DARE Dare Bioscience Inc.

1.77
+0.08  (+5%)
Previous Close 1.69
Open 1.7
52 Week Low 0.9447
52 Week High 3.85
Market Cap $124,823,903
Shares 70,521,979
Float 68,859,431
Enterprise Value $110,562,865
Volume 3,487,096
Av. Daily Volume 5,104,448
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Upcoming Catalysts

Drug Stage Catalyst Date
DARE-BV1
Bacterial Vaginosis
PDUFA priority review
PDUFA priority review
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Sildenafil Cream, 3.6% (RESPOND)
Female Sexual Arousal Disorder (FSAD)
Phase 2b
Phase 2b
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Ovaprene
Contraception
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
DARE-HRT1
Hormone replacement therapy
Phase 1
Phase 1
Phase 1 data released June 28, 2021 - successfully delivered estradiol and the progesterone over the 28-day evaluation period.

Latest News

  1. SAN DIEGO, Sept. 08, 2021 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, today announced that Sabrina Martucci Johnson, its President and Chief Executive Officer, will deliver a company presentation at the H.C. Wainwright 23rd Annual Global Investment Conference being held virtually September 13 – 15, 2021.

    Ms. Johnson's presentation will be available on-demand for conference participants beginning at 7:00 a.m. Eastern Time on Wednesday, September 13th. Registration and other information about the event can be found at https://hcwevents.com/annualconference/.

    Following the conclusion of the conference, an archived webcast of Ms. Johnson's presentation will be available until September 29…

    SAN DIEGO, Sept. 08, 2021 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, today announced that Sabrina Martucci Johnson, its President and Chief Executive Officer, will deliver a company presentation at the H.C. Wainwright 23rd Annual Global Investment Conference being held virtually September 13 – 15, 2021.

    Ms. Johnson's presentation will be available on-demand for conference participants beginning at 7:00 a.m. Eastern Time on Wednesday, September 13th. Registration and other information about the event can be found at https://hcwevents.com/annualconference/.

    Following the conclusion of the conference, an archived webcast of Ms. Johnson's presentation will be available until September 29, 2021 under "Presentations, Events & Webcasts" in the Investors section of the company's website at http://ir.darebioscience.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 product portfolio includes potential first-in-category candidates in clinical development: Ovaprene®, a novel, hormone-free monthly contraceptive 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 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 the Investors section of its 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 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 Daré's website mentioned above.

    Contacts:

    Investors on behalf of Daré Bioscience, Inc.:

    Lisa Walters-Hoffert, Chief Financial Officer

    Daré Bioscience, Inc.

    lwalters@darebioscience.com

    858.926.7655

    OR

    Media on behalf of Daré Bioscience, Inc.:

    Jake Robison

    Canale Communications

    jake.robison@canalecomm.com

    619.849.5383

    Source: Daré Bioscience, Inc.



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  2. The discussion, Women's Health Case Study: Optimizing Study Enrollment During the COVID-19 Pandemic, will review the DARE-BVFREE Phase 3 study that was successfully initiated and completed during 2020

    SAN DIEGO, Sept. 07, 2021 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, today announced its participation in the Women's Health Case Study: Optimizing Study Enrollment During the COVID-19 Pandemic panel at the Women's 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…

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

    SAN DIEGO, Sept. 07, 2021 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, today announced its participation in the Women's Health Case Study: Optimizing Study Enrollment During the COVID-19 Pandemic panel at the Women's 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 Daré 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. I'm 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 Summit
    Panel:Women's Health Case Study: Optimizing Study Enrollment During the Covid-19 Pandemic
    Date:Tuesday, September 14, 2021
    Time:12:00 p.m. EST / 9:00 a.m. PST
    Participants:Sabrina Martucci Johnson, President and CEO, Daré Bioscience

