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DARE

Dare Bioscience Inc. NASDAQ Capital Market
$1.33
Open: $1.38 High: $1.38 Low: $1.29 Close: $1.35
Range: 2021-05-06 - 2021-05-07
Volume: 689,068
Market: Closed
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DARE
Dare Bioscience Inc. 11119 North Torrey Pines Road San Diego CA, 92037 https://www.darebioscience.com
Dare Bioscience Inc is a healthcare company. The company develops and commercializes products in women's reproductive health. Its segment includes spectrum of categories like: contraception, vaginal health, pain and fertility.
  • CEO: Sabrina Martucci Johnson
  • Employees: 5
  • Sector: Healthcare
  • Industry: Biotechnology
DARE News
Latest news about the DARE
  • Daré Bioscience to Host First Quarter 2021 Financial Results and Company Update Conference Call and Webcast on May 13, 2021

    SAN DIEGO, May 06, 2021 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced that it will host a conference call and live webcast at 4:30 p.m. Eastern Time on Thursday, May 13, 2021, to review its financial results for the quarter ended March 31, 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 7857813. 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 7857813. The call and webcast replay will be available until May 27, 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 intravaginal 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. Contact: Investors on behalf of Daré Bioscience, Inc.:Tom MastersonAllele Capital Partnerstmasterson@allelecapital.com646.573.3216 Source: Daré Bioscience, Inc.

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  • Daré Bioscience Announces Ovaprene®, a Novel Investigational Hormone-Free Contraceptive, Poster Presentation at the 2021 Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists

    SAN DIEGO, April 27, 2021 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health innovation, today announced that data from the Company’s postcoital test (PCT) clinical study of its novel investigational hormone-free monthly intravaginal contraceptive, Ovaprene, will be presented at the 2021 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting. The meeting will be conducted virtually from April 30 - May 2, 2021. The poster will present topline results from the Ovaprene PCT clinical study, a pre-pivotal, multi-center, open-label, non-significant risk device trial. In the PCT study, Ovaprene prevented essentially all progressively motile sperm from entering the cervical canal (mean 0.48, median 0.00, per high powered field), a surrogate marker for contraceptive effectiveness. In PCT studies of similar size, products (diaphragms) that demonstrated no motile sperm in the cervical mucus during PCT assessments later demonstrated “typical use” contraceptive effectiveness of 86-91% in pivotal contraceptive studies evaluating pregnancy rates over six-month periods. If approved, Ovaprene could be the first monthly non-hormonal prescription contraceptive product addressing an important unmet need in the contraceptive method mix. "Market demographic data suggest there is a growing segment of women considering alternatives to hormonal contraceptive methods and it has already been established that there is a large segment of women who choose monthly contraceptive vaginal rings for the convenience of a non-daily option,” said Christine Mauck, MD, Medical Director for Daré Bioscience. “These PCT clinical study data are highly encouraging and give us confidence to move Ovaprene into the next stage of clinical development, a pivotal contraceptive effectiveness study, following our Investigational Device Exemption submission to the FDA planned for later this year.” “I believe this study was the most robust PCT clinical study ever conducted in the field of contraception and these findings are encouraging with regard to Ovaprene’s potential as an alternative to traditional hormone-based options. I am honored to present results from the PCT study at the ACOG’s annual meeting,” commented Andrea Thurman, MD, Professor of OBGYN at CONRAD/Eastern Virginia Medical School and a principal investigator in the Ovaprene PCT clinical study. The ePoster entitled Successful Postcoital Test Results of a New Monthly Hormone-Free Vaginal Contraceptive, authored by Andrea Thurman, MD, Jeffrey Baker, MD, Jeffrey Jensen, MD, MPH, Courtney Schreiber, MD, MPH, Nadene Zack, MS, Christine Mauck, MD, MPH, will be presented virtually by Andrea Thurman, MD and will be available to meeting attendees on the ACOG website at https://www.acog.org, beginning April 30, 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, investigational hormone-free monthly intravaginal 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 Ovaprene’s potential contraceptive efficacy, Ovaprene’s potential to be the first monthly non-hormonal prescription contraceptive product, potential market demand for Ovaprene if approved, the timing of Daré’s submission of an IDE to the U.S. Food and Drug Administration (FDA) for a pivotal contraceptive effectiveness and safety clinical study of Ovaprene, and the potential for FDA approval to market Ovaprene based largely on Daré’s planned contraceptive effectiveness study. 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, including the Ovaprene PCT clinical study, 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; 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; 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: Investors on behalf of Daré Bioscience, Inc.:Tom MastersonAllele Capital Partnerstmasterson@allelecapital.com646.573.3216 Source: Daré Bioscience, Inc.

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  • Daré Bioscience Announces the Presentation of DARE-BVFREE Phase 3 Clinical Trial Results at the 2021 Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists

    SAN DIEGO, April 26, 2021 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health innovation, today announced that data from the DARE-BVFREE Phase 3 study of DARE-BV1, a thermosetting vaginal gel for the treatment of bacterial vaginosis, will be presented at the 2021 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting. The meeting will be conducted virtually from April 30 - May 2, 2021. The poster presentation will highlight the positive topline results from the DARE-BVFREE Phase 3 randomized, double-blinded, placebo-controlled clinical trial evaluating Daré’s product candidate 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 results from the DARE-BVFREE study demonstrate DARE-BV1’s potential to provide improved clinical cure rates as compared to those of the current branded vaginal and oral prescription products for bacterial vaginosis. DARE-BVFREE randomized 307 women diagnosed with bacterial vaginosis at 32 centers across the United States in a 2:1 ratio to receive a single vaginal dose of DARE-BV1 or a single vaginal dose of placebo gel to be applied intravaginally within one day of randomization. Patients 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 (mITT) 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. DARE-BV1 was well-tolerated in the study, and there were no early discontinuations due to adverse events. “As a practicing physician focused on women’s sexual and vaginal health, I welcome new treatment options for women suffering with bacterial vaginosis, a condition that has serious and deleterious consequences if not adequately addressed,” said Andrew T. Goldstein, MD, FACOG, Medical Advisor of Daré Bioscience. “In the DARE-BVFREE trial, DARE-BV1 was well-tolerated and demonstrated clinical cure efficacy rates superior to those shown by current branded prescription products for treatment of bacterial vaginosis. The DARE-BVFREE trial followed the stringent enrollment criteria of the new 2019 FDA guidance document for developing drugs to treat bacterial vaginosis, and featured a patient population that we believe is very representative, including a large proportion of women, about 75%, who reported one or more episodes of bacterial vaginosis in the 12 months before they were randomized into the study.” In DARE-BVFREE, clinical cure was defined as resolution of the specific clinical signs that comprise the Amsel criteria; specifically, resolution of abnormal vaginal discharge associated with bacterial vaginosis, clue cells less than 20% of total epithelial cells on microscopy, and a negative 10% KOH “whiff” test. DARE-BV1 demonstrated clinical cure rates of 70% at Day 21-30 (primary endpoint) and 76% at Day 7-14 in the mITT population, compared to 36% and 24% for placebo cream, respectively, and 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. Consistent with the 2019 FDA guidance document, the mITT study population (N=180) excludes subjects from the intent-to-treat (ITT) population (N=307) who subsequently demonstrated a positive test result for other concomitant vaginal or cervical infections at baseline, or who have a baseline Nugent score of less than 7 (a score of 7 or greater represents bacterial vaginosis). The per protocol population (N=148) means subjects from the mITT population who have no major protocol violations that impact the primary or secondary endpoints or who received any other bacterial vaginosis therapy for any reason. “Studies have shown recurrence rates of up to 60% within 12 months of treatment for bacterial vaginosis, and currently marketed FDA-approved products for the treatment of bacterial vaginosis have clinical cure rates in the mid-30% to the high-60% range,” said David Friend, PhD, Chief Scientific Officer of Daré Bioscience. “Based on the topline results of the DARE-BVFREE study, DARE-BV1 delivered clinical cure rate values greater than those of currently marketed FDA-approved products. If approved, we believe DARE-BV1 will be an important new and convenient one-time vaginally-administered treatment option with the potential to improve clinical outcomes and overall quality of life for women suffering with bacterial vaginosis.” The ePoster entitled Phase 3 Study of a Single-Dose Bioadhesive Clindamycin 2% Gel for Bacterial Vaginosis, authored by Steven Chavoustie, MD, Andrew Goldstein, MD, Judy Gendreau, MD, Christine Mauck, MD, MPH, David Friend, PhD, and Sharon Hillier, PhD, will be presented virtually by Steven Chavoustie, MD and will be available to meeting attendees on the ACOG website at https://www.acog.org, beginning April 30, 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, investigational hormone-free monthly intravaginal 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 regarding DARE-BV1’s clinical cure potential for bacterial vaginosis, DARE-BV1’s potential importance to and utilization by women with bacterial vaginosis, if approved, 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 topline results from a clinical trial, including the DARE-BVFREE study, are based on preliminary analysis of key efficacy and safety data and, following a comprehensive review of study data, such results may change and topline results may not accurately reflect the complete results from the clinical trial; 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 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; 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; 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: Investors on behalf of Daré Bioscience, Inc.:Tom MastersonAllele Capital Partnerstmasterson@allelecapital.com646.573.3216 Source: Daré Bioscience, Inc.

