Phase 2b study demonstrated topical Sildenafil Cream, 3.6% improved outcomes among women with female sexual arousal disorder (FSAD), particularly in an exploratory subset of women with FSAD with or without concomitant decreased desire There are currently no FDA-approved therapies for FSAD SAN DIEGO, June 24, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in innovation for the health and wellbeing of women, today announced the publication in Obstetrics & Gynecology, the official publi ...

财务数据和关键指标变化 - 第一季度一般及行政费用约为270万美元 [13] - 第一季度研发费用约为330万美元,较2023年第一季度下降34% [14] - 第一季度综合亏损约680万美元 [15] - 截至3月31日,公司现金及现金等价物约360万美元,5月13日已发行约1.01亿股普通股 [15] - 公司最近宣布与XOMA达成2200万美元的无担保融资交易,加速了XACIATO未来净销售和里程碑付款的现金流 [15][16] 各条业务线数据和关键指标变化 - XACIATO在第一季度在全美范围内开始处方销售,Organon的妇科销售团队继续看到医生对XACIATO的强烈接受 [21] - 硅酸盐乳膏3.6%在第一季度完成了与FDA的临床前会议,这是首个针对女性性唤起障碍的治疗候选药物 [22][23][24] - Ovaprene无激素月经期避孕套的III期临床试验于2023年12月启动,目前在18个美国试验点进行患者入组,预计无法在今年获得最终数据 [25][26][27][28] - DARE-LARC1长效可逆避孕植入物在前期技术验证方面取得突破,未来有望在糖尿病、肥胖等慢性病领域应用 [28][29] 各个市场数据和关键指标变化 - 根据市场研究,美国约有2000万女性存在性唤起障碍症状,硅酸盐乳膏3.6%有望成为首个获批治疗该适应症的产品 [22] - 非激素避孕药物市场是一个重大商业机会,目前美国没有获批的月经期无激素避孕套,Ovaprene有望成为该领域的颠覆性产品,约3500万美国女性是潜在用户 [25] 公司战略和发展方向及行业竞争 - 公司致力于开发创新的女性健康产品,包括治疗女性性唤起障碍和无激素避孕套等 [7][8][10] - 公司正在与FDA就硅酸盐乳膏3.6%III期临床试验设计进行沟通,希望尽快启动临床试验 [24] - 公司正在与Bayer合作推进Ovaprene III期临床试验,预计单一注册试验即可支持FDA上市申请 [26][27] - 公司的DARE-LARC1长效可逆避孕植入物及其药物递送平台技术有望在慢性病领域产生广泛应用 [28][29] 管理层对经营环境和未来前景的评论 - 公司表示这是女性健康领域令人兴奋的时期,受益于白宫相关举措和参议院法案的支持 [76][77][78] - 公司有望在今年实现Ovaprene III期试验进展和硅酸盐乳膏3.6%III期试验启动等重要里程碑 [80] - 公司的独特模式和商业合作伙伴的支持,使其有望加速女性健康创新,为股东创造价值 [80] 问答环节重要的提问和回答 问题1 **Douglas Tsao 提问** 询问硅酸盐乳膏3.6%III期临床试验的启动时间安排 [34][35][36][37] **Sabrina Martucci Johnson 回答** 公司正在等待FDA的反馈,一旦获得反馈后将尽快启动III期试验,正在提前做好各项准备工作 [35][36][37][38][39][40] 问题2 **Kemp Dolliver 提问** 询问公司当前资金情况和未来资金需求 [45][46][47][48][49][50][51][52][53][54] **Sabrina Martucci Johnson 回答** 公司最近获得2200万美元无担保融资,加上目前较低的研发支出,有望支持Ovaprene试验和硅酸盐乳膏3.6%III期试验的启动,但公司会谨慎考虑III期试验的启动时间 [46][47][48][49][50][51][52][53][54] 问题3 **Catherine Novack 提问** 询问硅酸盐乳膏3.6%III期临床试验的设计细节,包括适应症、人群、疗效评估指标等 [59][60][61][62][63][64][65][66][67] **Sabrina Martucci Johnson 回答** 公司已与FDA达成共识的适应症为女性性唤起障碍,患者人群包括存在性唤起障碍并导致性欲降低的女性。疗效评估指标包括性唤起感觉、性唤起相关困扰等,公司正与FDA就具体指标及其层级进行沟通 [60][61][62][63][64][65][66][67]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36395 DARÉ BIOSCIENCE, INC. (Exact Name of Registrant as Specified in its Charter) Delaware (State or Other Jurisdiction of Incor ...