    Dr. Mary Gunn, Chief Operating Officer, Health Decisions
      

    Additional information about the 2021 Women's 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-BV1's 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%. Daré 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 company's 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 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 product portfolio includes potential first-in-category candidates in clinical development: Ovaprene®, a novel, hormone-free, monthly contraceptive whose U.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 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 the Investors section of its 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 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 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. In this press release, forward-looking statements include, but are not limited to, statements regarding DARE-BV1's clinical cure potential for bacterial vaginosis, DARE-BV1's 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-BV1's commercial potential. 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: the risk that the FDA, other regulatory authorities or members of the scientific or medical communities may not accept or agree with Daré's 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; Daré's failure to timely establish or leverage third-party partnerships or collaborations to commercialize its product candidates, if approved; 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 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 Daré's product candidates less competitive or obsolete; failure of Daré's product candidates, if approved, to gain market acceptance or obtain adequate coverage from third-party payers; 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; 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; cyber attacks, security breaches or similar events that compromise Daré's technology systems or those of third parties on which it relies and/or significantly disrupt Daré's business; 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.:

    Lisa Walters-Hoffert, Chief Financial Officer

    Daré Bioscience, Inc.

    lwalters@darebioscience.com

    858.926.7655

    OR

    Media on behalf of Daré Bioscience, Inc.:

    Jake Robison

    Canale Communications

    jake.robison@canalecomm.com

    619.849.5383

    Source: Daré Bioscience, Inc.



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  3. Presentation will highlight the positive topline results from the Phase 1 clinical trial of DARE-HRT1

    Study results demonstrate DARE-HRT1's ability to co-deliver two different active pharmaceutical ingredients reliably over a 28-day period

    SAN DIEGO, Sept. 01, 2021 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, today announced that David Friend, PhD, the company's Chief Scientific Officer, will present data from the company's Phase 1 pharmacokinetic and safety study of DARE-HRT1 at the European Menopause and Andropause Society's (EMAS) 13th European Congress on Menopause and Andropause being held virtually September 8 - 10, 2021.

    Dr. Friend will review the results of the Phase 1 clinical…

    Presentation will highlight the positive topline results from the Phase 1 clinical trial of DARE-HRT1

    Study results demonstrate DARE-HRT1's ability to co-deliver two different active pharmaceutical ingredients reliably over a 28-day period

    SAN DIEGO, Sept. 01, 2021 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, today announced that David Friend, PhD, the company's Chief Scientific Officer, will present data from the company's Phase 1 pharmacokinetic and safety study of DARE-HRT1 at the European Menopause and Andropause Society's (EMAS) 13th European Congress on Menopause and Andropause being held virtually September 8 - 10, 2021.

    Dr. Friend will review the results of the Phase 1 clinical trial of DARE-HRT1, a novel segmented intravaginal ring (IVR) designed to deliver bio-identical 17β-estradiol and bio-identical progesterone continuously over a 28-day period as part of a hormone therapy (HT) regimen to treat the vasomotor symptoms (VMS) and genitourinary syndrome associated with menopause. The topline data from the study support DARE-HRT1's potential to be the first FDA-approved product to offer vaginal delivery of combination bio-identical estradiol and bio-identical progesterone hormone therapy in a convenient monthly format to treat both VMS as well as vaginal symptoms of menopause.

    Find out more information about the 13th European Congress on Menopause and Andropause by visiting the EMAS website: https://2021.emas-online.org.

    Dr. Friend's presentation, entitled "Results of a Phase 1 pharmacokinetic and safety study of DARE-HRT1, a 28-day intravaginal ring for codelivery of bio-identical estradiol and progesterone," will be available following the conclusion of the 13th European Congress on Menopause and Andropause under "Presentations, Events & Webcasts" in the Investors section of the company's website at http://ir.darebioscience.com. Daré announced topline results of the Phase 1 study of DARE-HRT1 in June 2021, and a copy of that announcement is available under "Press Releases" in the Investors section of the company's website at http://ir.darebioscience.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 product portfolio includes potential first-in-category candidates in clinical development: Ovaprene®, a novel, hormone-free monthly contraceptive 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 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 the Investors section of its 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 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 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. In this press release, forward-looking statements include, but are not limited to, statements relating to DARE-HRT1's potential as a safe and effective hormone therapy for symptoms of menopause and to be the first monthly therapy for VMS and vaginal symptoms of menopause. 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: the risk that the FDA, other regulatory authorities or members of the scientific or medical communities may not accept or agree with Daré's interpretation of or conclusions regarding the study data; 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 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 Daré's product candidates less competitive or obsolete; failure of Daré's product candidates, if approved, to gain market acceptance or obtain adequate coverage from third-party payers; 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; Daré's failure to timely establish or leverage third-party partnerships or collaborations to commercialize its product candidates, if approved; 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; cyber attacks, security breaches or similar events that compromise Daré's technology systems or those of third parties on which it relies and/or significantly disrupt Daré's business; 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.:

