Daré Bioscience CEO Outlines Commercial Transformation, Pipeline Momentum and Potential Key Catalysts in Virtual Investor CEO Connect Segment

President & CEO, Sabrina Martucci Johnson, discusses the Company’s shift to commercial stage, upcoming revenue opportunities, Ovaprene’s positive interim Phase 3 results and what could drive value over the next 12–18 months
Access the segment here

SAN DIEGO, Aug. 25, 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 that Sabrina Martucci Johnson, President and Chief Executive Officer of Daré Bioscience, participated in a Virtual Investor CEO Connect segment.

As part of the segment, Ms. Johnson discussed the Company’s transition from a development-stage biotech to a commercial-stage company, highlighted by the launch of Flora Sync LF5™ and preparations for DARE to PLAY™ Sildenafil Cream* to begin generating revenue. Ms. Johnson outlines how Daré Bioscience is building a scalable commercial infrastructure designed to support multiple products, while sharing insights into customer acquisition, provider engagement and market access. She also discusses the Company’s broader pipeline momentum, including Ovaprene’s positive interim Phase 3 results and DARE-HPV’s advancement into Phase 2,** as well as the potential key catalysts that could drive greater recognition of the Company’s value over the next 12–18 months.

The Virtual Investor CEO Connect segment featuring Daré Bioscience is now available here.

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 Bioscience 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 Bioscience 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 Bioscience is working to change that. Learn more at darebioscience.com.

FORWARD-LOOKING STATEMENTS

Daré Bioscience cautions you that all statements, other than statements of historical facts, contained in this press release and in the Virtual Investor CEO Connect video segment, 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,” “progress,” “seek,” “should,” “would,” “build” or the negative version of these words and similar expressions.

In this press release and the video segment, forward-looking statements include, but are not limited to, statements relating to: Daré Bioscience’s multi-product and commercial strategy and plans; the capabilities of Daré Bioscience’s commercial infrastructure; the timing of DARE to PLAY and DARE to RECLAIM™ prescription dispensing and product revenue; the potential for “first-in-category” products; Ovaprene’s potential to be the first FDA-approved monthly hormone-free intravaginal contraceptive; the market opportunity for Daré Bioscience’s products and ability to gain market acceptance; potential commercial portfolio expansion; the potential impact of the products that Daré Bioscience brings to market for women and the Company; development and regulatory pathway plans and expectations regarding Daré Bioscience’s product candidates, including clinical development strategies, clinical trial design, timelines, costs, milestones, and results, regulatory strategy; timing and outcome of FDA communications, submissions and review of applications; the potential for Daré Bioscience’s portfolio approach to create multiple potential value-driving catalysts, provide a pipeline of differentiated products and build infrastructure and expertise to support successive women’s health products; the sufficiency of non-dilutive grant and other financial award funding to advance development of specified product candidates or programs; expectations regarding existing collaborations and plans for future collaborations; and Daré Bioscience’s ability to create meaningful long-term value for women and shareholders.

Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Daré Bioscience’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 or the video segment, including, without limitation, risks and uncertainties related to: Daré Bioscience’s ability to raise additional capital when and as needed to execute its business strategy and continue as a going concern; potential suspension and delisting of Daré Bioscience’s common stock from the Nasdaq Capital Market; Daré Bioscience’s dependence on grants and other financial awards from governmental entities and a private foundation; Daré Bioscience’s reliance on Section 503B-registered outsourcing facilities and other third parties to bring DARE to PLAY Sildenafil Cream and other solutions to market as compounded drugs or as consumer health products and facilitate access to such products 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 compound the drug substances in the proprietary formulations Daré Bioscience intends to bring or brings to market or changes the conditions under which those drug substances may be used in compounding or the compounded products may be distributed; the ability of outsourcing facilities for Daré Bioscience’s compounded products to maintain their registration with the FDA under Section 503B; the timing of establishing, and ability to maintain, state-required licensure or registration to enable fulfillment of prescriptions for DARE to PLAY Sildenafil Cream and other solutions brought to market via the Section 503B pathway; Daré Bioscience’s inexperience, as a company, in and limited infrastructure for commercializing products; the degree of market demand and acceptance for the products Daré Bioscience brings to market; competitive product launches; greater than expected costs to bring compounded drug products to market and marketing costs; shifts in consumer spending or behavior; Daré Bioscience’s reliance on third parties to manufacture and conduct clinical trials and preclinical studies of its product candidates and commercialize XACIATO™ (clindamycin phosphate) vaginal gel 2% and future FDA-approved products, if any; the risk that the FDA’s 505(b)(2) pathway for drug product approval in the U.S. is not available for a product candidate as Daré Bioscience anticipates***; Daré Bioscience’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 Bioscience’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; decisions not to make clinical study design modifications recommended by the FDA; Daré Bioscience’s dependence on third parties to conduct clinical trials and manufacture and supply clinical trial material and commercial product; 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 Bioscience’s interpretation of or conclusions regarding data from clinical studies of its product candidates; the risk that even if a pivotal clinical study achieves its primary efficacy endpoint, the FDA may determine the data package is not sufficient to support a favorable benefit-risk determination in a future marketing application; the risk that development of a product candidate requires more clinical or nonclinical studies than Daré Bioscience anticipates, or that the duration of a study or number of study subjects must be significantly greater than anticipated; the loss of, or inability to attract, key personnel; product pricing and coverage and reimbursement from third-party payors; Daré Bioscience’s ability to retain its licensed rights to develop and commercialize a product or product candidate; Daré Bioscience’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 Bioscience’s ability to adequately protect or enforce its, or its licensor’s, intellectual property rights; disputes or other developments concerning Daré Bioscience’s intellectual property rights; the lack of patent protection for the active ingredients in certain of Daré Bioscience’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 Bioscience’s products or product candidates or the business activities of Daré Bioscience, its commercial collaborators or other third parties on which Daré Bioscience relies; changes in healthcare, pharmaceutical, consumer protection or privacy laws and regulatory policies; increased scrutiny from regulators; global trends toward health care cost containment; the effects of macroeconomic conditions, geopolitical events, and major changes and disruptions in U.S. government policies and operations on Daré Bioscience’s ability to raise additional capital or on Daré’s operations, financial results and condition, and ability to achieve current plans and objectives; and cybersecurity incidents or similar events that compromise Daré Bioscience’s technology systems and/or significantly disrupt Daré Bioscience’s business or those of third parties on which it relies.
Daré Bioscience’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 Bioscience’s risks and uncertainties, you are encouraged to review its documents filed with the U.S. Securities and Exchange Commission (SEC), including Daré Bioscience’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 Bioscience 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.

*The terms DARE to PLAY and DARE to RECLAIM describe a 503B compounded drug products. Compounded drug products are not approved by the FDA. The FDA does not evaluate compounded drug products for safety, effectiveness, or quality. References to Section 503B, 503B, 503B compounding, 503B compounded product, and similar terms refer to Section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) and the production and supply of compounded drugs by Section 503B-registered outsourcing facilities without patient-specific prescriptions in accordance with Section 503B. Section 503B-registered outsourcing facilities are subject to FDA inspection and required to compound drug products under current Good Manufacturing Practice (cGMP) regulations to ensure quality, strength and consistency.

**Ovaprene® is an investigational hormone-free monthly intravaginal contraceptive currently being evaluated in a Phase 3 clinical study (ClinicalTrials.gov ID: NCT06127199), and DARE-HPV is an investigational, fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert currently being evaluated in women with persistent high-risk human papillomavirus (HPV) infection in a Phase 2 clinical study (ClinicalTrials.gov ID: NCT07601074).

***The term FDA 505(b)(2) regulatory pathway refers to Section 505(b)(2) of the FDCA, which enables an applicant to rely, in part, on the FDA’s prior findings of safety and efficacy data for an existing product, or published literature, in support of the applicant’s new drug application (NDA), providing an alternate path to FDA approval for new or improved formulations or new uses of previously approved drugs.

Contact:
Daré Bioscience Investor Relations
innovations@darebioscience.com
Source: Daré Bioscience, Inc.