Levonorgestrel

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, Dec. 04, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in innovation for the health and wellbeing of women, today announced it received a payment of $2.5 million as the latest installment under a grant agreement to advance the development of Daré’s investigational contraceptive DARE-LARC1 through nonclinical proof of principle studies and other IND-enabling work to allow for the submission of an Investigational New Drug (IND) application with the FDA, approval of which will be required to commence testing in humans. Under the terms of the grant agreement, Daré may receive a total of up to approximately $49 million to support nonclinical development of DARE-LARC1. To date, Daré has received payments totaling approximately $31.8 million. Additional payments are conditioned on the program meeting specified development and reporting milestones. “This latest installment continues to validate our progress and the importance of developing this technology, which can be used to address meaningful unmet needs in reproductive health as well as other therapeutic areas including diabetes, obesity, and other conditions requiring precise and prolonged treatment,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “Like the grant that we announced earlier this month to support development of a novel non-hormonal contraceptive candidate, the DARE-LARC1 product candidate is another one of our novel contraceptive technologies that continues to be supported by non-dilutive funding.” DARE-LARC1 is a potential new category of long-acting, reversible contraceptive (LARC). If successfully developed and approved, DARE-LARC1 could provide women with unparalleled control over the management of their fertility to better meet specific individual family planning goals and objectives. As with other types of LARC products, investigational DARE-LARC1 is intended to provide effective contraception for an extended period without requiring day-to-day effort. Unlike current LARC products, DARE-LARC1’s innovative features include precision dosing, extended device duration and wireless control. DARE-LARC1 utilizes levonorgestrel, which is the active pharmaceutical ingredient in a number of FDA-approved birth control methods. Earlier this year Daré announced that it achieved technological proof of concept for DARE-LARC1 and the underlying innovative drug delivery platform designed to store and precisely deliver therapeutic doses over months or years through a single device. That milestone reflects the drug delivery platform’s potential to address the treatment burden for various conditions where treatment requires frequent dosing or regular injections. The technology behind this drug delivery platform was originally developed at the Massachusetts Institute of Technology by renowned researchers Robert Langer, Ph.D. and Michael J. Cima, Ph.D. and was previously validated in a first-in-human study in osteoporosis patients using an earlier prototype. Daré has since made significant technological enhancements to the design and integration of custom electronics, hardware, and software to achieve drug delivery targets while incorporating user feedback to optimize form and function. Daré’s progress has resulted in a highly versatile platform technology with potential to address meaningful unmet needs in reproductive health as well as other therapeutic areas including diabetes, obesity, and other conditions requiring precise and prolonged treatment. To support development opportunities outside of the reproductive health category, including diabetes, obesity, and other conditions requiring precise and prolonged treatment, Daré is exploring strategic discussions with potential industry partners. Key features of the implant technology include: Precision dosing: Unique design allows for precise dose timing and amount using individually addressable drug micro-reservoirs.Extended duration and dosing interval control: The ability to house up to hundreds of individual doses means a single device can provide dosing over months to years.No external charging or recharging required: A custom implant grade battery is designed to last for up to 