Exenatide

LIBERATE-1, the first-in-human application of Vivani’s NanoPortalTM implant technology, showed a positive safety and tolerability profile, along with encouraging performance data for NPM-115 that met the study’s primary objectives New NPM-139 (semaglutide implant) preclinical feasibility data showed approximately 20% weight loss maintained longer than 6 months with a single implant, continuing to support the potential for annual dosing Based on these data, Vivani prioritizes the advancement of NPM-139, with clinical development expected to begin in 2026, pending regulatory clearance ALAMEDA, Calif., Aug. 05, 2025 (GLOBE NEWSWIRE) -- Vivani Medical, Inc. (Nasdaq: VANI) (“Vivani” or the “Company”), a clinical-stage, biopharmaceutical company developing miniature, ultra long-acting drug implants, today reported results from the LIBERATE-1 clinical study, the Phase 1 study of the exenatide GLP-1 implant NPM-115 representing the first-in-human test of the Company’s proprietary NanoPortal™ implant technology. The Company also reported new feasibility data for NPM-139 (semaglutide implant) from an ongoing preclinical study, supporting prioritization of the semaglutide implant in the Company’s pipeline and clinical development strategy. Semaglutide is the active ingredient in blockbuster drug products Ozempic®, Wegovy®, and Rybelsus®. Vivani Chief Executive Officer Adam Mendelsohn, Ph.D. stated, “We are very pleased to report that LIBERATE-1, our Phase 1 study in obese and overweight subjects and the first clinical application of NanoPortal technology, achieved its primary objectives. The results support the general safety and tolerability profile of the device and continued development with higher dose configurations, which we expect to produce clinically relevant weight management effects.” “In addition to the LIBERATE-1 results, we are very excited to report new preclinical feasibility data with our semaglutide implant candidate NPM-139, under development for chronic weight management which have shown approximately 20% weight loss with a single administration for over 6 months and continue to show potential for annual dosing. When we couple the successful completion of the LIBERATE-1 study with the new feasibility data for our semaglutide implant, it is an easy decision to focus our resources and prioritize efforts to accelerate NPM-139 into clinical-stage development.” The decision to prioritize NPM-139 is supported by several factors. These include the Company’s belief that the development timelines for the NPM-115 and NPM-139 programs are comparable, the increased confidence in NPM-139 due to the fact that semaglutide products have already established compelling weight loss data in humans, and the strong commercial performance of semaglutide-based products, including Ozempic, Wegovy, and Rybelsus, which have generated over $29B in sales in 2024 and are expected to have continued growth into the foreseeable future. LIBERATE-1 Study Results The LIBERATE-1 Phase 1 study successfully met its primary objectives, which were to evaluate the NPM-115 implant’s safety and tolerability profile and to characterize the pharmacokinetic (PK) profile of the implant over a 9-week duration. Throughout