Dar Bioscience Announces Return of Rights to Ovaprene ; Phase 3 Program Ongoing; Positive Interim Data and Grant Funding Position Asset for Value-Maximization

Bioscience Announces Return of Rights to Ovaprene ; Phase 3 Program Ongoing; Positive Interim Data and Grant Funding Position Asset

for Value-Maximization

DIEGO, December 1, 2025 - Dare 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 all rights to Ovaprene ,

the company's first-in-category, investigational, hormone-free monthly intravaginal contraceptive, will be returned to Dar

by Bayer HealthCare LLC as a result of Bayer electing to terminate the license agreement between the parties as part of a strategic prioritization.

In accordance with the license agreement, the termination will be effective in February 2026. With the Phase 3 program advancing with

non-dilutive grant support, the return of rights will provide Dar with full control of a late-stage asset that is differentiated

in a large market with significant unmet need.

First-in-Category Asset

consolidation of commercialization rights will strengthen Dar 's strategic position as Ovaprene advances through its pivotal

Phase 3 clinical study. Ovaprene has the potential to become the first FDA-approved hormone-free, monthly intravaginal contraceptive

option available to women, representing a meaningful innovation in a category that has seen limited advancement in decades.

view the consolidation of commercial rights under Dar at this stage of Ovaprene's development as value-enhancing for our

company," said Sabrina Martucci Johnson, President and CEO of Dar Bioscience. "The Phase 3 study is progressing,

supported by non-dilutive funding, and the positive interim data announced in July 2025 underscore the asset's potential. We will

have maximum strategic flexibility to capture the value of this opportunity."

Interim Results Reinforce Clinical and Commercial Potential

July 2025, Dar announced positive interim data from the ongoing open-label Phase 3 trial of Ovaprene (ClinicalTrials.gov

ID: NCT06127199) demonstrating encouraging results including consistent safety and tolerability; no serious safety concerns were identified,

and overall tolerability was favorable. The rate of pregnancy in women treated in the study at the time of the interim analysis was consistent

with the company's expectations based on the results of the pre-pivotal postcoital test clinical study of Ovaprene. These

interim findings support Ovaprene's potential as a meaningful hormone-free alternative. These fundamentals remain unchanged, and

the study is progressing toward anticipated completion of enrollment in 2026.

ongoing trial is supported by previously announced external grant funding, including the award from Gates Foundation announced in

2024, and continues without any change to timelines or operations.

Strategic Optionality

global commercialization rights consolidated at Dar , the company is now positioned to evaluate partnership structures that best

reflect the value of a late-stage, non-hormonal contraceptive with differentiation and relevance. The company believes that Ovaprene

will attract broad strategic interest across pharmaceutical and consumer health organizations.

believe this development gives us the ability to pursue the most attractive commercial and access pathways for Ovaprene, including partnerships,

non-traditional commercialization models, and opportunities to retain greater long-term economics," Johnson added. "This

increased optionality, combined with the clinical profile demonstrated to date, positions Ovaprene as one of the most exciting assets

in the women's health pipeline."

is an investigational, hormone-free monthly, intravaginal contraceptive that combines physical and chemical mechanisms. Ovaprene features

a proprietary knitted polymer barrier to physically block sperm from entering the cervical canal within a silicone-reinforced ring that

releases non-hormonal agent ferrous gluconate to impede sperm motility. Unlike current FDA-approved monthly intravaginal contraceptives,

Ovaprene does not contain hormones, but consistent with those monthly intravaginal contraceptives Ovaprene is designed to be a "one

size fits most" monthly, self-administered product. It is inserted at the end of one menstrual period and left until the beginning

of the next, requiring no action at intercourse. It requires no clinician fitting and a new product is used each month. If approved,

Ovaprene would represent the first product of its kind for women seeking new options in non-hormonal contraception.

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 Dar 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, Dar is working to close critical

gaps in care using science that serves her needs.

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. Dar was founded to change that.

As a female-led health biotech company, Dar 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.

learn more about Dar 's mission to deliver differentiated therapies for women and its innovation pipeline, please visit

www.darebioscience.com.

Bioscience leadership has been named on the Medicine Maker's Power List and Endpoints News' Women in Biopharma and Dar 's

CEO has been honored as one of Fierce Pharma's Most Influential People in Biopharma for Dar 's contributions to innovation

and advocacy in the women's health space.

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. Dar

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 Dar posts

on its investor relations website or through social media channels may be deemed to be material information. Dar encourages investors,

the media, and others interested in the company to review the information Dar posts in the Investors section of its website and

to follow these LinkedIn accounts: @Sabrina Johnson and @DareBioscience and 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

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," "view," "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 the potential benefits of the return of the rights to Ovaprene to Dar , that Ovaprene will

attract broad strategic interest across pharmaceutical and consumer health organizations, the importance of the interim results from

the ongoing pivotal Phase 3 trial of Ovaprene to Dar and Ovaprene, Ovaprene's potential as a safe and effective first-in-category,

hormone-free, intravaginal monthly contraceptive, Ovaprene's potential to be the first U.S. Food and Drug Administration (FDA)-approved

hormone-free, monthly intravaginal contraceptive, the potential market opportunity for Ovaprene, if approved, and that enrollment in

the ongoing pivotal Phase 3 clinical study of Ovaprene will be completed in 2026. 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 Dar 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 Dar '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: Dar '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; Dar 's dependence on third parties,

including to conduct clinical and nonclinical studies 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 Dar '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 Dar anticipates, or that the duration of a study or number of study subjects must be significantly greater than

anticipated; Dar 's ability to raise additional capital when and as needed to execute its business strategy and continue

as a going concern; Dar 's dependence on grants and other financial awards from governmental entities and the Gates Foundation,

or the foundation; the foundation's ability to modify, suspend, discontinue payment of grant funds or terminate a grant agreement

in certain circumstances largely in the foundation's discretion; limitations on Dar '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; Dar 's expanded business strategy to bring to market prescription compounded drug products and non-prescription

consumer health products; Dar 's inexperience, as a company, in and lack of infrastructure for commercializing products;

the degree of market demand and acceptance for the products Dar brings to market; competitive product launches; Dar 's