20 years, depending on the application.Upgradable platform: Device software can be updated without removal or replacement of the implant.Two-way communication: Smart technology can respond wirelessly to queries from an external communication device to provide status updates, modify dosing, and deliver other application specific information.Smartphone integration: Platform can be paired with custom mobile apps designed for each application to create a personalized experience for the user. About Daré Bioscience Daré Bioscience is a biopharmaceutical company committed to advancing 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 prioritize women's health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, sexual health, pelvic pain, fertility, infectious diseases, and menopause. The first FDA-approved product to emerge from Daré’s portfolio of women’s health product candidates is XACIATO™ (clindamycin phosphate) vaginal gel 2%, a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older, which is under a global license agreement with Organon. Visit www.xaciato.com for information about XACIATO. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene®, a novel, 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, the active ingredient in Viagra®, to treat female sexual arousal disorder (FSAD); and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy. 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 Bioscience leadership has been named on the Medicine Maker’s Power List and Endpoints News’ Women in Biopharma 2022. In 2023, Daré's CEO was honored as one of Fierce Pharma’s Most Influential People in Biopharma for Daré’s contributions to innovation and advocacy in the women’s health space. Daré Bioscience placed #1 in the Small Company category of the San Diego Business Journal’s 2023 Best Places to Work Awards. Daré may announce material information about its finances, product and 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 and 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 X (formerly Twitter) accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the list of social media channels the company may use to communicate information will be posted in the Investors section of Daré’s website. 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,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “project,” “target,” “objective,” or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to the potential for Daré to receive additional payments under the grant agreement relating to DARE-LARC1, DARE-LARC1’s potential as a safe and effective LARC product, the potential market opportunity for DARE-LARC1, if approved, the potential of the drug delivery technology underlying DARE-LARC1 to be utilized in products for the treatment of a broad range of diseases and conditions, and the potential for Daré to enter into strategic collaborations relating to the drug delivery technology. 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, risks and uncertainties related to: Daré’s ability to achieve the DARE-LARC1 pre-clinical development and other milestones required for it to receive additional payments under the grant agreement; the potential that no definitive agreements result from discussions regarding potential strategic collaborations for the drug delivery technology underlying DARE-LARC1; Daré’s ability to raise additional capital when and as needed to advance its product candidates, execute its business strategy and continue as a going concern; Daré’s ability to develop, obtain FDA or foreign regulatory approval for, and commercialize its product candidates and to do so on communicated timelines; failure or delay in starting, conducting and completing clinical trials of a product candidate; 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; Daré’s dependence on third parties to conduct clinical trials and manufacture and supply clinical trial material and commercial product; 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 the FDA, other regulatory authorities, members of the scientific or medical communities or investors may not accept or agree with Daré’s interpretation of or conclusions regarding data from clinical studies of its