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  • Daré Bioscience Appoints Dr. Sophia N. Ononye-Onyia to its Board of Directors

    SAN DIEGO, April 19, 2021 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced the appointment of Sophia N. Ononye-Onyia, PhD MPH MBA to its Board of Directors. “We are thrilled to add Dr. Ononye-Onyia to the Daré Board,” said Sabrina Martucci Johnson, Daré’s President and CEO. “Sophia has demonstrated the value of her leadership to global biopharmaceutical companies throughout her career. Her experience supporting commercialization of women's health products positions her to provide strategic guidance as our product candidates advance toward commercialization, and as we explore the variety of go-to-market partnering strategies to enhance their value for our shareholders.” Dr. Ononye-Onyia is the founder and CEO of The Sophia Consulting Firm, which provides strategic marketing and communications consulting services to pharmaceutical, biotech and health tech companies. Dr. Ononye-Onyia is also the creator, host and producer of the Amplifying Scientific Innovation Video Podcast which provides a platform for senior executives in the biotech and pharmaceutical industries to share their perspectives on the pharmaceutical industry on critical issues such as health equity, inclusion and diversity. Previously, Dr. Ononye-Onyia served in a variety of senior leadership roles including Executive Vice President, Managing Director at Rx Medical Dynamics LLC where she provided strategy consulting services related to commercial preparedness for global biopharmaceutical companies across various therapeutic areas including women’s health; Head of Corporate Communications of OncoSec Medical Inc., a biotechnology company focused on cytokine-based intratumoral cancer immunotherapies; and Director of Healthcare & Life Sciences Practice of The Beacon Group, a growth strategy consulting firm. “I’m immensely honored and delighted to join the Daré Board at a pivotal point in the Company’s trajectory as it prepares to achieve several meaningful portfolio objectives inclusive of the commerciazation of DARE-BV1,” said Dr. Sophia Ononye-Onyia. “I look forward to utilizing my multidisciplinary background, passion for scientific innovations and demonstrated proficiency in global commercialization programs to advance Daré’s leadership position in women’s health.” Dr. Ononye-Onyia was recently selected to join the inaugural class of the EY Entrepreneurs Access Network, serves on the Advisory Council of the Dell Women's Entrepreneur Network and is President of the New York Chapter Board of Directors for the Healthcare Businesswomen’s Association. Dr. Ononye-Onyia also serves as an Entrepreneur-in-Residence at the Yale University Office of Cooperative Research. Dr. Ononye-Onyia received a PhD in Medicinal Chemistry and MBA from the University of Connecticut, a Master’s in Public Health from Bowling Green State University and the University of Toledo, and a BS Honors in Chemistry, with a specialization in Biochemistry, from Bowling Green State University. Dr. Ononye-Onyia completed her postdoctoral training in breast medical oncology research at the Yale School of Medicine. 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, investigational hormone-free monthly intravaginal 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 potential commercial partnerships and their ability to enhance the value of Daré’s product candidates. 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; 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; 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: Investors on behalf of Daré Bioscience, Inc.:Tom MastersonAllele Capital Partnerstmasterson@allelecapital.com646.573.3216 Source: Daré Bioscience, Inc.

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  • Dare Bioscience Inc to Host Earnings Call

    NEW YORK, NY / ACCESSWIRE / March 30, 2021 / Dare Bioscience Inc (NASDAQ:DARE) will be discussing their earnings results in their 2020 Fourth Quarter Earnings call to be held on March 30, 2021 at 4:30 PM Eastern Time.To listen to the event live or access a replay of the call - visit https://www.

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  • Daré Bioscience Reports Full Year 2020 Financial Results and Provides a Company Update

