GlobeNewswire Inc | Sep 7, 2021 08:00AM EDT

September 07, 2021

The discussion, Womens Health Case Study: Optimizing Study Enrollment During the COVID-19 Pandemic, will review theDARE-BVFREE Phase 3 study that was successfully initiated and completed during 2020

SAN DIEGO, Sept. 07, 2021 (GLOBE NEWSWIRE) -- DarBioscience, Inc. (NASDAQ: DARE), a leader in womens health innovation, today announced its participation in the Womens Health Case Study: Optimizing Study Enrollment During the COVID-19 Pandemic panel at the Womens Innovation Summit being held in Boston, MA, September 14 15, 2021, at The Westin Copley Place.

The COVID-19 pandemic presented many challenges for clinical trials, especially around site selection, recruitment and enrollment of patients. We had to take a step back and reconsider study design, as well as how we would enroll patients and complete check-up visits, said Sabrina Martucci Johnson, President and CEO of Dar Bioscience. In 2020, we worked closely with our CRO for the study, Health Decisions, to successfully initiate and complete a Phase 3 study of our drug candidate DARE-BV1 for the treatment of bacterial vaginosis. Im excited to join Dr. Mary Gunn of Health Decisions to share our insights on how we successfully enrolled our study and did so more quickly than initially anticipated, despite launching after the COVID-19 pandemic shut down of non-essential operations across the United States.

Panel Details:Event: Women?s Health Innovation SummitPanel: Women?s Health Case Study: Optimizing Study Enrollment During the Covid-19 PandemicDate: Tuesday, September 14, 2021Time: 12:00 p.m. EST / 9:00 a.m. PSTParticipants: Sabrina Martucci Johnson, President and CEO, Dar Bioscience Dr. Mary Gunn, Chief Operating Officer, Health Decisions

Additional information about the 2021 Womens Health Innovation Summit is available at https://womenshealthinnovationusa.com/.

About DARE-BV1 and the DARE-BVFREE Phase 3 Study

DARE-BV1 is an investigational thermosetting bioadhesive hydrogel containing clindamycin phosphate 2% designed as a one-time vaginally-administered treatment for bacterial vaginosis. The DARE-BVFREE Phase 3 study was a double-blinded clinical trial that randomized 307 women diagnosed with bacterial vaginosis at 32 centers across the U.S. in a 2:1 ratio to receive a single vaginal dose of DARE-BV1 (clindamycin phosphate vaginal gel, 2%) or a single vaginal dose of placebo gel. The study met its primary endpoint, demonstrating that a single administration of DARE-BV1 was superior to placebo as a primary therapeutic intervention for women diagnosed with bacterial vaginosis, and the study results support DARE-BV1s potential to improve outcomes and convenience for women. A single dose of DARE-BV1 achieved clinical cure rates of 70-81% in the study. Clinical cure rates of current FDA-approved products for the treatment of bacterial vaginosis range from 37-68%. Dar submitted a new drug application (NDA) to the U. S. Food and Drug Administration (FDA) for DARE-BV1 for the treatment of bacterial vaginosis earlier this year. The FDA granted the NDA Priority Review and set a Prescription Drug User Fee Act (PDUFA) date of December 7, 2021 for the target completion of its review of the NDA.

More information about the DARE-BVFREE Phase 3 study can be found in the companys most recent investor presentation under Presentations, Events & Webcasts" in the Investors section of the company's website at http://ir.darebioscience.com.

About Bacterial Vaginosis

Bacterial vaginosis is the most common vaginal condition in women ages 15 44 and can cause serious health risks and very disruptive symptoms. Bacterial vaginosis is estimated to affect approximately 21 million women in the United States.

About Dar Bioscience

Dar Bioscience is a clinical-stage biopharmaceutical company committed to the advancement of innovative products for womens health. The companys mission is to identify, develop and bring to market a diverse portfolio of differentiated therapies that expand treatment options, improve outcomes and facilitate convenience for women, primarily in the areas of contraception, vaginal health, sexual health, and fertility.

Dars product portfolio includes potential first-in-category candidates in clinical development: Ovaprene, a novel, hormone-free, monthly contraceptive whoseU.S.commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a proprietary cream formulation of sildenafil to treat female sexual arousal disorder utilizing the active ingredient in Viagra; DARE-BV1, a unique hydrogel formulation of clindamycin phosphate 2% to treat bacterial vaginosis via a single application; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for hormone therapy following menopause. To learn more about Dars full portfolio of womens health product candidates, and mission to deliver differentiated therapies for women, please visitwww.darebioscience.com.

Dar may announce material information about its finances, product candidates, clinical trials and other matters using the Investors section of its website ( http://ir.darebioscience.com),SECfilings, 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, 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 Twitter accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the list of social media channels the company may use to communicate information will be posted on the investor relations page of Dars website mentioned above.

Forward-Looking Statements

Dar 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, predict, seek, should, would, contemplate, project, target, tend to, or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements regarding DARE-BV1s clinical cure potential for bacterial vaginosis, DARE-BV1s potential to provide more effective and convenient treatment for bacterial vaginosis as compared to current FDA-approved products for the treatment of bacterial vaginosis, and DARE-BV1s commercial potential. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Dars 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, risk and uncertainties related to: the risk that the FDA, other regulatory authorities or members of the scientific or medical communities may not accept or agree with Dars interpretation of or conclusions regarding the data from the DARE-BVFREE clinical study and/or may require additional clinical or nonclinical studies of DARE-BV1 prior to approving the NDA; whether and when the NDA for DARE-BV1 pending with the FDA may be approved, which will depend on a variety of factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether DARE-BV1 will be commercially successful; decisions by the FDA impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of DARE-BV1; Dars failure to timely establish or leverage third-party partnerships or collaborations to commercialize its product candidates, if approved; Dars ability to raise additional capital when and as needed to advance its product candidates and continue as a going concern; the effects of the COVID-19 pandemic on Dars operations, financial results and condition, and ability to achieve current plans and objectives, including the potential impact of the pandemic on Dars ability to timely enroll, conduct and report results of its clinical trials and on the ability of third parties on which Dar relies to assist in the conduct of its business, including its clinical trials, to fulfill their contractual obligations to Dar; Dars ability to develop, obtain regulatory approval for, and commercialize its product candidates; the failure or delay in starting, conducting and completing clinical trials or obtaining FDA or foreign regulatory approval for Dars product candidates in a timely manner; Dars 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;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; the risk that developments by competitors make Dars product candidates less competitive or obsolete; failure of Dars product candidates, if approved, to gain market acceptance or obtain adequate coverage from third-party payers; Dars ability to retain its licensed rights to develop and commercialize a product candidate; Dars 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 candidates; Dars dependence on third parties to conduct clinical trials and manufacture clinical trial material; Dars ability to adequately protect or enforce its, or its licensors, intellectual property rights; the lack of patent protection for the active ingredients in certain of Dars product candidates which could expose its products to competition from other formulations using the same active ingredients; cyber attacks, security breaches or similar events that compromise Dars technology systems or those of third parties on which it relies and/or significantly disrupt Dars business; and disputes or other developments concerning Dars intellectual property rights. Dars 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 Dars risks and uncertainties, you are encouraged to review its documents filed with theSECincluding Dars 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. Dar 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:

Investors on behalf of Dar Bioscience, Inc.:Lisa Walters-Hoffert, Chief Financial OfficerDar Bioscience, Inc.lwalters@darebioscience.com858.926.7655

OR

Media on behalf of DarBioscience, Inc.:Jake RobisonCanale Communicationsjake.robison@canalecomm.com619.849.5383

Source: Dar Bioscience, Inc.