the study, the implant was generally well tolerated, and drug release from the implant without any clinically meaningful burst was supported by PK analysis and by the absence of gastrointestinal adverse events in subjects with the implant. No serious adverse events were observed in the study. The release profile observed from the implants over 9 weeks provides encouragement regarding the potential for this technology to provide durable delivery over the 6-month duration that has already been established in preclinical studies of both NPM-115 and NPM-139. This study paves the way for future clinical development of the implant technology not just for exenatide (NPM-115 and NPM-119) but also for semaglutide (NPM-139) and any other application of NanoPortal technology that Vivani may pursue in the future. Semaglutide Implant Preclinical Feasibility Data In an ongoing preclinical study, substantial progress in the development of a miniature, ultra long-acting, semaglutide implant, NPM-139 has been established by showing weight loss from a single administration for over 231 days. NPM-139 (Semaglutide Implant) Weight difference versus control group in healthy Sprague-Dawley rats. The percentage weight change from baseline for NPM-139 (semaglutide implant) corrected to control (sham implant). Implants from 4 animals were removed on each of Day 21, Day 84, and Day 168 for characterization. Values are mean ± standard error. While the emerging preclinical data on the Company’s semaglutide implant currently supports the initial target profile of bi-annual dosing, the Company continues to anticipate that a semaglutide implant candidate may be able to support annual dosing in the future. Vivani’s near-term efforts are focused on completion of PK optimization activities and preparation of data to enable the submission of an Investigational New Drug application for NPM-139. About Vivani Medical, Inc. Leveraging its proprietary NanoPortal™ platform, Vivani develops biopharmaceutical implants designed to deliver drug molecules steadily over extended periods of time with the goal of guaranteeing adherence and improving patient tolerance to their medication. Vivani’s priority product candidate, NPM-139, is a miniature, six-month, subdermal, GLP-1 (semaglutide) implant under development for chronic weight management in obese or overweight subjects. NPM-139 has the added potential for once-yearly dosing. Vivani’s emerging pipeline also includes NPM-115 (exenatide implant) for chronic weight management in obese and overweight individuals, and NPM-119, an exenatide implant program for the treatment of type-2 diabetes. The Company is also considering another semaglutide implant for the treatment of type 2 diabetes. These NanoPortal implants are designed to provide patients with the opportunity to realize the full potential benefit of their medication by avoiding the numerous challenges associated with the daily or weekly administration of orals and injectables, including tolerability issues and loss of efficacy. Medication non-adherence occurs when patients do not take their medication as prescribed. This affects an alarming number of patients, approximately 50%, including those taking daily pills. Forward-Looking