    Conference Call and Webcast Today at 4:30 p.m. Eastern TimeSAN DIEGO, March 30, 2021 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today reported financial results for the year ended December 31, 2020 and provided a company update. “Despite the unique challenges posed during 2020, we achieved two important corporate firsts in 2020. We started the year in January by announcing our first commercial partnership agreement, with Bayer for Ovaprene® commercialization rights. We believe that this partnership not only validates the Ovaprene commercial opportunity and allows Daré to benefit from Bayer’s expertise in development, regulatory affairs and commercialization of first-in-category contraceptive products for women, but, with up to $310 million in commercial milestone payments, plus double-digit, tiered royalties on net sales, that it will also provide capital to support broader portfolio objectives. Then, we ended the year in December with the completion of our first portfolio Phase 3 study – specifically, we announced positive topline data from the DARE-BVFREE Phase 3 study of DARE-BV1 for the treatment of bacterial vaginosis, positioning Daré for our first NDA submission,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “The advances in 2020 across the portfolio set the stage for meaningful portfolio objectives in 2021.” 2021 Key Portfolio Objectives DARE-BV1: New Drug Application (NDA) submission and strategic commercialization agreement.Sildenafil Cream, 3.6%: Phase 2b clinical study commencement and topline data.Ovaprene: Investigational Device Exemption (IDE) submission.DARE-HRT1: Phase 1 clinical study topline data.DARE-VVA1: Initiation of Phase 1 clinical study. 2020 Portfolio Accomplishments and Management Expectations for 2021 DARE-BV1: Daré solution: Novel, investigational thermosetting bioadhesive hydrogel formulated with clindamycin phosphate 2% as a first-line, single-administration treatment for bacterial vaginosis.Successful completion of the DARE-BVFREE Phase 3 clinical study in 4Q 2020.Phase 3 study results: A single dose of DARE-BV1 delivered statistically significant efficacy (76.0% clinical cure rate at Day 7-14 and 70.2% at Day 21-30 (primary endpoint) in the modified intent-to-treat population). The study demonstrated DARE-BV1’s potential to provide improved clinical cure rates and improved patient outcomes compared to those of current branded prescription products for treatment of bacterial vaginosis.NDA submission to the U.S. Food and Drug Administration (FDA) planned for 2Q 2021.Fast track and Qualified Infectious Disease Product (QIDP) designations allow for a priority review request at the time of NDA submission, which, if granted by the FDA, could lead to a 2021 PDUFA goal date.Ongoing strategic discussions and other activities to support a robust market introduction in 2022, if approved. In 2021, Daré intends to finalize and announce the collaboration strategy for DARE-BV1 commercialization in the U.S. Sildenafil Cream, 3.6%: Daré solution: Proprietary, investigational cream formulation of sildenafil, the active ingredient in Viagra®, for topical administration to treat female sexual arousal disorder (FSAD).No FDA-approved products exist today to treat FSAD.Phase 2b RESPOND clinical study commenced in 1Q 2021.Topline data readout targeted for year-end 2021.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 large 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.1 DARE-HRT1: Daré solution: 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.Enrollment in Phase 1 clinical study in Australia completed during 1Q 2021.Topline data readout expected in 2Q 2021. Ovaprene: Daré solution: Novel, investigational hormone-free monthly intravaginal contraceptive.IDE submission to FDA planned for 4Q 2021, a requirement for initiating a pivotal contraceptive clinical study in the U.S.Pivotal Phase 3 clinical study commencement planned for 1Q 2022, enabling a 6-month data readout by the end of 2022. DARE-VVA1: Daré solution: 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.Phase 1 clinical study in Australia planned to commence during 2H 2021. DARE-FRT1: Daré solution: Investigational 14-day IVR containing bio-identical progesterone for the prevention of preterm birth and broader luteal phase support as part of an in vitro fertilization regimen.Continuation of pre-clinical development activities under grant awarded in 2020 by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), a division of the National Institutes of Health (NIH) supporting development activities for DARE-FRT1.Phase 1 clinical trial targeted for 2022. Financial Highlights for Fiscal Year ending December 31, 2020 Cash and cash equivalents: $4.7 million at December 31, 2020, compared to $4.8 million at December 31, 2019.Net cash from financing activities during FY2020 was approximately $25.1 million and consisted of approximately $23.0 million (net of fees) from sales of common stock, approximately $1.8 million from warrant and option exercises and approximately $367,000 in forgivable loan proceeds under the Paycheck Protection Program. In addition to these financing activities, the company received approximately $3.2 million in grant funding, $1.0 million from a license fee, and approximately $192,000 under Australia’s research and development tax incentive program bringing total net cash received during FY2020 to approximately $29.5 million.General and administrative expenses were approximately $6.5 million in FY2020, an increase of approximately $1.3 million over such expenses incurred in FY2019 reflecting higher expenses related to personnel, legal, professional and accounting services, insurance premiums, rent and facilities and stock-based compensation.Research and development expenses were approximately $20.8 million in FY2020, as compared to approximately $8.5 million in FY2019. The $12.2 million increase was due primarily to increases in expenses related to clinical and other development activities for DARE-BV1 and Ovaprene and expenses related to preclinical-stage programs including DARE-LARC1, as well as higher personnel costs, with such expenses partially offset by grant funding and cash received under Australia’s research and development tax incentive program.License expenses, which reflect up-front and annual license fees due to licensors under Daré’s various product license agreements, were approximately $83,000 in FY2020, as compared to approximately $533,000 during FY2019.Comprehensive loss for FY2020 was approximately $27.4 million, as compared to approximately $15.1 million for FY2019. Recent Financial Developments Between January 1, 2021 and March 29, 2021, Daré received additional cash of approximately $11.5 million, consisting of approximately $11.3 million (net of fees) from sales of common stock under the company’s “at-the-market” offerings program and equity line, approximately $50,000 from warrant exercises, and approximately $139,000 from grant funding.In January 2021, the company was notified that the principal balance of its loan obtained through the Paycheck Protection Program and all accrued interest was fully forgiven by the U.S. Small Business Administration.As of March 29, 2021, approximately 47.3 million shares of Daré common stock were outstanding. COVID-19 Update: Daré continues to monitor the pandemic, its associated restrictions and their potential effects on the company’s business, financial condition and results of operations, including the potential impacts on the company’s ongoing and planned clinical trials and the company’s ability to raise additional capital when needed. Due to the high level of uncertainty regarding the duration and impact of the COVID-19 pandemic on the U.S. and global economies, workplace environments and capital markets, Daré is unable to predict with any reasonable accuracy the full extent to which the pandemic will impact its business, financial condition or results of operations at this time. 1 Ad Hoc Market Research: FSAD Prevalence Report (Oct 2015) conducted for Strategic Science & Technologies, LLC. 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 year ended December 31, 2020 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 6441759. 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 6441759. The call and webcast replay will be available until April 13, 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, investigational hormone-free monthly intravaginal 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 Daré’s expectations for clinical development and FDA review of its product candidates, including the timing of commencement of and topline results and other data from its clinical studies, the timing of its NDA and IDE submissions, the potential timing of FDA approval and clearance, respectively, of such submissions, the commercial potential of Daré’s product candidates, Daré’s strategy and plans for commercialization of DARE-BV1 in the U.S., the potential for FDA approval of DARE-BV1 based largely on the results of the DARE-BVFREE Phase 3 study, DARE-BV1’s potential ability to improve clinical outcomes compared to current branded prescription products for the treatment of bacterial vaginosis, the potential for FDA approval to market Ovaprene based largely on Daré’s planned Phase 3 contraceptive safety and efficacy study, the potential benefits of Daré’s agreement with Bayer, including the potential significance to Daré of the commercial milestone payments and royalties on net sales, and the potential for Sildenafil Cream, 3.6% to be the first FDA-approved product to treat FSAD. 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; 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; 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: Investors on behalf of Daré Bioscience, Inc.:Tom MastersonAllele Capital Partnerstmasterson@allelecapital.com646.573.3216 Source: Daré Bioscience, Inc. Daré Bioscience, Inc. and SubsidiariesConsolidated Statements of Operations and Comprehensive Loss Years Ended December 31, 2020 2019 Operating expenses: General and administrative 6,549,508 $5,265,438 Research and development expenses 20,769,416 8,546,108 License expenses 83,333 533,334 Total operating expenses 27,402,257 14,344,880 Loss from operations (27,402,257) (14,344,880)Other income (expense) 1,514 81,050 Net loss$(27,400,743) $(14,263,830)Deemed dividend from trigger of down round provision feature$(6,863) $(789,594)Net loss to common shareholders$(27,407,606) $(15,053,424)Foreign currency translation adjustments$11,237 $(5,897)Comprehensive loss$(27,396,369) $(15,059,321)Loss per common share - basic and diluted$(0.91) $(0.97)Weighted average number of common shares outstanding: Basic and diluted 30,091,469 15,578,959 Daré Bioscience, Inc. and SubsidiariesConsolidated Balance Sheet Data December 31, 2020 December 31, 2019 Cash and cash equivalents$4,669,467 $4,780,107 Working capital (deficit)$(676,689) $831,526 Total assets$7,550,712 $7,442,788 Total liabilities$8,702,445 $7,001,962 Total stockholders' equity (deficit)$(1,151,733) $440,826

