Dar Bioscience Announces a Poster Presentation on a Pharmacokinetic Study of DARE-FRT1, in Development for Sustained-Release Progesterone Therapy for…

SAN DIEGO, Oct. 10, 2019 (GLOBE NEWSWIRE) -- Dar Bioscience, Inc. (DARE), a leader in womens health innovation, today announced a poster presentation at the American Society for Reproductive Medicine (ASRM) 2019 Scientific Congress & Expo, which will take place in Philadelphia, Pennsylvania, October 12-16, 2019.

Dars Chief Scientific Officer, David Friend, PhD, will present findings from a pharmacokinetic animal study of DARE-FRT1, which is being developed for the prevention of preterm birth and as a new option for luteal phase support following in-vitro fertilization (IVF). DARE-FRT1 is part of Dars novel intravaginal ring (IVR) technology platform and is designed to allow for convenient non-invasive, non-oral administration of bio-identical progesterone during a 14-day period.

The research being highlighted at this year's ASRM meeting reinforces our commitment to develop new treatment options for women at risk for preterm birth and to better support providers and women utilizing progesterone to improve outcomes following an IVF procedure, said Sabrina Martucci Johnson, President and CEO of Dar Bioscience.

Impaired fecundity (physical difficulties getting pregnant or carrying a pregnancy to live birth) affects an estimated 6.7 million women aged 15-44 in the U.S., or approximately 11% of women of reproductive age, and 25% of infertile couples have more than one factor leading to infertility.1,2According to Grand View Research, the global IVF market size was valued at $16.68 billion in 2018 and is estimated to expand at a compound annual growth rate of 10.2% during the next seven years. Increases in the cases of infertility and development of advanced technologies were cited as growth drivers.3

DARE-FRT1 has the potential to continuously deliver bio-identical progesterone in a convenient way during a period of 14 days, said Dr. Friend. With approximately 10% of all pregnancies in the U.S. resulting in preterm births,4 and the increasing demand for pregnancy support following IVF procedures, DARE-FRT1 could become an important new option for women and healthcare providers seeking better ways to address these significant unmet needs in womens health.

Poster Presentation Information

Poster Number: P-173Presentation Day: Tuesday, October 15, 2019Abstract Title: 1761: A Novel Progesterone Releasing Intravaginal Ring for Luteal Phase Support: Pharmacokinetics and Safety in a Sheep ModelSession Topic: IVF Outcome Predictors - Luteal Support

1 Chandra A, et al., Infertility and Impaired Fecundity in the United States, 19822010: Data From the National Survey of Family Growth, National Health Statistics Reports, No. 67, Aug 14, 2013, https://www.cdc.gov/nchs/data/nhsr/nhsr067.pdf

2 ASRM, https://www.reproductivefacts.org/faqs/quick-facts-about-infertility/

3 In-Vitro Fertilization (IVF) Market Size, Share & Trends Analysis Report By Type, By Instrument (Disposable Devices, Culture Media, Capital Equipment), By End Use, By Region, And Segment Forecasts, 2019 2026, Mar 2019, https://www.grandviewresearch.com/industry-analysis/in-vitro-fertilization-market

4Martin J, et al., Births: Final Data for 2017, National Vital Statistics Reports, Vol. 67, No. 8, Nov 7, 2018, https://www.cdc.gov/nchs/data/nvsr/nvsr67/nvsr67_08-508.pdf1

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 hormone-free, monthly contraceptive intravaginal ring; 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 replacement therapy following menopause. To learn more about Dars full portfolio of womens health product candidates, and mission to deliver differentiated therapies for women, please visit http://www.darebioscience.com.

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Dar may announce material information about its finances, product candidates, clinical trials and other matters using its investor relations 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, 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 on its investor relations website (https://darebioscience.gcs-web.com/) 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 the company's 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. Such statements include, but are not limited to, statements relating to Dars commitment to developing new treatment options for preventing preterm birth and improving outcomes following IVF procedures, DARE-FRT1s potential to deliver bio-identical progesterone continuously over 14 days in a convenient, non-systemic and non-invasive way, and DARE-FRT1s potential to prevent preterm birth and support pregnancy maintenance following IVF procedures. 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: Dars ability to raise additional capital when and as needed, to advance its product candidates; 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 conduct and design 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 promising results in pre-clinical studies may not be replicated when a product candidate is tested in human subjects; 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; developments by Dars competitors that make its product candidates less competitive or obsolete; 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; the risk of failure associated with product candidates in preclinical stages of development that may lead investors to assign them little to no value and make these assets difficult to fund; 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 the SEC including 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.:Lee RothBurns McClellanlroth@burnsmc.com212.213.0006

OR

Media on behalf of Dar Bioscience, Inc.:Jake RobisonCanale Communicationsjake@canalecomm.com619.849.5383

Source: Dar Bioscience

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Dar Bioscience Announces a Poster Presentation on a Pharmacokinetic Study of DARE-FRT1, in Development for Sustained-Release Progesterone Therapy for...