DARE Dare Bioscience Inc.

1.01
+0.03  (+3%)
Previous Close 0.98
Open 0.98
52 Week Low 0.6902
52 Week High 2.22
Market Cap $31,867,936
Shares 31,552,412
Float 29,889,864
Enterprise Value $27,480,564
Volume 196,319
Av. Daily Volume 543,459
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Upcoming Catalysts

Drug Stage Catalyst Date
DARE-BV1
Bacterial Vaginosis
Phase 3
Phase 3
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Sildenafil Cream, 3.6%
Female Sexual Arousal Disorder (FSAD)
Phase 2b
Phase 2b
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DARE-HRT1
Hormone replacement therapy
Phase 1
Phase 1
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Ovaprene
Contraception
Phase 3
Phase 3
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Latest News

  1. SAN DIEGO, Sept. 21, 2020 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, today announced that it received the final approximately $0.9 million in funding under the current grant from the Bill & Melinda Gates Foundation. The grant payment will support ongoing development activities for Daré's investigational user-controlled, long-acting reversible contraceptive (UC-LARC), DARE-LARC1. Development of DARE-LARC1 has been supported by approximately $19.5 million in grant funding from the foundation prior to this most recent disbursement.

    The technology underpinning DARE-LARC1 is designed to store and precisely deliver therapeutic doses over months or years in a single implant and was originally…

    SAN DIEGO, Sept. 21, 2020 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, today announced that it received the final approximately $0.9 million in funding under the current grant from the Bill & Melinda Gates Foundation. The grant payment will support ongoing development activities for Daré's investigational user-controlled, long-acting reversible contraceptive (UC-LARC), DARE-LARC1. Development of DARE-LARC1 has been supported by approximately $19.5 million in grant funding from the foundation prior to this most recent disbursement.

    The technology underpinning DARE-LARC1 is designed to store and precisely deliver therapeutic doses over months or years in a single implant and was originally developed at the Massachusetts Institute of Technology (MIT) by renowned researchers Robert Langer, Ph.D. and Michael J. Cima, Ph.D.

    "We believe the non-dilutive funding support from the foundation for the development of DARE-LARC1 is a clear validation of the unmet need in the long-acting, reversible contraceptive, or LARC, category," said Sabrina Martucci Johnson, President & CEO of Daré Bioscience. "LARCs are one of the most successful innovations in contraception, due to their exceedingly high effectiveness rates and duration of protection ranging from 3 to 10 years. The current FDA-approved LARCs require physician insertion and subsequent removal procedures for return to fertility, which can be a deterrent for women who know they will likely want to pause their contraception at some point during a typical 3 to 10 year implant duration. Our DARE-LARC1 program seeks to improve upon this product profile by providing a user-controlled LARC with a comparably high level of contraceptive effectiveness that will not require a woman to undergo procedures to remove and re-insert the device when she wants to return to fertility and, subsequently, when she wants resume contraception."

    DARE-LARC1 is a preclinical stage implantable contraceptive product that is designed to deliver the benefits of traditional long-acting, reversible contraceptive products with the added flexibility of wirelessly controlling the duration of drug release based on individual user needs. The implant is intended to be operated by the user to deliver medication on a pre-determined schedule that can be activated or deactivated wirelessly, as required to provide contraceptive protection or enable her to return to fertility.   This grant payment will support critical ongoing preclinical activities necessary to advance the program to the next stage of development.

    About Daré Bioscience

    Daré Bioscience is a clinical-stage biopharmaceutical company committed to the advancement of innovative products for women's health. The company's 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.

    Daré's clinical-stage product portfolio includes potential first-in-category candidates in clinical development: Ovaprene®, a hormone-free, monthly contraceptive intravaginal ring whose U.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 replacement therapy following menopause. To learn more about Daré's full portfolio of women's health product candidates, and mission to deliver differentiated therapies for women, please visit www.darebioscience.com.

    Daré 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. Daré 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 Daré posts on its investor relations website or through social media channels may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré 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 Daré's website mentioned above.