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  • Daré Bioscience Announces Initiation of Phase 2b RESPOND Study of Sildenafil Cream, 3.6% in Women with Female Sexual Arousal Disorder

    Topline data readout targeted for year-end 2021SAN DIEGO, March 24, 2021 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health innovation, and Strategic Science & Technologies, LLC (SST), a Cambridge, MA based novel topical drug delivery company, today announced the initiation of the Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6% for the treatment of female sexual arousal disorder (FSAD). Sildenafil Cream is a proprietary topical formulation of sildenafil, a phosphodiesterase-5 (PDE-5) inhibitor, being developed as a first-in-category option for the treatment of FSAD. FSAD is the inability to reach or maintain a sufficient physical response to sexual stimulation and, of the various types of female sexual dysfunction disorders, FSAD is most analogous to erectile dysfunction (ED) in men. Sildenafil is the active ingredient in a tablet for oral administration currently marketed under the brand name Viagra® for the treatment of erectile dysfunction in men. Unlike the oral formulations of PDE-5 inhibitors, Sildenafil Cream is applied locally to the vaginal tissue and is designed to facilitate vasodilation and increased blood flow directly to the genital tissue to improve the physical arousal response symptoms commonly associated with FSAD. If clinical development is successful, Sildenafil Cream has the potential to be the first FDA-approved FSAD treatment option. The Phase 2b RESPOND study will evaluate Sildenafil Cream compared to placebo cream in pre- and peri-menopausal women over 12 weeks of at-home use following both a non-drug and placebo run-in period. Patient reported outcome (PRO) instruments will be used to screen eligible women with FSAD and to measure achievement of the primary efficacy endpoint, namely improvement in localized genital sensations of arousal and reduction in the distress that women with FSAD experience. “We are honored to commence the Phase 2b study of Sildenafil Cream. Commencing the study now positions us for a potential topline data readout by the end of 2021, and over the next several months we will provide updates on our progress toward that target. Women have suffered far too long without a viable intervention to address FSAD and we believe Sildenafil Cream has the potential to be the first prescription product for this condition,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “This study is a significant milestone for Daré and our partner SST as we seek to bring to market a product that could address an important unmet need for women. The FSAD market is estimated to be as significant, if not more so, as the erectile dysfunction market in both the U.S. and the rest of the world.” Market research suggests that 16% of women in the U.S. ages 21 to 60, or approximately 10 million women, are distressed from experiencing symptoms of low or no sexual arousal and seeking a solution to improve their condition. To put the market opportunity for an FDA-approved FSAD treatment in context, the prevalence of complete ED in men is estimated to be about 5% of men at age 40, increasing to about 15% at age 70. “This is an important milestone in the field of female sexual dysfunction,” said Dr. Andrew Goldstein, Medical Advisor of Daré Bioscience and Past President of The International Society for the Study of Women's Sexual Health, as well as co-editor of the Textbook of Female Sexual Function and Dysfunction: Diagnosis and Treatment. “It is exciting to be working at the cutting edge of research focused on women’s sexual health and to advance a potential first-in-category treatment option for women suffering with FSAD.” About FSAD FSAD is distinct from hypoactive sexual desire disorder (HSDD) in women, which is characterized primarily by a lack of sexual desire. FSAD is a condition characterized primarily by a persistent or recurrent inability to attain or maintain sufficient genital arousal (an adequate lubrication-swelling response) during sexual activity, frequently resulting in distress or interpersonal difficulty. As with erectile dysfunction in men, FSAD in women is associated with insufficient blood flow to the genitalia. About Sildenafil Cream and the Phase 2b RESPOND Study Sildenafil Cream is an investigational proprietary cream formulation of sildenafil, a PDE-5 inhibitor, designed for topical administration to the vulva and vagina to increase genital blood flow and provide improvements in the female genital arousal response, while avoiding systemic side effects observed with oral formulations of sildenafil. Sildenafil Cream has been previously evaluated in Phase 1 and Phase 2a clinical studies. In a Phase 1 clinical study in 20 healthy post-menopausal women, topical sildenafil cream was safe and well tolerated at clinically relevant doses, and study subjects reported favorable product characteristics: easy to use and readily absorbed. In a Phase 2a study in women with FSAD (15 pre-menopausal and 16 post-menopausal), Sildenafil Cream increased measurable blood flow to the genital tissue compared to placebo cream. Further, data from a thermography study in healthy women demonstrated significantly greater increases in genital temperature after administration of Sildenafil Cream compared to placebo cream, indicating a positive impact on genital blood flow during the 30-minute testing session, with statistical separation from placebo within the first 15 minutes of dosing. Prior to commencement of the Phase 2b RESPOND clinical study of Sildenafil Cream, Daré previously completed a content validity study designed to identify and document the genital arousal symptoms that are the most important and relevant to women with FSAD. The findings of that study helped facilitate alignment with the FDA on acceptable efficacy endpoints for the Phase 2b RESPOND study and future Phase 3 program. The Phase 2b RESPOND study is expected to randomize 400 to 590 subjects into the double-blind dosing period from 40 to 50 sites in the U.S. to ensure a total of 300 (150:150) to 440 (220:220) subjects complete the 12-week double-blind dosing period. The final study sample size will be determined by a single interim analysis for unblinded sample size re-estimation, based on the study’s adaptive design. An adaptive design implemented in accordance with the FDA’s Guidance for Industry on adaptive designs for clinical trials of drugs mitigates the risk of the study being underpowered if the true treatment effect and variability are significantly different from estimates based on published data but are still clinically meaningful. The target timeline for topline data readout of the Phase 2b RESPOND study assumes an increase in sample size above 400 randomized subjects is not required. The primary efficacy endpoint of the study is a composite endpoint that includes patient-reported improvement in genital sensations of arousal and reduction in distress associated with FSAD. 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 intravaginal 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 regarding enrollment in and completion of the Phase 2b RESPOND clinical trial of Sildenafil Cream and the timing of topline data for the study, Sildenafil Cream’s potential to demonstrate safety and efficacy in treating FSAD, Sildenafil Cream’s potential to be the first FSAD treatment approved by the U.S. Food and Drug Administration (FDA), and the market opportunity for Sildenafil Cream. 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 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; 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; 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: Investors on behalf of Daré Bioscience, Inc.:Tom MastersonAllele Capital Partnerstmasterson@allelecapital.com646.573.3216 Source: Daré Bioscience, Inc.