Statements This press release contains certain “forward-looking statements” within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “target,” “believe,” “expect,” “will,” “may,” “anticipate,” “estimate,” “would,” “positioned,” “future,” and other similar expressions that in this press release, including statements regarding Vivani’s business, products in development, including the therapeutic potential thereof, the planned development therefor, the completion of the LIBERATE-1 Phase 1 study and reporting of study results, Vivani’s emerging development plans for NPM-139, NPM-115, NPM-119 or Vivani’s plans with respect its technology, strategy, cash position and financial runway. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on Vivani’s current beliefs, expectations, and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of Vivani’s control. Actual results and outcomes may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results and outcomes to differ materially from those indicated in the forward-looking statements include, among others, risks related to the development and commercialization of Vivani’s products, including NPM-139, NPM-115, and NPM-119; delays and changes in the development of Vivani’s products, including as a result of applicable laws, regulations and guidelines, potential delays in submitting and receiving regulatory clearance or approval to conduct Vivani’s development activities, including Vivani’s ability to commence clinical development of NPM-139; risks related to the initiation, enrollment and conduct of Vivani’s planned clinical studies and the results therefrom; or Vivani’s history of losses and Vivani’s ability to access additional capital or otherwise fund Vivani’s business. There may be additional risks that the Company considers immaterial, or which are unknown. A further list and description of risks and uncertainties can be found in the Company’s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on March 31, 2025, as updated by the Company’s subsequent Quarterly Reports on Form 10-Q. Any forward-looking statement made by Vivani in this press release is based only on information currently available to the Company and speaks only as of the date on which it is made. The Company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of added information, future developments or otherwise, except as required by law. Company Contact:Donald DwyerChief Business Officerinfo@vivani.com(415) 506-8462 Investor Relations Contact:Jami TaylorInvestor Relations Advisorinvestors@vivani.com(415) 506-8462 Media Contact:Mark CorbaeICR HealthcareMark.Corbae@ICRHealthcare.com(203) 682-8288 A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/8a049bc2-9622-4156-b325-dc73a1f1b9d1.

曾被誉为“欧洲市值之王”的诺和诺德，如今正遭遇前所未有的滑铁卢。撰文| Erin7月29日，市值一度“捅破天”的诺和诺德，股价暴跌21%，令一众股民彻夜难眠。如果将时间线拉长，真相更是“扎心”。过去一年，这家一度超越LVMH等消费品大亨、被誉为“欧洲市值最强王者”的制药巨头，市值一路从6350亿美元的巅峰滑落至了2394亿美元，整整蒸发了近4000亿美元。这个曾靠司美格鲁肽缔造“神药神话”的超级玩家，也正被现实按下价值重估键。而GLP-1“双姝”中的另一位——礼来，也应声下跌5.6%，市值一夜间跳水近400亿美元。去年，GLP-1凭借降糖减重“双王牌”、缔造庞大适应证“帝国”的能力，俨然成为资本市场最炙手可热的“黄金赛道”。从二级市场到上游供应链，从MNC巨头到Biotech，无不围绕它构建起“下一个百亿爆款”的商业故事。但一年过去，随着诺和诺德接连曝出临床研发受挫、业绩增长疲软、指引下调等利空信号，GLP-1产业链也迎来情绪逆转。资本正在重新审视：GLP-1还能火多久？增长是否已经触顶？头部玩家的剧烈震荡，是否意味着一个周期的更迭临近？“神药”的光辉，开始闪烁出危险信号。