    Forward-Looking Statements

    Daré 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 DARE-LARC1's potential to satisfy an unmet need in the contraceptive market, DARE-LARC1's ability to operate as designed and to demonstrate a rate of contraceptive effectiveness comparable to currently marketed LARCs and the potential for DARE-LARC1 to advance into clinical development. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Daré'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, risk and uncertainties related to: Daré's 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 Daré's operations, financial results and condition, and ability to achieve current plans and objectives, including the potential impact of the pandemic on Daré's ability to timely enroll, conduct and report results of its clinical trials and on the ability of third parties on which Daré relies to assist in the conduct of its business, including its clinical trials, to fulfill their contractual obligations to Daré; Daré's 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 Daré's product candidates in a timely manner; Daré's ability to conduct and design successful clinical trials, to enroll a sufficient number of study volunteers, 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; Daré's ability to retain its licensed rights to develop and commercialize a product candidate; Daré'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 candidates; the risks that the license agreement with Bayer may not become effective and, if it becomes effective, that future payments to Daré under the agreement may be significantly less than the anticipated or potential amounts; developments by Daré's competitors that make its product candidates less competitive or obsolete; Daré's dependence on third parties to conduct clinical trials and manufacture clinical trial material; Daré's ability to adequately protect or enforce its, or its licensor's, intellectual property rights; the lack of patent protection for the active ingredients in certain of Daré's 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 Daré's intellectual property rights. Daré'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's risks and uncertainties, you are encouraged to review its documents filed with the SEC including Daré'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 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 Daré Bioscience, Inc.:

    Lee Roth

    Burns McClellan

    Email:

    +1 212-213-0006

    Source: Daré Bioscience, Inc.

    Primary Logo

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  2. SAN DIEGO, Sept. 08, 2020 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, today announced that Sabrina Martucci Johnson, Daré's President and CEO, will participate in two upcoming virtual conferences:

    Women's Health Innovation Summit 2020

    Ms. Johnson will participate in two panel discussions:

    Health Decisions' Expert Panel: A Women-centric Approach to Clinical Research
    Date: Monday, September 14, 2020
    Time: 10:20 AM EDT

    CEO Leadership Panel
    Date: Tuesday, September 15, 2020
    Time: 9:25 AM EDT

    There will be a brief Live Q&A session following the CEO Leadership Panel. Both panel discussions will be available on-demand during the conference for all registered virtual event attendees.

    Event registration…

    SAN DIEGO, Sept. 08, 2020 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, today announced that Sabrina Martucci Johnson, Daré's President and CEO, will participate in two upcoming virtual conferences:

    Women's Health Innovation Summit 2020

    Ms. Johnson will participate in two panel discussions:

    Health Decisions' Expert Panel: A Women-centric Approach to Clinical Research

    Date: Monday, September 14, 2020

    Time: 10:20 AM EDT

    CEO Leadership Panel

    Date: Tuesday, September 15, 2020

    Time: 9:25 AM EDT

    There will be a brief Live Q&A session following the CEO Leadership Panel. Both panel discussions will be available on-demand during the conference for all registered virtual event attendees.

    Event registration for the Women's Health Innovation Summit 2020 is available at https://www.kisacoresearch.com/events/womens-health-innovation-summit#register.

    H.C. Wainwright 22nd Annual Global Investment Conference

    Ms. Johnson will present a Company update on September 15, 2020 at 4:00 PM EDT.

    A live webcast of the presentation will be available via the Investors section of the Company's website at https://ir.darebioscience.com/events-presentations. An archive of the presentation will be available for replay through September 29, 2020.

    About Daré Bioscience

    Daré Bioscience is a clinical-stage biopharmaceutical company committed to the advancement of innovative products for women's health. The company's 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.

    Daré's clinical-stage product portfolio includes potential first-in-category candidates in clinical development: Ovaprene®, a hormone-free, monthly contraceptive intravaginal ring whose U.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 replacement therapy following menopause. To learn more about Daré's full portfolio of women's health product candidates, and mission to deliver differentiated therapies for women, please visit www.darebioscience.com.

    Daré 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. Daré 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 Daré posts on its investor relations website or through social media channels may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré 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 Daré's website mentioned above.

    Contacts:

    Investors on behalf of Daré Bioscience, Inc.:

    Lee Roth

    Burns McClellan



    212.213.0006

    Source: Daré Bioscience, Inc.