product candidates; the risk that development of a product candidate requires more clinical or nonclinical studies than Daré anticipates; the loss of, or inability to attract, key personnel; the effects of macroeconomic conditions, geopolitical events, public health emergencies, and major disruptions in government operations on Daré’s operations, financial results and condition, and ability to achieve current plans and objectives; the risk that developments by competitors make Daré’s product or product candidates less competitive or obsolete; difficulties establishing and sustaining relationships with development and/or commercial collaborators; failure of Daré’s product or product candidates, if approved, to gain market acceptance or obtain adequate coverage or reimbursement from third-party payers; Daré’s ability to retain its licensed rights to develop and commercialize a product or 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 and product candidates; 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; product liability claims; governmental investigations or actions relating to Daré’s product or product candidates or the business activities of Daré, its commercial collaborators or other third parties on which Daré relies; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; cybersecurity incidents or similar events that compromise Daré’s technology systems or those of third parties on which it relies and/or significantly disrupt Daré’s business; and disputes or other developments concerning Daré’s intellectual property rights. Daré’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of Daré’s risks and uncertainties, you are encouraged to review its documents filed with the SEC including Daré’s recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Daré undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. Contacts: Daré Bioscience Investor Relationsinnovations@darebioscience.com Source: Daré Bioscience, Inc.

作者 | 陈芋 编辑｜遥望 来源 | 赛柏蓝 行业下行期，企业退出意愿加强，头部药企加速收割市场，产业整合提速。 01 进入2024年 接连有药企易主 今年2月，华润双鹤以31亿元收购华润紫竹100%股权，通过紫竹旗下毓婷、金毓婷等核心产品丰富双鹤专科领域产品线，形成“女性健康+儿科”专科产品序列，完善产品矩阵； 3月，主营中成药业务的新天药业宣布拟通过发行股份收购汇伦医药85.12%的股权，将业务拓展至小分子化学药领域； 6月，国内对比剂龙头北陆药业以2.02亿元收购承德天原药业80%股权，扩大其在中成药领域的覆盖； 10月，新诺威（石药创新）收购石药百克方案出炉，新诺威将以高达76亿元的总价收购石药百克100%股权，以增强其生物医药平台的创新能力； 10月，华润双鹤又以2.6亿元自有资金收购贵州天安药业89.681%股权，进一步充实糖尿病药物产品线； 11月，“四大老牌制药企业”之一东北制药作价1.87亿元收购北京鼎成肽源70%股权，从TCR-T进军创新药。 行业进入中低速增长存量博弈期，有企业退出意愿加剧，也有企业趁着标的估值合适大举收购。 02 行业低谷期 整合需求强烈 11月18日，在由赛柏蓝承办的第44届中国医药产业发展高峰论坛上，南京医药股份有限公司副总裁彭玉萍表示，中国医药行业已从高速增长的增量博弈发展模式转变为中低速增长的存量博弈的发展模式，内生增长的投资回报率逐渐下降。 据中国医药企业管理协会数据，2024年上半年，全国医药工业营收、利润双双下降，分别较上年同期下降了1.4%、1.2%，除中药饮片、药用辅料及包装材料、生物制品3个子行业外，化学制药、化学原料药、医疗仪器设备及器械、卫生材料及医药用品、中成药、制药专用设备6个子行业营收均下降。 据东海证券报告，今年前三季度医药生物行业上市公司整体实现营业收入18141.57亿元，同比下降0.39%；归母净利润1450.40亿元，同比下降9.01%（共纳入A股申万医药生物行业432只个股作为分析样本）。 同期医药生物上市公司盈利能力整体小幅下降——前三季度整体毛利率为32.06%，较去年同期下降0.88个百分点；净利率为8.45%，较去年同期下降0.78个百分点。 资本市场方面，IPO大幅减少。自证监会2023年8月27日提出“阶段性收紧IPO节奏”后一年内，484家企业IPO终止，同比增加71.03%；新增IPO受理企业135家，同比下滑74.67%；329家公司排队在审，同比减少57.82%。同时，128家企业上市融资938.44亿元，数量、金额也分别同比下滑69.69%、80.03%。 彭玉萍提到，行业整体增长缓慢甚至下降的压力下，产业链上下游之间的整合需求愈发强烈，部分医药企业主动发起产业并购，以此寻找“第二增长曲线”。 一拍即合的买与卖之下是买方和卖方在行业下行期下并不相同的心态。 面临营收、利润指标的压力时，手上有钱的大药企将收并购作为最快速的带来营收和利润的方式；而对于急于退出的药企及其背后的持股人来说，卖身在环境不好的时候成为了一个比坚持更容易的选择。 政策支持也是重组并购的重要推动力。 今年9月，证监会发布《关于深化上市公司并购重组市场改革的意见》，支持上市公司向新质生产力方向转型升级，鼓励上市公司加强产业整合，同时明确将提升重组市场交易效率等；10月，上交所召开券商座谈会，重点推动“并购六条”和“科创板八条”落地。 随着市场环境变化和系列政策出台，当下的并购市场由“套利并购”逐渐回归到“产业并购”的轨道上，并购重组从市值导向到产业导向的转变在加快。 03 谨慎选择标的 重视并购后管理 加入南京医药前，彭玉萍在江苏高投、沿海资本等投资机构有着十余年的工作经验，她坦言，与一级市场投资相比，企业间的收并购更加复杂。 战略导向下的产业并购重组交易不是两家公司间的资本游戏，而需要深刻的行业洞见与企业经营管理经验作支撑。 一方面企业在展开收并购前首先要明确自身产业定位和方向，理性对待诸多“风口”，以提升主业核心竞争力为导向，注重远期收益，合理制定发展规划和并购节奏，避免盲目并购。 其次，理解标的资产也是展开高质量收并购的前提，包括标的公司的商业模式、业务模式、资源组织模式等。 同时，还需结合行业背景判断标的公司风险，例如其毛利率水平与行业地位是否匹配，是否存在背离行业的特殊情况，应收帐款、存货预付款、现金流净额等是否存在异常波动等。 从更长的时间维度来看，企业展开收并购要循序渐进，对并购领域不熟悉的公司先从小额并购、现金并购做起，不盲目求大、求快，还可以引入分期收购等形式，根据业绩承诺完成以及整合情况决定是否收购剩余股份。 另一方面，完成交易流程后的并购后管理更加重要，彭玉萍指出，双方需要展开“钱&人&文化”的全方位整合。 在“钱”上，需要管理好银行账户、审批权限等；在“人”上，需要管理好法人、关键岗位、考核评价权等；在“文化”上，需要在价值取向上达成共识，通过对双方文化现状的准确把握确认文化融合的最佳方式。 为实现并购重组价值最大化，企业需要逐步完成从股权、财务报表等浅层整合，向业务、团队、文化、管理、价值观等产业链各环节深度融合的升级。收购方可通过向标的企业注入资金、资源及管理经验提高其经营效率和盈利水平，标的公司并入后带来的横向或纵向扩张也将完善企业布局、提升规模效应，协同提升整体价值。 END 内容沟通：郑瑶（13810174402） 左下角「关注账号」，右下角「在看」，防止失联