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  • Daré Bioscience to Host Full Year 2020 Financial Results and Company Update Conference Call and Webcast on March 30, 2021

    SAN DIEGO, March 23, 2021 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced that it will host a conference call and live webcast at 4:30 p.m. Eastern Time on Tuesday, March 30, 2021, to review its financial results for the year ended December 31, 2020 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 6441759. 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 6441759. The call and webcast replay will be available until April 13, 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 intravaginal 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. Contact: Investors on behalf of Daré Bioscience, Inc.:Tom MastersonAllele Capital Partnerstmasterson@allelecapital.com646.573.3216 Source: Daré Bioscience, Inc.

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  • Daré Bioscience Completes Recruitment in Phase 1 Clinical Trial of DARE-HRT1, a Novel Intravaginal Ring Designed to Deliver Non-Oral, Bio-identical Hormone Therapy for the Treatment of Vasomotor Symptoms and Genitourinary Syndrome Associated with Menopause

    Topline data readout anticipated in the second quarter 2021SAN DIEGO, March 22, 2021 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health innovation, today announced completion of patient recruitment in its Phase 1 clinical trial of DARE-HRT1 being conducted through its wholly owned subsidiary in Australia. DARE-HRT1 is a novel intravaginal ring (IVR) designed to deliver bio-identical 17β-estradiol and bio-identical progesterone continuously over a 28-day period. It is being developed for the treatment of vasomotor symptoms (VMS) and genitourinary syndrome associated with menopause as part of a hormone therapy regimen. The randomized Phase 1 study is designed to evaluate the pharmacokinetics (PK) of DARE-HRT1 in approximately 30 healthy, post-menopausal women. The primary objective of the study is to describe the PK parameters of two different dose combinations over 28 days. Secondary endpoints of the study include assessing the safety and tolerability of DARE-HRT1 and comparing the exposure of estradiol, estrone, and progesterone of DARE-HRT1 over 28 days against a daily combination of oral estrogen (Estrofem®) and oral progesterone (Prometrium®). “The IVR drug delivery technology used in DARE-HRT1 is an important platform for Daré as we believe it offers a versatile drug delivery system in women’s health with the potential to improve convenience and outcomes,” said David Friend, PhD, Chief Scientific Officer of Daré Bioscience. “The objective of this Phase 1 study of DARE-HRT1 is to evaluate the ability of DARE-HRT1 to achieve its dual release objectives, as well as the ability of the IVR technology to release two different active drugs at two different rates.” The IVR technology used in DARE-HRT1 was developed by Dr. Robert Langer from the Massachusetts Institute of Technology and Dr. William Crowley from Massachusetts General Hospital and Harvard Medical School. Unlike other vaginal ring technologies, Daré’s IVR drug delivery technology is designed to release more than one active ingredient via a solid ethylene vinyl acetate polymer matrix without the need for a membrane or reservoir to contain the active drug or to control the release, allowing for sustained drug delivery. Hormone therapy is considered the most effective treatment for vasomotor symptoms, commonly referred to as hot flashes, and the genitourinary syndrome of menopause, and has been shown to prevent bone loss and fracture. There are currently no FDA-approved IVRs that deliver bio-identical progesterone in combination with bio-identical estradiol. As such, DARE-HRT1 has the potential to be a first-in-category product that offers monthly convenience for women. Daré intends to leverage the existing safety and efficacy data on the active ingredients in DARE-HRT1, estradiol and progesterone, to utilize the FDA’s 505(b)(2) pathway to obtain marketing approval of DARE-HRT1 in the U.S. The Phase 1 study of DARE-HRT1 is being conducted by Daré’s wholly-owned Australian subsidiary at specialty women’s health sites in Australia. Currently, Australia’s research and development tax incentive (R&DTI) gives 43.5% of every dollar spent by eligible companies on eligible R&D activities back to those companies in a cash payment. Daré’s subsidiary has and intends to continue to apply for the maximum refundable cash credit available under the Australian R&DTI program for eligible study costs incurred. Daré anticipates reporting topline data from this study in the second quarter of 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 intravaginal 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 regarding the timing of topline data from the Phase 1 clinical trial of DARE-HRT1, the potential for Daré’s IVR technology to provide for safe and effective sustained release of one or more active ingredients in human subjects, and the potential therapeutic application of the IVR drug delivery technology in women’s health. 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 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; 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; 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; 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: Investors on behalf of Daré Bioscience, Inc.: Tom MastersonAllele Capital Partnerstmasterson@allelecapital.com646.573.3216 Source: Daré Bioscience, Inc.

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  • Daré Bioscience to Participate in Upcoming Virtual Conferences

    SAN DIEGO, March 10, 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 participate in the following upcoming virtual conferences: M Vest and Maxim Group Inaugural Emerging Growth Virtual ConferenceMarch 17-18, 2021Presentation available on-demand for event participants beginning Wednesday, March 17You may learn more about the event and register HERE. BIO-Europe Spring DigitalMarch 22-25, 2021You may learn more about the event and register HERE. A webcast of the company’s presentation at the M Vest and Maxim Group virtual conference will be available following the conference for two weeks 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 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 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. Contact: Investors on behalf of Daré Bioscience, Inc.:Tom MastersonAllele Capital Partnerstmasterson@allelecapital.com646.573.3216 Source: Daré Bioscience, Inc.

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  • Daré Bioscience to Participate at the 33rd Annual Roth Conference

    SAN DIEGO, March 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 participate in a panel discussion titled “Women’s Health Companies Blazing the Trail” at the 33rd Annual Roth Conference that will take place virtually March 15 – 17, 2021. A webcast of the panel discussion will be available beginning March 15, 2021 at 5:00pm Eastern Time under “Presentations, Events & Webcasts" in the Investors section of the company's website at http://ir.darebioscience.com. The webcast will be available until March 29, 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 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 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. Contact: Investors on behalf of Daré Bioscience, Inc.:Tom MastersonAllele Capital Partnerstmasterson@allelecapital.com646.573.3216 Source: Daré Bioscience, Inc.

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  • Daré Bioscience to Present at the H.C. Wainwright Global Life Sciences Conference

    SAN DIEGO, March 02, 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 present at the H.C. Wainwright Global Life Sciences Conference that will take place virtually March 9 – 10, 2021. Ms. Johnson’s presentation will be available beginning March 9, 2021 at 7:00am EST under "Presentations, Events & Webcasts" in the Investors section of the company's website at http://ir.darebioscience.com. The webcast will be available until March 24, 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 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 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. Contact: Investors on behalf of Daré Bioscience, Inc.:Tom MastersonAllele Capital Partnerstmasterson@allelecapital.com646.573.3216 Source: Daré Bioscience, Inc.

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  • Daré Bioscience to Participate in Maxim Group’s Late Stage Innovations in Women’s Health Virtual Event

    SAN DIEGO, Feb. 25, 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 participate in a panel discussion for Maxim Group LLC’s Late Stage Innovations in Women’s Health event, which is part of the M-Vest Virtual Conference Series. The virtual event will take place at 11:00 am Eastern Time on March 4, 2021. The panel will be moderated by Jason McCarthy, PhD, Senior Managing Director and Head of Biotechnology Research – Equity Research at Maxim Group. For additional information on the event and to register to attend, please visit: https://www.m-vest.com/events/late-stage-innovations-in-womens-health. 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 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 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. Contact: Investors on behalf of Daré Bioscience, Inc.:Tom MastersonAllele Capital Partnerstmasterson@allelecapital.com646.573.3216 Source: Daré Bioscience, Inc.