    Primary Logo

    View Full Article Hide Full Article
  3. SAN DIEGO and ANN ARBOR, Mich., Sept. 01, 2020 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, and Avomeen, an accredited, independent contract research, development, and manufacturing organization specializing in chemical analysis and product development, today announced that the companies have signed an agreement under which Avomeen will provide contract product development laboratory services with a team specifically assembled to support the advancement of Daré's innovative pipeline of investigational products designed to address persistent unmet needs in women's health.  The unique partnership model is intended to enable Daré to leverage Avomeen's scientific expertise, including advanced…

    SAN DIEGO and ANN ARBOR, Mich., Sept. 01, 2020 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, and Avomeen, an accredited, independent contract research, development, and manufacturing organization specializing in chemical analysis and product development, today announced that the companies have signed an agreement under which Avomeen will provide contract product development laboratory services with a team specifically assembled to support the advancement of Daré's innovative pipeline of investigational products designed to address persistent unmet needs in women's health.  The unique partnership model is intended to enable Daré to leverage Avomeen's scientific expertise, including advanced instrumentation and development techniques, and accelerate development of key programs in a capital-efficient manner. 

    Daré and Avomeen are currently collaborating on development-stage programs, including Ovaprene®, an investigational hormone-free, monthly contraceptive, and intend to expand their partnership to include more programs in Daré's women's health pipeline. Central to the collaboration is Avomeen's ability to develop customized protocols, test methods, and formulations with processes tailored to unique product requirements and specifications. This capability aligns with Daré's portfolio of potential first-in-category products, which often require a customized approach to method development.

    "One of the clear goals of this partnership is to leverage Avomeen's ingenuity and expertise in biopharmaceutical development to support our clinical program initiatives in women's health," said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. "Avomeen has a proven track record and impressive regulatory accreditations combined with cutting-edge technological capabilities that we believe will enable us to accelerate development activities across our portfolio.  Further, we believe that the partnership agreement will result in greater efficiencies and savings in our research and development expenditures."

    Under the terms of the agreement, Avomeen will be Daré's preferred provider of product development laboratory services for an initial three-year period, provided that Avomeen has the expertise, resources and availability to perform the services that Daré requires. In exchange for receiving that exclusive service provider status, Avomeen will assemble operating and oversight teams committed to the partnership and provide a preferred discounted pricing structure and, if volume reaches designated levels, will also provide scientific personnel dedicated exclusively to supporting Daré's development programs covered by the agreement.

    "Avomeen is excited about this partnership and is well positioned to augment the existing clinical technical and regulatory competencies at Daré," said Mark Harvill, CEO of Avomeen. "We have been able to apply our novel scientific and technical solutions to Daré's diverse portfolio, in large part due to the collaborative approach that Daré implements with its development partners like Avomeen."

    About Daré Bioscience

    Daré Bioscience is a clinical-stage biopharmaceutical company committed to the advancement of innovative products for women's health. The company's 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.

    Daré's clinical-stage product portfolio includes potential first-in-category candidates in clinical development: Ovaprene®, a hormone-free, monthly contraceptive intravaginal ring whose U.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 replacement therapy following menopause. To learn more about Daré's full portfolio of women's health product candidates, and mission to deliver differentiated therapies for women, please visit www.darebioscience.com.

    Daré 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. Daré 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 Daré posts on its investor relations website or through social media channels may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré 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 Daré's website mentioned above.

    About Avomeen

    Avomeen is an accredited, independent contract research organization (CRO) and contract development and manufacturing organization (CDMO), bringing chemists and scientists together to tackle scientific product-development challenges in the biopharmaceutical industry and  across other industries and applications. The company's unique approach is singularly focused on applying its expertise and working closely with clients to help transform their biggest goals into real solutions. Throughout each step of product development, Avomeen's scientists and experts work within a rigorous quality system to ensure products comply with regulatory requirements and consumer expectations.

    Avomeen's facility is FDA-Registered and DEA-Licensed (schedules 1-5), and its laboratories are also GLP/GMP-compliant, ISO 17025 accredited, and QP authorized for clinical trial material in the EU. Avomeen offers complete, comprehensive scientific solutions that support the entire product development lifecycle, with a focus on growing strategic partnerships. For a complete overview of service offerings and areas of expertise, please visit www.avomeen.com.