Exhibit 99.1 Daré Bioscience Reports First Quarter 2024 Financial Results and Provides Company Update *Please see below for important safety and other information. Ovaprene® Phase 3 Study Ovaprene is a novel, investigational hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer HealthCare. Working with study collaborators at the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of ...

$22 million of non-dilutive capital at close provides significant capital to achieve objectives Upon achieving a pre-specified return threshold, XOMA will make upside-sharing milestone payments to Daré representing 50% of the future payments otherwise payable to XOMA Transaction allows Daré to focus on advancing Phase 3 first-in-category investigational products Ovaprene®, a potential first FDA-approved hormone-free intravaginal monthly contraceptive, and Sildenafil Cream, 3.6%, a potential first FDA-appr ...

Daré Bioscience's DARE-LARC1 Platform Technology has Transformative Potential for Women's Health as well as in Treating a Broad Range of Diseases Strategic Process Underway to Explore Partnering Opportunities for Additional Indications such as with GLP-1s for Obesity and Metabolic Disorders and Other Conditions Requiring Precise, Prolonged Treatment SAN DIEGO, April 23, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, today announced it will receive a pay ...

Daré Bioscience, Inc. (NASDAQ:DARE) Q4 2023 Earnings Conference Call March 28, 2024 4:30 PM ET Company Participants Sabrina Martucci Johnson - President and CEO MarDee Haring-Layton - Chief Accounting Officer Conference Call Participants Douglas Tsao - H.C. Wainright Will Hidell - Brookline Capital Markets Operator Welcome to the conference call hosted by Daré Bioscience to review the company’s Fourth Quarter Financial Results and to provide a General Business Update. This call is being recorded. My name is ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________________________ FORM 10-K ___________________________________________________ ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM _____ TO_____ Commission File No. 001-36395 Securities registered unde ...

财务业绩 - Daré Bioscience报告2023年全年财务业绩，现金及现金等价物为1050万美元[21] - Daré在2023年实现了约280万美元的总收入，净亏损约3010万美元[22] - Daré的2023年研发费用约2150万美元，2024年预计研发费用将大幅减少[24] 产品信息 - XACIATO™（clindamycin phosphate）阴道凝胶2%已在美国上市，用于治疗细菌性阴道炎[6] - Ovaprene®无激素月经间隔避孕药候选品关键第三阶段临床研究正在美国进行招募[9] - Sildenafil Cream，3.6%用于治疗女性性唤醒障碍的临床研究已完成第二阶段会议，FDA即将提供额外反馈[13] - Daré宣布DARE-PDM1和DARE-VVA1的积极结果，分别用于治疗月经痛和性疼痛[17][19] - Daré的首个获得FDA批准的产品是XACIATO™（clindamycin phosphate）阴道凝胶2%，用于治疗12岁及以上女性患者的细菌性阴道炎[38] - Daré的产品组合还包括潜在的首创类别候选产品：Ovaprene®、Sildenafil Cream、3.6%和DARE-HRT1[38] 更新计划 - Daré将于2024年提供有关FDA反馈、第三阶段研究设计和计划的更新[15] - Daré将于2024年提供有关季度收入和上市产品XACIATO™的更新[7] - Daré将于2024年提供有关Ovaprene®和Sildenafil Cream的招募和数据更新[10][15] 行业影响力 - Daré的CEO被评为2023年Fierce Pharma生物制药领域最具影响力人物之一[39]

SAN DIEGO, Jan. 31, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, and its collaborator Strategic Science & Technologies, LLC (SST), a Cambridge, MA based novel topical drug delivery company, today announced the successful completion of an end-of-Phase 2 (EoP2) meeting with the U.S. Food and Drug Administration (FDA), supporting advancement of Sildenafil Cream, 3.6% (Sildenafil Cream) for the treatment of female sexual arousal disorder (FSAD) to a Phase ...