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  • Daré Bioscience to Participate at the Women’s Health Innovation Series: Contraception Innovation Summit to be held Virtually on February 23, 2021

    SAN DIEGO, Feb. 16, 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 participate in a live panel discussion titled, The Evolution of Birth Control: Considerations from Product Development to End-User Adoption from Leading Innovators, at 12:30 p.m. EST / 9:30 a.m. PST on Tuesday, February 23, 2021, at the Women’s Health Innovation Series: Contraception Innovation Summit, which will be held virtually. The panel will discuss the opportunities and challenges faced by innovators when advancing new methods of birth control. As a featured speaker, Ms. Johnson will share Daré’s commitment to addressing unmet needs in contraception and the Company’s own journey with three innovative product candidates under development: Ovaprene®, an investigational hormone-free, monthly contraceptive that the Company is advancing towards a pivotal contraceptive study and whose U.S. commercial rights are under a license agreement with Bayer; DARE-LARC1, an investigational user-controlled long acting reversible levonorgestrel drug delivery system designed to store in a single implant and precisely deliver hundreds of therapeutic doses over months or years, whose development has been supported by $20.5 million in grant funding from the Bill & Melinda Gates Foundation; and ORB-204 and ORB-214, investigational injectable formulations of etonogestrel being developed as longer-acting (6- and 12-months) methods of contraception with a more predictable return to fertility compared to currently marketed injectable contraceptive products. The Contraception Innovation Summit is part of the 2021 Women’s Health Innovation Series. The Summit is about putting women at the center of contraceptive research, innovations, and education to improve women’s contraceptive journeys throughout their lives. Participants will include a leading network of pharma, biotech, medical device companies, start-ups, investors, researchers, and health care providers driving innovation at the convergence of healthcare and technology. Find out more by downloading the agenda 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 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 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. Contact:Investors on behalf of Daré Bioscience, Inc.:Tom MastersonAllele Capital Partnerstmasterson@allelecapital.com646.573.3216 Source: Daré Bioscience, Inc.

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  • Daré Bioscience to Present at the 2021 BIO CEO & Investor Digital Conference

    SAN DIEGO, Feb. 09, 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 present at the BIO CEO & Investor Digital Conference that will take place virtually February 16 – 18, 2021. Following the conclusion of the event, a recording of Ms. Johnson’s presentation will be available for on-demand listening under “Presentations, Events & Webcasts" in the Investors section of the company's website at http://ir.darebioscience.com until March 4, 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 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 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. Contact: Investors on behalf of Daré Bioscience, Inc.:Tom MastersonAllele Capital Partnerstmasterson@allelecapital.com646.573.3216 Source: Daré Bioscience, Inc.

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  • Daré Bioscience to Participate in Fireside Chat at the H.C. Wainwright BIOCONNECT 2021 Virtual Conference

    SAN DIEGO, Jan. 05, 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 participate in a fireside chat at the H.C. Wainwright BIOCONNECT 2021 Virtual Conference to be held January 11-14, 2021. The fireside chat will be available for on-demand listening beginning Monday, January 11, 2021, at 6:00 AM Eastern Time under “Presentations, Events & Webcasts" in the Investors section of the company's website at http://ir.darebioscience.com. The archived fireside chat will be available until January 25, 2021.About Daré BioscienceDaré 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 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 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.Contact:Investors on behalf of Daré Bioscience, Inc.: Tom Masterson Allele Capital Partners tmasterson@allelecapital.com 646.573.3216Source: Daré Bioscience, Inc.

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  • Is Now An Opportune Moment To Examine Daré Bioscience, Inc. (NASDAQ:DARE)?

    Daré Bioscience, Inc. ( NASDAQ:DARE ), is not the largest company out there, but it saw a significant share price rise...

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  • Daré Bioscience Announces Positive Topline Results From DARE-BVFREE, a Phase 3 Trial of DARE-BV1 in Patients Diagnosed with Bacterial Vaginosis