    Forward-Looking Statements

    Daré 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 the anticipated benefits to Daré of its agreement with Avomeen. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Daré'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, risk and uncertainties related to: Daré's 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 Daré's operations, financial results and condition, and ability to achieve current plans and objectives, including the potential impact of the pandemic on Daré's ability to timely enroll, conduct and report results of its clinical trials and on the ability of third parties on which Daré relies to assist in the conduct of its business, including its clinical trials, to fulfill their contractual obligations to Daré; Daré's 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 Daré's product candidates in a timely manner; Daré's 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 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; Daré's ability to retain its licensed rights to develop and commercialize a product candidate; Daré'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 candidates; developments by Daré's competitors that make its product candidates less competitive or obsolete; Daré's dependence on third parties to conduct clinical trials and manufacture clinical trial material; Daré's ability to adequately protect or enforce its, or its licensor's, intellectual property rights; the lack of patent protection for the active ingredients in certain of Daré's 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 Daré's intellectual property rights. Daré'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's risks and uncertainties, you are encouraged to review its documents filed with the SEC including Daré'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 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:

    Investors on behalf of Daré Bioscience, Inc.:

    Lee Roth

    Burns McClellan



    212-213-0006

    Source: Daré Bioscience, Inc.

    Primary Logo

    View Full Article Hide Full Article
  4. SAN DIEGO, Aug. 20, 2020 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, today announced the publication of a proof of concept study of DARE-BV1 in Clinical and Experimental Obstetrics & Gynecology, an international journal focused on publication of high quality scientific research related to obstetrics and gynecology and women's health. DARE-BV1 is a novel thermosetting bioadhesive hydrogel containing clindamycin phosphate 2% that is being evaluated as a one-time vaginally administered treatment for bacterial vaginosis (BV). 

    The publication, entitled "Proof of concept study of a novel bioadhesive clindamycin phosphate 2% vaginal gel to treat bacterial vaginosis," reported that a single dose…

    SAN DIEGO, Aug. 20, 2020 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, today announced the publication of a proof of concept study of DARE-BV1 in Clinical and Experimental Obstetrics & Gynecology, an international journal focused on publication of high quality scientific research related to obstetrics and gynecology and women's health. DARE-BV1 is a novel thermosetting bioadhesive hydrogel containing clindamycin phosphate 2% that is being evaluated as a one-time vaginally administered treatment for bacterial vaginosis (BV). 

    The publication, entitled "Proof of concept study of a novel bioadhesive clindamycin phosphate 2% vaginal gel to treat bacterial vaginosis," reported that a single dose of the study drug, now known as DARE-BV1, administered to 30 patients diagnosed with bacterial vaginosis showed a meaningful clinical cure rate of 86% in evaluable patients at the test-of cure visit. Clinical cure was defined as the resolution of specified clinical signs and symptoms of bacterial vaginosis that were present at the time of enrollment in the study. 

    "This proof of concept study suggests that DARE-BV1 has the potential to be a highly effective treatment option for bacterial vaginosis, the most common cause of vaginal symptoms among women," said David Friend, PhD, Chief Scientific Officer of Daré Bioscience. "At the test-of-cure visit 7 to 14 days after dosing, 86% of the evaluable patients in the study were clinically cured of their bacterial vaginosis and 96% of those women remained clinically cured at the follow-up visit 21 to 30 days after dosing. There were no reports of adverse reactions to DARE-BV1 over the duration of the study."

    Bacterial vaginosis is the leading cause of vaginitis worldwide and is estimated to affect more than 21 million women in the United States.1,2 It is estimated that bacterial vaginosis is present in at least 15% of the sexually active population3 and is associated with a variety of serious health issues including preterm birth, pelvic inflammatory disease, increased susceptibility to sexual transmitted infections (including HIV), and other chronic health problems.2,4

    "Current FDA-approved treatments for the treatment of bacterial vaginosis offer clinical cure rates ranging from 37 to 68%," said Sabrina Martucci Johnson, President and Chief Executive Officer of Daré Bioscience. "Alarmingly, as many as 50% of women treated for bacterial vaginosis will experience a recurrence within 12 months of treatment, which underscores the need for more effective treatment options for women." 5

    Daré recently announced the initiation of the DARE-BVFREE study, a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical study of DARE-BV1 for the treatment of bacterial vaginosis. The DARE-BVFREE study is expected to enroll approximately 240 participants, ages 12 and older, diagnosed with bacterial vaginosis across multiple clinical sites in the United States. The primary endpoint is clinical cure of bacterial vaginosis, defined as resolution of specified clinical signs and symptoms, at the test-of-cure visit to occur 21 to 30 days after enrollment in the study.