纵览现美股市值TOP50的制药企业，唯剩GLP-1“双姝”，以及深陷“中年危机”的再生元，还在“逆势滑坡”。欧洲市值大王的价值重估时刻仅一年时间，诺和诺德的市值就从超6300多亿美元高峰，跌至如今仅剩三分之一，是自身实力的衰落？还是市场给的预期过于膨胀？一切的起点其实可以追溯回2009年。彼时，礼来凭借全球首个GLP-1药物艾塞那肽率先占据优势，对诺和诺德在全球糖尿病巨头的地位形成了不小的威胁。但很快，诺和诺德以利拉鲁肽反击成功，重夺糖尿病治疗领域的话语权。而后来诺和诺德又再次“自己战胜自己”推出了更长效的司美格鲁肽，被称为“史上最好的糖尿病药物”。司美格鲁肽如同传奇一样的存在，上市首个完整年度（2018年）销售额仅4亿美元，到了2024年就已高达292.96亿美元，年复合增长率达154.6%。要知道，K药自2015年登陆市场，到2024年创下销售高峰，10年时间的年复合增长率也不过53.1%。爆炸性增长的背后，是诺和诺德对GLP-1赛道的重仓：从注射、口服到“超”长效制剂，从控糖、减重延伸至CKD、心血管、抗炎乃至MASH等更多适应证，每一次延展都在持续强化其市场壁垒。2023年，摩根大通更新预测：到2032年，礼来与诺和诺德将共占全球GLP-1类产品近90%的市场份额。市场对司美格鲁肽的未来充满想象，而对诺和诺德的预期也被无限拔高。然而，预期爬得越高，现实落差也将越大。过高的未来预期导致一点风吹草动，表现在诺和诺德的二级市场股票上可能就是一场风暴。2024年上半年，司美格鲁肽销售额达129.6亿美元，同比增速达两位数，表现出超越K药的态势，诺和诺德市值也在此刻冲上6350亿美元历史最高点。但几乎就在同一时间，这家巨头悄然迎来了命运的分界点。内部研发上，适应证拓展、新药开发临床进展开始不及预期；与此同时，外部又给的压力太大了——礼来持续在GIP/GLP-1双靶点药物替尔泊肽和口服药GLP-1药物Orforglipron的临床上屡获突破，两大原因导致诺和诺德市值在过去一年间“跌跌不休”，加上昨天暴跌的21%，如今，诺和诺德市值仅有2394.43亿美元，也就是说，仅仅1年时间就蒸发掉将近4000亿美元。临床进展的“滑铁卢”成为第一根导火索。2024年9月，诺和诺德发布新一代减重产品Monlunabant治疗肥胖与代谢综合征的2a期临床结果，尽管在高剂量组中体重确有下降，但效果远未达到市场预期，股价随即下跌近6%。而真正的重击来自2024年末，被寄予厚望的CagriSema未能达到业界期待的25%减重效果，仅为22.7%。市场情绪骤然转向，当天美股收盘，诺和诺德股价大跌17.82%，市值蒸发625亿美元，创下公司历史最大单日跌幅。风声鹤唳之下，每一个变量都被放大。今年4月，礼来再度发布Orforglipron临床结果，根据市场分析，作为全球首个成功完成III期研究的口服小分子GLP-1药物，Orforglipron的减重效果直逼甚至超越诺和诺德注射剂型Ozempic。诺和诺德股价当天应声下挫超10%。市场也愈发焦虑：司美格鲁肽的“神药”地位还撑多久？接二连三的临床数据不尽人意、竞争者步步紧逼，最终演化为公司层面的震荡。今年5月16日，诺和诺德董事会决定，让CEO周赋德卸任。两个月后，新的CEO上任。同时，公司发布公告，下调全年预期：虽然上半年营收增长18%（按固定汇率计算，下同），利润增长29%，但全年预期大幅下调至营收增长8%-14%，营业利润增长10%-16%，这两组数字在两个月前还是13%-21%和16%-24%。对此，投资者的心态“崩不住”了。一切像是一场连锁反应：临床数据不及预期-股价暴跌-投资者信心动摇-高管更替-增长下调-股价再跌。截至7月29日收盘，诺和诺德市值仅剩2394亿美元，一年时间，蒸发近4000亿美元。 推荐阅读 *美国最大PBM“站队”诺和诺德，礼来大跌10%，GLP-1“双姝”价格战开打！*大变天！2030年全球制药TOP10：礼来登顶，辉瑞“垫底”，BMS、GSK掉队！“霸主”失速，还带崩了谁？有意思的是，在诺和诺德的剧烈下跌带动下，29日收盘时，其竞争对手礼来也应声下跌5.6%。曾几何时，“礼来市值何时突破万亿美元”还是行业争相押注的话题，而如今，这一近在咫尺的梦想显出“镜花水月”之像，其市值也从2024年8月底的超9100亿美元高点，跌至目前的7230亿美元，短短一年蒸发逾1800亿美元。市场对GLP-1“霸主”的热情，似乎正在降温。从整体来看，美股市值TOP50的制药企业在经历了年初的普遍下行后，大多于年中迎来不同程度的修复反弹。无论是经历过内部调整的强生、削减开支的BMS，还是饱受业绩下滑困扰的GSK和福泰制药，即便在研发与业绩方面不及预期，二级市场情绪也在缓慢修复。可以说，全球资本市场对制药行业的整体信心正逐步回暖。唯独GLP-1主线上的两家家企业——诺和诺德、礼来，以及深陷“中年危机”的再生元，仍在“逆势滑坡”。据悉，再生元在过去一年时间中，市值蒸发超700亿美元。而市值跳水的背后其实也是产品青黄不接的困境：曾凭借阿柏西普、度普利尤单抗打造“爆款神话”，如今却7年未能推出新重磅产品，加上2025年Q1仅实现30.29亿美元营收，创下自2023年以来最差单季度表现，更加反映出产品线后继乏力的困境。更具风向标意义的是，诺和诺德的失速已开始向整个GLP-1产业链下游传导。例如，在司美格鲁肽销售高峰期曾大为受益的A股多肽“概念股”们，如诺泰生物、常山药业、圣诺生物等，在今天均出现不同程度下跌，截至收盘，分别下挫0.16%、2.4%、5.27%。资本对GLP-1板块的信心出现明显松动。但值得注意的是，尽管二级市场陷入调整，这些企业的基本面却依然稳健。根据诺泰生物、圣诺生物发布的2025年上半年业绩预告，诺泰预计归母净利润为3亿至3.3亿元，同比增长32.06%-45.27%；圣诺生物则预计归母净利润7702.75万元至9414.48万元，同比大幅增长253.54%-332.1%。无论是订单体量还是利润释放，GLP-1赛道的“红利余温”仍在持续。不过，需要警醒的是，一边是制药巨头业绩指引下调、市值承压，一边是产业链企业仍在兑现红利，矛盾背后，并非单一企业的问题，而是一场由“神药光环”缔造的估值神话，正在遭遇集体重估。诺和诺德的剧烈震荡，或许只是压垮市场情绪的第一根引线，真正被点燃的，是过度乐观、层层加码的GLP-1“神话”本身。过去几年，这条赛道被资本赋予了想象力满满的预期，而如今，现实以业绩数字的形式开始反噬，新的估值逻辑正在重写。从高涨热情下的预期走向冷静，也是将是一个进入新周期的拐点，这个拐点可能开始了。一审| 黄佳二审| 李芳晨三审| 李静芝精彩推荐大事件 | IPO | 融资&交易 | 财报季 | 新产品 | 研发日 | 里程碑 | 行业观察 | 政策解读 | 深度案例 | 大咖履新 | 集采&国谈 | 出海 | 高端访谈 | 技术&赛道 | E企谈 | 新药生命周期 | 市值 | 新药上市 | 商业价值 | 医疗器械 | IND | 周年庆大药企 | 竞争力20强 | 恒瑞 | 石药 | 中生制药 | 齐鲁 | 复星 | 科伦 | 翰森 | 华润 | 国药 | 云南白药 | 天士力 | 华东 | 上药创新药企 | 创新100强 | 百济 | 信达 | 君实 | 复宏汉霖 | 康方 | 和黄 | 荣昌 | 亚盛｜康宁杰瑞｜贝达｜微芯｜再鼎｜亚虹跨国药企｜ＭＮＣ卓越｜辉瑞｜AZ｜诺华｜罗氏｜BMS｜默克｜赛诺菲｜GSK｜武田｜礼来｜诺和诺德｜拜耳供应链｜赛默飞｜药明｜凯莱英｜泰格｜思拓凡｜康龙化成｜博腾｜晶泰｜龙沙｜三星启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 中国医药手册