    DARE-BV1 met the primary endpoint of the study and all pre-specified secondary efficacy endpoints; demonstrated significantly greater clinical cure rates compared to placebo DARE-BV1 has Fast Track and QIDP designations from FDANew drug application (NDA) submission planned 1H of 2021 SAN DIEGO, Dec. 07, 2020 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced positive topline results from the DARE-BVFREE Phase 3 randomized, double-blinded, placebo-controlled clinical trial evaluating DARE-BV1 in 307 women diagnosed with bacterial vaginosis, a serious condition 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 convenient, one-time vaginally-administered treatment for bacterial vaginosis. The trial 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.“Based on these topline results, DARE-BV1 delivered clinical cure rate values greater than those of currently marketed FDA-approved products for the treatment of bacterial vaginosis. This successful Phase 3 clinical trial marks another important achievement for Daré. We began 2020 with the announcement of a commercial partnership for Ovaprene® with Bayer, marketer of one of the most successful contraceptive products in women’s health, and we’re concluding the year with another exciting milestone, the successful completion of our Phase 3 clinical trial of DARE-BV1 to support an NDA for the treatment of bacterial vaginosis,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “We believe there is a large unmet need for a more efficacious and convenient, single-dose vaginally-administered product to treat bacterial vaginosis, and we believe DARE-BV1 could become a new front-line treatment option. DARE-BV1 received Fast Track designation from the FDA earlier this year and, based on the topline results of this trial, we plan to file our NDA in the first half of 2021.”Topline Results of the Phase 3 Randomized Clinical Trial DARE-BVFREE randomized 307 women at 32 centers across the United States in a 2:1 ratio to receive a single vaginal dose of DARE-BV1 (N=204) or a single vaginal dose of placebo gel (N=103) to be applied intravaginally within one day of randomization.The primary endpoint for the study was clinical cure of bacterial vaginosis determined at the final study visit which occurred 21 to 30 days after study drug administration, also referred to as the test-of-cure (TOC) visit, in the modified intent-to-treat (mITT) study population (N=180). In accordance with U.S. Food and Drug Administration (FDA) guidance, the mITT population excludes subjects from the intent-to-treat (ITT) population (N=307) who subsequently demonstrated a positive test result for other concomitant vaginal or cervical infections at baseline.A single vaginal dose of DARE-BV1 proved statistically superior to placebo at p-value < 0.001 at the TOC visit that occurred 21 to 30 days after study drug administration (primary efficacy endpoint) and also at the assessment visit that occurred 7 to 14 days after study drug administration. DARE-BV1 also demonstrated statistically significant efficacy in all four additional pre-specified secondary efficacy assessments. The clinical cure endpoint results are shown in the following table:Summary of Clinical Cure Results (mITT Population), p-value < 0.001:   DARE-BV1 (N = 121) Placebo (N = 59) Clinical Cure at Day 7-14 visit76.0% 23.7% Clinical Cure at Day 21-30 visit (primary endpoint)70.2% 35.6% The clinical cure rate at the Day 21-30 visit for the ITT population was similar to that for the mITT population (70.1% for the DARE-BV1 group (N=204) and 36.9% for the placebo group (N=103), p-value < 0.001), demonstrating effectiveness of DARE-BV1 in treating bacterial vaginosis even when other concomitant vaginal or cervical infections were present.The DARE-BVFREE study’s two treatment arms were well balanced in terms of age, race, ethnicity, bacterial vaginosis history, and body mass index (BMI). The ITT population comprised primarily patients aged 15 to 51 years, with a mean age of 34.8 (standard deviation 8.84) and median age of 35. Over 53% of the ITT population qualified as obese (BMI ≥30.0), with a mean BMI of 31.50 (standard deviation 8.499). In the ITT population, 56.0% of women identified as Black or African American, 41% identified as white and 25.5% identified as of Hispanic or Latino origin (compared to 74.5% as not of Hispanic or Latino origin). In addition, more than 75% of the women in the ITT population reported one or more episodes of bacterial vaginosis diagnosed in the 12 months before they were randomized into the study (76.9% in the DARE-BV1 group and 73.8% in the placebo group).  DARE-BV1 was well-tolerated in the study. There were no early discontinuations due to adverse events (AEs), and the only serious AE occurred in a woman in the placebo group. In the DARE-BV1 group, 15.3% of patients reported AEs that were considered to be possibly, probably or definitely related to study treatment compared to 9.7% of patients in the placebo group.Only two AEs were reported by more than 2% of patients in the DARE-BV1 arm and at a rate higher than in patients in the placebo arm – vulvovaginal candidiasis, commonly called a vaginal yeast infection (17.2% in the DARE-BV1 group and 3.9% in the placebo group), and vulvovaginal pruritus, commonly referred to as vaginal itching (4.4% in the DARE-BV1 group and 1.9% in the placebo group). Over half of the vaginal yeast infections reported in the DARE-BV1 group and exactly half of those reported in the placebo group occurred in patients who exhibited a positive yeast culture prior to dosing.  "We believe these data demonstrate that DARE-BV1 is significantly effective in a representative patient population, including a large proportion of patients who have been previously treated for this infection. Today, about half of the patients treated for bacterial vaginosis experience recurrence of the infection within 12 months of their treatment, and currently marketed FDA-approved products for the treatment of bacterial vaginosis have clinical cure rates in the mid-30% to the high-60% range,” said David Friend, PhD, Chief Scientific Officer of Daré Bioscience. “If approved, we believe DARE-BV1 will be an important new and convenient one-time vaginally-administered treatment option with the potential to improve clinical outcomes and overall quality of life for women suffering with bacterial vaginosis.”Based on the topline results from the study, Daré expects to have a pre-NDA meeting with the FDA in early 2021 and to submit an NDA during the first half of 2021. DARE-BV1 received both Fast Track and Qualified Infectious Disease Product (QIDP) designations from the FDA for the treatment of bacterial vaginosis. Given these designations, the NDA could be eligible for priority review, which, if granted, could allow for a 2021 PDUFA date, and, assuming approval, an early 2022 commercial launch in the U.S.About the Phase 3 StudyDARE-BVFREE was a randomized, multicenter, double-blind, placebo-controlled study of a single administration of DARE-BV1 (clindamycin phosphate vaginal gel, 2%) compared to a single administration of placebo vaginal gel (HEC Universal Placebo Gel) for the treatment of bacterial vaginosis. Patients were evaluated during three clinic visits: Day 1 (screening and randomization visit), Day 7-14 (assessment visit), and Day 21-30 (TOC visit). Clinical cure was defined as resolution of the specific clinical signs that comprise the Amsel criteria; specifically, resolution of abnormal vaginal discharge associated with bacterial vaginosis, clue cells less than 20% of total epithelial cells on microscopy, and a negative 10% KOH “whiff” test. The total study duration was approximately one month for each individual patient.About Bacterial VaginosisBacterial vaginosis is the most common cause of vaginitis worldwide and is estimated to affect approximately 21 million women in the United States.1,2 Prevalence of bacterial vaginosis among non-white women in the U.S. is higher than among white women (African American 51%, Mexican American 32%, white 23%).2 While there are several therapeutic options for women in the U.S. diagnosed with bacterial vaginosis, currently approved options have relatively insufficient clinical cure rates, require sequential daily administrations or can be otherwise inconvenient for women to use. It is estimated that as many as 50% of women treated for bacterial vaginosis will experience a recurrence within 12 months of their treatment.3 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; https://www.cdc.gov/std/bv/stats.htm. Accessed December 5, 2020. 3. The Journal of Infectious Diseases 2006; 193:1478–86; https://www.ncbi.nlm.nih.gov/pubmed/16652274 About DARE-BV1DARE-BV1 is an investigational thermosetting bioadhesive hydrogel containing clindamycin phosphate 2% being evaluated as a one-time, vaginally-administered treatment for bacterial vaginosis.About Daré BioscienceDaré 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 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 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 StatementsDaré 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 Daré’s plans and strategies for regulatory approval and commercialization of DARE-BV1, including expected timing of Daré’s engagement with the FDA regarding an NDA for DARE-BV1, submission of an NDA for DARE-BV1, FDA review and approval of the NDA, and commercial launch of DARE-BV1 in the U.S. if approved; DARE-BV1’s potential importance to and utilization by women with bacterial vaginosis, including its potential ability to improve clinical outcomes and overall quality of life compared to currently available therapeutic options for bacterial vaginosis if approved; 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 topline results from a clinical trial, including the DARE-BVFREE study, are based on Daré’s preliminary analysis of key efficacy and safety data and, following a comprehensive review of study data, such results may change and topline results may not accurately reflect the complete results from the clinical trial; 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 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; 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 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; 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.Investors on behalf of Daré Bioscience, Inc.: Lee Roth Burns McClellan Email: lroth@burnsmc.com +1 212-213-0006Source: Daré Bioscience, Inc.

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  • Daré Bioscience Reports Third Quarter 2020 Financial Results and Provides Company Update