    "If DARE-BV1 delivers a similarly high clinical cure rate in the Phase 3 pivotal study as it did in the pilot study, we believe DARE-BV1 could become a new front-line treatment option for women diagnosed with bacterial vaginosis," said Ms. Johnson.  "Given the anticipated short duration of the Phase 3 study, we expect to report topline data from the study by year-end 2020. Positive results from this single pivotal study will enable us to submit a new drug application for DARE-BV1 with the FDA in early 2021, two years from licensing the technology."

    Earlier this year, Daré announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for DARE-BV1 for the treatment of bacterial vaginosis, in addition to receiving Qualified Infectious Disease Product (QIDP) designation for the treatment of bacterial vaginosis in August of 2019.  

    Fast Track designation is granted by the FDA for drugs that are intended for the treatment of serious or life-threatening disease or conditions, which demonstrate the potential to address an unmet medical need. The designation offers the opportunity for more frequent interactions with the FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support approval. The Fast Track program is intended to facilitate development and expedite review of a Fast Track drug so that an approved product can reach the market expeditiously.

    QIDP designation is available under Title VIII of the Food and Drug Administration Safety and Innovation Act, titled Generating Antibiotic Incentives Now (GAIN), which creates incentives for the development of antibacterial and antifungal drug products that treat serious or life-threatening infections. The primary incentive is a five-year exclusivity extension added to any exclusivity for which a QIDP qualifies upon FDA approval.

    The publication entitled "Proof of concept study of a novel bioadhesive clindamycin phosphate 2% vaginal gel to treat bacterial vaginosis" is currently available in the Latest Articles section on the journal's website, or at 

    https://ceog.imrpress.com/EN/10.31083/j.ceog.2020.04.5304.

    1. Clinical Infectious Diseases 2007; 44:213–9; https://doi.org/10.1086/509577
    2. Centers for Disease Control and Prevention, Bacterial Vaginosis (BV) Statistics, viewed at https://www.cdc.gov/std/bv/stats.htm
    3. Clinical Infectious Diseases 2007; 44:220–1;https://doi.org/10.1086/509584
    4. Onderdonk, A. et al. "The Human Microbiome during Bacterial Vaginosis," Clinical Microbiology Reviews, April 2016 Volume 29 Number 2
    5. The Journal of Infectious Diseases 2006; 193:1478–86; https://www.ncbi.nlm.nih.gov/pubmed/16652274

    About Daré Bioscience

    Daré Bioscience is a clinical-stage biopharmaceutical company committed to the advancement of innovative products for women's health. The company's 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.

    Daré's clinical-stage product portfolio includes potential first-in-category candidates in clinical development: Ovaprene®, a hormone-free, monthly contraceptive intravaginal ring whose U.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 replacement therapy following menopause. To learn more about Daré's full portfolio of women's health product candidates, and mission to deliver differentiated therapies for women, please visit www.darebioscience.com.

    Daré 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. Daré 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 Daré posts on its investor relations website or through social media channels may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré 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 Daré's website mentioned above.

