial in approximately 100 women. As previously announced, the study, as well as the broader DARE-HPV program, is funded by a $10 million contract funded by the Advanced Research Projects Agency for Health (ARPA-H). The Phase 2 study is expected to report topline data in 2027.

On May 12, 2026, Daré announced positive interim safety and efficacy results from its ongoing Phase 3 study of Ovaprene®, the Company's investigational monthly, hormone-free intravaginal contraceptive. The trial's independent Data Safety Monitoring Board (DSMB) conducted a second planned interim analysis focused on reviewing safety data from the study, and recommended the study continue without modification, consistent with its recommendation from the first interim analysis in July 2025. There currently are no FDA-approved, hormone-free, monthly intravaginal contraceptives.

Daré is also advancing DARE to PLAY™ Sildenafil Cream, a first-of-its-kind topical sildenafil cream for women, with dispensing through the DARE Health Hub targeted to commence this summer.

"We are building a company that generates revenue and advances science at the same time," Ms. Johnson continued. "Flora Sync LF5 will be the first chapter in Daré's consumer revenue story, and we intend to keep building from here, for women, and for our investors."

ABOUT DARÉ BIOSCIENCE, INC.

Daré Bioscience (NASDAQ: DARE) 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, sexual health 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 proven solutions is lagging. Daré is working to change that. Learn more at darebioscience.com.

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," "prepare," "seek," "should," "would," "target," "objective," "positioned," 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: the expected timing and commencement of Flora Sync LF5 consumer sales and product revenue; the company's anticipated commercial launch activities and promotional offer for Flora Sync LF5; expectations regarding the benefits, efficacy characteristics, and performance of, and manufacturing quality of, Flora Sync LF5; expected progress, timelines, and data readouts for DARE-HPV,; the targeted commencement of DARE to PLAY Sildenafil Cream dispensing this summer; and Daré's ability to generate revenue from its commercial 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 dependence on third parties, including to conduct clinical trials and manufacture, supply, and distribute products and clinical trial material; risks associated with supply chain disruptions, manufacturing delays, and quality control issues; risks related to consumer market acceptance of Flora Sync LF5 and other consumer health products; the effectiveness of promotional activities and consumer marketing efforts; risks that product performance or consumer experience may differ from expectations or clinical study results; 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; 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; the risk that positive findings in earlier clinical and/or nonclinical studies may not be predictive of success in subsequent studies; competitive product launches; shifts in consumer spending or behavior; changes in regulatory requirements applicable to consumer health products; and Daré's inexperience, as a company, in and lack of infrastructure for commercializing products.

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 U.S. Securities and Exchange Commission (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.