GlobeNewswire Inc | Jul 12, 2021 05:45AM EDT

July 12, 2021

Funding and Clinical Operations Support will be Provided by the National Institutes of Healths Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Under the CRADA

Dar Plans to Submit an Investigational Device Exemption (IDE) to the FDA in the Fourth Quarter of 2021 and Commence the Ovaprene Pivotal Study in 2022

SAN DIEGO, July 12, 2021 (GLOBE NEWSWIRE) -- DarBioscience, Inc.(NASDAQ:DARE), a leader in womens health innovation, today announced that it entered into a Cooperative Research and Development Agreement (CRADA) with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health (NIH), for the pivotal Phase 3 study of Ovaprene, an investigational hormone-free monthly intravaginal contraceptive currently in clinical development for the prevention of pregnancy. The agreement will allow Dar to leverage the contraceptive clinical trial expertise of NICHD while also sharing the costs of the Phase 3 pivotal study with NICHD. If Ovaprene is approved by the U.S. Food and Drug Administration (FDA), it could be the first monthly non-hormonal contraceptive option for women.

The pivotal Phase 3 study will be supported by the NICHDs Contraceptive Development Program (CDP). The CDP oversees the Contraceptive Clinical Trial Network (CCTN), which was established in 1996 to conduct studies of investigational contraceptives, and the Phase 3 study will be conducted within the CCTN with the NICHD contractor Health Decisions Inc. Dar will be responsible for providing clinical supplies of Ovaprene and coordinating interactions with and preparing and submitting supportive regulatory documentation to the FDA. Dar and NICHD will each provide medical oversight for the trial and final data review and analysis, and will work together to prepare the final report of the trial results.

Under the CRADA, Dar has also agreed to contribute $5.5 million toward the total estimated cost to conduct the pivotal Phase 3 study, which will be payable in four payments. The first payment is due within 30 days of the effective date of the CRADA and the final payment is due by April 1, 2023. NICHD will be responsible for the other costs related to the conduct of the pivotal study and will manage the payment of expenses to Health Decisions, the clinical sites, and other parties involved with the study.

We are thrilled to continue our work with NICHD to advance Ovaprene through this pivotal study, said Sabrina Martucci Johnson, President and CEO of Dar Bioscience, Inc. Grant funding previously provided by NICHD supported the conduct of our pre-pivotal clinical study of Ovaprene. With this CRADA, we have the opportunity to leverage NICHDs experience in the design and execution of contraceptive studies, as well as continued funding to support the development of Ovaprene. We look forward to collaborating with NICHD, along with our partner Bayer, to advance the development of additional non-hormonal contraceptive options for women.

Bayer and Dar entered into an exclusive licensing agreement for U.S. commercial rights to Ovaprene in January 2020. Under the agreement, Dar receives access to Bayers extensive clinical and market capabilities while retaining control over Ovaprenes development and regulatory approval process. Bayer has the right to obtain exclusive rights to commercialize the product in the U.S. following completion of the pivotal clinical trial being undertaken by Dar and the NICHD. If Bayer, in its sole discretion, makes payment to Dar of $20 million, which Dar intends to apply to reimbursement of its portion of the clinical study and manufacturing costs, then the exclusive license to commercialize Ovaprene in the U.S. will become effective. Dar will also be entitled to receive commercial milestone payments potentially totaling$310 million, in addition to double digit tiered royalties on net sales.

This collaboration between Dar and NICHD marks an important milestone in Womens Healthcare Innovation.Women are at the center of everything we do and we are so pleased to continue to partner with Dar in support of our mission Were For Her to provide women with education and access to contraceptive options, said John Berrios, Bayers Head of Womens Healthcare.

The multi-center, single arm, non-comparative, pivotal Phase 3 contraceptive study of Ovaprene will evaluate its effectiveness as a contraceptive device along with its safety and usability. Dar plans to file an IDE for Ovaprene in the forth quarter of 2021 and, pending the FDAs review and clearance of the IDE, to initiate the pivotal study of Ovaprene in 2022. If successful, Dar expects the pivotal study to support marketing approvals of Ovaprene in the U.S. and other countries.

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, investigational hormone-free monthly intravaginal contraceptive whoseU.S.commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel 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 relating to the conduct and funding of a Phase 3 pivotal clinical study of Ovaprene by the NICHD, anticipated timing of submission of the IDE and commencement of the Phase 3 study, Ovaprenes potential to become the first first monthly non-hormonal contraceptive approved by the FDA, the potential for regulatory approval to market Ovaprene in the U.S. and other countries based on a single pivotal study, and potential payments to Dar under its agreement with Bayer. 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 NICHDs ability to timely enroll, conduct and report results of the Phase 3 study of Ovaprene; the NICHDs ability to terminate the CRADA for any reason upon 30-days notice; 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, including the NICHD under the CRADA; 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; the risks that the license agreement with Bayer may not become effective and, if it becomes effective, that future payments to Dar under the agreement may be significantly less than the anticipated or potential amounts; Dars failure to timely establish or leverage third-party partnerships or collaborations to commercialize its product candidates, if approved; 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.

Contact

Lisa Walters-Hoffert, Chief Financial Officer Dar Bioscience, Inc.lwalters@darebioscience.com858.926.7655

Source: Dar Bioscience, Inc.