    Forward-Looking Statements

    Daré 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, the potential of a single administration of DARE-BV1 to safely and effectively treat bacterial vaginosis, the potential for DARE-BV1 to demonstrate a higher clinical cure rate than current FDA-approved drug products and become a front-line treatment option for bacterial vaginosis, the timing of availability of topline results of the DARE-BVFREE study and submission of a new drug application for DARE-BV1, the potential for regulatory approval of DARE-BV1 based on a single, successful Phase 3 clinical study, namely the DARE-BVFREE study, and the significance of Fast Track and QIDP designations for the DARE-BV1 program.  Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Daré'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, risk and uncertainties related to: Daré's 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 Daré's operations, financial results and condition, and ability to achieve current plans and objectives, including the potential impact of the pandemic on Daré's ability to timely enroll, conduct and report results of its clinical trials and on the ability of third parties on which Daré relies to assist in the conduct of its business, including its clinical trials, to fulfill their contractual obligations to Daré; Daré's 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 U.S. Food and Drug Administration (FDA) or foreign regulatory approval for Daré's product candidates in a timely manner; Daré's 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 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; Daré's ability to retain its licensed rights to develop and commercialize a product candidate; Daré'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 candidates; developments by Daré's competitors that make its product candidates less competitive or obsolete; Daré's dependence on third parties to conduct clinical trials and manufacture clinical trial material; Daré's ability to adequately protect or enforce its, or its licensor's, intellectual property rights; the lack of patent protection for the active ingredients in certain of Daré's 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 Daré's intellectual property rights. Daré'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's risks and uncertainties, you are encouraged to review its documents filed with the SEC including Daré'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 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:

    Investors on behalf of Daré Bioscience, Inc.:

    Lee Roth

    Burns McClellan



    212-213-0006

    Source: Daré Bioscience, Inc.

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  5. SAN DIEGO, Aug. 19, 2020 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, today announced that it received a Notice of Award of a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), a division of the National Institutes of Health (NIH). The award will support the clinical development of its novel intravaginal ring (IVR), DARE-FRT1. DARE-FRT1 is designed to deliver bio-identical progesterone continuously over a 14-day period and is being developed as a more convenient treatment option for the prevention of preterm birth and broader luteal phase support as part of an in vitro fertilization regimen.

    Daré's IVR technology is designed to allow for…

    SAN DIEGO, Aug. 19, 2020 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, today announced that it received a Notice of Award of a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), a division of the National Institutes of Health (NIH). The award will support the clinical development of its novel intravaginal ring (IVR), DARE-FRT1. DARE-FRT1 is designed to deliver bio-identical progesterone continuously over a 14-day period and is being developed as a more convenient treatment option for the prevention of preterm birth and broader luteal phase support as part of an in vitro fertilization regimen.

    Daré's IVR technology is designed to allow for sustained drug delivery over time periods ranging from weeks to months. Unlike other vaginal rings, Daré's IVRs feature a solid ethylene vinyl acetate (EVA) polymer matrix to contain and release a single or multiple active drugs without the need for a membrane or reservoir. DARE-FRT1 represents one of the potential unique applications of Daré's IVR technology in that it is designed to deliver non-oral bio-identical progesterone over multiple weeks without the need for daily administration, which has the potential to offer a better patient experience when compared to other delivery methods and may improve key aspects of treatment in terms of convenience and compliance.

    "The World Health Organization (WHO) estimates that every year 15 million babies are born preterm, before 37 completed weeks of gestation, that this number is rising, and that complications from preterm birth are the leading cause of death among children under five years of age, equating to approximately one million deaths in 2015¹," said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. "We continue to strive to deliver against our mission of addressing persistent unmet needs in women's health, and based on the latest data from the WHO, it's clear that preterm birth is an area of continued and growing unmet need. We are grateful to the NICHD for its commitment to advancing new innovation in this important therapeutic area and look forward to advancing the development of DARE-FRT1 with the NICHD's support."

    In July, Daré announced the initiation of a Phase 1 clinical trial of DARE-HRT1, a development-stage program utilizing the same IVR technology as DARE-FRT1 to deliver non-oral, bio-identical progesterone and estradiol for the treatment of menopausal symptoms.

    "We believe the DARE-HRT1 Phase 1 study will provide important scientific information for both DARE-HRT1 and DARE-FRT1, given that they both utilize the same IVR technology and bio-identical progesterone as an active ingredient," said David Friend, PhD, Chief Scientific Officer of Daré Bioscience. "Specifically, in the Phase 1 study of DARE-HRT1, we anticipate collecting useful pharmacokinetics characteristics of the bio-identical progesterone alone, which can be expected to directly apply to DARE-FRT1, and inform the work that the NICHD award will support."