    Lisa Walters-Hoffert, Chief Financial Officer

    Daré Bioscience, Inc.

    lwalters@darebioscience.com

    858.926.7655

    OR

    Media on behalf of Daré Bioscience, Inc.:

    Jake Robison

    Canale Communications

    jake.robison@canalecomm.com

    619.849.5383

    Source: Daré Bioscience, Inc.



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  4. SAN DIEGO, Aug. 12, 2021 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, today reported financial results for the quarter ended June 30, 2021 and provided a company update.

    "This has been, and continues to be, an incredibly productive year for Daré," said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. "Consistent with our guidance, we submitted our New Drug Application for DARE-BV1, a potential new first-line treatment for bacterial vaginosis, to the FDA in June. Our NDA was accepted for filing and received Priority Review with a PDUFA target date of December 7, 2021. This year we also commenced the Phase 2b RESPOND study of Sildenafil Cream, 3.6%, a potential first-in-category…

    SAN DIEGO, Aug. 12, 2021 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, today reported financial results for the quarter ended June 30, 2021 and provided a company update.

    "This has been, and continues to be, an incredibly productive year for Daré," said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. "Consistent with our guidance, we submitted our New Drug Application for DARE-BV1, a potential new first-line treatment for bacterial vaginosis, to the FDA in June. Our NDA was accepted for filing and received Priority Review with a PDUFA target date of December 7, 2021. This year we also commenced the Phase 2b RESPOND study of Sildenafil Cream, 3.6%, a potential first-in-category product in development to treat female sexual arousal disorder, a physiological condition for which there are no FDA approved products. In June, we announced positive topline results from our Phase 1 study of DARE-HRT1, a novel intravaginal ring designed to deliver bio-identical hormones which is being developed to treat vasomotor symptoms and the genitourinary syndrome commonly associated with menopause. And finally, we reported two new sources of non-dilutive funding for two of our programs – first, a grant intended to support the continued development of DARE-LARC1 over more than five years through the non-clinical proof of principle work, and second, a collaboration with the National Institutes of Health's Eunice Kennedy Shriver National Institute of Child Health and Human Development providing financial and operational support for the conduct of a pivotal Phase 3 clinical trial of Ovaprene®, an investigational hormone-free monthly contraceptive whose U.S. commercial rights are under a license agreement with Bayer."

    Portfolio Accomplishments and Management Expectations for 2021-2022

    • DARE-BV1:
      • Daré innovation: Novel, investigational thermosetting bioadhesive hydrogel formulated with clindamycin phosphate 2% as a first-line, single-administration treatment for bacterial vaginosis.
      • 4Q 2020: Successfully completed DARE-BVFREE Phase 3 clinical study.
      • June 2021: Submitted New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA).
      • 2021 Prescription Drug User Fee Act (PDUFA) goal date: NDA accepted and received Priority Review with a PDUFA target date of December 7, 2021.
      • 2021: Execute and announce commercialization strategy for DARE-BV1 in the U.S. to support a robust market introduction in 2022, if approved.
    • Sildenafil Cream, 3.6%:
      • Daré innovation: Proprietary, investigational cream formulation of sildenafil, the active ingredient in Viagra®, for topical administration to treat female sexual arousal disorder (FSAD).
      • 1Q 2021: Commenced Phase 2b RESPOND clinical study.
      • 2021: Ongoing enrollment in Phase 2b RESPOND clinical study.
      • FSAD is a physiological condition characterized by the inability to attain or maintain sufficient genital arousal during sexual activity and, of the various types of female sexual dysfunction disorders, is most analogous to erectile dysfunction in men.
      • FSAD represents a significant unmet need, with an estimated 10 million women in the U.S. experiencing distress from symptoms of low or no sexual arousal and actively seeking treatment.
    • DARE-HRT1:
      • Daré innovation: Unique, investigational 28-day intravaginal ring (IVR) containing bio-identical estradiol and bio-identical progesterone for the treatment of vasomotor symptoms and genitourinary syndrome associated with menopause.
      • June 2021: Reported positive topline data of Phase 1 clinical study.