    Conference Call Today at 4:30 p.m. Eastern TimeSAN DIEGO, Nov. 12, 2020 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today reported financial results for the third quarter ended September 30, 2020 and provided a company update. “We made great progress toward our strategic and operational objectives during the third quarter. I’m proud to report that despite this year’s challenging operating environment, our team continued to execute efficiently, allowing us to maintain our progress toward our anticipated milestones for 2020 and 2021,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “The completion of the DARE-BVFREE pivotal study of DARE-BV1 for the treatment of bacterial vaginosis will be an important milestone for Daré. We expect to report topline results from this Phase 3 study before the end of 2020 and to submit a new drug application to the FDA in the first half of 2021 if the study is successful. It has been roughly two years since we licensed the rights to the DARE-BV1 program, and the rapid pace at which we have advanced its development is evidence of the strength of the entire Daré team.”“The DARE-BVFREE topline data read-out in Q4 2020 represents the first in a series of anticipated milestones for our later-stage clinical-stage product candidates,” said David Friend, PhD, Chief Scientific Officer of Daré Bioscience. “In 2021, we are planning to initiate a Phase 2b study of Sildenafil Cream, 3.6%, our candidate for female sexual arousal disorder, the sexual dysfunction condition in women most analogous to erectile dysfunction in men, and look forward to reporting topline data from this study by the end of 2021. FSAD is a highly pervasive condition for which no FDA-approved product exists. A safe, effective and convenient option for women is long overdue, and we hope to be able to provide such a solution. In 2021, we also look forward to advancing Ovaprene®, our investigational hormone-free, monthly contraceptive, into a pivotal study that we expect, if successful, to support a premarket approval submission to the FDA.”U.S. commercial rights for Ovaprene are subject to a license agreement with Bayer, which was announced earlier this year.Recent Business Highlights * DARE-LARC1: Received approximately $0.9 million in funding that remained under a pre-existing grant from the Bill & Melinda Gates Foundation in further support of DARE-LARC1 development activities. Development of DARE-LARC1 has been supported by a total of approximately $20.5 million in grant funding from the foundation, including this recent disbursement. * DARE-FRT1: Received a Notice of Award of a grant of approximately $0.3 million from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), a division of the National Institutes of Health (NIH). 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 the DARE-FRT1 program based on the grant application it submitted to support the DARE-FRT1 Phase 1 human clinical study. DARE-FRT1 is being developed for the prevention of preterm birth and broader luteal phase support as part of an in vitro fertilization regimen. The potential additional grant funding of approximately $2.0 million is contingent upon satisfying specified requirements and the availability of funds in the future. * Strategic CRO partnership: Entered into an agreement with Avomeen, an accredited, independent contract research, development, and manufacturing organization specializing in chemical analysis and product development, under which Avomeen will provide contract product development laboratory services with a team specifically assembled to support the advancement of Daré’s innovative pipeline.Third Quarter 2020 Financial Results * General and administrative expenses were approximately $1.4 million for the third quarter of 2020, a modest increase over the approximately $1.3 million incurred in the third quarter of 2019, with increased personnel costs, rent and facilities expenses and stock-based compensation expense partially offset by lower expenses for professional services. * Research and development expenses were approximately $6.2 million for the third quarter of 2020, as compared to approximately $2.0 million for the third quarter of 2019. The increase was due primarily to increased expenses related to development activities for DARE-BV1, Ovaprene and DARE-LARC1, and higher personnel costs, with such expenses partially offset by grant funding related to both Ovaprene and DARE-LARC1, and a decrease in costs related to development activities for DARE-HRT1 and Sidenafil Cream, 3.6%. * License expenses, which reflect payments due under Daré’s various product license agreements, were approximately $25,000 for the third quarter of 2020, as compared to approximately $133,300 for the third quarter of 2019. * Comprehensive loss for the third quarter of 2020 was approximately $7.6 million, as compared to approximately $3.4 million for the same period in the prior year, substantially due to a greater loss from operations in the third quarter of 2020. * Net cash provided by financing activities for the nine months ended September 30, 2020 was approximately $16.7 million and consisted of net proceeds from sales of common stock in “at-the-market” offerings and under the company’s equity line, proceeds from exercises of warrants and options and loan proceeds. * Cash and cash equivalents were approximately $5.4 million at September 30, 2020, compared to approximately $4.8 million at December 31, 2019.Recent Developments * Additional cash of approximately $4.5 million (net of fees) was raised from sales of common stock in “at-the-market” offerings and under the company’s equity line after third quarter-end through November 11, 2020. * As of November 11, 2020, approximately 38 million shares of Daré common stock were outstanding.COVID-19 Update: Daré continues to monitor the pandemic, its associated restrictions and their potential effects on the company’s business, financial condition and results of operations, including the potential impacts on the company’s ongoing and planned clinical trials and the company’s ability to raise additional capital when needed. Due to the high level of uncertainty regarding the duration and impact of the COVID-19 pandemic on the U.S. and global economies, workplace environments and capital markets, Daré is unable to predict with any reasonable accuracy the full extent to which the pandemic will impact its business, financial condition or results of operations at this time.Conference CallDaré 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 September 30, 2020 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 6519434. 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 6519434. The call and webcast replay will be available until November 19, 2020.About Daré BioscienceDaré 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 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 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 StatementsDaré 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 Daré’s expectations for clinical development of its product candidates, including the timing of topline results of the DARE-BVFREE study and submission of an NDA for DARE-BV1 to the FDA, the potential for NDA filing and regulatory approval to market DARE-BV1 based on a single successful Phase 3 study, commencement and announcement of topline results of clinical studies of Sildenafil Cream, 3.6% and Ovaprene, the potential for Sildenafil Cream, 3.6% to be the first FDA-approved product to treat female sexual arousal dysfunction, the potential for a premarket application filing and regulatory approval to market Ovaprene based on a single successful contraceptive efficacy study, and potential additional grant funding from the NICHD for development of 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 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; 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:Investors on behalf of Daré Bioscience, Inc.: Lee Roth Burns McClellan lroth@burnsmc.com 212.213.0006Source: Daré Bioscience, Inc.  Daré Bioscience, Inc. and Subsidiaries Consolidated Statements of Operations and Comprehensive Loss (Unaudited)           Three months ended Nine months ended  September 30, September 30,   2020  2019  2020  2019 Operating expenses        General and administrative$1,353,069  $1,318,986  $4,772,382  $3,903,545  Research and development expenses 6,203,753   1,966,230   14,131,007   6,172,192  License expenses 25,000   133,333   58,333   408,333  Total operating expenses 7,581,822   3,418,549   18,961,722   10,484,070  Loss from operations (7,581,822)  (3,418,549)  (18,961,722)  (10,484,070) Other income (986)  25,471   2,454   86,703  Net loss$(7,582,808) $(3,393,078) $(18,959,268) $(10,397,367) Deemed dividend from trigger of down round provision feature$(6,864) $-  $(6,864) $(789,594) Net loss to common shareholders$(7,589,672) $(3,393,078) $(18,966,132) $(11,186,961) Foreign currency translation adjustments$672  $(15,378) $(10,182) $(15,674) Comprehensive loss$(7,589,000) $(3,408,456) $(18,976,314) $(11,202,635) Loss per common share - basic and diluted$(0.24) $(0.20) $(0.69) $(0.76) Weighted average number of common shares outstanding:        Basic and diluted 31,588,152   16,683,411   27,381,508   14,756,213           Daré Bioscience, Inc. and Subsidiaries Condensed Consolidated Balance Sheets           September 30, December 31,  2020 2019  (unaudited)            Cash and cash equivalents$5,389,414  $4,780,107  Working capital (deficit)$(980,230) $831,526  Total assets$7,661,742  $7,442,788  Total liabilities$9,047,630  $7,001,962  Total stockholders' equity (deficit)$(1,385,888) $440,826

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  • Daré Bioscience to Host Third Quarter 2020 Financial Results and Company Update Conference Call and Webcast on November 12, 2020

    SAN DIEGO, Nov. 05, 2020 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced that it will host a conference call and live webcast at 4:30 p.m. Eastern Time on Thursday, November 12, 2020, to review its financial results for the quarter ended September 30, 2020 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 6519434. 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 6519434. The call and webcast replay will be available until November 19, 2020.About Daré BioscienceDaré 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 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 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.Contact:Investors on behalf of Daré Bioscience, Inc.: Lee Roth Burns McClellan lroth@burnsmc.com 212.213.0006Source: Daré Bioscience

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