    Daré worked with Grant Engine on the development of its grant proposal to the NICHD. Grant Engine is regularly identified as a leading company to assist with federally funded grant opportunities, including through the Small Business Innovation Research (SBIR) program for the NIH, the Department of Defense, the Defense Advanced Research Projects Agency and others. Daré plans to continue to pursue non-dilutive funding opportunities to support the further development of its product candidates.

    NIH funding is awarded in phases and Daré may be eligible to receive up to a total of approximately $2.3 million in grant funding for its DARE-FRT1 program based on the grant application it submitted to support the DARE-FRT1 Phase 1 human clinical study. The NICHD award granted to date of approximately $300,000 is for what is referred to as the "Phase I" segment of the project outlined in Daré's grant application, which is to occur during the period of August 2020 through July 2021. Additional potential funding of up to approximately $2 million for the "Phase II" segment of the project outlined in the grant application is contingent upon satisfying specified requirements, including, assessment of the results of the Phase I segment, determination that the Phase I goals were achieved, and availability of funds.

    The content of this press release is solely the responsibility of Daré Bioscience, Inc. and does not necessarily represent the official views of the National Institutes of Health. This press release discusses a project that will be supported by Eunice Kennedy Shriver National Institute of Child Health & Human Development of the National Institutes of Health under Award Number R44HD101169.

    ¹ World Health Organization, Preterm birth key facts [accessed 2020 Aug 18], https://www.who.int/news-room/fact-sheets/detail/preterm-birth

    About the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    NICHD conducts and supports research in the United States and throughout the world on fetal, infant and child development; maternal, child and family health; reproductive biology and population issues; and medical rehabilitation. For more information, visit http://www.nichd.nih.gov.

    About Grant Engine

    Grant Engine principals are company builders first and last. Grant Engine helps leading companies build value through its proprietary process. The key principals have an excellent track record of building companies through non-dilutive funding as well as equity. For more information, visit grantengine.com.

    About Daré Bioscience

    Daré Bioscience is a clinical-stage biopharmaceutical company committed to the advancement of innovative products for women's health. The company's 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.

    Daré's clinical-stage product portfolio includes potential first-in-category candidates in clinical development: Ovaprene®, a hormone-free, monthly contraceptive intravaginal ring whose U.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 replacement therapy following menopause. To learn more about Daré's full portfolio of women's health product candidates, and mission to deliver differentiated therapies for women, please visit www.darebioscience.com.

    Daré 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. Daré 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 Daré posts on its investor relations website or through social media channels may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré 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 Daré's website mentioned above.

    Forward-Looking Statements

    Daré 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, the potential for DARE-FRT1 to provide a safe, effective and convenient treatment option for the prevention of preterm birth or broader luteal phase support as part of an in vitro fertilization regimen, the potential utility of Daré's IVR technology to address persistent unmet needs in women's health, the potential utility of the Phase 1 clinical study of DARE-HRT1 in the development of DARE-FRT1, Daré's plans to continue to pursue non-dilutive funding opportunities to support the further development of its product candidates, and the potential for Daré to receive up to approximately $2.3 million in total grant funding from the NICHD based on the grant application it submitted for DARE-FRT1. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Daré'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, risk and uncertainties related to: Daré's 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 Daré's operations, financial results and condition, and ability to achieve current plans and objectives, including the potential impact of the pandemic on Daré's ability to timely enroll, conduct and report results of its clinical trials and on the ability of third parties on which Daré relies to assist in the conduct of its business, including its clinical trials, to fulfill their contractual obligations to Daré; Daré's 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 Daré's product candidates in a timely manner; Daré's 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 positive findings 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; Daré's ability to retain its licensed rights to develop and commercialize a product candidate; Daré'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 candidates; developments by Daré's competitors that make its product candidates less competitive or obsolete; Daré's dependence on third parties to conduct clinical trials and manufacture clinical trial material; Daré's ability to adequately protect or enforce its, or its licensor's, intellectual property rights; the lack of patent protection for the active ingredients in certain of Daré's 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 Daré's intellectual property rights. Daré'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's risks and uncertainties, you are encouraged to review its documents filed with the SEC including Daré'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 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:

    Investors on behalf of Daré Bioscience, Inc.:

    Lee Roth

    Burns McClellan



    212-213-0006

    Source: Daré Bioscience, Inc.

    Primary Logo

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