    • Ovaprene:

      • Daré innovation: Novel, investigational hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer.
      • 3Q 2021:
        • Announced a Collaborative Research and Development Agreement (CRADA) for a pivotal Phase 3 clinical study of Ovaprene in the U.S.
        • The CRADA is with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health.
        • The CRADA will allow Daré to leverage the contraceptive clinical trial expertise of NICHD while also sharing the costs of the Phase 3 clinical study with NICHD.   Daré agreed to contribute $5.5 million toward the total estimated cost to conduct the study and to provide clinical supplies of Ovaprene.
      • 4Q 2021: Submit Investigational Device Exemption (IDE) to the FDA for a pivotal Phase 3 clinical study in the U.S.
      • 2022: Commence the pivotal Phase 3 clinical study.
    • DARE-VVA1:
      • Daré innovation: Proprietary, investigational formulation of tamoxifen for vaginal administration to treat vulvar and vaginal atrophy (VVA) in women with or at risk for hormone-receptor positive breast cancer.
      • 2H 2021: Initiate Phase 1 clinical study in Australia.

    Financial Highlights for period ended June 30, 2021

    • Cash and cash equivalents: $9.1 million at June 30, 2021, compared to $4.7 million at December 31, 2020.
    • Net cash from financing activities during the six months ending June 30, 2021 was approximately $24.6 million and included net proceeds from sales of common stock under the company's at-the-market offering program and equity line and warrant exercises.
    • General and administrative expenses were approximately $1.8 million in 2Q 2021, as compared with $1.6 million in 2Q 2020, with the increase reflecting higher personnel costs and stock-based compensation expense.
    • Research and development expenses were approximately $7.3 million in 2Q 2021, as compared to approximately $5.5 million in 2Q 2020. The $1.8 million increase was due primarily to increases in expenses related to clinical trial and other development and regulatory affairs activities for Sildenafil Cream, 3.6%, DARE-BV1, Ovaprene and DARE-HRT1.
    • Comprehensive loss for 2Q 2021 was approximately $9.2 million, as compared to approximately $7.1 million for 2Q 2020.

    Recent Financial Developments

    • Between July 1, 2021 and August 10, 2021, Daré received additional cash of approximately $25.4 million (net of fees) from sales of common stock under the company's at-the-market offering program.
    • In July 2021, Daré received an initial cash payment of $11.45 million in non-dilutive grant funding to support the non-clinical development of DARE-LARC1. The entire grant award is for up to $48.95 million and future payments are contingent upon the DARE-LARC1 program's achievement of specified development and reporting milestones.
    • As of August 10, 2021, approximately 70.5 million shares of Daré common stock were outstanding.

    Conference Call

    Daré will host a conference call and live webcast today at 4:30 p.m. Eastern Time to review the company's financial results for the quarter ended June 30, 2021 and to provide a company update.

    To access the conference call via phone, dial (844) 831-3031 (U.S.) or (443) 637-1284 (international). The conference ID number for the call is 5286254. The live webcast can be accessed under "Presentations, Events & Webcasts" in the Investors section of the Company's website at http://ir.darebioscience.com. Please log in approximately 5-10 minutes prior to the call to register and to download and install any necessary software. To access the replay, please call (855) 859-2056 (U.S.) or (404) 537-3406 (international). The conference ID number for the replay is 5286254. The call and webcast replay will be available until August 26, 2021.

