Lopinavir/Ritonavir

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.

Receipt of award notice for second $1.0 million tranche of NIAID funding brings total NIH funding award for DARE-HPV to $2.0 million Funding award milestone follows Daré's announcement last week of the initiation of its Phase 2 clinical study of DARE-HPV — representing the first time women with persistent high-risk HPV infection may have access to this pharmacologic treatment as part of a clinical trial DARE-HPV targets high-risk HPV infection, the cause of virtually all cervical cancer cases in the U.S., for which there are currently no FDA-approved pharmacologic treatments Award reflects Daré's strategy of leveraging non-dilutive government funding, including both NIH grants and ARPA-H contract support for DARE-HPV, to advance a differentiated pipeline addressing some of the most persistent unmet needs in women's health SAN DIEGO, May 26, 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 receipt of a Notice of Award from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH), obligating the second and final tranche of $1.0 million under the previously announced up to $2.0 million NIAID grant award for DARE-HPV, Daré's investigational treatment for persistent high-risk human papillomavirus (HPV) infection. The total amount of the award across the project period, which commenced in late 2024, is $2.0 million. This award (Award Number 5R44AI188623-02) was issued under the Small Business Innovation Research (SBIR) program in support of the project titled "A first-in-class product for the clearance of high-risk human papillomaviruses," with Andrea Ries Thurman, MD, Medical Director of Daré, serving as Project Director. The receipt of this award notice follows Daré's announcement on May 18, 2026 of the initiation of its Phase 2 clinical study of DARE-HPV, a significant clinical development milestone that marks the first time women with persistent high-risk HPV infection may have access to this pharmacologic treatment as part of a clinical trial. The Phase 2 study is a randomized, placebo-controlled, double-blind trial designed to evaluate the safety and antiviral activity of DARE-HPV in approximately 100 women with confirmed persistent high-risk HPV infection over an up to 21-day course of daily treatment, with topline data expected in 2027. "The NIH's continued commitment to DARE-HPV is a powerful validation of the unmet need driving this program," said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. "An estimated 6 million women in the United States each year experience a high-risk HPV infection and have no FDA-approved pharmacologic option. They are told to wait and watch as the virus either clears on its own or, in far too many cases, progresses to precancerous or cancerous disease. Last week, we initiated our Phase 2 study to advance our potential alternative to that 'watchful waiting' paradigm. The NIAID funding award we are announcing today will help sustain the non-clinical and translational work that underpins this program, together with our ARPA-H-funded contract that supports the Phase 2 study. Daré was built to pursue exactly these kinds of high-impact, underserved opportunities, and we are grateful to NIH, ARPA-H, our clinical investigators, and the women participating in the Phase 2 study for helping us do just that." About the DARE-HPV NIAID Award This Notice of Award (Award Number 5R44AI188623-02) obligates $1.0 million for the second project year budget period from December 1, 2025 through November 30, 2026. The total federal award across the project period, which commenced December 17, 2024, is $2.0 million. The NIAID grant supports non-clinical activities to advance the development of DARE-HPV. The project is supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award Number R44AI188623. The content of this press release is solely the responsibility of Daré Bioscience, Inc. and does not necessarily represent the official views of the National Institutes of Health. About DARE-HPV DARE-HPV is an investigational, proprietary fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert being developed as a potential non-surgical, localized, self-administered treatment for persistent high-risk HPV infection. Lopinavir and ritonavir are protease inhibitors with established antiviral activity. HPV infection is the underlying cause of virtually all cervical cancer cases in the United States. An estimated six million women per year in the United States experience high-risk HPV infection, for which there are currently no FDA-approved pharmacologic treatments. If clinically successful and approved, DARE-HPV could be the first FDA-approved pharmacologic treatment for HPV infection. DARE-HPV development is supported by an up to $10 million contract funded by ARPA-H (Advanced Research Projects Agency for Health), as well as the NIAID grant award described herein. Daré's Investigational New Drug (IND) application for DARE-HPV was cleared by the FDA in February 2026, and Daré initiated its Phase 2 clinical study (ClinicalTrials.gov ID: NCT07601074) in May 2026. About the National Institute of Allergy and Infectious Diseases (NIAID) NIAID conducts and supports research at NIH, throughout the United States, and worldwide to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website at 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 . Daré may announce material information about its finances, products and product candidates, clinical trials and other matters using the Investors section of its website ( ), SEC filings, press releases, public conference calls and webcasts, and social media channels. 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, to follow Daré Bioscience, Inc. on LinkedIn, 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,” “prepare,” “aim,” “should,” “would,” “target,” “advance,” “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 significance of the NIH award to Daré and the DARE-HPV program, DARE-HPV’s potential as a safe and effective treatment for clearance of high-risk HPV infection, DARE-HPV’s potential to be the first FDA-approved pharmacologic treatment for high-risk HPV infection, the conduct and completion of the Phase 2 clinical study of DARE-HPV and the timing of topline data from the study, the anticipated benefits of DARE-HPV, including its potential to reduce the incidence of cervical cancer in the U.S., the potential for DARE-HPV to redefine the treatment paradigm for HPV infection, Daré’s expectation of receipt of additional funding under its ARPA-H award, and the potential market opportunity for DARE-HPV, if approved. 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: failure or delay in conducting or completing a clinical trial and the inherent uncertainty of outcomes of clinical trials; 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; Daré’s ability to develop, obtain FDA or foreign regulatory approval for, and commercialize its product candidates and to do so on communicated timelines; the risk that Daré’s product candidates may fail to demonstrate acceptable safety and tolerability or sufficient efficacy in 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 potential that a product candidate in clinical development may never advance into or through a pivotal clinical study or obtain FDA or foreign regulatory approval; 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, or that the duration of a study or number of study subjects must be significantly greater than anticipated; Daré’s ability to achieve the milestones required for it to receive additional payments under its ARPA-H award; the potential for significant delays in disbursement of government awarded funds or termination of an award before Daré’s receipt of the full amount of obligated funds; 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 maintain compliance with Nasdaq’s continued listing requirements and continue to have its common stock listed on The Nasdaq Capital Market; 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; 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 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 products 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 products and product candidates; Daré’s ability to adequately protect or enforce its, or its licensor’s, intellectual property rights; 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 products 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; 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 U.S. Securities and Exchange Commission, 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.