    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 product portfolio includes potential first-in-category candidates in clinical development: Ovaprene®, a novel, hormone-free monthly contraceptive candidate 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 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 the Investors section of its 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 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 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. In this press release, forward-looking statements include, but are not limited to, statements relating to the market opportunity and commercial potential for Daré's product candidates and management's expectations for Daré's product candidates in 2021 and 2022, including anticipated timing for the conduct of clinical trials, topline and other clinical trial data readouts, IDE submissions, potential FDA review and approval, and a potential commercial launch of DARE-BV1. 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 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 Daré's product candidates less competitive or obsolete; failure of Daré's product candidates, if approved, to gain market acceptance or obtain adequate coverage from third-party payers; 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; Daré's failure to timely establish or leverage third-party partnerships or collaborations to commercialize its product candidates, if approved; 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; cyber attacks, security breaches or similar events that compromise Daré's technology systems or those of third parties on which it relies and/or significantly disrupt Daré's business; 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

    Lisa Walters-Hoffert, Chief Financial Officer

    Daré Bioscience, Inc.

    lwalters@darebioscience.com

    858.926.7655

    Source: Daré Bioscience, Inc.

    Daré Bioscience, Inc. and Subsidiaries
    Consolidated Statements of Operations and Comprehensive Loss
    (Unaudited)
     Three Months Ended

    June 30, 2021
      2021   2020 
    Operating expenses:   
    General and administrative$1,797,637  $1,557,548 
    Research and development expenses 7,340,289   5,547,450 
    License fees 25,000   20,833 
    Total operating expenses 9,162,926   7,125,831 
    Loss from operations (9,162,926)  (7,125,831)
    Other income 175   1,618 
    Net loss$(9,162,751) $(7,124,213)
    Foreign currency translation adjustments$(8,880) $12,090 
    Comprehensive loss$(9,171,631) $(7,112,123)
    Loss per common share - basic and diluted$(0.18) $(0.27)
    Weighted average number of common shares outstanding:   
    Basic and diluted 50,436,593   26,710,750 



    Daré Bioscience, Inc. and Subsidiaries
    Condensed Consolidated Balance Sheet Data
        
     June 30, 2021 December 30, 2021
     (unaudited)  
        
    Cash and cash equivalents$9,111,741  $4,669,467 
    Working capital (deficit)$8,054,330  $(676,689)
    Total assets$14,822,410  $7,550,712 
    Total stockholders' equity (deficit)$7,744,004  $(1,151,733)

     



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    • Six-month priority review granted for DARE-BV1 with PDUFA target action date set for December 7, 2021.
    • NDA supported by positive data from the DARE-BVFREE Phase 3 study, which demonstrated clinical cure rates of 70-81% from a single vaginal dose of DARE-BV1.
    • Ongoing strategic discussions underway to support a robust market introduction of the product in 2022, if approved.

    SAN DIEGO, Aug. 09, 2021 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, today announced that the U.S. Food and Drug Administration (FDA) accepted for filing the company's New Drug Application (NDA) for DARE-BV1 for the treatment of bacterial vaginosis. The FDA granted this application Priority Review and set a Prescription Drug…

    • Six-month priority review granted for DARE-BV1 with PDUFA target action date set for December 7, 2021.

    • NDA supported by positive data from the DARE-BVFREE Phase 3 study, which demonstrated clinical cure rates of 70-81% from a single vaginal dose of DARE-BV1.
    • Ongoing strategic discussions underway to support a robust market introduction of the product in 2022, if approved.

    SAN DIEGO, Aug. 09, 2021 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, today announced that the U.S. Food and Drug Administration (FDA) accepted for filing the company's New Drug Application (NDA) for DARE-BV1 for the treatment of bacterial vaginosis. The FDA granted this application 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. The FDA grants Priority Review to applications for potential drugs that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment of a serious condition.

    The NDA is supported by positive results from the DARE-BVFREE Phase 3 randomized, multi-center, double-blinded, placebo-controlled clinical trial evaluating DARE-BV1 in women diagnosed with bacterial vaginosis, a condition that can cause serious health risks and very disruptive symptoms and is estimated to affect approximately 21 million women in the United States. DARE-BV1 is an investigational thermosetting bioadhesive hydrogel containing clindamycin phosphate 2% designed as a one-time vaginally-administered treatment for bacterial vaginosis.

    "The acceptance of this NDA marks a major milestone not only for Daré as a company but importantly for the 21 million women impacted by bacterial vaginosis," said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. "It is our goal to bring to market a product that has the potential to improve outcomes and convenience for women, as DARE-BV1 demonstrated it has the potential to do in the Phase 3 study, where a single vaginal dose of DARE-BV1 achieved clinical cure rates of 70-81%."

    The results from the DARE-BVFREE study demonstrated DARE-BV1's potential to provide improved clinical cure rates in a convenient, one-time dose compared to those of currently branded FDA-approved products indicated for the treatment of bacterial vaginosis. Patients in the study were evaluated during three clinic visits: Day 1 (screening and randomization visit), Day 7-14 (assessment visit), and Day 21-30 (test-of-cure visit). The study met its primary endpoint, demonstrating that as a primary therapeutic intervention a single vaginal dose of DARE-BV1 was statistically superior to placebo at Day 21-30 in the modified intent-to-treat population (70% compared to 36% of subjects clinically cured). Additionally, DARE-BV1 demonstrated clinical cure rates of 77% at Day 21-30 and 81% at Day 7-14 in the per protocol population, compared to 43% and 30% for placebo cream, respectively. Current FDA-approved products have clinical cure rates in the range of only 37-68%.

    DARE-BV1 has received both Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA for the treatment of bacterial vaginosis. Under QIDP designation, if approved, DARE-BV1 will receive five years of additional market exclusivity on top of the three years available for having generated new clinical data.

    Ongoing strategic discussions and other activities intended to support a robust market introduction of DARE-BV1 in 2022, if approved, are underway in parallel with the regulatory process. The FDA's target date for the completion of its review of December 7, 2021 aligns with Daré's intent to finalize and announce the commercialization strategy for DARE-BV1 in the U.S. in 2021. Commercialization arrangements for DARE-BV1 may include granting pharmaceutical companies with other commercial products in women's health an out-license to exclusively market, sell and distribute the product, if approved, in specific geographies; engaging commercial sales organizations to utilize their internal sales organizations and other commercial functions for market access, marketing, distribution, and other related services; or assembling a hybrid of these potential options to co-promote the product.

    Information about the results from the DARE-BVFREE Phase 3 clinical study of DARE-BV1 currently can be found in the company's most recent investor presentation under "Presentations, Events & Webcasts" in the Investors section of the company's website at http://ir.darebioscience.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 product portfolio includes potential first-in-category candidates in clinical development: Ovaprene®, a novel, hormone-free, monthly contraceptive whose U.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 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 the Investors section of its 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 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 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. In this press release, forward-looking statements include, but are not limited to, statements regarding DARE-BV1's clinical cure potential for bacterial vaginosis, DARE-BV1's potential to provide more effective treatment for bacterial vaginosis as compared to currently branded FDA-approved products for the treatment of bacterial vaginosis, DARE-BV1's commercial potential, Daré's ability to finalize and announce a commercialization strategy for DARE-BV1 in the U.S. in 2021, and the potential for a robust market introduction of DARE-BV1 in 2022. 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: the risk that the FDA, other regulatory authorities or members of the scientific or medical communities may not accept or agree with Daré's 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; Daré's failure to timely establish or leverage third-party partnerships or collaborations to commercialize its product candidates, if approved; 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 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 Daré's product candidates less competitive or obsolete; failure of Daré's product candidates, if approved, to gain market acceptance or obtain adequate coverage from third-party payers; 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; 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; cyber attacks, security breaches or similar events that compromise Daré's technology systems or those of third parties on which it relies and/or significantly disrupt Daré's business; 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:

    Lisa Walters-Hoffert, Chief Financial Officer

    Daré Bioscience, Inc.

    lwalters@darebioscience.com

    858.926.7655

    Source: Daré Bioscience, Inc.



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